97. Ulcerative colitis Clinical trials / Disease details
Clinical trials : 2,527 / Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04991324 (ClinicalTrials.gov) | September 2022 | 27/7/2021 | Cholecalciferol Comedication in IBD - the 5C Study | Cholecalciferol Comedication in Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C Study | Inflammatory Bowel Diseases | Drug: Vitamin D3 | University Hospital, Basel, Switzerland | NULL | Not yet recruiting | 18 Years | N/A | All | 150 | Phase 3 | NULL |
| 2 | NCT05218850 (ClinicalTrials.gov) | July 1, 2022 | 20/1/2022 | The Use of Butyrate Therapy in Pediatric Ulcerative Colitis | Butyrate Therapy in Pediatric Ulcerative Colitis | Ulcerative Colitis | Drug: Butyrate | Children's Hospital Los Angeles | NULL | Not yet recruiting | 7 Years | 21 Years | All | 10 | Phase 1 | United States |
| 3 | NCT05242484 (ClinicalTrials.gov) | May 20, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804 | Janssen Research & Development, LLC | NULL | Not yet recruiting | 18 Years | 65 Years | All | 500 | Phase 2 | United States |
| 4 | NCT04314375 (ClinicalTrials.gov) | April 2022 | 17/3/2020 | Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Not yet recruiting | 5 Years | 17 Years | All | 70 | Phase 4 | NULL |
| 5 | NCT05287126 (ClinicalTrials.gov) | April 2022 | 10/3/2022 | A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis | An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod | Arena Pharmaceuticals | NULL | Not yet recruiting | 12 Years | 17 Years | All | 36 | Phase 2 | NULL |
| 6 | EUCTR2021-002537-41-ES (EUCTR) | 08/03/2022 | 09/03/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;Denmark;Netherlands;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 7 | EUCTR2021-002549-13-NO (EUCTR) | 07/03/2022 | 24/11/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 8 | EUCTR2018-002378-30-HU (EUCTR) | 01/03/2022 | 15/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 9 | NCT05176366 (ClinicalTrials.gov) | March 1, 2022 | 17/11/2021 | Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis | A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: ExoFlo | Direct Biologics, LLC | NULL | Not yet recruiting | 18 Years | 75 Years | All | 10 | Phase 1 | NULL |
| 10 | EUCTR2021-002549-13-HR (EUCTR) | 24/02/2022 | 28/02/2022 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 11 | EUCTR2021-004398-30-SI (EUCTR) | 24/02/2022 | 02/02/2022 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 12 | EUCTR2020-000311-71-FR (EUCTR) | 11/02/2022 | 17/09/2021 | Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset | Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Microbiote fécal | AP-HP/DRCD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France | ||
| 13 | NCT05118919 (ClinicalTrials.gov) | February 9, 2022 | 26/10/2021 | A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis | A Randomised Placebo-controlled Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Biological: BGP-014;Biological: Placebo | BioGaia Pharma AB | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 1/Phase 2 | Sweden |
| 14 | NCT05186623 (ClinicalTrials.gov) | February 5, 2022 | 22/12/2021 | Prediction Model for Response to Biologics and Small Molecular Agent for UC | Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data | Ulcerative Colitis | Drug: Vedolizumab, Ustekinumab, or Tofacitinib | Asan Medical Center | NULL | Recruiting | 18 Years | 79 Years | All | 300 | Korea, Republic of | |
| 15 | EUCTR2021-001644-10-HU (EUCTR) | 04/02/2022 | 15/12/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 16 | EUCTR2021-002537-41-BG (EUCTR) | 02/02/2022 | 19/01/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Spain;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 17 | NCT05117749 (ClinicalTrials.gov) | February 2022 | 21/10/2021 | Saffron and Ulcerative Colitis | The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial | Ulcerative Colitis | Drug: Saffron 100;Drug: Saffron 50;Drug: Placebo | Shiraz University of Medical Sciences | NULL | Not yet recruiting | 18 Years | 80 Years | All | 60 | Phase 2 | NULL |
| 18 | NCT04987307 (ClinicalTrials.gov) | January 31, 2022 | 26/7/2021 | Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Efavaleukin alfa;Drug: Placebo | Amgen | NULL | Recruiting | 18 Years | 80 Years | All | 320 | Phase 2 | United States;Austria;Bulgaria;Japan;Korea, Republic of;Poland |
| 19 | EUCTR2021-003050-23-LT (EUCTR) | 25/01/2022 | 11/10/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany | ||
| 20 | NCT04804540 (ClinicalTrials.gov) | January 10, 2022 | 15/3/2021 | A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease | A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn Disease | Drug: Vedolizumab IV | Takeda | NULL | Not yet recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | NULL |
| 21 | EUCTR2021-003050-23-PL (EUCTR) | 02/01/2022 | 29/09/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany | ||
| 22 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 23 | NCT05121402 (ClinicalTrials.gov) | December 30, 2021 | 5/11/2021 | Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis | A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TLL018 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: TLL018;Other: Placebo | Hangzhou Highlightll Pharmaceutical Co., Ltd | TLL Pharmaceutical, LLC | Not yet recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | NULL |
| 24 | JPRN-jRCT1051210145 | 28/12/2021 | 28/12/2021 | Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial | Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial | ulcerative colitis ulcerative colitis;D003093 | Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks | ooi makoto | NULL | Recruiting | >= 18age old | <= 80age old | Both | 150 | Phase 3 | Japan |
| 25 | JPRN-jRCT2011210047 | 22/12/2021 | 29/10/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis - EXPEDITION OLE | Ulcerative Colitis | Completers in the lead-in study will receive a maintenance dose of brazikumab 240 mg administered SC every 4 weeks (Group A). The 240 mg SC dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered. Participants in the lead-in study who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing with 1440 mg of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab 240 mg SC-administered every 4 weeks thereafter (up to Week 52). | Hibi Kazushige | NULL | Pending | >= 18age old | <= 80age old | Both | 21 | Phase 2 | India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan |
| 26 | EUCTR2021-001644-10-IT (EUCTR) | 21/12/2021 | 17/09/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis(EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 27 | EUCTR2021-002537-41-DE (EUCTR) | 15/12/2021 | 13/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 28 | EUCTR2021-004398-30-SK (EUCTR) | 14/12/2021 | 27/10/2021 | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 29 | EUCTR2021-002537-41-NL (EUCTR) | 08/12/2021 | 13/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 30 | EUCTR2021-001280-24-LT (EUCTR) | 07/12/2021 | 19/08/2021 | Study of VE202 in Patients with Ulcerative Colitis | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis | Mild-to-moderate ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VE202 Product Code: VE202 INN or Proposed INN: Not applicable Other descriptive name: JNJ-72537634 | Vedanta Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Czechia;Hungary;Poland;Ukraine;Lithuania;Russian Federation;Netherlands;United States | ||
| 31 | EUCTR2021-002537-41-HU (EUCTR) | 06/12/2021 | 25/10/2021 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active UlcerativeColitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Korea, Democratic People's Republic of;Ukraine;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 32 | NCT05177835 (ClinicalTrials.gov) | December 3, 2021 | 15/12/2021 | Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | A Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 25 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | NULL | Recruiting | 18 Years | N/A | All | 203 | Phase 2 | Belgium;Czechia;Hungary;Poland |
| 33 | EUCTR2021-002549-13-LT (EUCTR) | 02/12/2021 | 06/09/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 34 | EUCTR2021-002549-13-SK (EUCTR) | 02/12/2021 | 24/08/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 35 | EUCTR2021-004398-30-HU (EUCTR) | 01/12/2021 | 08/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 36 | NCT05112263 (ClinicalTrials.gov) | December 1, 2021 | 26/10/2021 | Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis | Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study | Ulcerative Colitis | Drug: Tofacitinib;Drug: Cyclosporine | Postgraduate Institute of Medical Education and Research | All India Institute of Medical Sciences, New Delhi | Not yet recruiting | 18 Years | 65 Years | All | 96 | N/A | NULL |
| 37 | NCT05084261 (ClinicalTrials.gov) | November 30, 2021 | 20/9/2021 | An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: BT051 up to 3200 mg;Drug: Matching Placebo | Bacainn Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 44 | Phase 1 | United States;Georgia;Moldova, Republic of;Poland;Ukraine |
| 38 | EUCTR2021-001644-10-ES (EUCTR) | 30/11/2021 | 12/08/2021 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of | ||
| 39 | NCT05156125 (ClinicalTrials.gov) | November 30, 2021 | 1/12/2021 | VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: VTX002;Drug: Placebo | Oppilan Pharma Ltd | NULL | Recruiting | 18 Years | 80 Years | All | 180 | Phase 2 | United States;Czechia;Georgia;Hungary;Poland;Ukraine |
| 40 | EUCTR2021-004398-30-IT (EUCTR) | 29/11/2021 | 01/10/2021 | Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis. | A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - Long-term safety and efficacy follow-up of ABX464 in Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABX464 Product Code: [ABX464] INN or Proposed INN: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 203 | Phase 2 | Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 41 | NCT04985968 (ClinicalTrials.gov) | November 24, 2021 | 22/7/2021 | The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | Ulcerative Colitis | Drug: Cobitolimod 250 mg;Drug: Cobitolimod 500 mg;Drug: Placebo | InDex Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 440 | Phase 3 | Hungary |
| 42 | EUCTR2021-003050-23-HU (EUCTR) | 22/11/2021 | 01/10/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany | ||
| 43 | EUCTR2018-001605-93-HU (EUCTR) | 22/11/2021 | 05/05/2020 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 44 | EUCTR2021-002549-13-IT (EUCTR) | 22/11/2021 | 19/10/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod | INDEX PHARMACEUTICALS AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 45 | EUCTR2020-001811-26-BE (EUCTR) | 18/11/2021 | 22/07/2021 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Belgium;Netherlands | ||
| 46 | EUCTR2020-004355-33-CZ (EUCTR) | 18/11/2021 | 01/07/2021 | First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MH002 Product Code: MH002 | MRM Health NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 1;Phase 2 | Czech Republic;Belgium | ||
| 47 | EUCTR2021-000091-11-IT (EUCTR) | 08/11/2021 | 02/09/2021 | A study of efficacy of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis - ARTEMIS-UC Study | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 Product Code: [PRA023] Other descriptive name: PRA023 | Prometheus Biosciences Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia;Bulgaria | ||
| 48 | NCT05181137 (ClinicalTrials.gov) | November 5, 2021 | 10/12/2021 | A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: SHR0302;Drug: Placebo | Reistone Biopharma Company Limited | NULL | Recruiting | 18 Years | 75 Years | All | 368 | Phase 3 | United States;China;Georgia;Poland;Ukraine |
| 49 | NCT04855799 (ClinicalTrials.gov) | November 2, 2021 | 20/4/2021 | GI Permeability Change in Response to Aquamin® | Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin® | Ulcerative Colitis;Healthy;Irritable Bowel Syndrome With Diarrhea | Drug: Aquamin | James Varani | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | United States |
| 50 | NCT04276740 (ClinicalTrials.gov) | November 1, 2021 | 12/2/2020 | MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis | Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC | Ulcerative Colitis Flare | Dietary Supplement: MitoQ;Other: Placebo | University of Edinburgh | JP Moulton Charitable Foundation;MitoQ | Not yet recruiting | 18 Years | N/A | All | 206 | Phase 2 | NULL |
| 51 | NCT05088369 (ClinicalTrials.gov) | November 2021 | 12/10/2021 | Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201 | A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults) | Ulcerative Colitis;Crohn's Disease | Drug: HM201;Drug: Placebo | Syneos Health | Himuka AM Pharma Corp. | Not yet recruiting | 18 Years | 55 Years | All | 68 | Early Phase 1 | NULL |
| 52 | NCT05076175 (ClinicalTrials.gov) | October 29, 2021 | 4/10/2021 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy | Colitis, Ulcerative | Drug: Ozanimod | Bristol-Myers Squibb | NULL | Not yet recruiting | 2 Years | 17 Years | All | 120 | Phase 2/Phase 3 | United States;France;Japan |
| 53 | JPRN-jRCT2041200098 | 28/10/2021 | 02/02/2021 | A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | -Ustekinumab Dose Based on BSA and Body Weight As per BSA and body weight Ustekinumab will be administered SC and IV. Induction Period (I):Ustekinumab Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) -Matching Placebo Placebo will be administered subcutaneously. Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) | Nishikawa Kazuko | NULL | Recruiting | >= 2age old | < 18age old | Both | 90 | Phase 3 | United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan |
| 54 | EUCTR2020-004457-76-PL (EUCTR) | 28/10/2021 | 15/09/2021 | A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions. | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED | Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | France;United States;Argentina;Poland;Turkey;Russian Federation;Japan | ||
| 55 | EUCTR2021-003050-23-CZ (EUCTR) | 25/10/2021 | 18/08/2021 | VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic | Oppilan Pharma Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Hungary;Poland;Georgia;Germany | ||
| 56 | NCT04499495 (ClinicalTrials.gov) | October 25, 2021 | 31/7/2020 | Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea | A Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea | Ulcerative Colitis | Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA) | Ferring Pharmaceuticals | NULL | Recruiting | 15 Years | N/A | All | 15000 | Korea, Republic of | |
| 57 | EUCTR2021-002537-41-IT (EUCTR) | 21/10/2021 | 26/01/2022 | Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2, Dose-Finding, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. - - | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: [AMG 592] INN or Proposed INN: EFAVALEUKIN ALFA | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Czechia;Taiwan;Finland;Ukraine;Korea, Democratic People's Republic of;Turkey;Austria;Russian Federation;Switzerland;Italy;Hungary;Mexico;Canada;Argentina;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;Japan;Sweden | ||
| 58 | EUCTR2021-000091-11-CZ (EUCTR) | 20/10/2021 | 22/04/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Georgia | ||
| 59 | EUCTR2021-002549-13-DE (EUCTR) | 20/10/2021 | 28/06/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Norway;New Zealand;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia | ||
| 60 | NCT04779307 (ClinicalTrials.gov) | October 19, 2021 | 1/3/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Drug: Vedolizumab | Takeda | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 3 | United States |
| 61 | JPRN-jRCT2071210030 | 19/10/2021 | 31/05/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm. Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee | Shikamura Mitsuhiro | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan |
| 62 | NCT05061446 (ClinicalTrials.gov) | October 16, 2021 | 20/9/2021 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 20 Years | 80 Years | All | 96 | Phase 2 | Japan |
| 63 | NCT04924114 (ClinicalTrials.gov) | October 14, 2021 | 26/2/2021 | A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002) | A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: MK-6194;Drug: MK-6194-matching placebo | Merck Sharp & Dohme Corp. | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1 | United States;Georgia;Germany;Moldova, Republic of;Ukraine;United Kingdom |
| 64 | EUCTR2020-004300-34-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - NA | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 65 | EUCTR2021-001280-24-HU (EUCTR) | 13/10/2021 | 18/08/2021 | Study of VE202 in Patients with Ulcerative Colitis | Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis | Mild-to-moderate ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VE202 Product Code: VE202 INN or Proposed INN: Not applicable Other descriptive name: JNJ-72537634 | Vedanta Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Czechia;Hungary;Poland;Ukraine;Lithuania;Russian Federation;Netherlands | ||
| 66 | NCT05058417 (ClinicalTrials.gov) | October 1, 2021 | 16/9/2021 | Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis | Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: Empagliflozin 10 MG | Sadat City University | NULL | Recruiting | 18 Years | 60 Years | All | 50 | Phase 2 | Egypt |
| 67 | NCT04999228 (ClinicalTrials.gov) | October 1, 2021 | 5/8/2021 | Top Down Versus Step up in Pediatric Ulcerative Colitis | First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis | Ulcerative Colitis;Infliximab;Children | Drug: Infliximab;Drug: Corticosteroids | Children's Hospital of Fudan University | NULL | Not yet recruiting | 6 Years | 18 Years | All | 40 | Phase 4 | NULL |
| 68 | NCT03843385 (ClinicalTrials.gov) | October 2021 | 14/2/2019 | Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis | Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo | Jena University Hospital | German Federal Ministry of Education and Research | Not yet recruiting | 18 Years | 75 Years | All | 174 | Phase 2/Phase 3 | NULL |
| 69 | NCT04857112 (ClinicalTrials.gov) | September 29, 2021 | 19/4/2021 | Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis | A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 336 | Phase 2 | United States |
| 70 | NCT04767984 (ClinicalTrials.gov) | September 24, 2021 | 23/2/2021 | Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis | A Randomized and Placebo-Controlled Phase II Trial Targeting Dominant-Negative Missense Mutant P53 by Atorvastatin for Reducing the Risk of Longstanding Ulcerative Colitis-Associated Cancer | Colorectal Carcinoma;Ulcerative Colitis | Drug: Atorvastatin Calcium;Procedure: Biospecimen Collection;Drug: Placebo Administration | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | 70 Years | All | 70 | Phase 2 | United States |
| 71 | EUCTR2021-002549-13-HU (EUCTR) | 24/09/2021 | 23/07/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 72 | EUCTR2020-004355-33-BE (EUCTR) | 23/09/2021 | 08/06/2021 | First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MH002 Product Code: MH002 | MRM Health NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 1;Phase 2 | Belgium | ||
| 73 | EUCTR2019-002485-12-IT (EUCTR) | 23/09/2021 | 22/10/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Entyvio Product Code: [NA] Other descriptive name: VEDULIZUMAB Trade Name: Entyvio Product Name: Entyvio Product Code: [NA] Other descriptive name: VEDOLIZUMAB | ALIMENTIV INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | United States;France;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 74 | EUCTR2020-004300-34-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 75 | JPRN-jRCT2051210087 | 17/09/2021 | 22/09/2021 | Safety and pharmacokinetics study in healthy Japanese volunteers | A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers | Ulcerative colitis | Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen. | Owada Yasuko | NULL | Pending | >= 20age old | <= 45age old | Male | 48 | Phase 1 | Japan |
| 76 | EUCTR2020-004461-40-IT (EUCTR) | 15/09/2021 | 18/10/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - | moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: [BMS-986165] INN or Proposed INN: deucravacitinib | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan | ||
| 77 | JPRN-jRCT2011210030 | 14/09/2021 | 30/08/2021 | Phase 2 Dose-finding UC Study | A 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Expedition Lead-in | Ulcerative Colitis, Colitis, Ulcerative, IBD | - Brazikumab low dose: IV brazikumab 720 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Brazikumab high-dose: IV brazikumab 1440 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Placebo: IV placebo at Week 0 (Day 1), Week 2, and Week 6 followed by SC placebo every 4 weeks beginning at Week 10 | Hibi Kazushige | NULL | Recruiting | >= 18age old | <= 80age old | Both | 21 | Phase 2 | India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan |
| 78 | EUCTR2021-000091-11-HU (EUCTR) | 13/09/2021 | 17/04/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Georgia | ||
| 79 | EUCTR2021-001940-86-PL (EUCTR) | 11/09/2021 | 09/08/2021 | A phase 3 Study to Evaluate the Efficacy and Safety of SHR0302 in Ulcerative Colitis. | A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 for Induction, Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHR0302 tablets Product Code: SHR0302 INN or Proposed INN: SHR0302 | Reistone Biopharma Company Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Poland;Ukraine;Georgia;China | ||
| 80 | NCT05030064 (ClinicalTrials.gov) | September 10, 2021 | 9/8/2021 | Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression | Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression | Ulcerative Colitis | Drug: Intestinal flora capsule;Procedure: placebo capsule | Third Military Medical University | NULL | Recruiting | 18 Years | 65 Years | All | 54 | N/A | China |
| 81 | EUCTR2021-002549-13-SE (EUCTR) | 07/09/2021 | 16/06/2021 | A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis | A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD | InDex Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 82 | EUCTR2018-003524-36-NO (EUCTR) | 06/09/2021 | 16/06/2021 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol Trade Name: Remsima Trade Name: Inflectra | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 4 | France;Ireland;Netherlands;Norway;United Kingdom | ||
| 83 | NCT04979832 (ClinicalTrials.gov) | September 6, 2021 | 30/6/2021 | GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery | A Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis Surgery | Pouchitis | Drug: GM-CSF, fosfomycin and metronidazole | Zealand University Hospital | NULL | Recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | Denmark |
| 84 | EUCTR2021-003023-14-SE (EUCTR) | 02/09/2021 | 23/06/2021 | Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis | Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Sweden | ||
| 85 | NCT03935451 (ClinicalTrials.gov) | September 1, 2021 | 23/4/2019 | Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease | A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study | IBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal Disorders | Drug: Apixaban 2.5 milligram;Drug: Placebo Oral Tablet | McMaster University | NULL | Recruiting | 18 Years | N/A | All | 60 | Early Phase 1 | Canada |
| 86 | NCT05019742 (ClinicalTrials.gov) | September 2021 | 13/8/2021 | Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis | A Double-Blind, Placebo-Controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: SPH3127;Drug: Placebo | Shanghai Pharma Biotherapeutics USA Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | United States |
| 87 | JPRN-jRCT2071210052 | 23/08/2021 | 19/08/2021 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy inModerately to Severely Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-WeekDose-Ranging Study to Assess the Efficacy and Safety of Etrasimod inJapanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | Eligible subjects will be randomized (1:1:1ratio) to receive either etrasimod (dose A), etrasimod (dose B), or matching placebo (once daily) in a double-blind fashion for 12 weeks | Tanabe Masakazu | NULL | Recruiting | >= 20age old | <= 80age old | Both | 96 | Phase 2 | Japan |
| 88 | EUCTR2020-004300-34-HR (EUCTR) | 18/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 89 | EUCTR2020-005232-30-SK (EUCTR) | 17/08/2021 | 09/06/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | United States;Serbia;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Georgia;Bulgaria;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 90 | JPRN-jRCT2031210210 | 16/08/2021 | 28/07/2021 | A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease | A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ | Ulcerative Colitis / Crohn's Disease - | Drug: Mirikizumab Administered SC Other Name: LY3074828 | Yoshimoto Yusuke | NULL | Recruiting | Not applicable | Not applicable | Both | 5 | Phase 3 | United States;Japan |
| 91 | EUCTR2021-002211-65-ES (EUCTR) | 13/08/2021 | 11/06/2021 | EFFECT OF TOFACITINIB ON COAGULATION | EFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10009790;Term: Coagulation time;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10061684;Term: Platelet function test;System Organ Class: 10022891 - Investigations;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Tofacitinib INN or Proposed INN: TOFACITINIB | Fundación Española de Gastroenterología | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Spain | ||
| 92 | NCT04624230 (ClinicalTrials.gov) | August 12, 2021 | 26/10/2020 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: tofacitinib | Pfizer | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 3 | United States;Australia;Canada;Israel;Japan;Poland;Spain |
| 93 | JPRN-jRCT2071210075 | 12/08/2021 | 07/10/2021 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: tofacitinib Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID. | Kawai Norisuke | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | Australia;Canada;United States;Japan |
| 94 | EUCTR2020-003420-16-ES (EUCTR) | 11/08/2021 | 23/06/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis. | SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT | Moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Other descriptive name: Amgevita | Instituto Clinico Humanitas | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Belgium;Spain;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 95 | EUCTR2020-004300-34-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 96 | EUCTR2021-000091-11-PL (EUCTR) | 06/08/2021 | 20/05/2021 | A study of PRA023 in patients with Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Czechia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia | ||
| 97 | EUCTR2020-005232-30-DE (EUCTR) | 05/08/2021 | 29/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | United States;Serbia;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;New Zealand;Moldova, Republic of;Japan;Korea, Republic of | ||
| 98 | EUCTR2020-004461-40-DE (EUCTR) | 04/08/2021 | 12/05/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis | moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: BMS-986165 INN or Proposed INN: deucravacitinib Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Germany;Japan;Romania;Poland;Brazil;Belgium;Canada;Mexico;Hungary;United Kingdom;Czechia;Korea, Republic of;China;Netherlands;Denmark;Australia;France;Switzerland;Italy;Israel;Russian Federation;Ireland;Spain;Taiwan;Portugal;United States | ||
| 99 | NCT04933162 (ClinicalTrials.gov) | August 3, 2021 | 15/6/2021 | UC Cohort - The Influence of Diet on Gut Microbiotas | UC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas | Ulcerative Colitis | Dietary Supplement: High Protein and Low Fiber Diet;Dietary Supplement: Low Protein and High Fiber Diet | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 70 | N/A | United States |
| 100 | NCT04898348 (ClinicalTrials.gov) | August 2021 | 13/5/2021 | A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis | A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: Vancomycin Pre-Treatment;Drug: KBL697;Drug: Placebo | KoBioLabs | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | NULL |
| 101 | EUCTR2020-005232-30-EE (EUCTR) | 27/07/2021 | 26/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 102 | NCT04963725 (ClinicalTrials.gov) | July 18, 2021 | 8/7/2021 | A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice | Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes | Ulcerative Colitis | Drug: Ustekinumab | Janssen Pharmaceutical K.K. | NULL | Recruiting | 16 Years | N/A | All | 140 | Japan | |
| 103 | EUCTR2018-002135-19-FR (EUCTR) | 16/07/2021 | 02/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 104 | EUCTR2020-003420-16-BE (EUCTR) | 16/07/2021 | 30/06/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis | SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT | Moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita INN or Proposed INN: Adalimumab 40mg Trade Name: Azathioprine Other descriptive name: AZATHIOPRINE BP | Instituto Clinico Humanitas | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 105 | ChiCTR2100048502 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 106 | NCT04996797 (ClinicalTrials.gov) | July 14, 2021 | 2/8/2021 | A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: PRA023 IV;Device: Companion Diagnostic (CDx) Testing;Other: Placebo | Prometheus Biosciences, Inc. | NULL | Recruiting | 18 Years | N/A | All | 170 | Phase 2 | United States |
| 107 | ChiCTR2100048176 | 2021-07-12 | 2021-07-04 | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | Ulcerative colitis | Experimental group:Xuyan Decoction;Control group:Mesalazine sustained-release granules; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Experimental group:44;Control group:44; | China | |
| 108 | EUCTR2019-004578-25-SE (EUCTR) | 09/07/2021 | 27/12/2019 | A clinical study in patients with mild to moderate ulcerative colitis to test the tolerability of Lactobacillus reuteri BGP-014 | A randomised placebo-controlled safety study of Lactobacillus reuteri BGP-014 in patients with active mild to moderate ulcerative colitis | Mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BGP-014 Capsules Product Code: BGP-014 INN or Proposed INN: Lactobacillus reuteri Other descriptive name: LACTOBACILLUS REUTERI | BioGaia Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 1;Phase 2 | Sweden | ||
| 109 | EUCTR2020-000609-10-DK (EUCTR) | 06/07/2021 | 23/09/2020 | A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patients | A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study | A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch. MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Repomol INN or Proposed INN: Molgramostim Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: Metronidazole Trade Name: Fosfomycin Product Name: Infectofos INN or Proposed INN: Fosfomycin disodium Other descriptive name: FOSFOMYCIN DISODIUM | Center for Surgical Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 1;Phase 2 | Denmark | ||
| 110 | ChiCTR2100046446 | 2021-07-01 | 2021-05-15 | Effect of probiotics supplementation combined with WeChat platform health management on nutritional status, inflammatory factors, and quality of life in patients with mild-to-moderate ulcerative colitis | Effect of probiotics supplementation combined with WeChat platform health management on nutritional status, inflammatory factors, and quality of life in patients with mild-to-moderate ulcerative colitis | ulcerative colitis | experimental group:Bifidobacterium triple live bacteria combined with WeChat platform for health management intervention;control group:Mesalazine Oral; | Affiliated Hospital of Jiangnan University | NULL | Recruiting | 18 | 80 | Both | experimental group:70;control group:70; | N/A | China |
| 111 | NCT04968951 (ClinicalTrials.gov) | July 2021 | 9/7/2021 | Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC) | REFOCUS: Refined Fecal Microbiota Transplantation (FMT) Delivered by Oral Capsules for Induction of Remission in Mild to Moderate Ulcerative Colitis - a Phase I Study | Ulcerative Colitis;FMT;Fecal Microbiota Transplant | Drug: Metronidazole;Drug: Placebo;Drug: Vancomycin;Biological: Fecal Microbiota Transplantation | Ari M Grinspan | NULL | Recruiting | 18 Years | 75 Years | All | 20 | Early Phase 1 | United States |
| 112 | EUCTR2019-003113-34-SK (EUCTR) | 29/06/2021 | 27/04/2021 | Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany | ||
| 113 | EUCTR2020-004300-34-LT (EUCTR) | 25/06/2021 | 21/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 114 | NCT04372108 (ClinicalTrials.gov) | June 24, 2021 | 30/4/2020 | A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis | An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab;Drug: Other Biologic Therapies | Janssen Scientific Affairs, LLC | NULL | Recruiting | 18 Years | N/A | All | 1056 | United States | |
| 115 | EUCTR2020-005232-30-BG (EUCTR) | 22/06/2021 | 02/06/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 116 | EUCTR2020-005232-30-HU (EUCTR) | 21/06/2021 | 23/04/2021 | Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis. | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 Product Name: Amiselimod Product Code: MT-1303 INN or Proposed INN: amiselimod Other descriptive name: MT-1303 | Salix Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 336 | Phase 2 | Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of | ||
| 117 | NCT04738942 (ClinicalTrials.gov) | June 4, 2021 | 2/2/2021 | A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W) | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Recruiting | 18 Years | 80 Years | All | 158 | Phase 3 | Japan |
| 118 | JPRN-jRCT2031200371 | 04/06/2021 | 19/02/2021 | A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcerative Colitis or Crohn's Disease | An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who Experienced Secondary Loss of Response During Maintenance Therapy with Vedolizumab IV Administered Every 8 Weeks (Q8W) | Ulcerative Colitis, Crohn's Disease | Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. | Shikamura Mitsuhiro | NULL | Recruiting | >= 18age old | <= 80age old | Both | 158 | Phase 3 | Japan |
| 119 | EUCTR2020-004300-34-ES (EUCTR) | 02/06/2021 | 01/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 120 | NCT04882683 (ClinicalTrials.gov) | June 1, 2021 | 6/5/2021 | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cells | Shandong Qilu Stem Cells Engineering Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 50 | N/A | China |
| 121 | NCT04617184 (ClinicalTrials.gov) | June 1, 2021 | 2/11/2020 | Registry and Biorepository for IBD in Central Texas | Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas | Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases | Other: NO INTERVENTION | University of Texas at Austin | NULL | Recruiting | 18 Years | 100 Years | All | 1000 | United States | |
| 122 | NCT04919252 (ClinicalTrials.gov) | June 1, 2021 | 6/4/2021 | Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease | Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease | Crohn's Disease and Ulcerative Colitis | Drug: Vedolizumab | Yonsei University | NULL | Not yet recruiting | 19 Years | 70 Years | All | 60 | Phase 3 | Korea, Republic of |
| 123 | EUCTR2020-004300-34-GR (EUCTR) | 01/06/2021 | 29/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 124 | NCT04908644 (ClinicalTrials.gov) | June 2021 | 25/5/2021 | MS-20 on Patients With Ulcerative Colitis(UC) | Study to Evaluate Efficacy and Safety of MS 20 on Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: MS-20 oral solution;Other: Placebo | National Taiwan University Hospital | Microbio Co Ltd | Not yet recruiting | 20 Years | 65 Years | All | 40 | N/A | NULL |
| 125 | EUCTR2018-004002-25-SK (EUCTR) | 28/05/2021 | 13/01/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 126 | EUCTR2018-004002-25-LV (EUCTR) | 27/05/2021 | 02/02/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan;Sweden | ||
| 127 | NCT04844606 (ClinicalTrials.gov) | May 26, 2021 | 12/4/2021 | A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) | A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Crohn's Disease | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 19 Years | All | 185 | Phase 3 | United States;Israel;Japan;Korea, Republic of |
| 128 | EUCTR2020-003017-35-SK (EUCTR) | 26/05/2021 | 28/12/2020 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of | ||
| 129 | NCT04879966 (ClinicalTrials.gov) | May 17, 2021 | 6/5/2021 | A Cohort Study Comparing IFX to CS for Moderate to Severe UC | A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: Infliximab;Drug: Corticosteroid | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 342 | China | |
| 130 | NCT04898530 (ClinicalTrials.gov) | May 15, 2021 | 13/5/2021 | Diet Patterns in IBD in Central Texas | A Cross-sectional Assessment of Diet in Patients With IBD in Central Texas | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Other: NO INTERVENTION | University of Texas at Austin | NULL | Recruiting | 18 Years | N/A | All | 500 | United States | |
| 131 | NCT04877990 (ClinicalTrials.gov) | May 7, 2021 | 4/5/2021 | A Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis | Crohn Disease;Ulcerative Colitis | Drug: BMS-986165 | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States;Australia;Brazil;China;Germany;Hungary;Italy;Japan;Poland;Romania;Russian Federation;United Kingdom |
| 132 | ChiCTR2100046284 | 2021-05-06 | 2021-05-12 | Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis | Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis | ulcerative colitis | Control group:Prednisone+Azathioprine/Adalimumab;Test group:Prednisone+Azathioprine/Adalimumab+umbilical cord blood mononuclear cells; | The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Control group:25;Test group:25; | China | |
| 133 | EUCTR2019-002485-12-PL (EUCTR) | 05/05/2021 | 22/09/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Alimentiv Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | France;United States;Belarus;Canada;Belgium;Poland;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 134 | NCT04862741 (ClinicalTrials.gov) | May 5, 2021 | 10/3/2021 | Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis | A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis | Ulcerative Colitis | Drug: NX-13 250mg IR;Drug: NX-13 500mg IR;Drug: NX-13 500mg MR;Drug: Placebo | Landos Biopharma Inc. | NULL | Active, not recruiting | 18 Years | 65 Years | All | 40 | Phase 1 | United States;Ukraine |
| 135 | NCT04231110 (ClinicalTrials.gov) | May 1, 2021 | 2/1/2020 | Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis | Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal microbiota transplantation | McMaster University | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 4 | Canada |
| 136 | EUCTR2019-002485-12-NL (EUCTR) | 23/04/2021 | 03/08/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Alimentiv Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | France;United States;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 137 | NCT04469062 (ClinicalTrials.gov) | April 20, 2021 | 10/7/2020 | A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SC | Eli Lilly and Company | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 3 | NULL |
| 138 | EUCTR2020-003556-33-PL (EUCTR) | 19/04/2021 | 17/02/2021 | A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis | A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase | Moderate to severe ulcerative colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BBT-401-1S Product Code: BBT-401-1S INN or Proposed INN: None Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate | Bridge Biotherapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Poland;Ukraine;New Zealand;Korea, Republic of | ||
| 139 | NCT04607837 (ClinicalTrials.gov) | April 19, 2021 | 23/10/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 18 Years | 80 Years | All | 162 | Phase 2 | United States;Australia;Belarus;Belgium;Bulgaria;Canada;Czechia;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Portugal;Russian Federation;Spain;Ukraine |
| 140 | EUCTR2020-003017-35-BE (EUCTR) | 15/04/2021 | 05/02/2021 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of | ||
| 141 | EUCTR2020-003507-34-BG (EUCTR) | 02/04/2021 | 10/02/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 142 | NCT04818788 (ClinicalTrials.gov) | April 1, 2021 | 20/3/2021 | Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis | Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy | Ulcerative Colitis | Drug: Biological Drug | Assiut University | NULL | Not yet recruiting | 18 Years | 55 Years | All | 24 | NULL | |
| 143 | NCT04630028 (ClinicalTrials.gov) | March 17, 2021 | 13/11/2020 | A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 90 | Phase 3 | United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom |
| 144 | NCT04613518 (ClinicalTrials.gov) | March 15, 2021 | 28/10/2020 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: BMS-986165 Dose 1;Drug: BMS-986165 Dose 2;Other: Placebo Comparator | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 2 | United States;Australia;Canada;Germany;Netherlands;Poland;Puerto Rico;United Kingdom |
| 145 | EUCTR2020-000047-31-PL (EUCTR) | 13/03/2021 | 15/07/2021 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Moldova, Republic of | ||
| 146 | EUCTR2019-002942-19-DK (EUCTR) | 12/03/2021 | 05/11/2020 | Nordic study of treatment strategy in inflammatory bowel disease | NORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile | Crohn's disease and Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Imurel INN or Proposed INN: Azathioprine Trade Name: Puri-nethol INN or Proposed INN: MERCAPTOPURINE | Region Örebro län | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 147 | EUCTR2019-003334-16-BG (EUCTR) | 11/03/2021 | 02/12/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany | ||
| 148 | EUCTR2016-004676-22-FR (EUCTR) | 09/03/2021 | 26/01/2021 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 149 | EUCTR2020-003017-35-CZ (EUCTR) | 04/03/2021 | 29/12/2020 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;Japan;China;Korea, Republic of | ||
| 150 | EUCTR2019-001653-99-BE (EUCTR) | 26/02/2021 | 26/02/2021 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Portugal;Serbia;United States;Slovakia | ||
| 151 | EUCTR2020-003507-34-PT (EUCTR) | 26/02/2021 | 04/01/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | United States;Portugal;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 152 | EUCTR2019-004224-38-DE (EUCTR) | 25/02/2021 | 20/10/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 153 | EUCTR2020-002833-13-PL (EUCTR) | 24/02/2021 | 19/11/2020 | A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Georgia;Netherlands | ||
| 154 | EUCTR2016-004677-40-FR (EUCTR) | 23/02/2021 | 24/12/2020 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 155 | NCT04691232 (ClinicalTrials.gov) | February 22, 2021 | 7/12/2020 | Autologous Ex Vivo Expanded Regulatory T Cells in Ulcerative Colitis | Phase I, Open-label, Fast-track Dose-escalation Clinical Trial Exploring the Safety and the Tolerability of Autologous ex Vivo Expanded Regulatory T Cells in Adults With Ulcerative Colitis | Ulcerative Colitis;Autoimmune Diseases | Biological: Regulatory T cells | University of Erlangen-Nürnberg Medical School | NULL | Recruiting | 18 Years | 18 Years | All | 10 | Phase 1 | Germany |
| 156 | EUCTR2020-003017-35-HU (EUCTR) | 17/02/2021 | 29/12/2020 | A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC) | An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of | ||
| 157 | EUCTR2020-000047-31-DE (EUCTR) | 11/02/2021 | 17/08/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 158 | EUCTR2020-003507-34-HU (EUCTR) | 11/02/2021 | 29/12/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;Korea, Republic of | ||
| 159 | EUCTR2019-004878-26-NL (EUCTR) | 10/02/2021 | 20/10/2020 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Australia;Germany;Netherlands;United Kingdom | ||
| 160 | EUCTR2020-003507-34-IT (EUCTR) | 09/02/2021 | 30/08/2021 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | Portugal;United States;Czechia;Spain;Israel;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 161 | EUCTR2020-003006-31-IT (EUCTR) | 08/02/2021 | 02/08/2021 | Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis | Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis - ASPIRE | Ulcerative colitis and concomitant peripheral arthritis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOFACINITIB Product Code: [TOFACINITIB] INN or Proposed INN: TOFACINITIB | FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Italy | ||
| 162 | NCT04750135 (ClinicalTrials.gov) | February 7, 2021 | 7/2/2021 | Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis | Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: metformin 500 mg TID Oral Tablet;Drug: Placebo | National Hepatology & Tropical Medicine Research Institute | NULL | Not yet recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | Egypt |
| 163 | EUCTR2020-002833-13-NL (EUCTR) | 05/02/2021 | 29/10/2020 | A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Poland;Ukraine;Georgia;Netherlands | ||
| 164 | EUCTR2020-003507-34-FR (EUCTR) | 02/02/2021 | 16/12/2020 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 2 | United States;Portugal;Czechia;Spain;Russian Federation;Israel;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 165 | JPRN-UMIN000043165 | 2021/02/01 | 31/01/2021 | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Crohn's disease, Ulcerative colitis, IBDU | witching from originator infliximab to infliximab biosimilar CT-P13 | Fukuoka University Chikushi Hospital | NULL | Pending | Not applicable | Not applicable | Male and Female | 220 | Not selected | Japan |
| 166 | EUCTR2019-001653-99-LT (EUCTR) | 01/02/2021 | 23/09/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland | ||
| 167 | EUCTR2020-003420-16-IT (EUCTR) | 29/01/2021 | 02/08/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis. | SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.” - SPRINT | Moderate to severe ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita Product Name: Adalimumab Product Code: [n.d.] INN or Proposed INN: ADALIMUMAB Product Name: Azatioprina Product Code: [n.d.] INN or Proposed INN: AZATIOPRINA Product Name: Prednisone Product Code: [n.d.] INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 168 | JPRN-jRCT1031200329 | 28/01/2021 | 28/01/2021 | UC Bio Study | Open-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness | Ulcerative colitis Biologics;D003093 | Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks. Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy. Body weight dose 55kg or less 260mg 55-85kg 390mg 85kg or more 520mg After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks. | Naganuma Makoto | NULL | Recruiting | >= 16age old | Not applicable | Both | 231 | N/A | Japan |
| 169 | EUCTR2019-001653-99-LV (EUCTR) | 18/01/2021 | 26/10/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 170 | JPRN-jRCT2071200081 | 12/01/2021 | 13/01/2021 | ELEVATE UC OLE: An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant s country, whichever comes first | IQVIA Services Japan K.K. ICCC: | NULL | Not Recruiting | >= 16age old | <= 80age old | Both | 35 | Phase 3 | Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Croatia;Czech Republic;Denmark;Egypt;Estonia;France;Germany;Hungary;India;Israel;Italy;Korea;Lebanon;Mexico;Moldova;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Japan |
| 171 | EUCTR2020-002306-12-PL (EUCTR) | 12/01/2021 | 08/09/2020 | GB004 in adult subjects with active ulcerative colitis | A Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate GB004 in adult subjects with mild-to-moderate active ulcerative colitis | Mild-to-moderate active ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GB004 INN or Proposed INN: Not applicable Other descriptive name: GB004-HCl Product Code: GB004 INN or Proposed INN: Not applicable Other descriptive name: GB004-HCl | GB004, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Poland;Ukraine;Romania;Australia;Russian Federation;Georgia;Italy;Moldova, Republic of;Korea, Republic of | ||
| 172 | EUCTR2019-001653-99-DE (EUCTR) | 08/01/2021 | 05/10/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 173 | EUCTR2019-004878-26-DE (EUCTR) | 05/01/2021 | 24/08/2020 | A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: TYK2 Inhibitor Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Australia;Netherlands;Germany;United Kingdom | ||
| 174 | EUCTR2019-004224-38-HU (EUCTR) | 30/12/2020 | 22/10/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 175 | JPRN-jRCT2071200080 | 25/12/2020 | 13/01/2021 | ELEVATE UC 40 JAPAN: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Japanese Subjects | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis | The investigational drug and the placebo are an oral tablet. The investigational drug is APD334 (etrasimod). | IQVIA Services Japan K.K. ICCC: | NULL | Not Recruiting | >= 16age old | <= 80age old | Both | 35 | Phase 3 | Japan |
| 176 | NCT04706793 (ClinicalTrials.gov) | December 25, 2020 | 11/1/2021 | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Active, not recruiting | 16 Years | 80 Years | All | 42 | Phase 3 | Japan |
| 177 | NCT04721873 (ClinicalTrials.gov) | December 18, 2020 | 19/1/2021 | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients | Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients: A Phase 2A, Randomized, Placebo-Controlled Trial | Colitis, Ulcerative;Obesity | Drug: Phentermine-Topiramate;Drug: Placebo | University of California, San Diego | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | United States |
| 178 | NCT04749576 (ClinicalTrials.gov) | December 15, 2020 | 9/12/2020 | Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Efficacy of Nutritional Saffron Supplement As An Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: saffron supplement for IBD | Howard University | NULL | Recruiting | 18 Years | 80 Years | All | 100 | N/A | United States |
| 179 | EUCTR2020-001398-59-BE (EUCTR) | 15/12/2020 | 13/10/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Serbia;Belarus;Hungary;Poland;Belgium;Ukraine;Lithuania;Croatia;Russian Federation;Georgia;Bulgaria;Latvia | ||
| 180 | NCT04424303 (ClinicalTrials.gov) | December 7, 2020 | 8/6/2020 | Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis | Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study | Ulcerative Colitis | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 280 | France | |
| 181 | NCT03414788 (ClinicalTrials.gov) | December 7, 2020 | 8/1/2018 | Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease | PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS | Inflammatory Bowel Disease | Biological: PF 06687234;Biological: [124I]IB PF 06687234 | Pfizer | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 182 | EUCTR2020-001398-59-HR (EUCTR) | 02/12/2020 | 07/12/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 183 | EUCTR2019-001653-99-FR (EUCTR) | 26/11/2020 | 12/10/2020 | A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Malaysia;Denmark;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 184 | EUCTR2020-000047-31-BG (EUCTR) | 25/11/2020 | 08/10/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of | ||
| 185 | EUCTR2019-002698-74-GB (EUCTR) | 17/11/2020 | 30/03/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 186 | NCT04312113 (ClinicalTrials.gov) | November 16, 2020 | 14/3/2020 | Angiographic Delivery of AD-MSC for Ulcerative Colitis | A Phase I Single Site Open Label Study of Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis | Ulcerative Colitis | Drug: Adipose derived, autologous mesenchymal stem cells | Mayo Clinic | NULL | Recruiting | 18 Years | 65 Years | All | 20 | Phase 1 | United States |
| 187 | NCT04331639 (ClinicalTrials.gov) | November 1, 2020 | 23/3/2020 | High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy | Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab | Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency | Dietary Supplement: vitamin D3 | Boston Children's Hospital | NULL | Recruiting | 5 Years | 25 Years | All | 50 | Phase 2 | United States |
| 188 | ChiCTR2000039161 | 2020-10-30 | 2020-10-20 | Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial | A systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility | Ulcerative colitis | control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema; | Chengdu University of Traditional Chinese Medicine | NULL | Recruiting | 20 | 45 | Female | control group:118;experimental group:118; | China | |
| 189 | EUCTR2020-004391-18-FR (EUCTR) | 28/10/2020 | 14/09/2020 | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ | CHU Amiens-Picardie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | France | ||
| 190 | EUCTR2018-005086-39-BG (EUCTR) | 27/10/2020 | 25/06/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 191 | NCT04556383 (ClinicalTrials.gov) | October 19, 2020 | 15/9/2020 | A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: GB004;Drug: Placebo | GB004, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 195 | Phase 2 | United States;Georgia;Korea, Republic of;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Ukraine;Australia |
| 192 | ChiCTR2000038888 | 2020-10-19 | 2020-10-09 | Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial | A systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility | Ulcerative colitis | control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema; | Chengdu University of Traditional Chinese Medicine | NULL | Recruiting | 20 | 45 | Female | control group:118;experimental group:118; | China | |
| 193 | EUCTR2020-002695-12-NL (EUCTR) | 14/10/2020 | 02/09/2020 | Treatment of refractory pouchitis with tofacitinib | Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis | Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz 5mg film-coated tablets | Amsterdam UMC, location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Netherlands | ||
| 194 | EUCTR2020-001398-59-BG (EUCTR) | 13/10/2020 | 18/09/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;South Africa;Latvia | ||
| 195 | EUCTR2020-000047-31-FR (EUCTR) | 07/10/2020 | 13/05/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of | ||
| 196 | NCT04577794 (ClinicalTrials.gov) | October 5, 2020 | 30/9/2020 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: GLPG3970;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 64 Years | All | 31 | Phase 2 | Georgia;Moldova, Republic of;Poland;Ukraine |
| 197 | NCT04882007 (ClinicalTrials.gov) | October 2, 2020 | 13/4/2021 | Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis | Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s) | Ulcerative Colitis | Drug: OSE-127;Drug: Placebo | OSE Immunotherapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | Belarus;Belgium;Bulgaria;Croatia;Georgia;Hungary;Latvia;Poland;Russian Federation;South Africa;Ukraine |
| 198 | ChiCTR2000037261 | 2020-10-01 | 2020-08-27 | Study on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironment | Study on the clinic of stasis removing and renewal therapy for ulcerative colitis based on serum exosome miRNA to regulate the immune microenvironment | Ulcerative Colitis | experimental group:stasis removing and immunoregulation therapy;control group:mesalamine; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai | NULL | Recruiting | 18 | 65 | Both | experimental group:30;control group:30; | China | |
| 199 | NCT04535882 (ClinicalTrials.gov) | October 1, 2020 | 28/8/2020 | Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD | Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis | LRG Levels | Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels | Showa Inan General Hospital | NULL | Recruiting | N/A | N/A | All | 125 | Japan | |
| 200 | JPRN-UMIN000041972 | 2020/10/01 | 01/10/2020 | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. | Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. - BS-UC-2020 | ulcerative colitis | Broccoli Sprouts (20 g/day, 8 weeks) Alfalfa Sprouts (20 g/day, 8 weeks) | University of Tsukuba | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 201 | NCT04225819 (ClinicalTrials.gov) | October 1, 2020 | 3/1/2020 | Adjunctive Treatment With Vitamin D3 in Patients With Active IBD | Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial | IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency | Dietary Supplement: Vitamin D3;Other: Placebo | Massachusetts General Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | United States |
| 202 | ChiCTR2000036950 | 2020-10-01 | 2020-08-25 | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Uicerative colitis | Jianpi Huashi Decoction Group:Jianpi Huashi Decoction;Mesalazine Group:Mesalazine; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM | NULL | Recruiting | Both | Jianpi Huashi Decoction Group:45;Mesalazine Group:45; | China | |||
| 203 | ChiCTR2000035497 | 2020-10-01 | 2020-08-13 | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Experimental group:Qingyusan;Control group:Mesalazine; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | Both | Experimental group:40;Control group:40; | China | |||
| 204 | ChiCTR2000037220 | 2020-10-01 | 2020-08-27 | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Traditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Recruiting | Both | Traditional Chinese medicine group:40;Western medicine group:40; | China | |||
| 205 | EUCTR2020-001811-26-NL (EUCTR) | 30/09/2020 | 08/07/2020 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Netherlands | ||
| 206 | EUCTR2020-001398-59-LV (EUCTR) | 21/09/2020 | 28/07/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 207 | NCT04223518 (ClinicalTrials.gov) | September 20, 2020 | 6/1/2020 | Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD) | Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo | Monisha Hitesh Shah | NULL | Recruiting | 6 Years | 30 Years | All | 43 | Early Phase 1 | United States |
| 208 | NCT04353791 (ClinicalTrials.gov) | September 16, 2020 | 24/3/2020 | Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis | A Phase Ib/IIa, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Treatment With OST-122 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe | Drug: OST-122;Drug: Placebo | Oncostellae S.L | NULL | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1/Phase 2 | Spain |
| 209 | NCT03996369 (ClinicalTrials.gov) | September 15, 2020 | 21/6/2019 | Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 16 Years | 80 Years | All | 354 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Thailand;Turkey;Ukraine;United Kingdom |
| 210 | NCT04373473 (ClinicalTrials.gov) | September 14, 2020 | 28/4/2020 | Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis | A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis | Adults With Ulcerative Colitis | Drug: PRIM-DJ2727;Drug: Placebos | The University of Texas Health Science Center, Houston | NULL | Recruiting | 18 Years | N/A | All | 58 | Phase 2 | United States |
| 211 | NCT04338204 (ClinicalTrials.gov) | September 14, 2020 | 4/4/2020 | Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden | Observational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN) | Ulcerative Colitis | Drug: tofacitinib | Pfizer | NULL | Recruiting | 18 Years | 99 Years | All | 120 | Sweden | |
| 212 | EUCTR2020-000659-11-PL (EUCTR) | 10/09/2020 | 23/07/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with ulcerative colitis | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Georgia;Moldova, Republic of | ||
| 213 | EUCTR2020-000047-31-HU (EUCTR) | 09/09/2020 | 07/07/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 214 | EUCTR2019-002698-74-DE (EUCTR) | 08/09/2020 | 21/02/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 215 | NCT04205643 (ClinicalTrials.gov) | September 2, 2020 | 18/12/2019 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: CT-P13 SC (Infliximab);Other: Placebo SC | Celltrion | NULL | Active, not recruiting | 18 Years | 75 Years | All | 548 | Phase 3 | Poland |
| 216 | ChiCTR2000032498 | 2020-09-01 | 2020-04-30 | Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis: a randomized double-blind controlled trial | Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis | Ulcerative colitis | Experimental group:Probiotics and prebiotics;placebo group:maltodextrin; | Capital Medical University | NULL | Pending | Both | Experimental group:15;placebo group:15; | China | |||
| 217 | JPRN-jRCTs031200103 | 01/09/2020 | 01/09/2020 | Alginate combined fecal microbiota transplantation for ulcerative colitis | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | Ulcerative colitis Ulcerative colitis | A-FMT plus algin acid therapy arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take algin acid two times a day every single day. A-FMT plus placebo arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take Placebo two times a day every single day. | Ishikawa Dai | NULL | Recruiting | >= 20age old | Not applicable | Both | 60 | N/A | Japan |
| 218 | NCT04348890 (ClinicalTrials.gov) | September 1, 2020 | 13/4/2020 | Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis | A Phase I/II Open-Label, Proof-of-Concept Study of Vamorolone in Children and Adolescents With Mild-Moderately Active Ulcerative Colitis | Pediatric Ulcerative Colitis | Drug: Vamorolone 4% suspension for oral dosing | ReveraGen BioPharma, Inc. | NULL | Withdrawn | 4 Years | 17 Years | All | 0 | Phase 1/Phase 2 | NULL |
| 219 | NCT04521205 (ClinicalTrials.gov) | September 2020 | 18/8/2020 | A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Inflammatory Bowel Disease, Ulcerative Colitis Type | Drug: fecal microbiota capsule | Zhongshan Hospital Xiamen University | NULL | Recruiting | 18 Years | 65 Years | All | 200 | Phase 1 | China |
| 220 | EUCTR2019-004652-11-SI (EUCTR) | 28/08/2020 | 31/08/2020 | A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis | RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: RO5490261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany | ||
| 221 | NCT04583358 (ClinicalTrials.gov) | August 26, 2020 | 16/9/2020 | Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD) | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD) | Ulcerative Colitis | Drug: AMT-101 (oral);Other: Placebo (oral) | Applied Molecular Transport | NULL | Recruiting | 18 Years | 80 Years | All | 102 | Phase 2 | United States;Bulgaria;Canada;France;Georgia;Germany;Hungary;Moldova, Republic of;Poland;Russian Federation;Switzerland;Ukraine;United Kingdom |
| 222 | EUCTR2018-000930-37-HU (EUCTR) | 17/08/2020 | 24/06/2020 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 223 | EUCTR2019-003999-39-NO (EUCTR) | 17/08/2020 | 29/04/2020 | A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06826647 Product Code: PF-06826647 INN or Proposed INN: PF-06826647 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 2 | United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway | ||
| 224 | JPRN-UMIN000042017 | 2020/08/13 | 05/10/2020 | Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis | Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis - Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis | Ulcerative colitis | hydrogen gas 8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation placebo gas 8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation | Juntendo University Hospital | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 225 | EUCTR2019-004469-41-DE (EUCTR) | 11/08/2020 | 26/03/2020 | A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943 | Protagonist Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 169 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of | ||
| 226 | EUCTR2019-004469-41-BG (EUCTR) | 11/08/2020 | 27/04/2020 | A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943 | Protagonist Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 169 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of | ||
| 227 | NCT04504383 (ClinicalTrials.gov) | August 5, 2020 | 5/8/2020 | PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe | Drug: PN-943;Drug: Placebo | Protagonist Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | United States;Austria;Bulgaria;Canada;Georgia;Germany;Hungary;Italy;Korea, Republic of;Poland;Russian Federation;Serbia;Ukraine |
| 228 | EUCTR2019-004208-37-BE (EUCTR) | 03/08/2020 | 04/03/2020 | Statins for treating ulcerative colitis through GI microbiome | Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy | There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Rosuvastatine EG Product Name: rosuvastatin INN or Proposed INN: rosuvastatin Other descriptive name: ROSUVASTATIN CALCIUM | UZ Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Belgium | ||
| 229 | EUCTR2020-000047-31-GB (EUCTR) | 03/08/2020 | 20/04/2020 | A study of AMT-101 in patients with Ulcerative Colitis. | A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 | Applied Molecular Transport Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 230 | ChiCTR2000035099 | 2020-08-01 | 2020-07-31 | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Uicerative colitis | ulcerative colitis damp-heat syndrome group:nil;ulcerative colitis qi deficiency syndrome group:nil;healthy control group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;damp-heat syndrome control group:Mesalazine;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;qi deficiency syndrome control group:Mesalazine; | Jiangsu Province Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | ulcerative colitis damp-heat syndrome group:30;ulcerative colitis qi deficiency syndrome group:30;healthy control group:30;damp-heat syndrome treatment group:60;damp-heat syndrome control group:30;qi deficiency syndrome treatment group:60;qi deficiency s | China | |
| 231 | EUCTR2019-003596-19-DE (EUCTR) | 29/07/2020 | 29/07/2020 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India | ||
| 232 | EUCTR2019-004469-41-AT (EUCTR) | 27/07/2020 | 26/03/2020 | A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943 | Protagonist Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of | ||
| 233 | NCT03920254 (ClinicalTrials.gov) | July 23, 2020 | 28/3/2019 | TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC) | Ulcerative Colitis (UC) | Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C | Theravance Biopharma | NULL | Terminated | 18 Years | N/A | All | 46 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine |
| 234 | EUCTR2019-002485-12-GB (EUCTR) | 14/07/2020 | 30/03/2020 | Determination of the Optimal Treatment Target in Ulcerative Colitis | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Alimentiv Inc. (formerly Robarts Clinical Trials) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 660 | Phase 4 | France;Belarus;United States;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 235 | NCT04458805 (ClinicalTrials.gov) | July 10, 2020 | 16/6/2020 | Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers | A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers | Ulcerative Colitis | Drug: NX-13 250 mg;Drug: Placebo | Landos Biopharma Inc. | NULL | Completed | 18 Years | 64 Years | All | 56 | Phase 1 | Australia |
| 236 | EUCTR2018-004002-25-NL (EUCTR) | 06/07/2020 | 17/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 237 | EUCTR2018-004694-27-FR (EUCTR) | 06/07/2020 | 10/04/2020 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Poland;Australia;Germany;Japan;Korea, Republic of;United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium | ||
| 238 | EUCTR2018-003986-33-PT (EUCTR) | 06/07/2020 | 28/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Thailand;Spain | ||
| 239 | EUCTR2017-004092-31-AT (EUCTR) | 02/07/2020 | 20/09/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 240 | EUCTR2019-004469-41-IT (EUCTR) | 02/07/2020 | 15/06/2021 | A trial to investigate the safety and efficacy of PN-943 in patients withmoderate or severe Ulcerative Colitis (a long-term condition where thecolon and rectum become inflamed) | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis - PN-943-03 | Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PN-943 Product Code: [PN-943] INN or Proposed INN: ACETATO DI AMMONIO Other descriptive name: PN-943 Product Name: PN-943 Product Code: [PN-943] INN or Proposed INN: ACETATO DI AMMONIO | Protagonist Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 241 | ChiCTR2000033953 | 2020-07-01 | 2020-06-18 | Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) | Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) | Ulcerative colitis | Placebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059; | Jiangnan University | NULL | Pending | Both | Placebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20; | China | |||
| 242 | NCT04360343 (ClinicalTrials.gov) | July 1, 2020 | 6/4/2020 | Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects | A Randomized, Open-label, Single Dose, 2-period, 2-sequence, 2-treatment, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects | Ulcerative Colitis | Drug: Film-coated tablet | LG Chem | NULL | Completed | 19 Years | 45 Years | All | 18 | Phase 1 | Korea, Republic of |
| 243 | NCT04457960 (ClinicalTrials.gov) | July 1, 2020 | 1/7/2020 | A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433 | Healthy;Colitis, Ulcerative | Drug: JNJ-66525433;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 60 Years | All | 140 | Phase 1 | Georgia;Germany;Moldova, Republic of |
| 244 | NCT04209556 (ClinicalTrials.gov) | June 30, 2020 | 1/12/2019 | A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis | A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD | Pfizer | NULL | Recruiting | 18 Years | 75 Years | All | 202 | Phase 2 | United States |
| 245 | EUCTR2019-003596-19-IT (EUCTR) | 26/06/2020 | 17/06/2021 | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. - CESSA | Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 90 mg idrocortisone acetato in supposta con applicatore per supposte Sephure Product Code: [90 mg idrocortisone acetato in supposta con appli INN or Proposed INN: IDROCORTISONE ACETATO | Cristcot HCA LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 618 | Phase 3 | United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Russian Federation;Germany;Italy;India | ||
| 246 | EUCTR2019-003334-16-DE (EUCTR) | 26/06/2020 | 05/05/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany | ||
| 247 | EUCTR2019-001430-33-DE (EUCTR) | 18/06/2020 | 25/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Canada;Belgium;Poland;Australia;Germany;United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic | ||
| 248 | NCT04188990 (ClinicalTrials.gov) | June 15, 2020 | 2/12/2019 | Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition | Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition | Pancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal Cancer | Dietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current care | Hospital Galdakao-Usansolo | NULL | Active, not recruiting | 18 Years | N/A | All | 900 | N/A | Spain |
| 249 | EUCTR2018-003987-29-FR (EUCTR) | 11/06/2020 | 12/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Ukraine;Spain;Thailand;Slovakia;Estonia;Taiwan;Belarus;Portugal;Serbia;United States;Bulgaria;Georgia;Germany;Japan | ||
| 250 | EUCTR2019-003849-15-HR (EUCTR) | 05/06/2020 | 20/11/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 251 | EUCTR2019-002698-74-BE (EUCTR) | 03/06/2020 | 02/04/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 252 | NCT04259060 (ClinicalTrials.gov) | June 2020 | 27/1/2020 | Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis Research | Hydroxocobalamin Approach to Reduction of Nitrite With Butyrate for Ulcerative Colitis | Ulcerative Colitis | Drug: Hydroxocobalamin with Butyrate;Drug: Placebo with Butyrate | Joshua Korzenik | NULL | Not yet recruiting | 18 Years | 75 Years | All | 42 | Phase 2 | United States |
| 253 | EUCTR2019-003849-15-CZ (EUCTR) | 28/05/2020 | 16/03/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Belarus;Serbia;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of | ||
| 254 | JPRN-JapicCTI-194980 | 22/5/2020 | 30/09/2019 | A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC. | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 1000 | Phase 2-3 | Japan, Asia except Japan, North America, Europe | |
| 255 | EUCTR2019-002698-74-IT (EUCTR) | 20/05/2020 | 15/06/2021 | A study to evaluate the efficacy and safety of PF-06480605 in adult participants with moderate to severe ulcerative colitis. | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS. - TUSCANY 2 | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY IN ADULT WITH MODERATE TO SEVERE ULCERATIVE COLITIS. MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: [PF-06480605] INN or Proposed INN: PF-06480605 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;China;Japan | ||
| 256 | EUCTR2018-001605-93-DE (EUCTR) | 20/05/2020 | 04/06/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 257 | EUCTR2019-002698-74-FR (EUCTR) | 20/05/2020 | 24/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China | ||
| 258 | EUCTR2019-001430-33-PL (EUCTR) | 20/05/2020 | 28/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany | ||
| 259 | NCT04004611 (ClinicalTrials.gov) | May 18, 2020 | 29/6/2019 | A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) | Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 17 Years | All | 30 | Phase 2 | United States;Canada;Israel;Japan;Korea, Republic of |
| 260 | EUCTR2019-001430-33-AT (EUCTR) | 15/05/2020 | 31/01/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany | ||
| 261 | EUCTR2019-000733-39-FR (EUCTR) | 14/05/2020 | 20/02/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 262 | EUCTR2018-004002-25-BG (EUCTR) | 13/05/2020 | 24/02/2020 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 263 | EUCTR2019-003849-15-ES (EUCTR) | 12/05/2020 | 28/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 264 | EUCTR2019-001430-33-GB (EUCTR) | 05/05/2020 | 21/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 INN or Proposed INN: to be confirmed Product Code: GS-4875 INN or Proposed INN: to be confirmed | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Australia;Germany | ||
| 265 | EUCTR2019-001430-33-IT (EUCTR) | 05/05/2020 | 27/01/2021 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis - FALCON | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GS-4875 Product Code: [GS-4875] Product Name: GS-4875 Product Code: [GS-4875] | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany | ||
| 266 | EUCTR2019-003780-21-NL (EUCTR) | 04/05/2020 | 21/02/2020 | Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) | Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Janus kinase Inhibitor INN or Proposed INN: Janus kinase Inhibitor | Alimentiv Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | United States;Canada;Spain;Belgium;Netherlands;Italy | ||
| 267 | EUCTR2019-003113-34-NO (EUCTR) | 04/05/2020 | 21/01/2020 | Ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Russian Federation;Bulgaria;Germany;Norway | ||
| 268 | NCT04156984 (ClinicalTrials.gov) | May 2020 | 24/10/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens | Ulcerative Colitis | Drug: Golimumab Prefilled Syringe | David Drobne | NULL | Not yet recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | Slovenia |
| 269 | ChiCTR2000028767 | 2020-04-27 | 2020-01-03 | A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis | A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis | ulcerative colitis | Experimental group:Oseltamivir and mesalazine;Control group:mesalazine; | Xiangya Hospital of Central South University | NULL | Recruiting | 18 | 75 | Both | Experimental group:53;Control group:53; | N/A | China |
| 270 | EUCTR2018-003278-28-BG (EUCTR) | 22/04/2020 | 23/05/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of | ||
| 271 | EUCTR2019-000733-39-GB (EUCTR) | 16/04/2020 | 31/01/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 272 | EUCTR2019-003849-15-IT (EUCTR) | 15/04/2020 | 17/06/2021 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis - NA | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima (CT-P13) Product Code: [Remsima (CT-P13)] INN or Proposed INN: INFLIXIMAB Product Name: CT-P13 Product Code: [CT-p13] INN or Proposed INN: INFLIXIMAB | CELLTRION INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 273 | EUCTR2019-002698-74-HU (EUCTR) | 15/04/2020 | 20/04/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China | ||
| 274 | EUCTR2018-003987-29-AT (EUCTR) | 15/04/2020 | 09/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 275 | EUCTR2018-003986-33-AT (EUCTR) | 07/04/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 276 | EUCTR2018-004002-25-DE (EUCTR) | 07/04/2020 | 23/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 277 | EUCTR2017-003703-22-BG (EUCTR) | 07/04/2020 | 06/02/2020 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina | ||
| 278 | EUCTR2019-003849-15-GR (EUCTR) | 03/04/2020 | 02/04/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 279 | EUCTR2019-003849-15-BG (EUCTR) | 03/04/2020 | 07/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Latvia;Moldova, Republic of | ||
| 280 | EUCTR2019-003849-15-FR (EUCTR) | 03/04/2020 | 03/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 281 | EUCTR2019-001430-33-FR (EUCTR) | 02/04/2020 | 20/02/2020 | A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-4875 Product Code: GS-4875 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany | ||
| 282 | NCT03980405 (ClinicalTrials.gov) | April 1, 2020 | 5/6/2019 | Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis | Combination Therapy With Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative Colitis: A Single Blinded, International Randomized Controlled Trial | Ulcerative Colitis | Dietary Supplement: Group 1- Control Diet;Dietary Supplement: Group 2- UCD Diet | Prof. Arie Levine | NULL | Recruiting | 10 Years | 19 Years | All | 62 | N/A | Israel |
| 283 | NCT04332328 (ClinicalTrials.gov) | April 1, 2020 | 31/3/2020 | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt | Diet in Ulcerative Colitis Patients | Dietary Supplement: Diet | Assiut University | NULL | Not yet recruiting | N/A | N/A | All | 50 | NULL | |
| 284 | EUCTR2019-002698-74-ES (EUCTR) | 01/04/2020 | 23/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China | ||
| 285 | NCT04096573 (ClinicalTrials.gov) | April 2020 | 18/9/2019 | Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis | A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: LC51-0255;Drug: Placebo | LG Chem | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 286 | EUCTR2019-002698-74-BG (EUCTR) | 27/03/2020 | 31/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan | ||
| 287 | EUCTR2019-002698-74-SK (EUCTR) | 26/03/2020 | 31/01/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 100 mg/ml Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;China;Japan | ||
| 288 | EUCTR2018-003524-36-IE (EUCTR) | 25/03/2020 | 05/11/2019 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: NA Product Code: NA INN or Proposed INN: INFLIXIMAB Trade Name: Metoject INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 4 | Ireland;Netherlands | ||
| 289 | EUCTR2019-002698-74-PL (EUCTR) | 24/03/2020 | 11/02/2020 | A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2 | A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A | Pfizer Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Belgium;Japan;China;Germany;South Africa;Bulgaria;Australia;Romania;Poland | ||
| 290 | EUCTR2019-000733-39-DE (EUCTR) | 20/03/2020 | 13/03/2020 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 291 | EUCTR2019-003849-15-AT (EUCTR) | 20/03/2020 | 06/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany;Serbia;Belarus;United States | ||
| 292 | EUCTR2016-000642-62-SE (EUCTR) | 18/03/2020 | 25/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic | ||
| 293 | EUCTR2016-000642-62-FR (EUCTR) | 10/03/2020 | 30/07/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 294 | EUCTR2018-001605-93-AT (EUCTR) | 09/03/2020 | 07/11/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 295 | NCT04277546 (ClinicalTrials.gov) | March 3, 2020 | 18/2/2020 | Open-label Extension Study of Brazikumab in Ulcerative Colitis | A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) | Ulcerative Colitis | Drug: Brazikumab Maintenance Dose;Drug: Brazikumab Induction Dose | AstraZeneca | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 165 | Phase 2 | United States;Austria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Bulgaria;Romania |
| 296 | EUCTR2018-003987-29-PT (EUCTR) | 02/03/2020 | 28/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Germany;Japan;Georgia;United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria | ||
| 297 | EUCTR2017-003703-22-PT (EUCTR) | 02/03/2020 | 18/12/2019 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina | ||
| 298 | NCT02277223 (ClinicalTrials.gov) | March 1, 2020 | 25/10/2014 | Curcumin in Pediatric Ulcerative Colitis | Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: Placebo | Schneider Children's Medical Center, Israel | NULL | Withdrawn | 6 Years | 18 Years | All | 0 | Phase 3 | Israel |
| 299 | NCT04309058 (ClinicalTrials.gov) | March 2020 | 24/2/2020 | Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism | Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort Study | Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement | Drug: Vitamin D drops | Second Affiliated Hospital of Wenzhou Medical University | NULL | Not yet recruiting | N/A | N/A | All | 100 | Early Phase 1 | China |
| 300 | EUCTR2018-003986-33-DK (EUCTR) | 28/02/2020 | 02/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 301 | EUCTR2018-004002-25-ES (EUCTR) | 28/02/2020 | 04/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden | ||
| 302 | EUCTR2019-003220-21-GB (EUCTR) | 26/02/2020 | 12/12/2019 | Management of diarrhoea in ulcerative colitis: multi-arm multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. | Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide: MODULATE. - MODULATE | Diarrhoea in patients with stable ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10066557;Term: Chronic diarrhoea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amitriptyline Product Name: Amitriptyline INN or Proposed INN: Amitriptyline hydrochloride Product Name: Ondansetron INN or Proposed INN: Ondansetron hydrochloride dihydrate Product Name: Loperamide INN or Proposed INN: loperamide hydrochloride | University of Leeds | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 491 | Phase 2;Phase 3 | United Kingdom | ||
| 303 | EUCTR2019-003987-37-SI (EUCTR) | 26/02/2020 | 27/11/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi Product Code: CNTO-148 | University Medical Centre Ljubljana, Department of gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Slovenia | ||
| 304 | EUCTR2017-004092-31-RO (EUCTR) | 26/02/2020 | 17/03/2022 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 305 | EUCTR2019-003113-34-HU (EUCTR) | 25/02/2020 | 09/01/2020 | Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany | ||
| 306 | EUCTR2018-003986-33-GB (EUCTR) | 24/02/2020 | 17/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 307 | EUCTR2019-003113-34-DE (EUCTR) | 19/02/2020 | 08/11/2019 | Ulcerative colitis | A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA | Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Germany;Norway;Czech Republic;Hungary;United States | ||
| 308 | EUCTR2018-003987-29-BG (EUCTR) | 17/02/2020 | 23/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 309 | NCT04254783 (ClinicalTrials.gov) | February 16, 2020 | 3/2/2020 | A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis (UC);Crohn's Disease | Drug: Risankizumab;Drug: Cytochrome P450 (CYP) Substrates | AbbVie | NULL | Recruiting | 18 Years | 80 Years | All | 20 | Phase 1 | United States;Germany;Israel |
| 310 | EUCTR2018-003986-33-ES (EUCTR) | 14/02/2020 | 24/02/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany | ||
| 311 | EUCTR2019-000733-39-AT (EUCTR) | 13/02/2020 | 14/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belgium;Poland;Germany;Serbia;Belarus;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada | ||
| 312 | EUCTR2018-003558-26-GB (EUCTR) | 11/02/2020 | 05/11/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 313 | EUCTR2018-003986-33-BG (EUCTR) | 11/02/2020 | 23/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 314 | EUCTR2019-004090-50-ES (EUCTR) | 07/02/2020 | 11/11/2019 | Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis | A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis | Moderate to severe ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OST-122 INN or Proposed INN: Not available yet Other descriptive name: OST-122 Product Name: OST-122 INN or Proposed INN: Not available yet Other descriptive name: OST-122 | ONCOSTELLAE S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain | ||
| 315 | NCT04074590 (ClinicalTrials.gov) | February 3, 2020 | 29/8/2019 | Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis | A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: LYS006;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Bulgaria;Czechia;Germany;Hungary;Norway;Poland;Russian Federation;Slovakia;United Kingdom |
| 316 | EUCTR2018-004002-25-PT (EUCTR) | 03/02/2020 | 06/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden | ||
| 317 | EUCTR2018-004491-35-RO (EUCTR) | 30/01/2020 | 18/03/2022 | A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE | Incyte Corporation | NULL | Not Recruiting | Female: yes Male: yes | 206 | Phase 2 | United States;Czechia;Poland;Romania;Germany | ||
| 318 | EUCTR2018-002135-19-IT (EUCTR) | 30/01/2020 | 17/06/2021 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 319 | EUCTR2018-003986-33-LV (EUCTR) | 24/01/2020 | 01/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 320 | EUCTR2018-003987-29-DE (EUCTR) | 23/01/2020 | 30/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 321 | EUCTR2018-003985-15-AT (EUCTR) | 21/01/2020 | 08/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 322 | EUCTR2018-003985-15-FR (EUCTR) | 20/01/2020 | 12/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 323 | NCT04223479 (ClinicalTrials.gov) | January 15, 2020 | 6/1/2020 | Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan | Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan | Ulcerative Colitis | Drug: Probiotic Formula Capsule;Drug: Placebos | University of Jordan | NULL | Recruiting | 35 Years | 65 Years | All | 30 | Phase 2/Phase 3 | Jordan |
| 324 | EUCTR2018-003986-33-FR (EUCTR) | 14/01/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 325 | NCT04023396 (ClinicalTrials.gov) | January 13, 2020 | 5/7/2019 | Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 217 | Phase 2 | Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom |
| 326 | EUCTR2018-002136-24-IT (EUCTR) | 10/01/2020 | 17/06/2021 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 327 | EUCTR2019-000733-39-IT (EUCTR) | 08/01/2020 | 22/01/2021 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. - na | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABX464 Product Code: [ABX464] INN or Proposed INN: ABX464 Other descriptive name: ABX464 | Abivax | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands | ||
| 328 | ChiCTR2000028869 | 2020-01-03 | 2020-01-05 | phase IIa clinical trial of Colitis Suppositories | A multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) | mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome) | Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.; | Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University | NULL | Recruiting | 18 | 65 | Both | Experimental group:30;The control group:30; | Phase 2 | China |
| 329 | EUCTR2018-003986-33-LT (EUCTR) | 31/12/2019 | 08/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 330 | NCT04130919 (ClinicalTrials.gov) | December 20, 2019 | 16/10/2019 | Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Tilpisertib;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States;Australia;Austria;Canada;France;Germany;Italy;Poland;Switzerland |
| 331 | EUCTR2018-003987-29-ES (EUCTR) | 20/12/2019 | 20/12/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 332 | NCT04090411 (ClinicalTrials.gov) | December 19, 2019 | 12/9/2019 | A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to Severe Ulcerative Colitis | Drug: 50 mg;Drug: 450 mg;Drug: 150 mg;Other: 0 mg | Pfizer | NULL | Active, not recruiting | 18 Years | 75 Years | All | 246 | Phase 2 | United States;Australia;Belgium;Bulgaria;Colombia;France;Germany;Hungary;India;Italy;Japan;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Thailand;Turkey;Ukraine;United Kingdom;Austria;Canada |
| 333 | EUCTR2019-003662-40-DE (EUCTR) | 18/12/2019 | 22/10/2019 | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED | MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 82 | Phase 4 | Germany | ||
| 334 | EUCTR2018-005086-39-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 335 | EUCTR2018-003278-28-NL (EUCTR) | 13/12/2019 | 22/07/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 336 | EUCTR2019-000733-39-ES (EUCTR) | 11/12/2019 | 11/11/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany | ||
| 337 | EUCTR2018-003558-26-FR (EUCTR) | 10/12/2019 | 08/02/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 338 | ChiCTR1900025900 | 2019-12-01 | 2019-09-13 | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Ulcerative colitis | Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion; | Nanjing Hospital of Chinese Medicine | NULL | Pending | Both | Experimental group:200;control group:100; | Phase 3 | China | ||
| 339 | NCT04133194 (ClinicalTrials.gov) | November 28, 2019 | 10/10/2019 | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial) | Ulcerative Colitis | Drug: Mesalazine | Flemming Bendtsen | NULL | Recruiting | 18 Years | 60 Years | All | 200 | Phase 4 | Denmark |
| 340 | EUCTR2018-000334-35-NO (EUCTR) | 27/11/2019 | 12/06/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 341 | ChiCTR2000029648 | 2019-11-26 | 2020-02-09 | The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study | The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study | Ulcerative Colitis | GC treatment:1mg/kg prednison or other GC with same dose;Health Control:NO intervention; | Peking Union Medical College Hospital | NULL | Recruiting | 18 | 65 | Both | GC treatment:120;Health Control:30; | N/A | China |
| 342 | EUCTR2018-001605-93-CZ (EUCTR) | 21/11/2019 | 05/08/2019 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of | ||
| 343 | EUCTR2019-000733-39-SK (EUCTR) | 21/11/2019 | 06/09/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 217 | Phase 2 | Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 344 | EUCTR2019-003068-39-NL (EUCTR) | 20/11/2019 | 04/11/2019 | In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels. | Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study | Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | UMC Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Netherlands | ||
| 345 | EUCTR2017-003703-22-HR (EUCTR) | 20/11/2019 | 13/01/2020 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Bosnia and Herzegovina;Netherlands;Germany;Bulgaria;Romania;Croatia;Poland;Belgium;United Kingdom;Russian Federation;North Macedonia;Ukraine;Spain;Czechia;Portugal;Belarus;Serbia;United States | ||
| 346 | EUCTR2018-003987-29-DK (EUCTR) | 20/11/2019 | 02/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 347 | EUCTR2018-003987-29-LT (EUCTR) | 14/11/2019 | 06/11/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 348 | EUCTR2019-000733-39-SI (EUCTR) | 11/11/2019 | 16/10/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 349 | EUCTR2019-000733-39-PL (EUCTR) | 09/11/2019 | 12/09/2019 | Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients | A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 2 | Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Germany | ||
| 350 | EUCTR2018-003986-33-HR (EUCTR) | 08/11/2019 | 17/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 351 | EUCTR2018-003987-29-LV (EUCTR) | 07/11/2019 | 16/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Moldova, Republic of;China;Korea, Republic of;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Latvia;Netherlands;South Africa;Denmark;Australia;France;India;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Lebanon;Ukraine;Spain;Thailand;Slovakia;Taiwan;Estonia;Belarus;United States;Portugal;Serbia;Lithuania;Turkey;Austria;United Kingdom | ||
| 352 | EUCTR2018-003987-29-HU (EUCTR) | 07/11/2019 | 17/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 353 | EUCTR2018-003986-33-HU (EUCTR) | 07/11/2019 | 08/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 354 | EUCTR2016-000642-62-DE (EUCTR) | 04/11/2019 | 18/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Belarus;Serbia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 355 | EUCTR2018-000334-35-HU (EUCTR) | 31/10/2019 | 06/09/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH&Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Norway;Netherlands;Germany;Japan;Korea, Republic of;Denmark;Australia;Belgium;Poland;Canada;Czech Republic;Hungary;Italy;United Kingdom;Russian Federation;Austria;Spain;Greece;United States | ||
| 356 | EUCTR2018-003349-41-DE (EUCTR) | 30/10/2019 | 19/12/2018 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany;Ukraine;United States;Serbia;Belarus | ||
| 357 | EUCTR2018-003558-26-DE (EUCTR) | 30/10/2019 | 15/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 358 | EUCTR2018-002135-19-BG (EUCTR) | 30/10/2019 | 11/07/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Japan;Germany;Bulgaria;Georgia;Romania;Croatia;Poland;Canada;Hungary;United Kingdom;Korea, Republic of;South Africa;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Portugal;Serbia;United States | ||
| 359 | EUCTR2018-005086-39-HU (EUCTR) | 28/10/2019 | 08/04/2019 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 360 | EUCTR2018-003278-28-HU (EUCTR) | 24/10/2019 | 25/03/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 361 | EUCTR2018-004002-25-IT (EUCTR) | 24/10/2019 | 17/06/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.4 Solution for infusion in pre-filled syringe Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.4 Solution for infusion in pre-filled syringe Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: Guselkumab Other descriptive name: * D.3.4 Solution for injection/infusion in pre-filled syringe Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.4 Solution for injection in pre-filled syringe | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | United States;Bulgaria;Germany;Japan;Sweden;Poland;Belgium;Argentina;Canada;Hungary;United Kingdom;Turkey;Czechia;Korea, Republic of;China;Netherlands;Latvia;Australia;Malaysia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Slovakia;Hong Kong;Taiwan;Portugal | ||
| 362 | EUCTR2018-003986-33-IT (EUCTR) | 23/10/2019 | 22/01/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Other descriptive name: APD334 L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 363 | EUCTR2018-004002-25-BE (EUCTR) | 21/10/2019 | 10/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 364 | EUCTR2018-003985-15-ES (EUCTR) | 21/10/2019 | 21/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 365 | NCT03914261 (ClinicalTrials.gov) | October 15, 2019 | 11/4/2019 | Expanded Access to Risankizumab | Expanded Access to Risankizumab | Crohn's Disease;Ulcerative Colitis (UC) | Drug: Risankizumab | AbbVie | NULL | Available | 18 Years | N/A | All | Belgium;Israel;Spain;Switzerland;United States | ||
| 366 | EUCTR2018-003987-29-IT (EUCTR) | 15/10/2019 | 22/01/2021 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] Other descriptive name: etrasimod L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy | ||
| 367 | EUCTR2018-004002-25-FR (EUCTR) | 15/10/2019 | 14/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden | ||
| 368 | EUCTR2018-004002-25-SE (EUCTR) | 15/10/2019 | 03/07/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 369 | EUCTR2018-003986-33-BE (EUCTR) | 14/10/2019 | 15/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany | ||
| 370 | EUCTR2018-003985-15-PT (EUCTR) | 14/10/2019 | 10/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Belarus;Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 371 | NCT04131322 (ClinicalTrials.gov) | October 10, 2019 | 10/10/2019 | Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. | Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study | Crohn Disease;Ulcerative Colitis | Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | NULL | Terminated | 18 Years | N/A | All | 24 | Phase 4 | Spain |
| 372 | EUCTR2018-001605-93-RO (EUCTR) | 10/10/2019 | 15/03/2022 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 373 | EUCTR2018-004002-25-GB (EUCTR) | 09/10/2019 | 20/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Germany;Japan;Sweden;Bulgaria;Romania;Poland;Belgium;Brazil;Argentina;Canada;Hungary;Czech Republic;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Taiwan;Portugal;United States | ||
| 374 | EUCTR2018-001605-93-BG (EUCTR) | 09/10/2019 | 20/09/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 375 | EUCTR2018-004890-28-IT (EUCTR) | 09/10/2019 | 07/10/2020 | Study for the research of predictive factors of response to Tofacitinib therapy in patients with ulcerative rectal colitis. | (A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study). - AVATAR | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Product Name: Xeljanz Product Code: [N/A] | DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 376 | EUCTR2018-005086-39-PL (EUCTR) | 07/10/2019 | 06/05/2019 | A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 377 | EUCTR2018-003987-29-NL (EUCTR) | 07/10/2019 | 22/08/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 378 | EUCTR2017-004230-28-CZ (EUCTR) | 04/10/2019 | 11/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Korea, Republic of;China;Japan;Germany;Netherlands;Norway;Denmark;Australia;Belgium;Poland;Argentina;Canada;Mexico;Hungary;Czech Republic;Italy;United Kingdom;Israel;Russian Federation;Austria;Spain;Greece;Taiwan;United States | ||
| 379 | EUCTR2018-003986-33-NL (EUCTR) | 03/10/2019 | 22/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 380 | EUCTR2018-003985-15-IT (EUCTR) | 02/10/2019 | 22/01/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Other descriptive name: APD334 L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 381 | EUCTR2018-003987-29-HR (EUCTR) | 02/10/2019 | 20/01/2020 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 382 | EUCTR2018-004002-25-HU (EUCTR) | 01/10/2019 | 13/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Bulgaria;Germany;Japan;Sweden;Belgium;Poland;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;Malaysia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Thailand;Hong Kong;Taiwan;United States;Portugal | ||
| 383 | EUCTR2018-003490-10-FR (EUCTR) | 30/09/2019 | 26/09/2019 | An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial | An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial - CONTROL | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 238 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France | ||
| 384 | EUCTR2018-003985-15-DK (EUCTR) | 27/09/2019 | 24/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 385 | EUCTR2018-003985-15-BG (EUCTR) | 27/09/2019 | 12/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Serbia;Belarus;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 386 | NCT04033445 (ClinicalTrials.gov) | September 26, 2019 | 24/7/2019 | A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: Guselkumab | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 1000 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania |
| 387 | EUCTR2018-003985-15-CZ (EUCTR) | 26/09/2019 | 31/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 388 | EUCTR2018-001605-93-IT (EUCTR) | 26/09/2019 | 29/01/2021 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFU | ALLERGAN LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 389 | EUCTR2018-003278-28-CZ (EUCTR) | 25/09/2019 | 15/04/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Czechia;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 390 | EUCTR2018-004694-27-DE (EUCTR) | 24/09/2019 | 24/05/2019 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 391 | NCT03760003 (ClinicalTrials.gov) | September 23, 2019 | 29/11/2018 | Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment | Ulcerative Colitis | Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo | Abivax S.A. | NULL | Completed | 18 Years | 75 Years | All | 254 | Phase 2 | United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom |
| 392 | EUCTR2018-001605-93-BE (EUCTR) | 23/09/2019 | 07/06/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 393 | NCT03950232 (ClinicalTrials.gov) | September 20, 2019 | 13/5/2019 | An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod | Arena Pharmaceuticals | NULL | Recruiting | 16 Years | 80 Years | All | 912 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Thailand;Turkey;Ukraine;United Kingdom |
| 394 | EUCTR2017-004496-31-NL (EUCTR) | 20/09/2019 | 27/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 395 | EUCTR2018-003985-15-NL (EUCTR) | 18/09/2019 | 09/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 396 | EUCTR2018-003987-29-BE (EUCTR) | 16/09/2019 | 01/07/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 397 | EUCTR2018-001605-93-FR (EUCTR) | 13/09/2019 | 25/06/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 398 | EUCTR2018-002135-19-GR (EUCTR) | 13/09/2019 | 04/06/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 399 | NCT04176588 (ClinicalTrials.gov) | September 10, 2019 | 22/11/2019 | A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Everstar Therapeutics Limited | NULL | Recruiting | 18 Years | 75 Years | All | 333 | Phase 3 | China |
| 400 | NCT03885713 (ClinicalTrials.gov) | September 10, 2019 | 4/3/2019 | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | Spain |
| 401 | EUCTR2018-002136-24-FR (EUCTR) | 10/09/2019 | 19/12/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 402 | EUCTR2017-004230-28-HU (EUCTR) | 06/09/2019 | 08/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece | ||
| 403 | EUCTR2019-002070-31-DK (EUCTR) | 05/09/2019 | 24/06/2019 | Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial) | Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) | Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Asacol® INN or Proposed INN: MESALAZINE | Copenhagen University Hospital Hvidovre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | Denmark | ||
| 404 | EUCTR2017-004092-31-DE (EUCTR) | 05/09/2019 | 15/05/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 405 | EUCTR2016-000642-62-HR (EUCTR) | 30/08/2019 | 20/01/2020 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 406 | EUCTR2018-003558-26-BE (EUCTR) | 29/08/2019 | 27/05/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 407 | EUCTR2018-003985-15-LT (EUCTR) | 27/08/2019 | 10/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 408 | NCT03724175 (ClinicalTrials.gov) | August 26, 2019 | 12/10/2018 | The Role of Secondary Bile Acids in Intestinal Inflammation | The Role of Secondary Bile Acids in Intestinal Inflammation | Ulcerative Colitis;Pouchitis | Drug: ursodiol (ursodeoxycholic acid, UDCA) | Stanford University | NULL | Recruiting | 18 Years | 70 Years | All | 15 | Phase 2/Phase 3 | United States |
| 409 | EUCTR2018-002135-19-DE (EUCTR) | 26/08/2019 | 25/02/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 410 | EUCTR2018-003985-15-EE (EUCTR) | 26/08/2019 | 15/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 411 | EUCTR2018-004694-27-IT (EUCTR) | 21/08/2019 | 25/01/2021 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis - na | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: [BMS-986165] | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Czechia;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 412 | EUCTR2017-004092-31-HR (EUCTR) | 19/08/2019 | 20/01/2020 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan;Turkey;Lithuania;Korea, Republic of;China;Moldova, Republic of;Latvia;Netherlands;Denmark;Australia;Malaysia;France;India;Switzerland;Italy;Israel;Russian Federation;Ireland;Ukraine;Spain;Slovakia;Taiwan;Saudi Arabia;United States;Serbia | ||
| 413 | EUCTR2018-004491-35-PL (EUCTR) | 19/08/2019 | 03/07/2019 | A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 206 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Romania;Germany | ||
| 414 | NCT03861143 (ClinicalTrials.gov) | August 14, 2019 | 27/2/2019 | Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: Placebo | Landos Biopharma Inc. | NULL | Completed | 18 Years | 65 Years | All | 198 | Phase 2 | United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia |
| 415 | EUCTR2018-003985-15-HR (EUCTR) | 14/08/2019 | 24/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey | ||
| 416 | EUCTR2017-004092-31-IT (EUCTR) | 14/08/2019 | 17/06/2021 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: [LY3074828] INN or Proposed INN: Mirikizumab Other descriptive name: Mirikizumab | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 417 | EUCTR2018-004694-27-CZ (EUCTR) | 13/08/2019 | 19/07/2019 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 418 | EUCTR2017-004092-31-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Lilly S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 419 | NCT03977480 (ClinicalTrials.gov) | August 13, 2019 | 27/4/2019 | Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Hemay007;Drug: Placebo | Tianjin Hemay Pharmaceutical Co.,Ltd | NULL | Recruiting | 18 Years | 70 Years | All | 70 | Phase 2 | China |
| 420 | NCT03869905 (ClinicalTrials.gov) | August 8, 2019 | 8/3/2019 | Aquamin® as an Adjuvant Intervention for Ulcerative Colitis | Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission | Ulcerative Colitis | Drug: Aquamin®;Drug: Placebo first then Aquamin® | James Varani | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | United States |
| 421 | EUCTR2018-001605-93-ES (EUCTR) | 07/08/2019 | 09/08/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 422 | EUCTR2018-003278-28-PL (EUCTR) | 03/08/2019 | 11/06/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of | ||
| 423 | ChiCTR1900024086 | 2019-08-01 | 2019-06-24 | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Ulcerative Colitis | intervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | intervention period:10;control period:10; | N/A | China |
| 424 | NCT04029649 (ClinicalTrials.gov) | August 2019 | 17/7/2019 | Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis | The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial | Ulcerative Colitis | Drug: Beta-1,3/1,6-D-Glucan;Drug: Placebo | Fakultas Kedokteran Universitas Indonesia | NULL | Not yet recruiting | 18 Years | N/A | All | 204 | Phase 2/Phase 3 | Indonesia |
| 425 | NCT03591770 (ClinicalTrials.gov) | July 31, 2019 | 9/7/2018 | Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib | The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib | Inflammatory Bowel Diseases | Biological: SHINGRIX | Boston Medical Center | NULL | Recruiting | 50 Years | N/A | All | 100 | Phase 4 | United States |
| 426 | NCT03948919 (ClinicalTrials.gov) | July 31, 2019 | 10/5/2019 | Low Sulfur Fecal Transplant for Ulcerative Colitis | Low Sulfur Fecal Transplant for Ulcerative Colitis | Ulcerative Colitis | Drug: Fecal microbiota;Other: Placebo | University of Minnesota | NULL | Recruiting | 18 Years | 89 Years | All | 20 | Phase 1 | United States |
| 427 | EUCTR2016-004676-22-BG (EUCTR) | 30/07/2019 | 14/05/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 428 | EUCTR2016-000642-62-PT (EUCTR) | 29/07/2019 | 16/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Belarus;Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 429 | EUCTR2018-003985-15-HU (EUCTR) | 29/07/2019 | 16/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 430 | EUCTR2016-000642-62-GB (EUCTR) | 26/07/2019 | 25/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 431 | NCT03986996 (ClinicalTrials.gov) | July 25, 2019 | 4/6/2019 | Antimicrobial Therapy for Ulcerative Colitis (UC) | Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: amoxicillin, metronidazole and doxycycline;Drug: amoxicillin and doxycyclin | Wolfson Medical Center | NULL | Recruiting | 13 Years | 60 Years | All | 40 | Phase 2 | Israel |
| 432 | EUCTR2018-004694-27-GB (EUCTR) | 23/07/2019 | 30/04/2019 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 433 | EUCTR2019-001032-54-FR (EUCTR) | 23/07/2019 | 19/06/2019 | Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy | Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy - CYTOVEDO | Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058881;Term: Cytomegalovirus viremia;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: valganciclovir Product Name: valganciclovir Trade Name: vedolizumab Product Name: vedolizumab | CHU de Saint Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France | ||
| 434 | ChiCTR1900024591 | 2019-07-22 | 2019-07-18 | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Ulcerative colitis | TCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk); | Peking University First Hospital | NULL | Pending | 18 | 65 | Both | TCM Group:40;Convenience medicine Group:40;Combined Group:40; | China | |
| 435 | NCT04030676 (ClinicalTrials.gov) | July 17, 2019 | 19/7/2019 | QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis | Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC) | Cytomegalovirus Infections | Procedure: Biopsies;Biological: Blood samples | Centre Hospitalier Universitaire de Saint Etienne | NULL | Recruiting | 18 Years | N/A | All | 196 | N/A | France |
| 436 | EUCTR2018-003349-41-IT (EUCTR) | 16/07/2019 | 17/06/2021 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis - CYC-202 | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: [FP-CYA-050] INN or Proposed INN: CICLOSPORIN Product Name: ST-0529 Product Code: [FP-CYA-053] INN or Proposed INN: CICLOSPORIN | Sublimity Therapeutics HoldCo Limited | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 437 | EUCTR2018-003349-41-FR (EUCTR) | 11/07/2019 | 27/05/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Belarus;Serbia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 438 | EUCTR2018-003985-15-LV (EUCTR) | 05/07/2019 | 02/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 439 | EUCTR2018-001605-93-GB (EUCTR) | 01/07/2019 | 04/04/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 440 | EUCTR2018-003986-33-SK (EUCTR) | 01/07/2019 | 02/05/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 441 | NCT03934216 (ClinicalTrials.gov) | July 1, 2019 | 30/4/2019 | Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 80 Years | All | 131 | Phase 2 | United States;Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom;Canada |
| 442 | EUCTR2017-004230-28-GR (EUCTR) | 01/07/2019 | 03/05/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 443 | EUCTR2018-004694-27-PL (EUCTR) | 30/06/2019 | 15/05/2019 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of | ||
| 444 | EUCTR2019-000717-37-ES (EUCTR) | 27/06/2019 | 28/06/2019 | Loss of response of the Adalimumba biosimilar compared with the original drug | LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study | Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: Humira (adalimumab original) | Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI) | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 4 | Spain | ||
| 445 | EUCTR2018-002136-24-DE (EUCTR) | 25/06/2019 | 27/12/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 446 | EUCTR2016-004677-40-BG (EUCTR) | 25/06/2019 | 18/04/2019 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 447 | EUCTR2018-003987-29-SK (EUCTR) | 25/06/2019 | 15/04/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 448 | EUCTR2017-004997-32-DE (EUCTR) | 25/06/2019 | 14/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 449 | EUCTR2018-004694-27-HU (EUCTR) | 25/06/2019 | 06/05/2019 | Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Spain;Russian Federation;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Germany;Japan;Korea, Republic of | ||
| 450 | NCT03923478 (ClinicalTrials.gov) | June 24, 2019 | 15/4/2019 | ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Drug: ABI-M201;Drug: Placebo | Assembly Biosciences | NULL | Terminated | 18 Years | 70 Years | All | 15 | Phase 1 | United States;Canada |
| 451 | EUCTR2018-003985-15-SK (EUCTR) | 21/06/2019 | 16/04/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Chile;Russian Federation;Lebanon;Ukraine;Spain;Thailand;Slovakia;Estonia;Taiwan;Belarus;Portugal;Serbia;United States | ||
| 452 | EUCTR2016-000642-62-GR (EUCTR) | 21/06/2019 | 25/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 453 | EUCTR2018-002135-19-PL (EUCTR) | 19/06/2019 | 05/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 454 | EUCTR2016-000642-62-IE (EUCTR) | 18/06/2019 | 26/11/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 455 | EUCTR2017-004230-28-DK (EUCTR) | 14/06/2019 | 24/03/2019 | BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Denmark A/S | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 456 | NCT03945188 (ClinicalTrials.gov) | June 13, 2019 | 8/5/2019 | Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 16 Years | 80 Years | All | 433 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Colombia;Switzerland |
| 457 | EUCTR2016-000642-62-NL (EUCTR) | 13/06/2019 | 11/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 458 | EUCTR2018-002136-24-BG (EUCTR) | 12/06/2019 | 18/01/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 459 | EUCTR2018-003558-26-SI (EUCTR) | 12/06/2019 | 07/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 460 | EUCTR2018-003558-26-IT (EUCTR) | 11/06/2019 | 22/01/2021 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - ABX464-103 | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABX464 Product Code: [ABX464] Product Name: ABX464 Product Code: [ABX464] | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands | ||
| 461 | EUCTR2018-002135-19-ES (EUCTR) | 10/06/2019 | 12/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 462 | EUCTR2018-002135-19-PT (EUCTR) | 05/06/2019 | 15/03/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan | ||
| 463 | EUCTR2013-004279-11-FR (EUCTR) | 03/06/2019 | 09/04/2019 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 464 | NCT03915769 (ClinicalTrials.gov) | June 3, 2019 | 12/4/2019 | To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 195 | Phase 3 | Japan |
| 465 | NCT03941418 (ClinicalTrials.gov) | June 1, 2019 | 5/5/2019 | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Ulcerative Colitis;Crohn Disease | Dietary Supplement: Boulardii;Dietary Supplement: Placebo | University Clinic Dr Dragisa Misovic-Dedinje | University Clinic Zvezdara | Not yet recruiting | 18 Years | 80 Years | All | 150 | N/A | NULL |
| 466 | JPRN-JapicCTI-194721 | 01/6/2019 | 17/04/2019 | A Phase I Study of RO7021610 in Patients with Ulcerative Colitis | A Phase I Multiple-Dose Study of RO7021610 in Japanese Patients with Ulcerative Colitis | Ulcerative colitis | Intervention name : RO7021610 INN of the intervention : Efmarodocokin alfa Dosage And administration of the intervention : RO7021610 will be administrated repeatedly by IV. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo will be administrated repeatedly by IV. | Chugai Pharmaceutical Co., Ltd. | NULL | complete | 18 | 80 | BOTH | 24 | Phase 1 | Japan |
| 467 | EUCTR2018-003349-41-BG (EUCTR) | 29/05/2019 | 27/02/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Spain;Belarus;Serbia;United States;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 468 | NCT03720002 (ClinicalTrials.gov) | May 29, 2019 | 21/10/2018 | HF2 Therapy in the Treatment of Active Ulcerative Colitis | HF2 Therapy in the Treatment of Active Ulcerative Colitis: | Ulcerative Colitis | Dietary Supplement: HF2 | Sheba Medical Center | NULL | Recruiting | 18 Years | 70 Years | All | 34 | Phase 1/Phase 2 | Israel |
| 469 | EUCTR2018-002135-19-SK (EUCTR) | 28/05/2019 | 15/03/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 470 | EUCTR2018-000930-37-ES (EUCTR) | 27/05/2019 | 22/01/2019 | A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABBV-323 INN or Proposed INN: RAVAGALIMAB Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 471 | EUCTR2018-003558-26-SK (EUCTR) | 23/05/2019 | 20/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 472 | EUCTR2018-002136-24-ES (EUCTR) | 23/05/2019 | 11/04/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 473 | EUCTR2018-003558-26-CZ (EUCTR) | 22/05/2019 | 14/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;France;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy | ||
| 474 | EUCTR2017-004092-31-FR (EUCTR) | 21/05/2019 | 18/04/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan | ||
| 475 | EUCTR2018-003558-26-HU (EUCTR) | 21/05/2019 | 25/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 476 | EUCTR2016-004677-40-SI (EUCTR) | 20/05/2019 | 06/02/2019 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 477 | ChiCTR1900023158 | 2019-05-20 | 2019-05-14 | Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Ulcerative colitis | TCM Group:Hudi Enteric-coated Capsules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Hudi Enteric-coated Capsules Simulator; | Jiangsu Province Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | TCM Group:120;Medical Group:120; | Phase 4 | China |
| 478 | ChiCTR1900023159 | 2019-05-20 | 2019-05-14 | Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Ulcerative colitis | ?????????+???????(???)???:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk); | Dongfang Hospital of Beijing University of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | ?????????+???????(???)???:90;Medical Group:90;Combined Group:90; | China | |
| 479 | EUCTR2016-004676-22-SI (EUCTR) | 20/05/2019 | 06/02/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Bulgaria;Romania;Croatia;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Denmark;Australia;Malaysia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Belarus;Portugal;Serbia;United States;Sweden;Japan;New Zealand;Germany;Brazil;Belgium | ||
| 480 | EUCTR2018-003558-26-PL (EUCTR) | 20/05/2019 | 12/04/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | Germany;Belgium;Poland;Canada;Hungary;France;Italy;United Kingdom;Austria;Ukraine;Spain;Slovakia;Slovenia;Czechia;United States;Serbia;Belarus | ||
| 481 | EUCTR2017-004576-57-PL (EUCTR) | 18/05/2019 | 01/08/2019 | Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 482 | NCT03917095 (ClinicalTrials.gov) | May 15, 2019 | 12/4/2019 | The Safety and Efficacy of TET Enema in the Treatment of UC | Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Device: The Colonic Transendoscopic enteral Tubing.;Drug: Glutamine;Drug: Mesalazine | The Second Hospital of Nanjing Medical University | NULL | Recruiting | 18 Years | 65 Years | All | 75 | N/A | China |
| 483 | NCT03943550 (ClinicalTrials.gov) | May 14, 2019 | 7/5/2019 | Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC) | A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis | Ulcerative Colitis | Drug: RO7049665;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | 70 Years | All | 45 | Phase 1 | United States;Georgia;Hungary;Moldova, Republic of;Ukraine |
| 484 | EUCTR2013-001682-16-DK (EUCTR) | 09/05/2019 | 13/05/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan | ||
| 485 | EUCTR2018-003278-28-FR (EUCTR) | 07/05/2019 | 09/05/2019 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 486 | EUCTR2018-000930-37-FR (EUCTR) | 07/05/2019 | 07/12/2018 | A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABBV-323 Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 487 | NCT03893565 (ClinicalTrials.gov) | May 6, 2019 | 26/3/2019 | Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis | A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK2831781 - Double Blind Phase;Drug: Placebo;Drug: GSK2831781 - Open Label phase | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 104 | Phase 2 | United States;Bulgaria;Czechia;Estonia;France;India;Japan;Netherlands;Poland;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;United Kingdom;Belgium;Canada;Hungary;Korea, Republic of |
| 488 | EUCTR2018-001510-15-DE (EUCTR) | 02/05/2019 | 19/11/2018 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany | ||
| 489 | EUCTR2018-003594-95-NL (EUCTR) | 30/04/2019 | 30/04/2019 | Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy | Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response | Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 490 | EUCTR2018-003278-28-GB (EUCTR) | 29/04/2019 | 14/12/2018 | Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis. | A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781 | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of | ||
| 491 | EUCTR2017-004576-57-DE (EUCTR) | 26/04/2019 | 08/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 492 | EUCTR2018-003524-36-NL (EUCTR) | 25/04/2019 | 19/11/2018 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 493 | EUCTR2017-003703-22-PL (EUCTR) | 25/04/2019 | 26/04/2018 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina | ||
| 494 | EUCTR2018-000930-37-DE (EUCTR) | 24/04/2019 | 18/10/2018 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 495 | NCT03860896 (ClinicalTrials.gov) | April 24, 2019 | 14/2/2019 | GB004 in Adult Subjects With Active Ulcerative Colitis | A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: GB004;Drug: Placebo | GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | NULL | Completed | 18 Years | 74 Years | All | 34 | Phase 1 | United States;Georgia;Moldova, Republic of |
| 496 | EUCTR2018-004587-61-NL (EUCTR) | 23/04/2019 | 13/05/2019 | Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab | Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: TOFACITINIB Trade Name: Inflectra Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Erasmus Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 497 | EUCTR2018-000930-37-IT (EUCTR) | 19/04/2019 | 14/06/2021 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy - NA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Product Code: [ABBV-323] | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 498 | EUCTR2017-004576-57-LV (EUCTR) | 15/04/2019 | 14/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia | ||
| 499 | NCT03675477 (ClinicalTrials.gov) | April 13, 2019 | 16/9/2018 | A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis. | A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: SHR0302;Drug: Placebos | Reistone Biopharma Company Limited | NULL | Completed | 18 Years | 75 Years | All | 164 | Phase 2 | United States;China;Poland;Puerto Rico;Ukraine |
| 500 | EUCTR2018-002135-19-HU (EUCTR) | 11/04/2019 | 19/02/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 501 | EUCTR2013-004277-27-HU (EUCTR) | 11/04/2019 | 25/02/2019 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 502 | EUCTR2018-002136-24-PL (EUCTR) | 04/04/2019 | 18/01/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 503 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 312 | Phase 1 | United States;Canada |
| 504 | EUCTR2018-002136-24-GR (EUCTR) | 03/04/2019 | 18/02/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany | ||
| 505 | NCT04224857 (ClinicalTrials.gov) | April 1, 2019 | 23/5/2019 | SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101 | Ulcerative Colitis | Drug: AMT-101;Drug: Placebos | Applied Molecular Transport | NULL | Completed | 18 Years | N/A | All | 52 | Phase 1 | Georgia;Germany;Moldova, Republic of;Ukraine |
| 506 | NCT03794765 (ClinicalTrials.gov) | April 1, 2019 | 4/1/2019 | Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis | Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial | Ulcerative Colitis;Inflammatory Bowel Diseases;Acute Severe Colitis | Drug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusion | Postgraduate Institute of Medical Education and Research | NULL | Completed | 13 Years | N/A | All | 50 | Phase 2 | India |
| 507 | NCT04057547 (ClinicalTrials.gov) | April 1, 2019 | 10/8/2019 | Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat Syndrome | The Correlation Within Dampness-heat Syndrome of Ulcerative Colitis(UC) and Intestinal Microbiota Via C1orf106/Cytohesin-1(CYTH-1) /Adenosine Diphosphate-ribosylation Factor 6(ARF6) Signal Pathway and the Intervention Mechanism of Classic Chinese Compound Formula With Clearing Heat and Promoting Dieresis | Ulcerative Colitis | Drug: Modified Gegen Qinlian Decoction | Xiyuan Hospital of China Academy of Chinese Medical Sciences | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Early Phase 1 | China |
| 508 | ChiCTR1900022243 | 2019-04-01 | 2019-03-31 | Effect of curcumin combined with probiotics on prevention and treatment in ileal pouchitis after operation of ulcerative colitis. | Effect of curcumin combined with probiotics on prevention and treatment in ileal pouchitis after operation of ulcerative colitis. | ileal pouchitis after operation of ulcerative colitis | Experimental group:Curcumin+Probiotics;Control group:Probiotics; | Tianjin Medical University General Hospital | NULL | Recruiting | Both | Experimental group:20;Control group:10; | China | |||
| 509 | EUCTR2018-003349-41-GB (EUCTR) | 28/03/2019 | 21/12/2018 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 510 | EUCTR2017-004576-57-CZ (EUCTR) | 27/03/2019 | 15/03/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 511 | NCT03695185 (ClinicalTrials.gov) | March 26, 2019 | 2/10/2018 | A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis (UC) | Drug: ABBV-323 Dose A;Drug: ABBV-323 Dose B | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 42 | Phase 2 | United States;Canada;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Spain;United Kingdom |
| 512 | EUCTR2018-000334-35-NL (EUCTR) | 21/03/2019 | 29/08/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim bv Netherlands | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of | ||
| 513 | EUCTR2016-000642-62-LT (EUCTR) | 19/03/2019 | 15/11/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 514 | NCT03884439 (ClinicalTrials.gov) | March 18, 2019 | 4/3/2019 | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis) | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis) | Crohn's Disease;Ulcerative Colitis | Drug: Infliximab [infliximab biosimilar 3] | Pfizer | NULL | Recruiting | N/A | N/A | All | 300 | Japan | |
| 515 | EUCTR2013-004277-27-CZ (EUCTR) | 18/03/2019 | 29/03/2019 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 516 | EUCTR2018-002136-24-PT (EUCTR) | 18/03/2019 | 02/01/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 517 | NCT03768219 (ClinicalTrials.gov) | March 18, 2019 | 30/11/2018 | Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis | Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis | Psoriasis;Ulcerative Colitis | Biological: APVO210;Biological: Placebo | Aptevo Therapeutics | NULL | Terminated | 18 Years | 65 Years | All | 85 | Phase 1 | Australia |
| 518 | EUCTR2017-004576-57-LT (EUCTR) | 15/03/2019 | 29/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 519 | EUCTR2018-003364-31-PL (EUCTR) | 15/03/2019 | 23/01/2019 | A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis. | A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis. | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHR0302 INN or Proposed INN: Pending | Reistone Biopharma Company Limited | NULL | Not Recruiting | Female: yes Male: yes | 152 | Phase 2 | United States;Poland;Ukraine;China | ||
| 520 | EUCTR2016-000642-62-PL (EUCTR) | 14/03/2019 | 12/06/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey | ||
| 521 | EUCTR2017-004576-57-SK (EUCTR) | 12/03/2019 | 18/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Germany;Latvia;Russian Federation;Lithuania;Ukraine;Poland;Slovakia;Hungary;Czech Republic;Czechia;Serbia | ||
| 522 | NCT03758443 (ClinicalTrials.gov) | March 11, 2019 | 19/11/2018 | Efficacy & Safety of TD-1473 in Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C;Drug: Placebo | Theravance Biopharma | NULL | Terminated | 18 Years | N/A | All | 243 | Phase 2/Phase 3 | Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United States;Bulgaria;Australia |
| 523 | EUCTR2017-004576-57-HU (EUCTR) | 11/03/2019 | 16/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 524 | EUCTR2016-000642-62-IT (EUCTR) | 05/03/2019 | 11/03/2021 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis - NA | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 525 | EUCTR2018-001510-15-PL (EUCTR) | 01/03/2019 | 04/02/2019 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany | ||
| 526 | EUCTR2018-003349-41-PL (EUCTR) | 27/02/2019 | 15/01/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany | ||
| 527 | NCT04700449 (ClinicalTrials.gov) | February 27, 2019 | 22/10/2020 | A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) | Moderate to Severe Ulcerative Colitis | Drug: CBP-307;Drug: Placebo | Suzhou Connect Biopharmaceuticals, Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 134 | Phase 2 | United States;China;Pakistan;Ukraine |
| 528 | EUCTR2017-000574-11-GR (EUCTR) | 26/02/2019 | 27/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 529 | NCT03942861 (ClinicalTrials.gov) | February 21, 2019 | 25/4/2019 | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Ulcerative Colitis;Ultrasound Therapy; Complications | Drug: Solu-Medrol | Copenhagen University Hospital at Herlev | NULL | Recruiting | 18 Years | 70 Years | All | 50 | Denmark | |
| 530 | EUCTR2018-000334-35-PL (EUCTR) | 21/02/2019 | 07/12/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH&Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of | ||
| 531 | EUCTR2018-003349-41-HU (EUCTR) | 19/02/2019 | 08/01/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany | ||
| 532 | EUCTR2018-002136-24-SK (EUCTR) | 19/02/2019 | 28/12/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 533 | EUCTR2018-002136-24-HU (EUCTR) | 18/02/2019 | 29/03/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 534 | ChiCTR1900021229 | 2019-02-18 | 2019-02-02 | The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis | The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis | Ulcerative colitis | Intervention group:Increasing the dose of mesalamine according to fecal calprotectin levels;Control group:Maintaining current dosage of mesalamine; | Beijing Friendship Hospital, Capital Medical University | NULL | Pending | Both | Intervention group:74;Control group:74; | China | |||
| 535 | EUCTR2017-004496-31-IT (EUCTR) | 18/02/2019 | 17/06/2021 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: SIMPONI Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: [CNTO312] INN or Proposed INN: INFLIXIMAB Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 536 | EUCTR2017-003238-96-HR (EUCTR) | 08/02/2019 | 17/05/2019 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | ||
| 537 | EUCTR2017-003229-14-HR (EUCTR) | 08/02/2019 | 16/05/2019 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | ||
| 538 | NCT03832400 (ClinicalTrials.gov) | February 4, 2019 | 21/11/2018 | Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC) | A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative Colitis | Ulcerative Colitis | Biological: MET-2;Drug: Placebo oral capsule | NuBiyota | NULL | Completed | 18 Years | N/A | All | 11 | Phase 1 | Canada |
| 539 | EUCTR2017-004997-32-HU (EUCTR) | 04/02/2019 | 04/04/2019 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 540 | NCT03824561 (ClinicalTrials.gov) | February 1, 2019 | 29/1/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis] | Ulcerative Colitis | Drug: Vedolizumab | Takeda | NULL | Recruiting | N/A | N/A | All | 1000 | Japan | |
| 541 | JPRN-JapicCTI-194603 | 01/2/2019 | 30/01/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis] | Ulcerative colitis | Intervention name : Vedolizumab INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab intravenous (IV) infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | recruiting | BOTH | 1000 | NA | Japan | ||
| 542 | EUCTR2016-004676-22-HR (EUCTR) | 01/02/2019 | 16/05/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Lithuania;Slovenia;Korea, Republic of;China;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Belarus;United States;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 543 | EUCTR2016-004677-40-HR (EUCTR) | 31/01/2019 | 16/05/2019 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 720 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 544 | EUCTR2017-004496-31-PL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Belgium;Brazil;Poland;Israel;Netherlands;Italy;Korea, Republic of | ||
| 545 | EUCTR2017-004997-32-NL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 546 | EUCTR2016-000642-62-SK (EUCTR) | 28/01/2019 | 28/01/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 547 | EUCTR2017-004092-31-HU (EUCTR) | 23/01/2019 | 15/06/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan | ||
| 548 | EUCTR2016-004676-22-DE (EUCTR) | 22/01/2019 | 15/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 549 | NCT03804931 (ClinicalTrials.gov) | January 20, 2019 | 6/1/2019 | Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Procedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone | Guangzhou First People's Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 120 | Phase 2/Phase 3 | China |
| 550 | EUCTR2016-000642-62-ES (EUCTR) | 17/01/2019 | 24/01/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 551 | EUCTR2016-004676-22-BE (EUCTR) | 14/01/2019 | 04/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 552 | NCT03650413 (ClinicalTrials.gov) | January 14, 2019 | 16/8/2018 | An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: UTTR1147A | Genentech, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 143 | Phase 2 | United States;Bulgaria;Georgia;Germany;Greece;Ireland;Italy;Moldova, Republic of;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France;Hungary;Israel;Netherlands |
| 553 | EUCTR2016-000642-62-CZ (EUCTR) | 14/01/2019 | 14/11/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 554 | EUCTR2017-004997-32-IT (EUCTR) | 10/01/2019 | 18/06/2021 | Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE - NA | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) Product Code: [NA] | GENENTECH, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 555 | EUCTR2017-004092-31-PL (EUCTR) | 08/01/2019 | 17/10/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Japan | ||
| 556 | NCT03679546 (ClinicalTrials.gov) | January 4, 2019 | 18/9/2018 | EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis | EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial | Ulcerative Colitis | Drug: Infliximab;Drug: Vedolizumab Injection | Rennes University Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 4 | France |
| 557 | EUCTR2017-004997-32-GB (EUCTR) | 04/01/2019 | 09/10/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States | ||
| 558 | EUCTR2018-000930-37-GB (EUCTR) | 03/01/2019 | 01/11/2018 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;France;Hungary;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Korea, Republic of | ||
| 559 | EUCTR2016-000642-62-AT (EUCTR) | 02/01/2019 | 30/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 560 | EUCTR2018-002925-47-ES (EUCTR) | 28/12/2018 | 16/11/2018 | prediction of response to therapy in inflammatory bowel disease | Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches | Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Vedolizumab INN or Proposed INN: VEDOLIZUMAB Other descriptive name: VEDOLIZUMAB | Fundación de Investigación Biomédica del Hospital Universitario de La Princesa | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 561 | EUCTR2018-000930-37-NL (EUCTR) | 21/12/2018 | 11/10/2018 | A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ravagalimab Product Code: ABBV-323 INN or Proposed INN: Not assigned Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Hungary;Canada;Spain;Germany;Netherlands;United Kingdom;Italy;Korea, Republic of | ||
| 562 | NCT03765450 (ClinicalTrials.gov) | December 21, 2018 | 4/12/2018 | Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis | Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab | Alimentiv Inc. | NULL | Recruiting | 18 Years | N/A | All | 30 | United States;Canada | |
| 563 | EUCTR2016-004676-22-GB (EUCTR) | 20/12/2018 | 03/07/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 564 | EUCTR2016-000642-62-HU (EUCTR) | 19/12/2018 | 08/01/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 565 | NCT03759041 (ClinicalTrials.gov) | December 19, 2018 | 27/11/2018 | A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis | ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Vancomycin Pre-Treatment;Drug: Placebo for Vancomycin Pre-Treatment;Drug: SER-287;Drug: Placebo for SER-287 | Seres Therapeutics, Inc. | NULL | Terminated | 18 Years | 80 Years | All | 203 | Phase 2 | United States;Canada |
| 566 | JPRN-JapicCTI-184131 | 18/12/2018 | 28/09/2018 | A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675] | Ulcerative Colitis | Intervention name : ABT-494 INN of the intervention : upadacitinib Dosage And administration of the intervention : Will be orally administered Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Will be orally administered | AbbVie GK | NULL | complete | 16 | 75 | BOTH | 45 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa, - |
| 567 | EUCTR2017-004496-31-FR (EUCTR) | 17/12/2018 | 14/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 568 | EUCTR2017-004997-32-IE (EUCTR) | 14/12/2018 | 13/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: efmarodocokin alfa INN or Proposed INN: efmarodocokin alfa Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 569 | EUCTR2016-000642-62-LV (EUCTR) | 13/12/2018 | 15/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Slovakia;Taiwan;Serbia;Belarus;United States;Portugal;Croatia;Germany;Norway;Japan;Sweden | ||
| 570 | EUCTR2018-000334-35-DE (EUCTR) | 12/12/2018 | 20/08/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 571 | EUCTR2017-004997-32-ES (EUCTR) | 10/12/2018 | 17/09/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 572 | EUCTR2017-002350-36-GB (EUCTR) | 10/12/2018 | 13/04/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 2 | Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States | ||
| 573 | NCT03574948 (ClinicalTrials.gov) | December 6, 2018 | 22/6/2018 | 5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores | Multicentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue Scores | Crohn Disease;Ulcerative Colitis;Fatigue;Remission | Drug: 5-HTP;Drug: Placebo oral capsule | University Hospital, Ghent | NULL | Completed | 18 Years | 60 Years | All | 175 | Phase 2 | Belgium |
| 574 | EUCTR2016-004677-40-DE (EUCTR) | 04/12/2018 | 26/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjectswith Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled InductionStudy to Evaluate the Efficacy and Safety of Risankizumab in Subjects withModerately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 575 | ChiCTR1800019676 | 2018-12-01 | 2018-11-22 | Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis | Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis: a single center, prospective cohort study | ulcerative colitis | Gold Standard:Histopathological examination;Index test:1, Gland density (grade) 2. Gland morphology (grade) 3. Vascular changes (grade); | Peking University First Hospital | NULL | Pending | 18 | 80 | Both | Target condition:40;Difficult condition:0 | China | |
| 576 | JPRN-UMIN000034016 | 2018/12/01 | 03/09/2018 | The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study | The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study | ulcerative colitis | Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema The continuation of concomitant treatment at the remission induction by budesonide form enema (control group) | Hyogo College of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 84 | Not selected | Japan |
| 577 | EUCTR2016-004677-40-BE (EUCTR) | 29/11/2018 | 04/04/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey | ||
| 578 | EUCTR2016-000642-62-NO (EUCTR) | 28/11/2018 | 15/10/2020 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil | ||
| 579 | NCT03662542 (ClinicalTrials.gov) | November 20, 2018 | 6/9/2018 | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 65 Years | All | 214 | Phase 2 | United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine |
| 580 | EUCTR2017-003238-96-DK (EUCTR) | 20/11/2018 | 09/10/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Austria;Turkey;Lithuania;Korea, Republic of;China;Latvia;Netherlands;Denmark;Australia;Malaysia;France;India;Italy;Switzerland;Israel;Russian Federation;Ireland;Ukraine;Spain;Slovakia;Taiwan;Saudi Arabia;United States;Serbia | ||
| 581 | EUCTR2017-003229-14-DK (EUCTR) | 20/11/2018 | 11/10/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly Cork Limited | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 582 | EUCTR2016-004676-22-DK (EUCTR) | 15/11/2018 | 02/05/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 583 | EUCTR2016-000642-62-FI (EUCTR) | 13/11/2018 | 16/10/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 584 | NCT03653026 (ClinicalTrials.gov) | November 12, 2018 | 28/8/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Upadacitinib (ABT-494);Drug: Placebo | AbbVie | NULL | Completed | 16 Years | 75 Years | All | 522 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Egypt;Ireland;Romania;Sweden |
| 585 | EUCTR2017-004496-31-BE (EUCTR) | 07/11/2018 | 25/07/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Brazil;Belgium;Israel;Netherlands;Italy;Korea, Republic of | ||
| 586 | EUCTR2017-004092-31-LV (EUCTR) | 02/11/2018 | 27/08/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan | ||
| 587 | EUCTR2018-000334-35-IT (EUCTR) | 30/10/2018 | 17/06/2021 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130(SPESOLIMAB) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials - - | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Australia;Norway;Germany | ||
| 588 | NCT03596645 (ClinicalTrials.gov) | October 29, 2018 | 13/7/2018 | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Drug: Infliximab | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan |
| 589 | NCT03648541 (ClinicalTrials.gov) | October 29, 2018 | 24/8/2018 | BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis | An Open Label, Long Term Safety Trial of BI 65513 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials | Colitis, Ulcerative | Drug: Spesolimab IV infusion;Drug: Spesolimab SC solution for injection | Boehringer Ingelheim | NULL | Active, not recruiting | 18 Years | N/A | All | 79 | Phase 2 | United States;Austria;Belgium;Canada;Germany;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom |
| 590 | NCT03558152 (ClinicalTrials.gov) | October 26, 2018 | 1/6/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC) | A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: UTTR1147A;Drug: UTTR1147A Placebo;Drug: Vedolizumab;Drug: Vedolizumab Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 195 | Phase 2 | United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France;Netherlands |
| 591 | EUCTR2016-004676-22-GR (EUCTR) | 26/10/2018 | 04/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Bulgaria;Germany;Japan;New Zealand;Sweden;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey | ||
| 592 | EUCTR2016-004677-40-GR (EUCTR) | 26/10/2018 | 04/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 720 | Phase 2;Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 593 | EUCTR2017-003238-96-AT (EUCTR) | 24/10/2018 | 22/06/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | Latvia;Netherlands;China;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 594 | EUCTR2017-003229-14-GB (EUCTR) | 24/10/2018 | 04/05/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 595 | EUCTR2017-003229-14-AT (EUCTR) | 24/10/2018 | 22/06/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 596 | EUCTR2017-004092-31-DK (EUCTR) | 23/10/2018 | 26/06/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 597 | EUCTR2017-003238-96-GB (EUCTR) | 22/10/2018 | 04/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 598 | EUCTR2018-000334-35-BE (EUCTR) | 22/10/2018 | 06/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany | ||
| 599 | EUCTR2018-000334-35-GB (EUCTR) | 22/10/2018 | 25/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim LImited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 600 | NCT03524092 (ClinicalTrials.gov) | October 19, 2018 | 10/5/2018 | A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2) | Ulcerative Colitis | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 18 Years | 80 Years | All | 1044 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil;Croatia;Saudi Arabia |
| 601 | EUCTR2017-000402-38-SE (EUCTR) | 19/10/2018 | 25/05/2018 | A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis | To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: no Male: yes | 250 | Phase 2 | United States;Portugal;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden | ||
| 602 | EUCTR2017-004496-31-ES (EUCTR) | 15/10/2018 | 28/08/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 603 | EUCTR2017-003238-96-DE (EUCTR) | 15/10/2018 | 03/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 604 | EUCTR2017-003229-14-DE (EUCTR) | 15/10/2018 | 30/04/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 605 | NCT02921555 (ClinicalTrials.gov) | October 11, 2018 | 22/9/2016 | Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis | Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. | Ulcerative Colitis | Drug: Methylprednisolone;Drug: Prednisone | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | NULL | Recruiting | 18 Years | N/A | All | 148 | Phase 4 | Spain |
| 606 | EUCTR2017-004092-31-NL (EUCTR) | 10/10/2018 | 01/06/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 607 | EUCTR2017-000574-11-EE (EUCTR) | 03/10/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 608 | EUCTR2017-002350-36-GR (EUCTR) | 03/10/2018 | 10/09/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 609 | EUCTR2016-004676-22-SE (EUCTR) | 02/10/2018 | 16/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 610 | EUCTR2016-004677-40-SE (EUCTR) | 02/10/2018 | 16/04/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 611 | EUCTR2017-002350-36-DE (EUCTR) | 27/09/2018 | 13/04/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 612 | EUCTR2017-003238-96-HU (EUCTR) | 27/09/2018 | 13/06/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Austria;Turkey;Lithuania;Korea, Republic of;China;Latvia;Netherlands;Denmark;Australia;Malaysia;France;India;Italy;Switzerland;Israel;Russian Federation;Ireland;Ukraine;Spain;Slovakia;Taiwan;Saudi Arabia;United States;Serbia | ||
| 613 | EUCTR2017-003229-14-HU (EUCTR) | 27/09/2018 | 15/06/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly Cork Limited | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan | ||
| 614 | EUCTR2016-004677-40-NL (EUCTR) | 26/09/2018 | 24/04/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 615 | NCT03606499 (ClinicalTrials.gov) | September 26, 2018 | 20/7/2018 | Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases | Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab | Janssen Cilag S.A.S. | NULL | Recruiting | 18 Years | N/A | All | 214 | France | |
| 616 | EUCTR2016-004676-22-NL (EUCTR) | 26/09/2018 | 02/05/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Portugal;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 617 | NCT03627052 (ClinicalTrials.gov) | September 20, 2018 | 8/8/2018 | A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: Itacitinib;Drug: Placebo | Incyte Corporation | NULL | Withdrawn | 18 Years | 74 Years | All | 0 | Phase 2 | United States |
| 618 | EUCTR2018-000334-35-ES (EUCTR) | 17/09/2018 | 17/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | ||
| 619 | EUCTR2017-004092-31-BE (EUCTR) | 13/09/2018 | 07/06/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 620 | EUCTR2018-002794-21-GB (EUCTR) | 11/09/2018 | 04/09/2018 | Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis | Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis - FAVOUR | Ulcerative colitis (UC) MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Vedolizumab Product Name: Vedolizumab | Guy's & St Thomas NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 621 | EUCTR2018-001051-12-FR (EUCTR) | 07/09/2018 | 19/04/2018 | VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis | VEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: ENTYVIO Product Code: 1 | CHU Saint-Etienne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 4 | France | ||
| 622 | EUCTR2017-003229-14-SK (EUCTR) | 06/09/2018 | 06/07/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan | ||
| 623 | EUCTR2017-003238-96-SK (EUCTR) | 04/09/2018 | 20/07/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 624 | EUCTR2018-002673-21-FR (EUCTR) | 04/09/2018 | 06/07/2018 | EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. | EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Entyvio Product Name: Vedolizumab Other descriptive name: VEDOLIZUMAB | Centre Hospitalier Universitaire de Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | France | ||
| 625 | EUCTR2016-004676-22-LV (EUCTR) | 30/08/2018 | 29/08/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 626 | EUCTR2017-004230-28-NL (EUCTR) | 30/08/2018 | 15/03/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 627 | EUCTR2017-003238-96-LV (EUCTR) | 30/08/2018 | 21/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | ||
| 628 | EUCTR2017-002350-36-IE (EUCTR) | 28/08/2018 | 16/04/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 629 | NCT03398135 (ClinicalTrials.gov) | August 28, 2018 | 8/1/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: risankizumab;Drug: placebo for risankizumab | AbbVie | NULL | Enrolling by invitation | 16 Years | 80 Years | All | 942 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Hungary |
| 630 | EUCTR2017-002350-36-NL (EUCTR) | 28/08/2018 | 24/04/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 2 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 631 | JPRN-JapicCTI-184008 | 28/8/2018 | 21/06/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066] | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066] | Ulcerative Colitis (UC) | Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | AbbVie GK | NULL | recruiting | 16 | 80 | BOTH | 70 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa |
| 632 | EUCTR2017-000573-37-EE (EUCTR) | 27/08/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United States;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 633 | NCT03452501 (ClinicalTrials.gov) | August 26, 2018 | 26/2/2018 | Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients | An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD | Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis | Drug: Infliximab | Hikma Pharmaceuticals LLC | NULL | Completed | 18 Years | N/A | All | 157 | Saudi Arabia | |
| 634 | EUCTR2016-004677-40-LT (EUCTR) | 23/08/2018 | 13/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 635 | EUCTR2016-004676-22-LT (EUCTR) | 23/08/2018 | 26/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 636 | EUCTR2017-003238-96-IT (EUCTR) | 22/08/2018 | 01/10/2021 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: N/A Product Name: mirikizumab Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: N/A Product Name: mirikizumab Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 637 | EUCTR2017-002350-36-BG (EUCTR) | 22/08/2018 | 28/05/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 638 | EUCTR2018-000334-35-AT (EUCTR) | 20/08/2018 | 09/07/2018 | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH&Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 639 | EUCTR2017-003238-96-CZ (EUCTR) | 16/08/2018 | 30/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 640 | EUCTR2017-003229-14-CZ (EUCTR) | 16/08/2018 | 30/05/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 641 | EUCTR2016-004677-40-SK (EUCTR) | 14/08/2018 | 05/04/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;Sweden;Japan;New Zealand;Germany;Bulgaria;Croatia;Romania;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Hungary;Czech Republic;Egypt;United Kingdom | ||
| 642 | EUCTR2016-004676-22-SK (EUCTR) | 14/08/2018 | 05/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 643 | NCT03546868 (ClinicalTrials.gov) | August 14, 2018 | 10/5/2018 | Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease | Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease. | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Drug: [18F]FSPG | Asan Foundation | NULL | Completed | 19 Years | 79 Years | All | 20 | Phase 2 | Korea, Republic of |
| 644 | EUCTR2017-003229-14-IT (EUCTR) | 13/08/2018 | 27/09/2021 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: n/A Product Name: mirikizumab Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 645 | NCT04718818 (ClinicalTrials.gov) | August 7, 2018 | 19/1/2021 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Brazikumab;Drug: Vedolizumab;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 80 Years | All | 225 | Phase 2 | United States;Canada;India;Korea, Republic of;Puerto Rico;Romania;Taiwan |
| 646 | NCT03616821 (ClinicalTrials.gov) | August 7, 2018 | 1/8/2018 | Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) | Ulcerative Colitis;IBD | Drug: Brazikumab;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 80 Years | All | 256 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 647 | EUCTR2017-003229-14-LV (EUCTR) | 03/08/2018 | 21/05/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan | ||
| 648 | EUCTR2016-004677-40-LV (EUCTR) | 03/08/2018 | 27/07/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 649 | JPRN-JapicCTI-184062 | 02/8/2018 | 10/08/2018 | I6T-MC-AMAP | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Mirikizumab administered subcutaneously (SC) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Eli Lilly Japan K.K. | NULL | complete | 18 | 80 | BOTH | 142 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Middle East |
| 650 | EUCTR2016-004676-22-IT (EUCTR) | 02/08/2018 | 21/01/2022 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 - na | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: [ABBV-006] INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 651 | EUCTR2017-003238-96-ES (EUCTR) | 01/08/2018 | 04/06/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 652 | ChiCTR2000038316 | 2018-08-01 | 2020-09-17 | Effect of ursodeoxycholic acid on ulcerative colitis and serumal IL-23, IL-17 and intestinal flora levels | Effect of ursodeoxycholic acid on ulcerative colitis and serumal IL-23, IL-17 and intestinal flora levels | Ulcerative colitis | control group:Mesalazine alone;trial group:Mesalazine and ursodeoxycholic acid soft capsule;Patients with mild bile reflux gastritis: ursodeoxycholic acid soft capsule;Healthy control group:Nil; | The 900th Hospital of PLA | NULL | Completed | 18 | 75 | Both | control group:20;trial group:20;Patients with mild bile reflux gastritis:20;Healthy control group:20; | Phase 4 | China |
| 653 | EUCTR2017-003238-96-BE (EUCTR) | 27/07/2018 | 07/06/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan | ||
| 654 | EUCTR2017-003229-14-BE (EUCTR) | 27/07/2018 | 08/06/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Japan;Germany;Croatia;Romania;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Lithuania;Korea, Republic of | ||
| 655 | EUCTR2015-001600-64-AT (EUCTR) | 25/07/2018 | 17/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 656 | EUCTR2017-002108-28-DE (EUCTR) | 25/07/2018 | 27/03/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of | ||
| 657 | EUCTR2017-000402-38-BE (EUCTR) | 25/07/2018 | 30/05/2018 | A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease | To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden | ||
| 658 | EUCTR2017-003703-22-NL (EUCTR) | 24/07/2018 | 05/03/2018 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Bosnia and Herzegovina | ||
| 659 | EUCTR2017-003238-96-NL (EUCTR) | 24/07/2018 | 14/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Phase 3 | Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;United States;Serbia;Croatia;Germany;Japan | ||
| 660 | EUCTR2017-003229-14-ES (EUCTR) | 24/07/2018 | 04/06/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 661 | EUCTR2015-001600-64-GR (EUCTR) | 23/07/2018 | 19/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 662 | EUCTR2015-000319-41-GR (EUCTR) | 23/07/2018 | 18/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 663 | NCT03519945 (ClinicalTrials.gov) | July 18, 2018 | 7/5/2018 | A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3 | Ulcerative Colitis | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 18 Years | 80 Years | All | 960 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Georgia;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Moldova, Republic of;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Croatia;Saudi Arabia |
| 664 | EUCTR2016-004676-22-PT (EUCTR) | 16/07/2018 | 02/07/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 665 | EUCTR2016-004677-40-PT (EUCTR) | 16/07/2018 | 01/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 666 | EUCTR2017-000402-38-ES (EUCTR) | 13/07/2018 | 25/07/2018 | A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis | To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Sweden | ||
| 667 | EUCTR2015-000319-41-ES (EUCTR) | 12/07/2018 | 21/05/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 668 | EUCTR2015-001600-64-ES (EUCTR) | 12/07/2018 | 21/05/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 669 | EUCTR2018-001546-33-GB (EUCTR) | 11/07/2018 | 14/05/2018 | The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease | IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0 | Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab | University Southampton Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 670 | NCT03860571 (ClinicalTrials.gov) | July 6, 2018 | 3/2/2019 | Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers | A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers | Ulcerative Colitis;Crohn Disease | Drug: BT-11 Placebo;Drug: BT-11 Active | Landos Biopharma Inc. | NULL | Completed | 18 Years | 65 Years | All | 70 | Phase 1 | United States |
| 671 | EUCTR2017-003238-96-LT (EUCTR) | 05/07/2018 | 31/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1044 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 672 | EUCTR2017-004092-31-LT (EUCTR) | 05/07/2018 | 25/05/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 960 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 673 | EUCTR2017-003229-14-LT (EUCTR) | 05/07/2018 | 31/05/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 674 | NCT03609905 (ClinicalTrials.gov) | July 1, 2018 | 1/6/2018 | Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis | A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients | Ulcerative Colitis (UC) | Biological: Adipose-cord mesenchymal stromal cells (A-MSCs);Other: Conventional drugs | Liaocheng People's Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 1/Phase 2 | China |
| 675 | NCT02469220 (ClinicalTrials.gov) | July 1, 2018 | 8/6/2015 | Diet Treatment of Patients With Ulcerative Colitis in Remission | Diet Treatment of Patients With Ulcerative Colitis in Remission | Ulcerative Colitis | Dietary Supplement: Low FODMAP;Dietary Supplement: Standardized FODMAP | Vendsyssel Hospital | NULL | Active, not recruiting | 18 Years | 70 Years | All | 19 | N/A | Denmark |
| 676 | ChiCTR1800016438 | 2018-06-30 | 2018-06-01 | Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitis | Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitis | ulcerative colitis | control:mesalazine 1 po qid;observation group:mesalazine 1 po qid; flupentixol-melitracen 1pill po tid; | Guiyang 1st People's Hospital | NULL | Pending | 15 | 75 | Both | control:30;observation group:30; | China | |
| 677 | EUCTR2016-004677-40-DK (EUCTR) | 28/06/2018 | 12/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 678 | EUCTR2016-002765-58-IT (EUCTR) | 28/06/2018 | 17/06/2021 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis - NA | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden | ||
| 679 | EUCTR2017-002274-39-NL (EUCTR) | 27/06/2018 | 19/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 680 | EUCTR2017-000574-11-BE (EUCTR) | 27/06/2018 | 14/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 681 | EUCTR2017-004967-11-FR (EUCTR) | 26/06/2018 | 06/04/2018 | Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis. | Poca - Poca | Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized MedDRA version: 20.1;Level: LLT;Classification code 10000638;Term: Active ileal inflammation;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: suspension de microbiote fécal Product Code: PRD5973697 | CHU Nantes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France | ||
| 682 | EUCTR2017-004092-31-GB (EUCTR) | 25/06/2018 | 14/05/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Turkey;Lithuania;Korea, Republic of;China;Moldova, Republic of;Latvia;Netherlands;Denmark;Australia;Malaysia;France;India;Switzerland;Italy;Israel;Russian Federation;Ireland;Ukraine;Spain;Slovakia;Taiwan;Saudi Arabia;United States;Serbia;Japan | ||
| 683 | EUCTR2016-004677-40-AT (EUCTR) | 25/06/2018 | 06/04/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 684 | EUCTR2016-004676-22-AT (EUCTR) | 25/06/2018 | 06/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 942 | Phase 3 | Czechia;Slovenia;Lithuania;Turkey;Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 685 | EUCTR2015-000319-41-LV (EUCTR) | 22/06/2018 | 13/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 686 | EUCTR2015-001600-64-LV (EUCTR) | 22/06/2018 | 13/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;Latvia;South Africa;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Germany;New Zealand | ||
| 687 | EUCTR2016-004677-40-ES (EUCTR) | 21/06/2018 | 17/04/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 720 | Phase 2;Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 688 | EUCTR2017-002350-36-HU (EUCTR) | 14/06/2018 | 19/04/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 689 | NCT04329481 (ClinicalTrials.gov) | June 12, 2018 | 29/3/2020 | The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients | The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients | Ulcerative Colitis;Crohn Disease;Inflammatory Bowel Diseases | Dietary Supplement: Mycodigest supplement | Tel-Aviv Sourasky Medical Center | NULL | Recruiting | 18 Years | 70 Years | All | 100 | N/A | Israel |
| 690 | EUCTR2017-000572-28-BE (EUCTR) | 08/06/2018 | 14/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 691 | NCT03504930 (ClinicalTrials.gov) | June 7, 2018 | 12/4/2018 | COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity. | COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity. | Ulcerative Colitis | Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis | Hospices Civils de Lyon | NULL | Recruiting | 13 Years | N/A | All | 330 | France | |
| 692 | EUCTR2016-004676-22-ES (EUCTR) | 05/06/2018 | 13/04/2018 | NA | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 693 | EUCTR2017-003284-35-ES (EUCTR) | 05/06/2018 | 09/04/2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - A follow-up study in patients with moderate to severe active ulcerative colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain | ||
| 694 | EUCTR2017-004230-28-DE (EUCTR) | 04/06/2018 | 31/01/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 695 | NCT03477032 (ClinicalTrials.gov) | June 1, 2018 | 19/3/2018 | FMT in Inflammatory Bowel Disease | Faecal Transplantation in Inflammatory Bowel Disease | Faecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic Colitis | Biological: Faecal Microbiota Transplantation | St Vincent's Hospital Melbourne | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Australia | |
| 696 | NCT04775732 (ClinicalTrials.gov) | June 1, 2018 | 25/2/2021 | Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease | Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic Trial | Crohn Disease;Ulcerative Colitis | Biological: infliximab therapeutic drug monitoring | Imelda GI Clinical Research Center | NULL | Completed | N/A | N/A | All | 187 | Phase 4 | Belgium |
| 697 | JPRN-JapicCTI-183997 | 29/5/2018 | 12/06/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067] | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067] | Ulcerative Colitis (UC) | Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | AbbVie GK | NULL | recruiting | 16 | 80 | BOTH | 65 | Phase 2-3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa |
| 698 | EUCTR2017-003228-54-ES (EUCTR) | 28/05/2018 | 09/04/2018 | A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis. | A Phase IIa (proof of concept), randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis. | Inflammatory Bowel disease, mild to moderate Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PBF-677 INN or Proposed INN: PBF-677 | PaloBiofarma S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Spain | ||
| 699 | EUCTR2015-000319-41-AT (EUCTR) | 25/05/2018 | 17/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 700 | EUCTR2017-000402-38-NL (EUCTR) | 24/05/2018 | 13/11/2017 | A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease | To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;New Zealand;Sweden | ||
| 701 | EUCTR2017-004230-28-IT (EUCTR) | 22/05/2018 | 05/11/2020 | BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - - | Moderate-to-severely active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: - Product Code: [BI 655130] Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Japan;Korea, Republic of;United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands | ||
| 702 | EUCTR2017-002108-28-IT (EUCTR) | 15/05/2018 | 22/01/2021 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: [PF-06687234] INN or Proposed INN: PF-06687234 | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Serbia;Saudi Arabia;Spain;Belgium;Korea, Democratic People's Republic of;Australia;Israel;Germany;Italy | ||
| 703 | EUCTR2017-003649-10-GB (EUCTR) | 15/05/2018 | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 704 | NCT03521232 (ClinicalTrials.gov) | May 15, 2018 | 17/4/2018 | A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis | A Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-Sigmoiditis | Ulcerative Colitis;Ulcerative Proctitis;Ulcerative Proctosigmoiditis | Drug: Niclosamide | First Wave Bio, Inc. | NULL | Recruiting | 18 Years | N/A | All | 56 | Phase 1/Phase 2 | Italy |
| 705 | EUCTR2017-002231-41-NL (EUCTR) | 14/05/2018 | 26/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary | ||
| 706 | EUCTR2017-002350-36-IT (EUCTR) | 10/05/2018 | 22/01/2021 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - NA | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio 300mg Product Name: RO7246311 Product Code: [RO7246311] INN or Proposed INN: Vedolizumab Product Name: NA Product Code: [UTTR1147A/RO7021610 (Active)] | GENENTECH, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 707 | NCT03565939 (ClinicalTrials.gov) | May 4, 2018 | 22/5/2018 | Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) | Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) | Ulcerative Colitis Chronic Moderate | Biological: Trichuris suis ova;Biological: Placebo | ParaTech A/S | NULL | Active, not recruiting | 18 Years | 75 Years | All | 119 | Phase 2 | Denmark |
| 708 | EUCTR2017-003703-22-GB (EUCTR) | 03/05/2018 | 31/01/2018 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium dihydrate Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium dihydrate Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina | ||
| 709 | EUCTR2017-003649-10-BE (EUCTR) | 02/05/2018 | 27/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 710 | EUCTR2017-003649-10-DE (EUCTR) | 30/04/2018 | 07/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 711 | NCT03594708 (ClinicalTrials.gov) | April 30, 2018 | 19/1/2018 | Immunonutrition in Ulcerative Colitis | Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplement | Baptist Memorial Health Care Corporation | NULL | Unknown status | 18 Years | N/A | All | 30 | N/A | United States |
| 712 | EUCTR2017-003703-22-ES (EUCTR) | 29/04/2018 | 20/02/2018 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom | ||
| 713 | EUCTR2017-000574-11-HR (EUCTR) | 27/04/2018 | 27/08/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 714 | EUCTR2017-000574-11-PT (EUCTR) | 23/04/2018 | 22/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 715 | EUCTR2017-000573-37-HR (EUCTR) | 23/04/2018 | 07/12/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Serbia;Portugal;Estonia;Slovakia;Greece | ||
| 716 | EUCTR2016-003708-29-BG (EUCTR) | 20/04/2018 | 17/01/2018 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 717 | EUCTR2017-000599-27-HR (EUCTR) | 20/04/2018 | 07/12/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 718 | EUCTR2017-000573-37-IT (EUCTR) | 19/04/2018 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,compared with placebo (dummy treatment) ¿ using a randomised andblinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel groupEfficacy and Safety Study of SHP647 as Maintenance Therapy in SubjectsWith Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: [SHP647] INN or Proposed INN: ontamalimab Product Code: [SHP647] INN or Proposed INN: ontamalimab | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 719 | EUCTR2017-000574-11-IT (EUCTR) | 19/04/2018 | 20/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: - Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: ontamalimab Trade Name: - Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: ontamalimab | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 720 | EUCTR2017-000599-27-IT (EUCTR) | 19/04/2018 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,compared with placebo (dummy treatment) ¿ using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects withModerate to Severe Ulcerative Colitis (FIGARO UC 301) - FIGARO UC 301 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: - Product Code: [SHP647] INN or Proposed INN: ontamalimab Product Name: - Product Code: [SHP647] INN or Proposed INN: ontamalimab | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Czechia;Slovenia;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 721 | NCT03209232 (ClinicalTrials.gov) | April 16, 2018 | 1/7/2017 | Infliximab Accelerated Induction in Moderate to Severe Pediatric UC | Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial | Ulcerative Colitis | Drug: Infliximab | Schneider Children's Medical Center, Israel | NULL | Terminated | 6 Years | 18 Years | All | 10 | N/A | Israel |
| 722 | EUCTR2017-002350-36-ES (EUCTR) | 15/04/2018 | 06/06/2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 723 | EUCTR2017-004230-28-GB (EUCTR) | 13/04/2018 | 01/02/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 724 | EUCTR2017-002274-39-GB (EUCTR) | 12/04/2018 | 20/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 725 | EUCTR2017-002108-28-ES (EUCTR) | 12/04/2018 | 20/04/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: Dekavil Other descriptive name: F8IL10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of | ||
| 726 | EUCTR2017-000599-27-DE (EUCTR) | 10/04/2018 | 24/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 727 | EUCTR2017-000574-11-DE (EUCTR) | 10/04/2018 | 25/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 728 | EUCTR2017-000573-37-DE (EUCTR) | 10/04/2018 | 24/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 729 | NCT03298022 (ClinicalTrials.gov) | April 10, 2018 | 27/9/2017 | Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis | Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial | Ulcerative Colitis | Biological: AbGn-168H | AbGenomics International, Inc. | NULL | Completed | 18 Years | 75 Years | All | 24 | Phase 2 | United States;Puerto Rico |
| 730 | EUCTR2017-004230-28-ES (EUCTR) | 09/04/2018 | 08/02/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 731 | EUCTR2017-003284-35-PL (EUCTR) | 06/04/2018 | 05/03/2018 | A follow-up study in patients with moderate to severe active ulcerative colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Belgium;Poland | ||
| 732 | JPRN-jRCTs041190010 | 06/04/2018 | 10/04/2019 | The usefulness of kestose for ulcerative colitis | The usefulness of kestose for ulcerative colitis | Ulcerative colitis | arm A Kestose(10g) every day 8 weeksar arm B Maltose(5g) every day 8 weeks | Honda Takashi | NULL | Recruiting | >= 20age old | <= 80age old | Both | 40 | N/A | Japan |
| 733 | EUCTR2016-004112-35-SE (EUCTR) | 04/04/2018 | 21/06/2017 | A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel disease | Low-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study | Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imurel Product Name: Azathioprine Product Code: NA Trade Name: Allopurinol Product Name: Allopurinol Product Code: NA | SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Sweden | ||
| 734 | NCT03290781 (ClinicalTrials.gov) | April 4, 2018 | 6/9/2017 | An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) | Ulcerative Colitis | Drug: Ontamalimab;Other: Placebo | Shire | NULL | Completed | 16 Years | 81 Years | All | 366 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;France |
| 735 | EUCTR2017-002108-28-BE (EUCTR) | 30/03/2018 | 22/03/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of | ||
| 736 | EUCTR2016-000641-31-BE (EUCTR) | 29/03/2018 | 31/10/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel | ||
| 737 | NCT03482635 (ClinicalTrials.gov) | March 27, 2018 | 15/3/2018 | BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy | Colitis, Ulcerative | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 98 | Phase 2/Phase 3 | United States;Austria;Belgium;Canada;Germany;Greece;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Australia;Czechia;Denmark;Hungary;Norway |
| 738 | NCT03478956 (ClinicalTrials.gov) | March 27, 2018 | 26/3/2018 | A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease | A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Etrolizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 4 Years | 17 Years | All | 24 | Phase 1 | Belgium;Poland;Spain;United Kingdom;Germany;United States |
| 739 | EUCTR2017-003524-75-NL (EUCTR) | 27/03/2018 | 19/02/2018 | Mesenchymal Stromal Cells for the treatment of Ulcerative Colitis | Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in Ulcerative Colitis - BMMSCproctitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Mesenchymal stromal cells Product Code: MSC INN or Proposed INN: n.a. Other descriptive name: MESENCHYMAL CELLS | Leiden University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 14 | Phase 2 | Netherlands | ||
| 740 | NCT03581149 (ClinicalTrials.gov) | March 26, 2018 | 27/3/2018 | Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients | Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial | Ulcerative Colitis | Drug: Sodium Picosulfate/Magnesium Citrate Laxative;Drug: 2L polyethylene glycol/ascorbic acid | American University of Beirut Medical Center | NULL | Recruiting | 18 Years | 65 Years | All | 68 | Phase 4 | Lebanon |
| 741 | EUCTR2017-002182-21-NL (EUCTR) | 20/03/2018 | 28/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom | ||
| 742 | NCT04969679 (ClinicalTrials.gov) | March 16, 2018 | 7/7/2021 | Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment. | A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment. | Ulcerative Colitis | Drug: E. coli Nissle 1917 (Mutaflor®);Drug: Placebo | Kangbuk Samsung Hospital | NULL | Completed | 19 Years | N/A | All | 134 | Phase 4 | Korea, Republic of |
| 743 | NCT03341962 (ClinicalTrials.gov) | March 15, 2018 | 8/11/2017 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis | Ulcerative Colitis | Drug: IMU-838;Drug: Placebo | Immunic AG | NULL | Active, not recruiting | 18 Years | 80 Years | All | 263 | Phase 2 | United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Netherlands;North Macedonia;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 744 | EUCTR2017-000573-37-NL (EUCTR) | 15/03/2018 | 02/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 745 | EUCTR2017-000599-27-NL (EUCTR) | 15/03/2018 | 02/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 746 | EUCTR2017-000574-11-NL (EUCTR) | 15/03/2018 | 02/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 747 | NCT03518086 (ClinicalTrials.gov) | March 15, 2018 | 4/5/2018 | An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) | Ulcerative Colitis | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 18 Years | 80 Years | All | 1281 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil |
| 748 | JPRN-JapicCTI-173803 | 14/3/2018 | 08/12/2017 | Maintenance phase study of MD-0901 in pediatric ulcerative colitis. | The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with ulcerative colitis in remission. | Ulcerative colitis in remission | Intervention name : MD-0901 INN of the intervention : mesalazine Dosage And administration of the intervention : Mesalazine 40 mg/day are administrated orally once daily after breakfast for 48 weeks. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | MOCHIDA PHARMACEUTICAL CO., LTD | NULL | complete | 16 | BOTH | 26 | Phase 2-3 | Japan | |
| 749 | EUCTR2017-000573-37-PT (EUCTR) | 13/03/2018 | 21/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 772 | Phase 3 | Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Turkey;Lithuania;Czechia;Bosnia and Herzegovina;Korea, Republic of;Netherlands;South Africa;Australia;France;Italy;Switzerland;Colombia;Israel;Russian Federation;Lebanon;Ireland;Ukraine;Spain;Greece;Slovakia;Estonia;United States;Serbia;Portugal | ||
| 750 | EUCTR2017-000572-28-PT (EUCTR) | 13/03/2018 | 22/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 751 | EUCTR2017-000574-11-IE (EUCTR) | 13/03/2018 | 04/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 752 | EUCTR2017-000573-37-IE (EUCTR) | 13/03/2018 | 04/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 753 | EUCTR2017-004230-28-BE (EUCTR) | 09/03/2018 | 22/01/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 754 | NCT03444311 (ClinicalTrials.gov) | March 8, 2018 | 8/2/2018 | Combined Nutritional Therapies for the Treatment of Ulcerative Colitis | Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota. | Colitis, Ulcerative | Dietary Supplement: A: 1 dosis;Dietary Supplement: B: 2 dosis | AB Biotics, SA | NULL | Terminated | 18 Years | 65 Years | All | 12 | N/A | Spain |
| 755 | EUCTR2017-000573-37-GB (EUCTR) | 07/03/2018 | 25/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 772 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 756 | NCT03398148 (ClinicalTrials.gov) | March 7, 2018 | 8/1/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: risankizumab IV;Drug: placebo for risankizumab;Drug: risankizumab SC | AbbVie | NULL | Recruiting | 16 Years | 80 Years | All | 1547 | Phase 2/Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Hungary |
| 757 | EUCTR2017-000599-27-GB (EUCTR) | 07/03/2018 | 05/12/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan | ||
| 758 | EUCTR2017-000574-11-GB (EUCTR) | 06/03/2018 | 21/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 759 | NCT03412682 (ClinicalTrials.gov) | March 2, 2018 | 22/1/2018 | To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis | A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects | Colitis, Ulcerative | Drug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg) | Ferring Pharmaceuticals | NULL | Completed | 16 Years | 75 Years | All | 274 | Phase 3 | Japan |
| 760 | NCT03460847 (ClinicalTrials.gov) | March 1, 2018 | 22/2/2018 | Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa | Can Fecal Microbiota Alterations Predict a Refractory Disease Course to Standard Steroid Therapy in Patients With Active Ulcerative Colitis? | Colitis, Ulcerative | Drug: Steroids | Medical University of Graz | NULL | Completed | 18 Years | N/A | All | 114 | Austria | |
| 761 | NCT03378921 (ClinicalTrials.gov) | February 27, 2018 | 11/12/2017 | Fecal Microbiota Transplantation in the Treatment of Pouchitis | Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis | Pouchitis;Ulcerative Colitis | Biological: Fecal microbiota transplantation;Biological: Placebo | Helsinki University Central Hospital | NULL | Completed | 18 Years | 75 Years | All | 26 | Phase 2 | Finland |
| 762 | NCT03283085 (ClinicalTrials.gov) | February 27, 2018 | 12/9/2017 | A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) | Crohn's Disease;Ulcerative Colitis | Drug: 25 mg Ontamalimab;Drug: 75 mg Ontamalimab | Shire | NULL | Recruiting | 16 Years | 80 Years | All | 451 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 763 | EUCTR2017-004230-28-AT (EUCTR) | 27/02/2018 | 18/01/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 764 | EUCTR2017-000573-37-CZ (EUCTR) | 27/02/2018 | 01/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 765 | EUCTR2017-000599-27-CZ (EUCTR) | 26/02/2018 | 01/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 766 | NCT03801928 (ClinicalTrials.gov) | February 23, 2018 | 11/12/2018 | Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease | OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA | Inflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Drug: Inflectra | Pfizer | NULL | Completed | 18 Years | N/A | All | 118 | United States;Canada | |
| 767 | EUCTR2017-000937-30-AT (EUCTR) | 22/02/2018 | 03/01/2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 768 | EUCTR2016-004217-26-IT (EUCTR) | 22/02/2018 | 22/02/2018 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMs0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | INDEX PHARMACEUTICALS AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Phase 2 | Serbia;Spain;Ukraine;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Germany;Sweden | ||
| 769 | EUCTR2017-002274-39-BE (EUCTR) | 22/02/2018 | 18/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 770 | NCT03849599 (ClinicalTrials.gov) | February 21, 2018 | 17/2/2019 | A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: PRV-300;Biological: Placebo | Provention Bio, Inc. | NULL | Completed | 18 Years | 75 Years | All | 37 | Phase 1 | Georgia;Moldova, Republic of;Ukraine |
| 771 | EUCTR2017-002274-39-IT (EUCTR) | 20/02/2018 | 12/02/2021 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLELGROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION - NA | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 772 | EUCTR2017-000572-28-FR (EUCTR) | 16/02/2018 | 16/02/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 773 | EUCTR2017-000572-28-ES (EUCTR) | 16/02/2018 | 19/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 774 | EUCTR2017-000574-11-ES (EUCTR) | 16/02/2018 | 19/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis (AIDA) - AIDA | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1114 | Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 775 | EUCTR2017-000573-37-ES (EUCTR) | 16/02/2018 | 19/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 776 | NCT03259334 (ClinicalTrials.gov) | February 9, 2018 | 21/8/2017 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative Colitis | Drug: Ontamalimab;Other: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 380 | Phase 3 | United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom |
| 777 | JPRN-UMIN000030000 | 2018/02/07 | 01/12/2017 | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis. | ulcerative colitispouchitis | Topical budesonido 2weeks of 2mg daily Topical prednisolone 2weeks 20mg daily Topical aminosalicylate 2weeks 1g daily | Department of Inflammatory Bowel DiseaseHyogo College of Medicine | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 30 | Phase 1 | Japan |
| 778 | NCT03235752 (ClinicalTrials.gov) | February 6, 2018 | 28/7/2017 | Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis | A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: TJ301 300mg;Drug: TJ301 600mg;Drug: Placebo | I-Mab Biopharma HongKong Limited | NULL | Recruiting | 18 Years | 70 Years | All | 90 | Phase 2 | Australia;China;Korea, Republic of;Taiwan |
| 779 | EUCTR2017-004772-65-DK (EUCTR) | 05/02/2018 | 04/12/2017 | Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) | Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTO | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TSO INN or Proposed INN: TSO Other descriptive name: SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML | ParaTech A/S | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Denmark | ||
| 780 | NCT03358706 (ClinicalTrials.gov) | February 2, 2018 | 27/11/2017 | A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis | A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis. | Crohn Disease;Ulcerative Colitis | Drug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mg | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 57 | Phase 1 | United States;Belgium;Germany;United Kingdom;Austria;Denmark;Sweden |
| 781 | JPRN-UMIN000030988 | 2018/02/01 | 01/02/2018 | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy | Ulcerative Colitis | Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab | Sakura Medical Center, Toho university | NULL | Pending | 15years-old | Not applicable | Male and Female | 53 | Not applicable | Japan | |
| 782 | NCT03059849 (ClinicalTrials.gov) | February 1, 2018 | 13/2/2017 | Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD | Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD | Crohn Disease;Ulcerative Colitis | Drug: Adalimumab | McMaster University | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 4 | NULL |
| 783 | JPRN-JapicCTI-173802 | 30/1/2018 | 08/12/2017 | Active phase study of MD-0901 in pediatric ulcerative colitis. | The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis. | Mildly to moderately active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : mesalazine Dosage And administration of the intervention : Mesalazine 80 mg/day are administrated orally once daily after breakfast for 8 weeks. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | MOCHIDA PHARMACEUTICAL CO., LTD | NULL | complete | 16 | BOTH | 26 | Phase 2-3 | Japan | |
| 784 | EUCTR2017-000573-37-LT (EUCTR) | 30/01/2018 | 31/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 785 | EUCTR2017-000599-27-LT (EUCTR) | 30/01/2018 | 31/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Czechia;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 786 | EUCTR2017-000574-11-LT (EUCTR) | 30/01/2018 | 31/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Portugal;Serbia;Estonia;Slovakia | ||
| 787 | EUCTR2017-000402-38-PT (EUCTR) | 29/01/2018 | 13/11/2017 | A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease | To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: no Male: yes | 250 | Phase 2 | Portugal;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden | ||
| 788 | EUCTR2017-000573-37-BG (EUCTR) | 24/01/2018 | 22/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 789 | EUCTR2017-000402-38-DE (EUCTR) | 23/01/2018 | 27/10/2017 | A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease | To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | United States;Portugal;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden | ||
| 790 | EUCTR2017-000574-11-HU (EUCTR) | 23/01/2018 | 27/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 791 | EUCTR2013-001744-65-BE (EUCTR) | 23/01/2018 | 27/02/2017 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 792 | EUCTR2017-000573-37-HU (EUCTR) | 22/01/2018 | 23/01/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 793 | EUCTR2017-000572-28-HU (EUCTR) | 22/01/2018 | 27/10/2017 | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 794 | EUCTR2017-000402-38-AT (EUCTR) | 19/01/2018 | 30/10/2017 | A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease | To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: no Male: yes | 250 | Phase 2 | United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden | ||
| 795 | EUCTR2017-000402-38-GB (EUCTR) | 19/01/2018 | 23/10/2017 | A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease | To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 250 | Phase 2 | United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden | ||
| 796 | EUCTR2017-000572-28-BG (EUCTR) | 19/01/2018 | 24/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 797 | EUCTR2017-002182-21-PL (EUCTR) | 17/01/2018 | 13/10/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 798 | EUCTR2017-002231-41-PL (EUCTR) | 17/01/2018 | 13/10/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 799 | EUCTR2017-002274-39-CZ (EUCTR) | 16/01/2018 | 14/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 800 | EUCTR2017-002231-41-BE (EUCTR) | 10/01/2018 | 14/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 801 | EUCTR2013-001744-65-DE (EUCTR) | 10/01/2018 | 20/02/2017 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 802 | EUCTR2017-002182-21-BE (EUCTR) | 10/01/2018 | 14/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 803 | EUCTR2017-000574-11-BG (EUCTR) | 04/01/2018 | 24/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil | ||
| 804 | EUCTR2017-002274-39-AT (EUCTR) | 04/01/2018 | 20/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 805 | EUCTR2017-003284-35-HU (EUCTR) | 03/01/2018 | 22/11/2017 | A follow-up study in patients with moderate to severe active ulcerative colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium | ||
| 806 | NCT03394586 (ClinicalTrials.gov) | January 1, 2018 | 28/12/2017 | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Ulcerative Colitis;Flare Up, Symptom | Drug: Exposure to golimumab | University of Zurich | NULL | Unknown status | N/A | N/A | All | 100 | Switzerland | |
| 807 | ChiCTR2100043797 | 2018-01-01 | 2021-02-28 | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | Ulcerative colitis | Case series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.; | Department of Gastroenterology, Jinan Central Hospital | NULL | Completed | 21 | 81 | Both | Case series:28; | N/A | China |
| 808 | NCT03309865 (ClinicalTrials.gov) | December 25, 2017 | 7/10/2017 | Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis. | A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis. | Ulcerative Colitis;Dietary Modification | Dietary Supplement: semi-vegetarian diet;Drug: Vedolizumab Injection | Mayo Clinic | NULL | Withdrawn | 18 Years | N/A | All | 0 | Early Phase 1 | United States |
| 809 | EUCTR2017-000573-37-AT (EUCTR) | 22/12/2017 | 30/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 810 | EUCTR2017-000599-27-AT (EUCTR) | 22/12/2017 | 30/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | ||
| 811 | EUCTR2017-000574-11-AT (EUCTR) | 22/12/2017 | 30/10/2017 | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 812 | EUCTR2017-002274-39-HU (EUCTR) | 21/12/2017 | 19/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 813 | EUCTR2017-002274-39-ES (EUCTR) | 21/12/2017 | 22/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 814 | NCT03269695 (ClinicalTrials.gov) | December 20, 2017 | 30/8/2017 | Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) | Ulcerative Colitis | Drug: PF-06687234;Drug: Placebo | Pfizer | NULL | Terminated | 18 Years | 75 Years | All | 20 | Phase 2 | United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain |
| 815 | EUCTR2014-001594-14-DE (EUCTR) | 19/12/2017 | 22/09/2014 | Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site | Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: FITC-Adalimumab Product Code: FITC-Adalimumab INN or Proposed INN: FITC-Adalimumab Other descriptive name: FITC-ADALIMUMAB | Universitätsklinikum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 1;Phase 2 | Germany | ||
| 816 | EUCTR2017-003284-35-BE (EUCTR) | 19/12/2017 | 09/11/2017 | A follow-up study in patients with moderate to severe active ulcerative colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium | ||
| 817 | EUCTR2017-002182-21-DE (EUCTR) | 18/12/2017 | 13/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 818 | EUCTR2017-002182-21-FR (EUCTR) | 18/12/2017 | 15/12/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 819 | EUCTR2017-002231-41-DE (EUCTR) | 18/12/2017 | 14/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 820 | JPRN-jRCTs041180035 | 15/12/2017 | 31/01/2019 | Dual center study of pCLE for UCAN | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia | suspected ulcerative colitis-associated neoplasia | pCLE after intravenous administration of fluorescein | Ohmiya Naoki | NULL | Recruiting | >= 20age old | < 80age old | Both | 30 | N/A | Japan |
| 821 | EUCTR2017-000572-28-SK (EUCTR) | 13/12/2017 | 21/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina | ||
| 822 | EUCTR2017-000937-30-PL (EUCTR) | 13/12/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Belgium;Poland;Austria;Germany | ||
| 823 | EUCTR2017-000574-11-SK (EUCTR) | 13/12/2017 | 21/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 824 | EUCTR2017-000573-37-GR (EUCTR) | 11/12/2017 | 01/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 825 | EUCTR2017-000572-28-GR (EUCTR) | 11/12/2017 | 28/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 826 | EUCTR2017-000573-37-SK (EUCTR) | 08/12/2017 | 21/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 827 | EUCTR2017-002274-39-SK (EUCTR) | 08/12/2017 | 27/10/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 828 | NCT03259308 (ClinicalTrials.gov) | December 5, 2017 | 21/8/2017 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis | Drug: Ontamalimab;Drug: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 279 | Phase 3 | United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Turkey;Ukraine;France |
| 829 | NCT02559713 (ClinicalTrials.gov) | November 29, 2017 | 23/9/2015 | Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease | An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | N/A | Female | 11 | Phase 4 | United States |
| 830 | EUCTR2017-000937-30-ES (EUCTR) | 27/11/2017 | 10/10/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Poland;Belgium;Spain;Austria;Germany | ||
| 831 | EUCTR2015-005753-12-GB (EUCTR) | 22/11/2017 | 02/08/2018 | A research study looking at faecal transplant as a treatment for ulcerative colitis, and the best way to use it in children and adults with the condition | Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis. - STOP-Colitis Pilot Trial | Ulcerative colitis for at least 3 months prior to trial entry;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Faecal Microbiota Transplant Product Code: FMT INN or Proposed INN: faecal matter | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | United Kingdom | ||
| 832 | EUCTR2016-000420-26-BG (EUCTR) | 17/11/2017 | 19/04/2017 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy | ||
| 833 | NCT03281304 (ClinicalTrials.gov) | November 16, 2017 | 11/9/2017 | A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative Colitis | Drug: CP-690,500 5 mg;Drug: CP-690,550 10 mg | Pfizer | NULL | Active, not recruiting | 18 Years | N/A | All | 141 | Phase 4 | United States;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom |
| 834 | EUCTR2017-002182-21-GB (EUCTR) | 16/11/2017 | 11/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 835 | EUCTR2017-002231-41-GB (EUCTR) | 15/11/2017 | 11/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 836 | EUCTR2015-001346-29-CZ (EUCTR) | 13/11/2017 | 03/06/2016 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden | ||
| 837 | EUCTR2016-003708-29-NL (EUCTR) | 09/11/2017 | 19/07/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | Serbia;Slovakia;Spain;Ukraine;Ireland;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of;United States | ||
| 838 | EUCTR2017-000937-30-FR (EUCTR) | 07/11/2017 | 19/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 839 | EUCTR2016-002765-58-NL (EUCTR) | 06/11/2017 | 16/08/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 840 | EUCTR2016-001392-78-NL (EUCTR) | 06/11/2017 | 16/08/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 841 | EUCTR2017-002182-21-HU (EUCTR) | 25/10/2017 | 12/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 842 | EUCTR2017-002231-41-HU (EUCTR) | 25/10/2017 | 19/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 843 | EUCTR2013-004278-88-PL (EUCTR) | 24/10/2017 | 09/09/2017 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 605 | Phase 3 | Korea, Republic of;Germany;Netherlands;Denmark;Australia;Romania;Brazil;Belgium;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;France;United Kingdom;Switzerland;Italy;Israel;Austria;Lithuania;Spain;Greece;United States | ||
| 844 | EUCTR2016-001170-15-ES (EUCTR) | 19/10/2017 | 02/08/2017 | Intravenous corticosteroids in moderate ulcerative colitis | Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM | Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Urbason INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Spain | ||
| 845 | EUCTR2016-002691-27-NL (EUCTR) | 19/10/2017 | 01/06/2017 | An open label study to study changes in the structure of the mucosa of the bowel in subjects during treatment with tofacitinib for moderate to severe ulcerative colitis | An open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis - TOFA-histo | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz 5 mg film-coated tablets | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Netherlands | ||
| 846 | EUCTR2014-005443-40-HU (EUCTR) | 13/10/2017 | 30/08/2017 | An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of ulcerative colitis versus subject with longer exisiting ulcerative colitis | An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) - LOVE-UC | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Hungary;Belgium;Netherlands | ||
| 847 | NCT03172195 (ClinicalTrials.gov) | October 11, 2017 | 23/5/2017 | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | Colitis, Ulcerative | Procedure: rectosigmoidoscopy;Biological: biopsies;Biological: blood sample | Centre Hospitalier Universitaire de Saint Etienne | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | France |
| 848 | EUCTR2017-000937-30-DE (EUCTR) | 10/10/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 849 | NCT03093259 (ClinicalTrials.gov) | October 1, 2017 | 17/3/2017 | ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids | Ulcerative Colitis | Drug: ABX464;Drug: Placebo oral capsule | Abivax S.A. | NULL | Completed | 18 Years | 70 Years | All | 32 | Phase 2 | Belgium |
| 850 | EUCTR2017-000937-30-BE (EUCTR) | 29/09/2017 | 03/08/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 851 | EUCTR2017-001389-10-GB (EUCTR) | 28/09/2017 | 17/08/2017 | Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial | A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO | Acute Severe Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Anakinra Product Name: Anakinra Product Code: N/A INN or Proposed INN: Anakinra | Cambridge University Hospitals NHS Foundation Trust & University of Cambridge | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 214 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 852 | EUCTR2016-004217-26-SE (EUCTR) | 20/09/2017 | 03/03/2017 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden | ||
| 853 | EUCTR2016-003708-29-IT (EUCTR) | 01/09/2017 | 22/01/2021 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 10 mg Product Code: [PF-06651600 10 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06651600 50 mg Product Code: [PF-06651600 50 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg Product Code: [PF-06700841 5 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg Product Code: [PF-06700841 25 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 854 | EUCTR2016-000641-31-HR (EUCTR) | 21/08/2017 | 06/11/2017 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 855 | EUCTR2016-000674-38-HR (EUCTR) | 21/08/2017 | 06/11/2017 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;Serbia;Belarus;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 856 | EUCTR2016-003708-29-DE (EUCTR) | 07/08/2017 | 24/04/2017 | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 857 | EUCTR2016-003708-29-AT (EUCTR) | 07/08/2017 | 24/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 858 | NCT03221036 (ClinicalTrials.gov) | August 3, 2017 | 14/7/2017 | Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis | Drug: Vedolizumab IV;Drug: Placebo | Takeda | NULL | Recruiting | 18 Years | 80 Years | All | 302 | Phase 3 | China |
| 859 | NCT03162432 (ClinicalTrials.gov) | August 1, 2017 | 15/5/2017 | High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade | High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade | IBD;Ulcerative Colitis;Crohn Disease | Drug: Vitamin D3 | Boston Children's Hospital | NULL | Completed | 7 Years | 25 Years | All | 50 | Phase 3 | United States |
| 860 | EUCTR2016-004572-21-DE (EUCTR) | 26/07/2017 | 24/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Denmark;Netherlands;Norway;Germany;United Kingdom | ||
| 861 | EUCTR2017-001374-42-GB (EUCTR) | 21/07/2017 | 19/07/2017 | Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis | Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVEL | Ulcerative Colitis (UC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab | Guy's and St Thomas' NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 862 | EUCTR2017-000100-20-GB (EUCTR) | 17/07/2017 | 14/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;United Kingdom | ||
| 863 | EUCTR2016-003708-29-HU (EUCTR) | 30/06/2017 | 11/05/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 864 | EUCTR2016-003708-29-DK (EUCTR) | 27/06/2017 | 21/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 865 | EUCTR2016-002765-58-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 866 | EUCTR2016-001392-78-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Georgia;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Singapore;Belgium | ||
| 867 | JPRN-UMIN000026175 | 2017/06/23 | 01/03/2017 | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis | Ulcerative colitis | Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa . PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part . | Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University | NULL | Complete: follow-up complete | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan |
| 868 | EUCTR2016-003452-75-NL (EUCTR) | 23/06/2017 | 04/01/2017 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina | ||
| 869 | EUCTR2016-004217-26-FR (EUCTR) | 22/06/2017 | 31/08/2017 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden | ||
| 870 | EUCTR2016-004572-21-NL (EUCTR) | 21/06/2017 | 28/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV Netherlands | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Germany;Norway;Netherlands;United Kingdom | ||
| 871 | NCT03178669 (ClinicalTrials.gov) | June 21, 2017 | 5/6/2017 | The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | Ulcerative Colitis | Drug: cobitolimod;Drug: Placebo | InDex Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 213 | Phase 2 | Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine |
| 872 | NCT03122613 (ClinicalTrials.gov) | June 19, 2017 | 7/4/2017 | Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis | A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis | Ulcerative Colitis in Remission | Dietary Supplement: Curcumin;Drug: Placebo | Chinese University of Hong Kong | NULL | Recruiting | 18 Years | N/A | All | 172 | N/A | Hong Kong |
| 873 | EUCTR2016-000674-38-IE (EUCTR) | 19/06/2017 | 04/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 874 | EUCTR2016-004572-21-GB (EUCTR) | 09/06/2017 | 26/04/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway;United Kingdom | ||
| 875 | EUCTR2016-004217-26-CZ (EUCTR) | 09/06/2017 | 31/03/2017 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden | ||
| 876 | EUCTR2016-004217-26-ES (EUCTR) | 08/06/2017 | 10/03/2017 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden | ||
| 877 | EUCTR2016-004572-21-DK (EUCTR) | 07/06/2017 | 09/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway;United Kingdom | ||
| 878 | EUCTR2016-003708-29-PL (EUCTR) | 07/06/2017 | 26/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 879 | NCT03123120 (ClinicalTrials.gov) | June 7, 2017 | 13/4/2017 | A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy | Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy | Colitis, Ulcerative | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 22 | Phase 2 | Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland |
| 880 | EUCTR2016-003708-29-LT (EUCTR) | 06/06/2017 | 18/04/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 881 | EUCTR2017-000100-20-DE (EUCTR) | 06/06/2017 | 09/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;United Kingdom | ||
| 882 | EUCTR2016-001392-78-NO (EUCTR) | 31/05/2017 | 13/05/2019 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Italy;United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Iceland;New Zealand;Japan;Sweden | ||
| 883 | JPRN-UMIN000027465 | 2017/05/29 | 24/05/2017 | Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis | Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients | ulcerative colitis | Infliximab (5mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months) | University of Toyama | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 884 | EUCTR2016-004572-21-NO (EUCTR) | 24/05/2017 | 14/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Norway KS | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;United Kingdom;Norway;Germany;Netherlands | ||
| 885 | EUCTR2016-001392-78-SE (EUCTR) | 24/05/2017 | 12/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 886 | EUCTR2016-002765-58-SE (EUCTR) | 24/05/2017 | 12/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Portugal;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 887 | NCT03705117 (ClinicalTrials.gov) | May 23, 2017 | 9/10/2018 | Open-label V565 Target Engagement Study | An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565 | Ulcerative Colitis | Biological: V565 | VHsquared Ltd. | NULL | Completed | 18 Years | 75 Years | All | 5 | Phase 1 | United Kingdom |
| 888 | NCT03100864 (ClinicalTrials.gov) | May 22, 2017 | 31/3/2017 | This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC) | Colitis, Ulcerative | Drug: Spesolimab | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 8 | Phase 2 | Belgium;Germany;United Kingdom |
| 889 | EUCTR2016-000641-31-FR (EUCTR) | 22/05/2017 | 02/06/2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 890 | EUCTR2016-003708-29-ES (EUCTR) | 22/05/2017 | 31/05/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | Serbia;United States;Philippines;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of | ||
| 891 | EUCTR2016-001158-16-NL (EUCTR) | 17/05/2017 | 01/06/2017 | Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: PF-06480605 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;France;Poland;Belgium;Netherlands;Italy;Korea, Republic of | ||
| 892 | EUCTR2015-001942-28-FR (EUCTR) | 16/05/2017 | 02/12/2015 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand | ||
| 893 | EUCTR2017-000330-61-ES (EUCTR) | 16/05/2017 | 07/04/2017 | Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study | Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study - BeCalCU | Clinically inactive Ulcerative Colitis at risk of relapse MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Clipper Product Name: Beclometasone dipropionate INN or Proposed INN: BECLOMETASONE DIPROPIONATE | CHIESI ESPAÑA S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Spain | |||
| 894 | NCT03327558 (ClinicalTrials.gov) | May 15, 2017 | 26/10/2017 | Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects | Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects | Ulcerative Colitis | Drug: Apriso 0.375G ER CAP;Drug: APRISO 375 mg extended-release capsules | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 60 | Phase 1 | United States |
| 895 | EUCTR2016-004572-21-ES (EUCTR) | 11/05/2017 | 31/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway | ||
| 896 | EUCTR2016-003452-75-HR (EUCTR) | 11/05/2017 | 07/06/2017 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina | ||
| 897 | EUCTR2017-000100-20-BE (EUCTR) | 08/05/2017 | 17/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Belgium;Germany;United Kingdom | ||
| 898 | EUCTR2016-002765-58-GR (EUCTR) | 05/05/2017 | 14/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 899 | NCT03103412 (ClinicalTrials.gov) | May 4, 2017 | 24/3/2017 | TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects | Drug: TD-3504;Drug: 15N2-tofacitinib;Drug: Placebo | Theravance Biopharma | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | United States |
| 900 | EUCTR2016-001392-78-IS (EUCTR) | 24/04/2017 | 21/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Czech Republic;Hungary;Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 901 | EUCTR2016-001833-29-NL (EUCTR) | 24/04/2017 | 23/01/2017 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis | A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis. | Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Poland;Germany;Netherlands;United Kingdom;Sweden | ||
| 902 | EUCTR2016-002765-58-IS (EUCTR) | 24/04/2017 | 21/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 903 | NCT02994836 (ClinicalTrials.gov) | April 21, 2017 | 24/10/2016 | GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) | Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation | Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis | Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus) | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Active, not recruiting | 18 Years | N/A | All | 194 | Phase 4 | Spain |
| 904 | EUCTR2016-004217-26-DE (EUCTR) | 21/04/2017 | 16/02/2017 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Phase 2 | Serbia;France;Hungary;Czech Republic;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden | ||
| 905 | EUCTR2016-004217-26-HU (EUCTR) | 20/04/2017 | 23/02/2017 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 215 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;Czech Republic;Hungary;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden | ||
| 906 | EUCTR2016-001684-36-ES (EUCTR) | 19/04/2017 | 10/03/2017 | EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO | PPM SERVICES SA | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 2 | France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy | ||
| 907 | EUCTR2016-003708-29-SK (EUCTR) | 18/04/2017 | 24/02/2017 | Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon | A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato | Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 908 | EUCTR2016-000674-38-CZ (EUCTR) | 06/04/2017 | 22/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 909 | EUCTR2016-001392-78-BG (EUCTR) | 04/04/2017 | 07/02/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 910 | EUCTR2016-002765-58-BG (EUCTR) | 04/04/2017 | 31/03/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden | ||
| 911 | EUCTR2016-003452-75-CZ (EUCTR) | 03/04/2017 | 19/12/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina;Slovenia;Serbia;United States | ||
| 912 | EUCTR2016-001392-78-GR (EUCTR) | 31/03/2017 | 14/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 913 | EUCTR2016-000641-31-LT (EUCTR) | 31/03/2017 | 11/10/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Croatia;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil | ||
| 914 | EUCTR2016-002765-58-BE (EUCTR) | 31/03/2017 | 09/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 915 | EUCTR2016-001392-78-BE (EUCTR) | 31/03/2017 | 09/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 916 | EUCTR2016-002707-25-IT (EUCTR) | 31/03/2017 | 13/01/2021 | n.a. | Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a. | patients with ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO INN or Proposed INN: INFLIXIMAB Trade Name: AZAFOR - 50 MG COMPRESSE RIVESTITE CON FILM 50 COMPRESSE IN BLISTER PVC/PVDC/AL INN or Proposed INN: AZATIOPRINA | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Italy | ||
| 917 | EUCTR2016-000674-38-LT (EUCTR) | 31/03/2017 | 25/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 918 | NCT03029143 (ClinicalTrials.gov) | March 29, 2017 | 20/1/2017 | Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis | A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET) | Colitis, Ulcerative | Drug: Vedolizumab IV | Takeda | NULL | Completed | 18 Years | 85 Years | All | 278 | Phase 4 | United States;Canada |
| 919 | NCT03090139 (ClinicalTrials.gov) | March 28, 2017 | 22/3/2017 | Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets | Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE) | Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel Diseases | Drug: Anti-TNF Therapy | Takeda | NULL | Completed | 18 Years | N/A | All | 1731 | Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey | |
| 920 | EUCTR2016-001392-78-DE (EUCTR) | 27/03/2017 | 05/04/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 921 | EUCTR2015-001942-28-DE (EUCTR) | 27/03/2017 | 13/10/2015 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 922 | EUCTR2016-002765-58-DE (EUCTR) | 27/03/2017 | 05/04/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 923 | EUCTR2016-003633-26-PL (EUCTR) | 23/03/2017 | 27/12/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 924 | EUCTR2015-002557-35-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 925 | EUCTR2015-002558-11-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 926 | EUCTR2016-001392-78-PT (EUCTR) | 13/03/2017 | 13/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 927 | EUCTR2016-002765-58-PT (EUCTR) | 13/03/2017 | 13/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Hungary;Mexico;Canada;Argentina;Poland;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;South Africa;Australia;Malaysia;France;India;Switzerland;Italy;Israel;Russian Federation;Ireland;Ukraine;Spain;Greece;Slovakia;Hong Kong;Taiwan;Portugal;United States;Serbia;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 928 | EUCTR2016-003633-26-CZ (EUCTR) | 10/03/2017 | 12/12/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 929 | EUCTR2016-000641-31-CZ (EUCTR) | 02/03/2017 | 29/09/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway | ||
| 930 | NCT03006809 (ClinicalTrials.gov) | March 2, 2017 | 21/12/2016 | Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis | Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbiota Transplantation (FMT), OpenBiome;Other: pretreatment antibiotics | Najwa Elnachef | NULL | Completed | 18 Years | 64 Years | All | 30 | Phase 1 | United States |
| 931 | EUCTR2016-003797-40-BE (EUCTR) | 23/02/2017 | 28/10/2016 | A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | ||
| 932 | EUCTR2016-000674-38-FI (EUCTR) | 21/02/2017 | 26/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;United States;Serbia;Belarus;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 933 | EUCTR2016-003797-40-DE (EUCTR) | 21/02/2017 | 09/11/2016 | A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | ||
| 934 | EUCTR2016-003452-75-LV (EUCTR) | 20/02/2017 | 23/11/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina | ||
| 935 | EUCTR2016-001684-36-LV (EUCTR) | 20/02/2017 | 22/12/2016 | EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO | PPM SERVICES SA | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 2 | France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy | ||
| 936 | EUCTR2016-002765-58-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 937 | EUCTR2016-001392-78-SK (EUCTR) | 16/02/2017 | 14/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 938 | EUCTR2016-003452-75-HU (EUCTR) | 13/02/2017 | 01/12/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina | ||
| 939 | EUCTR2016-003452-75-BE (EUCTR) | 13/02/2017 | 07/12/2016 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina | ||
| 940 | EUCTR2016-003452-75-PL (EUCTR) | 09/02/2017 | 04/01/2017 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A | Protagonist Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina | ||
| 941 | EUCTR2016-002765-58-CZ (EUCTR) | 09/02/2017 | 12/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 942 | NCT03071081 (ClinicalTrials.gov) | February 8, 2017 | 20/2/2017 | Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy Volunteers | Ulcerative Colitis | Drug: TOP1288;Drug: Placebo to TOP1288 | Topivert Pharma Ltd | NULL | Completed | 18 Years | 55 Years | Male | 37 | Phase 1 | United Kingdom |
| 943 | EUCTR2016-000641-31-FI (EUCTR) | 07/02/2017 | 26/09/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 944 | NCT02958865 (ClinicalTrials.gov) | February 3, 2017 | 4/11/2016 | Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-06651600 or Placebo;Drug: PF-06700841 or Placebo;Drug: PF-06700841;Drug: PF-06651600 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 319 | Phase 2 | United States;Austria;Bulgaria;Czechia;Denmark;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Turkey;Ukraine;Canada;Netherlands |
| 945 | ChiCTR-IPR-17010306 | 2017-02-01 | 2017-01-01 | Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis | Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis | Ulcerative colitis | Group A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control; | Affiliated Hospital of Inner Mongolia Medical University | NULL | Pending | 18 | Both | Group A:30; Group B:30;Group C:30;Normal control group:30; | China | ||
| 946 | JPRN-UMIN000025846 | 2017/02/01 | 01/02/2017 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | ulcerative colitis, Crohn's disease | Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks | Juntendo university school of medicineDepartment of gastroenterology | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 947 | NCT03038711 (ClinicalTrials.gov) | February 1, 2017 | 26/1/2017 | A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers | A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects | Ulcerative Colitis | Drug: BMS-986166;Other: Placebo matching BMS-986166 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 213 | Phase 1 | United States |
| 948 | JPRN-jRCTs031180415 | 01/02/2017 | 22/03/2019 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) | AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults). FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. A-FMT arm : Patient undergoes FMT two days after AFM therapy. | Ishikawa Dai | NULL | Recruiting | >= 6age old | Not applicable | Both | 120 | N/A | Japan |
| 949 | EUCTR2016-002765-58-AT (EUCTR) | 31/01/2017 | 13/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 950 | EUCTR2016-002765-58-ES (EUCTR) | 31/01/2017 | 01/02/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 951 | EUCTR2016-000420-26-PL (EUCTR) | 31/01/2017 | 01/02/2017 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Czech Republic;Spain;Poland;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom | ||
| 952 | NCT03006068 (ClinicalTrials.gov) | January 31, 2017 | 20/12/2016 | A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Upadacitinib (ABT-494);Drug: Placebo | AbbVie | NULL | Enrolling by invitation | 16 Years | 75 Years | All | 950 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Egypt;Romania |
| 953 | EUCTR2016-001392-78-AT (EUCTR) | 31/01/2017 | 13/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 954 | EUCTR2016-001392-78-ES (EUCTR) | 31/01/2017 | 01/02/2017 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 955 | EUCTR2016-000674-38-SE (EUCTR) | 30/01/2017 | 28/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 956 | EUCTR2016-001392-78-HU (EUCTR) | 30/01/2017 | 01/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 957 | EUCTR2016-000641-31-SE (EUCTR) | 30/01/2017 | 29/09/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 958 | EUCTR2016-002765-58-HU (EUCTR) | 30/01/2017 | 01/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 959 | EUCTR2016-002765-58-FR (EUCTR) | 25/01/2017 | 19/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;Argentina;Poland;Belgium;Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada | ||
| 960 | EUCTR2015-001600-64-HR (EUCTR) | 19/01/2017 | 05/06/2017 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 961 | EUCTR2015-000319-41-HR (EUCTR) | 17/01/2017 | 05/06/2017 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 962 | EUCTR2016-003633-26-NL (EUCTR) | 17/01/2017 | 24/10/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 963 | EUCTR2016-000674-38-PT (EUCTR) | 09/01/2017 | 11/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;European Union;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;Japan;New Zealand | ||
| 964 | EUCTR2016-001833-29-PL (EUCTR) | 09/01/2017 | 26/10/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis. | Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Poland;Netherlands;Germany;United Kingdom;Sweden | ||
| 965 | EUCTR2016-000641-31-PT (EUCTR) | 09/01/2017 | 06/10/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;European Union;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 966 | EUCTR2016-000674-38-BE (EUCTR) | 06/01/2017 | 31/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden | ||
| 967 | EUCTR2016-000678-40-BG (EUCTR) | 05/01/2017 | 01/11/2016 | Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Limited | NULL | Not Recruiting | Female: yes Male: yes | 385 | Phase 4 | Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of | ||
| 968 | NCT03798210 (ClinicalTrials.gov) | January 1, 2017 | 7/1/2019 | Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis | The Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative Colitis | Ulcerative Colitis Flare | Dietary Supplement: Lactobacillus reuteri;Dietary Supplement: Placebo | Uppsala University | NULL | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | Sweden |
| 969 | NCT02862132 (ClinicalTrials.gov) | January 2017 | 31/7/2016 | Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases | Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Vedolizumab | Shaare Zedek Medical Center | NULL | Recruiting | N/A | 18 Years | All | 120 | N/A | United States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom |
| 970 | EUCTR2016-003633-26-HU (EUCTR) | 23/12/2016 | 08/11/2016 | A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands | ||
| 971 | EUCTR2016-000641-31-IE (EUCTR) | 22/12/2016 | 04/10/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 972 | EUCTR2016-000674-38-GR (EUCTR) | 21/12/2016 | 03/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 973 | EUCTR2016-000641-31-GR (EUCTR) | 19/12/2016 | 12/10/2016 | Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: - Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: - Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: - Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 974 | EUCTR2016-000641-31-ES (EUCTR) | 16/12/2016 | 14/12/2016 | Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 975 | EUCTR2016-000674-38-ES (EUCTR) | 16/12/2016 | 14/12/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand | ||
| 976 | JPRN-UMIN000024520 | 2016/12/15 | 22/10/2016 | Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis | ulcerative colitis | placebo metronidazole metronidazole,amoxicillin metronidazole,amoxicillin,tetracycline | Hokkaido University Hospital | NULL | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 212 | Not selected | Japan | |
| 977 | EUCTR2016-001684-36-SK (EUCTR) | 12/12/2016 | 26/07/2016 | EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO | PPM SERVICES SA | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 2 | France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom | ||
| 978 | EUCTR2016-002765-58-GB (EUCTR) | 08/12/2016 | 06/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 979 | EUCTR2016-000674-38-EE (EUCTR) | 08/12/2016 | 04/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden | ||
| 980 | EUCTR2016-001392-78-GB (EUCTR) | 08/12/2016 | 06/12/2016 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 981 | EUCTR2016-000641-31-EE (EUCTR) | 08/12/2016 | 03/11/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 982 | EUCTR2016-000641-31-GB (EUCTR) | 07/12/2016 | 11/01/2017 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 983 | EUCTR2016-001409-18-NO (EUCTR) | 06/12/2016 | 09/05/2016 | A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence | A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Helse More og Romsdal Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Norway | |||
| 984 | EUCTR2016-001158-16-BE (EUCTR) | 05/12/2016 | 15/09/2016 | Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: PF-06480605 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Poland;Belgium;Netherlands;Italy;Korea, Republic of | ||
| 985 | EUCTR2016-001158-16-IT (EUCTR) | 01/12/2016 | 07/01/2021 | Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-06480605 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Poland;Belgium;Netherlands;Italy;Korea, Republic of | ||
| 986 | NCT02985593 (ClinicalTrials.gov) | December 2016 | 28/11/2016 | A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis | A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis | Healthy Men and Subjects With Ulcerative Colitis | Drug: KHK4083;Drug: Placebo | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 155 | Phase 1 | Japan |
| 987 | NCT02425852 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 988 | NCT02895100 (ClinicalTrials.gov) | December 2016 | 4/9/2016 | Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis | A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis | Drug: PTG-100;Drug: Placebo | Protagonist Therapeutics, Inc. | NULL | Terminated | 18 Years | 80 Years | All | 100 | Phase 2 | United States;Australia;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Germany;Hungary;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Ukraine |
| 989 | NCT02425865 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET | ULCERATIVE COLITIS | Drug: GOLIMUMAB | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Active, not recruiting | 18 Years | 75 Years | All | 202 | Phase 4 | Belgium;France |
| 990 | JPRN-UMIN000024936 | 2016/11/30 | 22/11/2016 | Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis | Ulcerative colitis | patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml. | Keio University Gastroenterology and Hepatology | NULL | Recruiting | 16years-old | 150years-old | Male and Female | 30 | Not selected | Japan | |
| 991 | EUCTR2016-000641-31-HU (EUCTR) | 29/11/2016 | 28/09/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 992 | NCT02808390 (ClinicalTrials.gov) | November 28, 2016 | 14/6/2016 | Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC | A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: Placebo | PPM Services S.A. | NULL | Terminated | 18 Years | N/A | All | 19 | Phase 2 | United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine |
| 993 | NCT03018054 (ClinicalTrials.gov) | November 28, 2016 | 10/1/2017 | Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis | A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis | Moderate Active Ulcerative Colitis | Drug: E6007;Drug: Placebo | EA Pharma Co., Ltd. | NULL | Completed | 20 Years | 74 Years | All | 147 | Phase 2 | Japan |
| 994 | EUCTR2016-000674-38-GB (EUCTR) | 25/11/2016 | 28/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 995 | EUCTR2016-000674-38-HU (EUCTR) | 24/11/2016 | 10/10/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 19.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand | ||
| 996 | EUCTR2016-000641-31-NL (EUCTR) | 23/11/2016 | 08/08/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Norway;Germany;New Zealand;Japan;Kazakhstan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore | ||
| 997 | EUCTR2016-000674-38-AT (EUCTR) | 23/11/2016 | 23/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia | ||
| 998 | EUCTR2016-000674-38-NL (EUCTR) | 23/11/2016 | 22/08/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden;South Africa;Latvia;Netherlands;Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia | ||
| 999 | EUCTR2016-000674-38-LV (EUCTR) | 22/11/2016 | 29/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand | ||
| 1000 | EUCTR2016-000641-31-LV (EUCTR) | 22/11/2016 | 10/10/2016 | Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 1001 | EUCTR2016-001684-36-BG (EUCTR) | 17/11/2016 | 18/10/2016 | EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 100000016704 MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 MedDRA version: 20.0;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO | PPM SERVICES SA | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 2 | France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom | ||
| 1002 | NCT02903966 (ClinicalTrials.gov) | November 15, 2016 | 13/9/2016 | GSK2982772 Study in Subjects With Ulcerative Colitis | A Multicentre, Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled Study With Open Label Extension to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK2982772;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Germany;Netherlands;Poland;Russian Federation;Sweden;United Kingdom |
| 1003 | EUCTR2016-000674-38-IT (EUCTR) | 08/11/2016 | 17/06/2021 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) - N.A. | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic | ||
| 1004 | EUCTR2016-000518-31-CZ (EUCTR) | 07/11/2016 | 30/08/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 1005 | NCT02764229 (ClinicalTrials.gov) | November 1, 2016 | 4/5/2016 | Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis | A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: LYC-30937-EC | Lycera Corp. | NULL | Terminated | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Czechia;Hungary;Netherlands;Poland;Serbia |
| 1006 | NCT02760615 (ClinicalTrials.gov) | November 1, 2016 | 2/5/2016 | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study | An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab | Takeda | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 4 | United States |
| 1007 | NCT02291523 (ClinicalTrials.gov) | November 2016 | 11/11/2014 | The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis | The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbial Transplant | Children's Hospital Los Angeles | NULL | Active, not recruiting | 7 Years | 21 Years | All | 101 | Phase 1 | United States |
| 1008 | NCT02962245 (ClinicalTrials.gov) | November 2016 | 14/10/2016 | Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis | Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial | Ulcerative Colitis | Drug: berberine;Drug: regular treatment | Xijing Hospital of Digestive Diseases | NULL | Not yet recruiting | 18 Years | 70 Years | Both | 238 | Phase 4 | NULL |
| 1009 | NCT03136419 (ClinicalTrials.gov) | October 31, 2016 | 5/4/2017 | Microbiota and Immune microEnvironment in Pouchitis | Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa | Pouchitis;Ulcerative Colitis;Ileal Pouch | Dietary Supplement: Lactobacillus casei DG;Dietary Supplement: Placebo | University of Padova | NULL | Recruiting | 18 Years | 100 Years | All | 32 | N/A | Italy |
| 1010 | EUCTR2016-000509-35-BG (EUCTR) | 27/10/2016 | 03/08/2016 | Drug OPRX-106 in Patients with Ulcerative Colitis | An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative Colitis | Active mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg Product Code: OPRX-106 Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg Product Code: OPRX-106 | Protalix Biotherapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Serbia;Israel;Bulgaria | ||
| 1011 | NCT02840721 (ClinicalTrials.gov) | October 26, 2016 | 27/6/2016 | Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis. | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Colitis, Ulcerative | Drug: PF-06480605 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 50 | Phase 2 | United States;Belgium;Italy;Korea, Republic of;Netherlands;Poland;France |
| 1012 | EUCTR2016-000674-38-PL (EUCTR) | 25/10/2016 | 27/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 1013 | EUCTR2016-000641-31-PL (EUCTR) | 25/10/2016 | 30/09/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;European Union;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 1014 | EUCTR2016-000518-31-PL (EUCTR) | 21/10/2016 | 19/08/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 1015 | EUCTR2013-004280-31-SK (EUCTR) | 21/10/2016 | 26/07/2016 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany | ||
| 1016 | EUCTR2016-001684-36-HU (EUCTR) | 19/10/2016 | 10/08/2016 | EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO | PPM SERVICES SA | NULL | Not Recruiting | Female: yes Male: yes | 207 | Phase 2 | United States;Slovakia;Spain;Ukraine;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Bulgaria;Latvia | ||
| 1017 | EUCTR2016-000641-31-AT (EUCTR) | 17/10/2016 | 11/10/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Czech Republic;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Mexico;European Union;Canada;Brazil;Belarus | ||
| 1018 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 1019 | EUCTR2015-001600-64-BG (EUCTR) | 13/10/2016 | 01/10/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1020 | EUCTR2015-005260-41-NL (EUCTR) | 13/10/2016 | 15/02/2016 | Efficacy of optimized thiopurine therapy in ulcerative colitis. | Efficacy of optimized thiopurine therapy in ulcerative colitis. - OPTIC | Ulcerative Colitis MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mercaptopurine (Puri-Nethol) | Academic Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 1021 | EUCTR2016-000420-26-CZ (EUCTR) | 06/10/2016 | 27/07/2016 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom | ||
| 1022 | EUCTR2016-000518-31-HU (EUCTR) | 05/10/2016 | 27/07/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands | ||
| 1023 | EUCTR2016-000420-26-ES (EUCTR) | 05/10/2016 | 05/08/2016 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Poland;Spain;Romania;France;Czech Republic;Bulgaria;South Africa;Georgia;United Kingdom;Moldova, Republic of;Italy | ||
| 1024 | NCT02818686 (ClinicalTrials.gov) | October 3, 2016 | 23/6/2016 | TD-1473 for Active Ulcerative Colitis (UC) | A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis | Ulcerative Colitis, Active Moderate;Ulcerative Colitis, Active Severe | Drug: TD-1473;Drug: Placebo | Theravance Biopharma | NULL | Completed | 18 Years | 75 Years | All | 40 | Phase 1 | United States;Georgia;Moldova, Republic of;Romania |
| 1025 | NCT02516384 (ClinicalTrials.gov) | October 1, 2016 | 29/7/2015 | Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) | Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) | Ulcerative Colitis | Biological: Fecal Microbiota Transplantation | Weill Medical College of Cornell University | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 1026 | NCT03018925 (ClinicalTrials.gov) | October 2016 | 13/12/2016 | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study | Ulcerative Colitis | Drug: Golimumab | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | NULL | Recruiting | 18 Years | N/A | All | 15 | N/A | Spain |
| 1027 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1028 | NCT02883452 (ClinicalTrials.gov) | September 29, 2016 | 25/8/2016 | A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis | An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis | Crohn's Disease;Ulcerative Colitis (Part 2 Only) | Biological: CT-P13 | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 181 | Phase 1 | Korea, Republic of |
| 1029 | EUCTR2013-004280-31-PL (EUCTR) | 29/09/2016 | 12/09/2016 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;South Africa;Denmark;Brazil;Poland;Canada;Mexico;Hungary;Czech Republic;Italy;Israel;Ukraine;Slovakia;United States | ||
| 1030 | JPRN-JapicCTI-163356 | 29/9/2016 | 23/08/2016 | I6T-MC-AMAC | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Induction:High, Mid or Low dose LY3074828. Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:LY3074828 dose schedule1 or 2. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction:Placebo Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:Placebo | Eli Lilly Japan K.K. | NULL | complete | 18 | 75 | BOTH | 30 | Phase 2 | Japan, North America, Europe, Oceania |
| 1031 | NCT02819635 (ClinicalTrials.gov) | September 26, 2016 | 28/6/2016 | A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Placebo;Drug: Updacitinib (ABT-494) | AbbVie | NULL | Active, not recruiting | 16 Years | 75 Years | All | 844 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Egypt;Romania |
| 1032 | EUCTR2016-001158-16-PL (EUCTR) | 23/09/2016 | 21/09/2016 | Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: PF-06480605 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;United States;Belgium;Poland;Netherlands;Italy;Korea, Republic of | ||
| 1033 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 1034 | EUCTR2016-000641-31-SK (EUCTR) | 20/09/2016 | 26/07/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | ||
| 1035 | EUCTR2016-000674-38-SK (EUCTR) | 20/09/2016 | 26/07/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Colombia;Italy;Switzerland;Puerto Rico;Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | ||
| 1036 | EUCTR2016-001833-29-GB (EUCTR) | 16/09/2016 | 08/08/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis. | Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Poland;Netherlands;Germany;United Kingdom;Sweden | ||
| 1037 | NCT02864264 (ClinicalTrials.gov) | September 14, 2016 | 9/8/2016 | Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis | Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis | Healthy Volunteers;Ulcerative Colitis | Drug: BMS-986184;Drug: Placebo matching BMS-986184 | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 75 Years | All | 7 | Phase 1 | Australia;Georgia;Moldova, Republic of;Romania |
| 1038 | EUCTR2015-002109-12-LT (EUCTR) | 09/09/2016 | 21/03/2016 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1039 | EUCTR2016-001833-29-SE (EUCTR) | 07/09/2016 | 19/07/2016 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis | A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis. | Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | United States;Poland;Russian Federation;Netherlands;Germany;United Kingdom;Sweden | ||
| 1040 | EUCTR2015-002558-11-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 1041 | NCT02825914 (ClinicalTrials.gov) | September 1, 2016 | 30/6/2016 | CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) | CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) | Colitis, Ulcerative;Inflammatory Bowel Diseases | Dietary Supplement: Casein glycomacropeptide (CGMP);Dietary Supplement: Placebo | University of Aarhus | NULL | Completed | 18 Years | N/A | All | 80 | N/A | Denmark |
| 1042 | JPRN-UMIN000022588 | 2016/09/01 | 01/07/2016 | Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection. | Ulcerative colitis | Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks) Additional immunosuppressive therapies without administration of ganciclovir | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 120 | Not applicable | Japan | |
| 1043 | EUCTR2015-002557-35-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 1044 | NCT02768974 (ClinicalTrials.gov) | September 2016 | 27/3/2016 | Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis | An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: OPRX-106 | Protalix | NULL | Recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | Israel |
| 1045 | NCT02888379 (ClinicalTrials.gov) | September 2016 | 30/8/2016 | Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients With Moderate to Severe Disease Activity | Ulcerative Colitis | Drug: TOP1288;Drug: Placebo (for TOP1288) | Topivert Pharma Ltd | NULL | Completed | 18 Years | 75 Years | All | 77 | Phase 2 | Bulgaria;Czechia;Hungary;Latvia;Lithuania;Poland;Ukraine;United Kingdom;Czech Republic |
| 1046 | EUCTR2016-000390-20-BG (EUCTR) | 29/08/2016 | 18/07/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1047 | EUCTR2015-002109-12-AT (EUCTR) | 26/08/2016 | 22/06/2016 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia | ||
| 1048 | EUCTR2015-001942-28-AT (EUCTR) | 26/08/2016 | 28/06/2016 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia | ||
| 1049 | EUCTR2015-003123-57-PL (EUCTR) | 26/08/2016 | 16/05/2016 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1050 | EUCTR2016-002433-30-DK (EUCTR) | 25/08/2016 | 21/06/2016 | Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitis | Low-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imurel INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Allopurinol INN or Proposed INN: ALLOPURINOL | Hvidovre Hospital | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Denmark | ||
| 1051 | EUCTR2015-001346-29-BE (EUCTR) | 22/08/2016 | 22/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden | ||
| 1052 | EUCTR2016-000678-40-EE (EUCTR) | 22/08/2016 | 20/06/2016 | Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 385 | Phase 4 | Serbia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 1053 | EUCTR2016-000678-40-LV (EUCTR) | 19/08/2016 | 10/05/2016 | Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Limited | NULL | Not Recruiting | Female: yes Male: yes | 385 | Phase 4 | Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 1054 | EUCTR2016-000518-31-NL (EUCTR) | 16/08/2016 | 27/06/2016 | A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937 | Lycera Corp. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands | ||
| 1055 | NCT02743806 (ClinicalTrials.gov) | August 1, 2016 | 15/4/2016 | Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab | Takeda | NULL | Active, not recruiting | 18 Years | 90 Years | All | 331 | Phase 4 | Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan |
| 1056 | EUCTR2015-002109-12-BG (EUCTR) | 27/07/2016 | 27/04/2016 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 1057 | EUCTR2016-000390-20-CZ (EUCTR) | 18/07/2016 | 18/07/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe DiseaseActivity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1058 | EUCTR2016-000390-20-LT (EUCTR) | 15/07/2016 | 05/07/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1059 | EUCTR2016-000205-36-DE (EUCTR) | 11/07/2016 | 14/03/2016 | A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD). | A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE | Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: FE 999301 | University Hospital Schleswig-Holstein (UKSH) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany | |||
| 1060 | EUCTR2016-000678-40-HU (EUCTR) | 07/07/2016 | 19/05/2016 | Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 385 | Phase 4 | Serbia;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 1061 | EUCTR2016-000390-20-HU (EUCTR) | 05/07/2016 | 14/06/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1062 | JPRN-UMIN000019958 | 2016/07/02 | 27/11/2015 | Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments | Crohn's disease, ulcerative colitis | Patients with Crohn's disease or ulcerative colitis Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens. | Iwate Medical UniversityKochi Medical School HospitalKeio University School of Medicine | NULL | Complete: follow-up continuing | 15years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | |
| 1063 | NCT02762500 (ClinicalTrials.gov) | July 2016 | 3/5/2016 | An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: LYC-30937-EC;Drug: Placebo | Lycera Corp. | NULL | Completed | 18 Years | 75 Years | All | 124 | Phase 2 | United States;Canada;Czechia;Hungary;Netherlands;Poland;Serbia;Czech Republic |
| 1064 | EUCTR2015-000480-14-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1065 | EUCTR2015-000482-31-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Bosnia and Herzegovina;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;United States;Serbia | ||
| 1066 | EUCTR2014-005217-24-ES (EUCTR) | 29/06/2016 | 10/11/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis - NA | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1067 | EUCTR2016-000390-20-PL (EUCTR) | 28/06/2016 | 16/06/2016 | English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1068 | EUCTR2016-000678-40-CZ (EUCTR) | 27/06/2016 | 18/05/2016 | Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: vedolizumab IV Product Code: MLN002 INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 385 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 1069 | EUCTR2015-002109-12-BE (EUCTR) | 20/06/2016 | 14/04/2016 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia | ||
| 1070 | EUCTR2016-000390-20-LV (EUCTR) | 17/06/2016 | 14/06/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1071 | NCT02365480 (ClinicalTrials.gov) | June 16, 2016 | 17/2/2015 | Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission | Phase I Trial of Berberine in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: Berberine Chloride;Other: Laboratory Biomarker Analysis;Other: Placebo Administration | National Cancer Institute (NCI) | NULL | Active, not recruiting | 18 Years | 70 Years | All | 18 | Phase 1 | United States;China |
| 1072 | EUCTR2015-000480-14-DE (EUCTR) | 14/06/2016 | 09/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1073 | NCT02665845 (ClinicalTrials.gov) | June 13, 2016 | 25/1/2016 | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis). | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial. | Ulcerative Colitis | Drug: 5-ASA;Drug: Corticosteroids | Centre Hospitalier Universitaire de Saint Etienne | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 1074 | EUCTR2015-000482-31-HR (EUCTR) | 13/06/2016 | 06/07/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1075 | EUCTR2016-000390-20-GB (EUCTR) | 10/06/2016 | 06/06/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 1076 | EUCTR2015-000480-14-HR (EUCTR) | 10/06/2016 | 06/07/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1077 | EUCTR2016-001278-13-FI (EUCTR) | 08/06/2016 | 15/04/2016 | Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis | Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD | Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | Taina Sipponen | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Finland | ||
| 1078 | EUCTR2015-003123-57-DK (EUCTR) | 03/06/2016 | 22/03/2016 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1079 | EUCTR2015-003123-57-NL (EUCTR) | 02/06/2016 | 12/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1080 | NCT02647866 (ClinicalTrials.gov) | June 2016 | 8/12/2015 | Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UC | Ulcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal Pain | Drug: KHK4083;Drug: Placebo | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico |
| 1081 | NCT02687724 (ClinicalTrials.gov) | June 2016 | 16/2/2016 | Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis | GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC). | Colitis | Drug: Golimumab (GLM) | University College Dublin | NULL | Unknown status | 18 Years | N/A | All | 136 | Phase 4 | Ireland |
| 1082 | EUCTR2015-000480-14-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1083 | EUCTR2015-000482-31-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1084 | EUCTR2015-000482-31-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn?s Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1085 | EUCTR2015-000480-14-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1086 | EUCTR2015-000482-31-NL (EUCTR) | 25/05/2016 | 27/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: - Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1087 | EUCTR2014-005217-24-DE (EUCTR) | 24/05/2016 | 23/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1088 | EUCTR2014-005217-24-IS (EUCTR) | 10/05/2016 | 28/04/2016 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Germany;Iceland;New Zealand;Sweden | ||
| 1089 | EUCTR2015-002109-12-CZ (EUCTR) | 09/05/2016 | 22/02/2016 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1090 | EUCTR2015-000482-31-DE (EUCTR) | 09/05/2016 | 09/03/2016 | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;Serbia;United States | ||
| 1091 | EUCTR2015-000480-14-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1092 | EUCTR2015-000482-31-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1093 | EUCTR2015-000480-14-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1094 | EUCTR2015-000482-31-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1095 | EUCTR2015-001942-28-BE (EUCTR) | 03/05/2016 | 17/03/2016 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia | ||
| 1096 | EUCTR2015-001942-28-PL (EUCTR) | 29/04/2016 | 19/01/2016 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 1097 | EUCTR2015-001600-64-NL (EUCTR) | 28/04/2016 | 13/10/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 1098 | EUCTR2015-001555-69-PL (EUCTR) | 28/04/2016 | 22/12/2015 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation | ||
| 1099 | EUCTR2015-004618-10-BE (EUCTR) | 19/04/2016 | 20/11/2015 | PhArmaCo-kinetics of InFliximab during treatment Induction | Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis | Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Other descriptive name: Inflectra | CUB- Hopital Erasme | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Belgium | |||
| 1100 | EUCTR2015-000482-31-IT (EUCTR) | 18/04/2016 | 22/01/2021 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn¿s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1101 | EUCTR2015-000480-14-IT (EUCTR) | 18/04/2016 | 08/06/2021 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis. | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy. - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENTYVIO - 300 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1102 | JPRN-JapicCTI-163220 | 15/4/2016 | 08/04/2016 | A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease | Ulcerative colitis or Crohn's disease | Intervention name : Vedolizumab SC 108 mg INN of the intervention : Vedolizumab Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure, or Participants from current study who experience treatment failure while on study will receive vedolizumab SC 108 mg QW. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | 80 | BOTH | 746 | Phase 3 | Japan, Refer to Othersection |
| 1103 | NCT02620046 (ClinicalTrials.gov) | April 15, 2016 | 19/11/2015 | A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab SC | Takeda | NULL | Active, not recruiting | 18 Years | 80 Years | All | 746 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic |
| 1104 | EUCTR2015-000482-31-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1105 | EUCTR2015-000480-14-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1106 | NCT02749630 (ClinicalTrials.gov) | April 11, 2016 | 12/4/2016 | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD) | An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 70 | Phase 1 | Germany;United Kingdom;Canada |
| 1107 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 1108 | EUCTR2015-000482-31-SE (EUCTR) | 05/04/2016 | 16/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1109 | EUCTR2015-000480-14-SE (EUCTR) | 04/04/2016 | 16/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1110 | JPRN-UMIN000020029 | 2016/04/01 | 01/12/2015 | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation | Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies. | Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more. | Saitama Medical University | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 300 | Not selected | Japan |
| 1111 | EUCTR2015-001346-29-ES (EUCTR) | 31/03/2016 | 30/10/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden | ||
| 1112 | EUCTR2014-005217-24-HR (EUCTR) | 29/03/2016 | 28/04/2016 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1113 | EUCTR2015-003123-57-GB (EUCTR) | 29/03/2016 | 04/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1114 | EUCTR2015-000482-31-BG (EUCTR) | 23/03/2016 | 16/02/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1115 | EUCTR2015-000480-14-NL (EUCTR) | 21/03/2016 | 29/12/2015 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1116 | EUCTR2015-000482-31-GB (EUCTR) | 21/03/2016 | 08/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1117 | EUCTR2015-000480-14-BG (EUCTR) | 17/03/2016 | 16/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1118 | EUCTR2015-002109-12-GB (EUCTR) | 14/03/2016 | 29/12/2015 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand | ||
| 1119 | EUCTR2015-000480-14-GB (EUCTR) | 14/03/2016 | 07/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1120 | EUCTR2013-001205-84-BE (EUCTR) | 11/03/2016 | 17/02/2015 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1121 | EUCTR2013-001205-84-HU (EUCTR) | 07/03/2016 | 04/01/2016 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1122 | EUCTR2015-001555-69-CZ (EUCTR) | 07/03/2016 | 14/12/2015 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation | ||
| 1123 | EUCTR2014-005217-24-SE (EUCTR) | 02/03/2016 | 03/11/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1124 | NCT02818543 (ClinicalTrials.gov) | March 2016 | 30/3/2016 | Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis | An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: LYC-30937 | Lycera Corp. | NULL | Completed | 18 Years | 75 Years | Both | 6 | Phase 1 | Hungary |
| 1125 | EUCTR2015-002109-12-ES (EUCTR) | 25/02/2016 | 10/12/2015 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1126 | EUCTR2015-000939-33-HR (EUCTR) | 16/02/2016 | 28/04/2016 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1127 | EUCTR2015-003123-57-BE (EUCTR) | 09/02/2016 | 01/10/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1128 | EUCTR2015-003364-36-BG (EUCTR) | 09/02/2016 | 28/01/2016 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | ||
| 1129 | EUCTR2015-002558-11-HU (EUCTR) | 09/02/2016 | 16/11/2015 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Serbia;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 1130 | EUCTR2015-002557-35-HU (EUCTR) | 09/02/2016 | 16/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 1131 | EUCTR2015-003270-32-IT (EUCTR) | 09/02/2016 | 20/03/2019 | Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease | Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab | Ulcerative colitis (UC) and Crohn disease (CD) MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: entyvio INN or Proposed INN: VEDOLIZUMAB | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Italy | ||
| 1132 | EUCTR2015-003364-36-HU (EUCTR) | 09/02/2016 | 02/12/2015 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | ||
| 1133 | EUCTR2015-001346-29-GB (EUCTR) | 08/02/2016 | 28/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden | ||
| 1134 | EUCTR2014-005606-38-PL (EUCTR) | 05/02/2016 | 17/11/2015 | A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1135 | EUCTR2015-001346-29-HU (EUCTR) | 02/02/2016 | 28/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Hungary;Canada;Spain;Australia;Israel;United Kingdom;New Zealand | ||
| 1136 | JPRN-UMIN000020840 | 2016/02/02 | 02/02/2016 | A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients | ulcerative colitis | discontinuation of adalimumab therapy | Fukuyama Medical Center | NULL | Recruiting | 15years-old | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 1137 | NCT02522780 (ClinicalTrials.gov) | February 1, 2016 | 12/8/2015 | Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine;Drug: Placebo | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 276 | Phase 3 | United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium |
| 1138 | NCT02683733 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis | The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicylic acid | Asian Institute of Gastroenterology, India | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 1139 | NCT02683759 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis | The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicyclic acid | Asian Institute of Gastroenterology, India | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 1140 | EUCTR2015-000319-41-NL (EUCTR) | 26/01/2016 | 01/07/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1141 | NCT02536404 (ClinicalTrials.gov) | January 25, 2016 | 24/8/2015 | Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis | Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | All | 118 | Phase 2 | Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Lithuania;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom;Australia;Austria;United States |
| 1142 | EUCTR2015-003364-36-SK (EUCTR) | 22/01/2016 | 07/12/2015 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | ||
| 1143 | EUCTR2015-000482-31-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1144 | EUCTR2015-000480-14-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 1145 | EUCTR2015-000939-33-NL (EUCTR) | 21/01/2016 | 30/09/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 658 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1146 | EUCTR2014-002981-64-BG (EUCTR) | 20/01/2016 | 25/09/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 1147 | EUCTR2015-002109-12-HU (EUCTR) | 18/01/2016 | 21/01/2016 | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand | ||
| 1148 | JPRN-UMIN000022954 | 2016/01/15 | 05/07/2016 | A study related to usability of Mesalazine Controlled-Release Tablets and Granules. | A study related to usability of Mesalazine Controlled-Release Tablets and Granules. - A study related to usability of Mesalazine Controlled-Release Tablets and Granules. | ulcerative colitis | Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks | Kitasato University Kitasato Institute Hospital | NULL | Complete: follow-up complete | Not applicable | 100years-old | Male and Female | 60 | Not applicable | Japan |
| 1149 | EUCTR2015-001555-69-HU (EUCTR) | 15/01/2016 | 17/11/2015 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation | ||
| 1150 | EUCTR2015-003123-57-CZ (EUCTR) | 14/01/2016 | 05/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1151 | EUCTR2014-005217-24-BE (EUCTR) | 14/01/2016 | 26/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1152 | NCT02618187 (ClinicalTrials.gov) | January 13, 2016 | 20/11/2015 | A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis | A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: SER-287;Drug: Placebo;Drug: Placebo Pre-Treat;Drug: Vancomycin Pre-Treat | Seres Therapeutics, Inc. | NULL | Completed | 18 Years | 75 Years | All | 58 | Phase 1 | United States |
| 1153 | EUCTR2015-001942-28-GB (EUCTR) | 12/01/2016 | 21/09/2015 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1154 | EUCTR2015-000939-33-PT (EUCTR) | 08/01/2016 | 25/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 658 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1155 | EUCTR2015-000939-33-PL (EUCTR) | 08/01/2016 | 24/11/2015 | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Denmark;Australia;Latvia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 1156 | EUCTR2015-002109-12-LV (EUCTR) | 08/01/2016 | 20/11/2015 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1157 | EUCTR2015-000939-33-ES (EUCTR) | 05/01/2016 | 05/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 658 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1158 | EUCTR2015-000939-33-HU (EUCTR) | 05/01/2016 | 03/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1159 | EUCTR2015-003123-57-HU (EUCTR) | 05/01/2016 | 06/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1160 | EUCTR2015-001600-64-IT (EUCTR) | 05/01/2016 | 28/01/2021 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 asTherapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 1161 | EUCTR2014-005217-24-BG (EUCTR) | 05/01/2016 | 19/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1162 | EUCTR2015-001942-28-LT (EUCTR) | 31/12/2015 | 20/11/2015 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Czech Republic;Canada;Poland;Belgium;Romania;United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Australia;Bulgaria;Latvia;Germany;New Zealand;Korea, Republic of | ||
| 1163 | EUCTR2015-003123-57-LT (EUCTR) | 31/12/2015 | 17/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 1164 | EUCTR2014-005217-24-CZ (EUCTR) | 22/12/2015 | 06/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1165 | EUCTR2015-004724-62-IE (EUCTR) | 22/12/2015 | 05/11/2015 | Golimumab dose variation to achieve response in Colitis | Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: GOLIMUMAB INN or Proposed INN: GOLIMUMAB | UCD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 4 | Ireland | ||
| 1166 | JPRN-JapicCTI-163222 | 18/12/2015 | 08/04/2016 | Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Intervention name : Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 108 mg SC : Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab subcutaneous (SC), 108 mg, injection, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W), starting at Week 6 up to approximately Week 50. Intervention name : Vedolizumab IV, Placebo SC INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 300 mg IV: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50. Intervention name : Vedolizumab IV, Placebo IV, Placebo SC INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Placebo: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching SC injections, Q2W and placebo-matching IV infusions, Q8W starting at Week 6 up to approximately Week 50. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | 80 | BOTH | 383 | Phase 3 | Japan, Japan, Refer to Other section |
| 1167 | NCT02611830 (ClinicalTrials.gov) | December 18, 2015 | 19/11/2015 | Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Drug: Vedolizumab 300 mg IV;Drug: Placebo IV;Drug: Vedolizumab 108 mg SC;Drug: Placebo SC | Takeda | NULL | Completed | 18 Years | 80 Years | All | 383 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic |
| 1168 | EUCTR2014-005217-24-NL (EUCTR) | 17/12/2015 | 26/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1169 | NCT02601300 (ClinicalTrials.gov) | December 14, 2015 | 6/11/2015 | An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis | A Phase 2, Open-Label, Multicenter Study to Explore the Efficacy and Safety of MONGERSON (GED-0301) in Subjects With Active Ulcerative Colitis. | Colitis, Ulcerative | Drug: GED-0301 | Celgene | NULL | Completed | 18 Years | N/A | All | 41 | Phase 2 | United States;Bulgaria;Canada;Hungary;Poland;Slovakia |
| 1170 | EUCTR2015-000939-33-SK (EUCTR) | 11/12/2015 | 27/08/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1171 | EUCTR2015-001942-28-CZ (EUCTR) | 10/12/2015 | 15/09/2015 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1172 | NCT02589665 (ClinicalTrials.gov) | December 9, 2015 | 27/10/2015 | A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 75 Years | All | 249 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Denmark;France;Georgia;Hungary;Japan;Lithuania;Moldova, Republic of;Netherlands;Poland;Romania;United Kingdom;Czech Republic;Puerto Rico;Russian Federation;Ukraine |
| 1173 | EUCTR2015-000939-33-LT (EUCTR) | 08/12/2015 | 12/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1174 | EUCTR2015-000939-33-BE (EUCTR) | 07/12/2015 | 04/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1175 | EUCTR2015-002558-11-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 1176 | EUCTR2015-002557-35-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia | ||
| 1177 | EUCTR2015-000939-33-DK (EUCTR) | 04/12/2015 | 25/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1178 | EUCTR2015-001942-28-ES (EUCTR) | 04/12/2015 | 05/10/2015 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | ||
| 1179 | NCT02531126 (ClinicalTrials.gov) | December 2, 2015 | 20/8/2015 | Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063 | Celgene | NULL | Active, not recruiting | 18 Years | 75 Years | All | 871 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;United Kingdom;Czech Republic;Spain |
| 1180 | EUCTR2015-001022-42-IT (EUCTR) | 01/12/2015 | 29/03/2019 | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis | Active, Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: IBD98-M Delayed-release Capsules Product Code: IBD98-M INN or Proposed INN: SODIUM HYALURONATE Other descriptive name: SODIUM HYALURONATE INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-ASA | Holy Stone Healthcare Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 51 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 1181 | NCT02390726 (ClinicalTrials.gov) | December 2015 | 19/2/2015 | Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis | Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis | Ulcerative Colitis, Active Moderate | Biological: Fecal Microbiota Transplant;Biological: Placebo | University of Vermont | NULL | Unknown status | 18 Years | 75 Years | All | 20 | Early Phase 1 | United States |
| 1182 | NCT02368743 (ClinicalTrials.gov) | December 2015 | 16/2/2015 | QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®) | QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®) | Distal Ulcerative Colitis | Drug: mesalazine | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 117 | France | |
| 1183 | NCT02636517 (ClinicalTrials.gov) | December 2015 | 16/12/2015 | Fecal Microbiome Transplant | Fecal Microbiome Transplant in Pediatric C. Difficile | Clostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Children's Hospital of Philadelphia | NULL | Active, not recruiting | 3 Years | 21 Years | All | 250 | N/A | United States |
| 1184 | NCT02586259 (ClinicalTrials.gov) | December 2015 | 23/10/2015 | Effectiveness of Cortiment® in Patients With Ulcerative Colitis | A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice | Ulcerative Colitis | Drug: budesonide MMX® | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 378 | Canada;Germany;Ireland;Italy;Netherlands;Poland;Sweden;United Kingdom;Israel;Switzerland | |
| 1185 | EUCTR2015-001600-64-BE (EUCTR) | 30/11/2015 | 01/03/2016 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1186 | EUCTR2014-005217-24-GB (EUCTR) | 27/11/2015 | 22/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | United States;Belarus;Philippines;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Croatia;Romania;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1187 | EUCTR2015-000939-33-LV (EUCTR) | 27/11/2015 | 05/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1188 | NCT02632175 (ClinicalTrials.gov) | November 26, 2015 | 14/12/2015 | Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis | Biological: Adalimumab | AbbVie | NULL | Active, not recruiting | 4 Years | 17 Years | All | 101 | Phase 3 | United States;Japan;Poland;Slovakia;Spain;United Kingdom |
| 1189 | EUCTR2015-000939-33-BG (EUCTR) | 26/11/2015 | 05/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1190 | EUCTR2015-000939-33-IT (EUCTR) | 24/11/2015 | 08/06/2021 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitiscompared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;Serbia;United States;Taiwan;Hong Kong;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1191 | EUCTR2014-005217-24-HU (EUCTR) | 19/11/2015 | 22/09/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1192 | EUCTR2015-000319-41-IT (EUCTR) | 19/11/2015 | 29/01/2021 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis. - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: NA Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | CELGENE INTERNATIONAL II SàRL | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1193 | EUCTR2015-000939-33-EE (EUCTR) | 16/11/2015 | 10/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1194 | EUCTR2015-001600-64-DE (EUCTR) | 13/11/2015 | 04/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 1195 | EUCTR2014-005217-24-IE (EUCTR) | 12/11/2015 | 11/12/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | United Kingdom;Hungary;Austria;Turkey;Slovenia;Korea, Republic of;Moldova, Republic of;Netherlands;Latvia;South Africa;Australia;Malaysia;India;Vietnam;Switzerland;Colombia;Israel;Ireland;Ukraine;Spain;Slovakia;Hong Kong;Taiwan;Philippines;United States;Belarus;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1196 | EUCTR2014-005217-24-SK (EUCTR) | 12/11/2015 | 07/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1197 | EUCTR2015-001346-29-SK (EUCTR) | 12/11/2015 | 30/10/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 20 mg solution for injection in pre-filled syringe (20 mg/0.2mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe (40 mg/0.4 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 80 mg solution for injection in pre-filled syringe (80 mg/0.8 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 59 | Phase 3 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Poland;Japan;New Zealand;Sweden | ||
| 1198 | EUCTR2015-000939-33-CZ (EUCTR) | 11/11/2015 | 18/08/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1199 | EUCTR2015-000939-33-DE (EUCTR) | 10/11/2015 | 30/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1200 | EUCTR2015-000939-33-GB (EUCTR) | 06/11/2015 | 29/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 1201 | EUCTR2014-005217-24-AT (EUCTR) | 06/11/2015 | 22/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden;Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain | ||
| 1202 | EUCTR2014-005217-24-LV (EUCTR) | 06/11/2015 | 03/11/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 2;Phase 3 | Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden | ||
| 1203 | EUCTR2013-003032-77-PL (EUCTR) | 05/11/2015 | 28/08/2014 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand | ||
| 1204 | EUCTR2014-005606-38-DK (EUCTR) | 02/11/2015 | 30/06/2015 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1205 | JPRN-UMIN000019310 | 2015/11/01 | 01/11/2015 | Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis | ulcerative colitis | Arm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks) Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 weeks) | Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 90 | Not selected | Japan | |
| 1206 | NCT02330653 (ClinicalTrials.gov) | November 2015 | 29/12/2014 | Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis | A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's Colitis | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo | Stacy A. Kahn | NULL | Completed | 5 Years | 30 Years | All | 15 | Phase 1/Phase 2 | United States |
| 1207 | EUCTR2015-000319-41-SK (EUCTR) | 22/10/2015 | 04/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Latvia;South Africa;Australia;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Serbia | ||
| 1208 | EUCTR2014-005606-38-SK (EUCTR) | 22/10/2015 | 07/07/2015 | A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1209 | EUCTR2014-005606-38-BG (EUCTR) | 21/10/2015 | 03/09/2015 | A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Bulgaria;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1210 | EUCTR2014-005635-14-LT (EUCTR) | 21/10/2015 | 03/07/2015 | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC | Patients with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Lithuania;Latvia | ||
| 1211 | JPRN-UMIN000021460 | 2015/10/20 | 13/03/2016 | Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. | Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. - Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture | patients with ulcerative colitis had high risk of colitic cancer.A:patients suspected dysplasia(low/high grade) or cancer.B:patients had plan of treatment of the dysplasia or cancer. | 40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded. | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan |
| 1212 | EUCTR2015-001600-64-CZ (EUCTR) | 14/10/2015 | 31/07/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 1213 | EUCTR2015-001600-64-SK (EUCTR) | 13/10/2015 | 27/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Djibouti;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1214 | EUCTR2014-005606-38-IT (EUCTR) | 13/10/2015 | 22/01/2021 | A Study to Evaluate the Safety and Efficacy of the Ustekinumab Inductionand Maintenance Therapy in Participants with Moderately to SeverelyActive Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group,Multicenter Protocol to Evaluate the Safety and Efficacy of UstekinumabInduction and Maintenance Therapy in Subjects with Moderately toSeverely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Trade Name: STELARA - 90 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 1.0 ML (90 MG/ML) 1 FLACONCINO Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 951 | Phase 3 | Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1215 | EUCTR2013-001205-84-AT (EUCTR) | 13/10/2015 | 02/09/2015 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1216 | EUCTR2015-001600-64-HU (EUCTR) | 12/10/2015 | 01/09/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sárl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 1217 | EUCTR2014-002981-64-NL (EUCTR) | 12/10/2015 | 19/05/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand | ||
| 1218 | ChiCTR-IOR-15007194 | 2015-10-10 | 2015-08-26 | The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis. | The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis. | Ulreative colitis | Qing chang wen zhong: Qing chang wen zhong of traditional Chinese medicine;Mesalazine:Mesalazine; | Dongfang hospital, Beijing univetsity of Chinese Medicine | NULL | Recruiting | 16 | 65 | Both | Qing chang wen zhong:36;Mesalazine:36; | China | |
| 1219 | ChiCTR-ICR-15007188 | 2015-10-09 | 2015-10-09 | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Ulcerative colitis | Percutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d; | Southern Medical University, Nanfang Hospital, Department of Gastroenterology | NULL | Recruiting | Both | Percutaneous endoscopic mini-colostomy group:21;Control Group:21; | China | |||
| 1220 | EUCTR2014-005606-38-DE (EUCTR) | 07/10/2015 | 04/05/2015 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1221 | EUCTR2015-000319-41-BE (EUCTR) | 06/10/2015 | 24/07/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1222 | NCT02522767 (ClinicalTrials.gov) | October 2015 | 12/8/2015 | Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC) | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine;Drug: Placebo | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 228 | Phase 3 | United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium |
| 1223 | NCT02550418 (ClinicalTrials.gov) | October 2015 | 14/9/2015 | Budesonide 9 mg Capsules in Active UC | Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Budesonide | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | Germany |
| 1224 | EUCTR2014-002981-64-DE (EUCTR) | 29/09/2015 | 08/06/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 1225 | EUCTR2015-001600-64-GB (EUCTR) | 28/09/2015 | 06/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (Clinical Study”) - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 1226 | JPRN-UMIN000019066 | 2015/09/25 | 18/09/2015 | An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis | Ulcerative colitis | Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks. In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks | Sakura Medical Center,Toho university | NULL | Pending | 20years-old | Not applicable | Male and Female | 58 | Not applicable | Japan | |
| 1227 | EUCTR2014-005606-38-BE (EUCTR) | 24/09/2015 | 08/07/2015 | A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1228 | JPRN-JapicCTI-163122 | 24/9/2015 | 06/01/2016 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative, Inflammatory Bowel Diseases | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Janssen Pharmaceutical K.K. | NULL | complete | 18 | BOTH | 92 | Phase 3 | Japan, Asia except Japan, North America, Europe, Oceania | |
| 1229 | EUCTR2015-000319-41-DE (EUCTR) | 18/09/2015 | 02/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 1230 | EUCTR2014-005606-38-NL (EUCTR) | 16/09/2015 | 03/07/2015 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 1231 | EUCTR2014-002981-64-HU (EUCTR) | 14/09/2015 | 27/05/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 2 | United States;Slovakia;Ukraine;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand | ||
| 1232 | EUCTR2015-000319-41-CZ (EUCTR) | 14/09/2015 | 16/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Germany;New Zealand;Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Austria;Korea, Republic of;Latvia;Netherlands;South Africa;Australia;Italy;Russian Federation;Israel;Ukraine;Spain;Greece;Slovakia;United States;Belarus | ||
| 1233 | EUCTR2015-001954-14-NL (EUCTR) | 14/09/2015 | 25/08/2015 | Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial” | SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research | ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240 | Santeon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 1234 | JPRN-UMIN000018745 | 2015/09/01 | 01/09/2015 | The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy | ulcerative colitis | Administration of Infliximab and enteral nutrition Administration of Infliximab | Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology | NULL | Pending | 15years-old | 75years-old | Male and Female | 40 | Not selected | Japan | |
| 1235 | NCT02520284 (ClinicalTrials.gov) | September 2015 | 7/8/2015 | Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: Andecaliximab;Biological: Placebo | Gilead Sciences | NULL | Terminated | 18 Years | 75 Years | All | 165 | Phase 2/Phase 3 | United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Hungary;Ireland;Italy;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Switzerland;Taiwan;Ukraine;United Kingdom;Austria;Croatia;Czech Republic;Germany;Hong Kong;Iceland;Israel;Serbia;Spain;Sweden |
| 1236 | NCT02345733 (ClinicalTrials.gov) | September 2015 | 19/1/2015 | Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis | Use of a Novel Diet (UC DIET) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study | Ulcerative Colitis (UC) | Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail | Prof. Arie Levine | NULL | Recruiting | 8 Years | 19 Years | All | 20 | Phase 4 | United States;Canada;Israel |
| 1237 | NCT02084550 (ClinicalTrials.gov) | September 2015 | 5/3/2014 | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial | Ulcerative Colitis | Dietary Supplement: Vaminolac;Other: Saline | Aarhus University Hospital | NULL | Active, not recruiting | 18 Years | 50 Years | All | 8 | N/A | Denmark |
| 1238 | JPRN-UMIN000018801 | 2015/08/27 | 27/08/2015 | Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis | ulcerative colitis | Colonosocopy using carbon dioxide insufflation Colonosocopy using air insufflation | Osaka University, Graduate School of Medicine,Department of Gastroenterology and Hepatology | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 250 | Not selected | Japan | |
| 1239 | EUCTR2014-005606-38-CZ (EUCTR) | 27/08/2015 | 26/06/2015 | A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1240 | EUCTR2014-002981-64-IT (EUCTR) | 20/08/2015 | 05/11/2020 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na | Subjects with active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: [CC-10004] INN or Proposed INN: Apremilast Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 1241 | EUCTR2014-002981-64-CZ (EUCTR) | 13/08/2015 | 05/05/2015 | Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Subjects with active ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 1242 | EUCTR2014-005606-38-HU (EUCTR) | 12/08/2015 | 16/06/2015 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1243 | JPRN-UMIN000018642 | 2015/08/12 | 11/08/2015 | A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis | ulcerative colitis | Antibiotics therapy:Taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks. FMT:Administration of the fecal material from healthy donors to patients. | Juntendo university school of medicine Department of gastroenterology | NULL | Recruiting | 6years-old | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 1244 | EUCTR2015-000319-41-GB (EUCTR) | 10/08/2015 | 13/07/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 1245 | EUCTR2015-000319-41-HU (EUCTR) | 10/08/2015 | 05/06/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sárl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 1246 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 1247 | EUCTR2014-005635-14-HU (EUCTR) | 29/07/2015 | 03/06/2015 | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC | Patients with active ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Lithuania;Latvia | ||
| 1248 | EUCTR2014-005606-38-AT (EUCTR) | 20/07/2015 | 16/06/2015 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 951 | Phase 3 | United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1249 | EUCTR2014-005443-40-NL (EUCTR) | 15/07/2015 | 08/01/2015 | An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC | An open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio | Academic Medical Center/ Gastroenterology | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Hungary;Belgium;Netherlands | ||
| 1250 | NCT02407236 (ClinicalTrials.gov) | July 10, 2015 | 30/3/2015 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative;Inflammatory Bowel Diseases | Drug: Placebo IV;Drug: Placebo SC;Drug: Ustekinumab IV;Drug: Ustekinumab SC | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 961 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic;South Africa |
| 1251 | EUCTR2014-005635-14-LV (EUCTR) | 10/07/2015 | 23/02/2015 | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC | Patients with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Lithuania;Latvia | ||
| 1252 | NCT02447302 (ClinicalTrials.gov) | July 2015 | 13/5/2015 | Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | All | 156 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Lithuania;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom |
| 1253 | NCT04434872 (ClinicalTrials.gov) | July 2015 | 28/5/2015 | Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis | Ulcerative Colitis | Procedure: Colonoscopy;Procedure: Gastroscopy;Drug: Fecal Microbiota;Procedure: Enema | Tel-Aviv Sourasky Medical Center | NULL | Terminated | 18 Years | 70 Years | All | 80 | Phase 2 | Israel | |
| 1254 | NCT02426372 (ClinicalTrials.gov) | July 2015 | 21/4/2015 | Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis | An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Biological: QBECO SSI | Qu Biologics Inc. | NULL | Completed | 19 Years | N/A | All | 11 | Phase 2 | Canada |
| 1255 | NCT01671956 (ClinicalTrials.gov) | July 2015 | 9/8/2012 | Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis | Ulcerative Colitis, Active Moderate;Ulcerative Colitis, Active Severe | Biological: Bertilimumab;Biological: Placebo | Immune Pharmaceuticals | NULL | Unknown status | 18 Years | 70 Years | All | 42 | Phase 2 | Israel |
| 1256 | NCT02497469 (ClinicalTrials.gov) | June 29, 2015 | 10/7/2015 | An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Colitis, Ulcerative | Drug: Vedolizumab;Drug: Adalimumab placebo;Drug: Adalimumab;Drug: Vedolizumab placebo | Takeda | NULL | Completed | 18 Years | 85 Years | All | 771 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Chile;Czech Republic;Finland;Norway;South Africa;Sweden |
| 1257 | JPRN-UMIN000018075 | 2015/06/26 | 25/06/2015 | Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions | Ulcerative colitis | normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA no optimized therapy | Center for Diagnostic and Therapeutic Endoscopy,Keio University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan | |
| 1258 | JPRN-UMIN000017844 | 2015/06/22 | 22/06/2015 | Antibiotic combination therapy for ulcerative colitis | ulcerative colitis | amoxicillin, tetracycline, and metronidazole | Shiga University of Medical Science | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Not selected | Japan | |
| 1259 | NCT02435992 (ClinicalTrials.gov) | June 17, 2015 | 24/4/2015 | Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063;Drug: Placebo | Celgene | NULL | Completed | 12 Years | 75 Years | All | 1012 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| 1260 | EUCTR2014-005635-14-DE (EUCTR) | 08/06/2015 | 18/02/2015 | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC | Patients with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Lithuania;Latvia;Germany | ||
| 1261 | EUCTR2014-005443-40-BE (EUCTR) | 02/06/2015 | 03/02/2015 | An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC | An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab | Academic Medical Center/ Gastroenterology | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Hungary;Belgium;Netherlands | ||
| 1262 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 1263 | NCT02463045 (ClinicalTrials.gov) | May 2015 | 26/5/2015 | Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects | A Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: TOP1288 | Topivert Pharma Ltd | NULL | Completed | 18 Years | 55 Years | All | 67 | Phase 1 | United Kingdom |
| 1264 | NCT02575040 (ClinicalTrials.gov) | May 2015 | 6/10/2015 | Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease | Ulcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction) | Biological: Fecal microbiota transplantation | Gulhane Military Medical Academy | NULL | Recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Turkey |
| 1265 | NCT02413047 (ClinicalTrials.gov) | May 2015 | 6/3/2015 | Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator | A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate | Indiana University | NULL | Terminated | 18 Years | 80 Years | All | 3 | N/A | United States |
| 1266 | NCT02435160 (ClinicalTrials.gov) | May 2015 | 23/4/2015 | The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Biological: Fecal Microbiota Transplantation | Jun Liu | NULL | Not yet recruiting | 25 Years | 60 Years | Male | 20 | Phase 2/Phase 3 | NULL | |
| 1267 | EUCTR2014-000784-41-DK (EUCTR) | 15/04/2015 | 28/01/2015 | Amino acids in j-pouch surgery for ulcerative colitis | Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis | Ileal pouch-anal anastomosis for ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Vaminolac, komb. Product Name: Vaminolac, komb. INN or Proposed INN: Vaminolac, komb. Other descriptive name: Vaminolac, komb. | Department of Medicine and Endocrinology | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Denmark | ||
| 1268 | EUCTR2013-000366-11-RO (EUCTR) | 25/03/2015 | 11/03/2015 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1269 | NCT02674308 (ClinicalTrials.gov) | March 24, 2015 | 29/1/2016 | Entyvio (Vedolizumab) Long Term Safety Study | Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis and Crohn's Disease | Drug: Vedolizumab;Other: Other Biologic Agents | Takeda | NULL | Completed | 18 Years | N/A | All | 5302 | United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom | |
| 1270 | EUCTR2013-001205-84-SK (EUCTR) | 23/03/2015 | 05/02/2015 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1271 | EUCTR2013-004435-72-BG (EUCTR) | 16/03/2015 | 06/11/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMab Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1272 | EUCTR2014-002579-27-IT (EUCTR) | 03/03/2015 | 19/01/2015 | Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone | Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL | active steroid-dependent ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA INN or Proposed INN: GOLIMUMAB | Istituto Clinico Humanitas | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Italy | ||
| 1273 | EUCTR2013-001744-65-NL (EUCTR) | 02/03/2015 | 07/08/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom | ||
| 1274 | NCT04564638 (ClinicalTrials.gov) | March 1, 2015 | 11/9/2020 | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Ulcerative Colitis | Drug: Corticosteroid | Tampere University Hospital | NULL | Completed | N/A | N/A | All | 217 | NULL | |
| 1275 | NCT02368717 (ClinicalTrials.gov) | March 2015 | 16/2/2015 | An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase | A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets | Ulcerative Colitis | Drug: Mesalazine Enema;Drug: Placebo Enema | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 281 | Phase 3 | China |
| 1276 | NCT02412085 (ClinicalTrials.gov) | March 2015 | 26/3/2015 | Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission | Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Istituto Clinico Humanitas | NULL | Recruiting | 18 Years | 65 Years | Both | 100 | Phase 4 | Italy |
| 1277 | NCT02318667 (ClinicalTrials.gov) | February 27, 2015 | 12/12/2014 | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). | An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab. | Colitis, Ulcerative | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 65 Years | All | 38 | Phase 4 | Portugal |
| 1278 | EUCTR2013-004435-72-IT (EUCTR) | 27/02/2015 | 29/09/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ND Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2568 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1279 | EUCTR2013-001205-84-LV (EUCTR) | 26/02/2015 | 23/12/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands | ||
| 1280 | EUCTR2013-004435-72-DE (EUCTR) | 06/02/2015 | 18/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1281 | EUCTR2013-002042-36-FR (EUCTR) | 04/02/2015 | 22/06/2015 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;United States | ||
| 1282 | NCT02465385 (ClinicalTrials.gov) | February 2015 | 27/5/2015 | Single-dose Linaclotide for Capsule Endoscopy Preparation | Single-dose Linaclotide for Capsule Endoscopy Preparation | Crohn's;Ulcerative Colitis;Gastrointestinal Bleeding | Drug: Linaclotide | University of Virginia | NULL | Completed | 18 Years | N/A | Both | 30 | Phase 4 | United States |
| 1283 | NCT02200445 (ClinicalTrials.gov) | February 2015 | 22/7/2014 | Low Dose IL-2 for Ulcerative Colitis | A Phase I Study of Low Dose Subcutaneous Interleukin-2 (IL-2) For The Treatment of Ulcerative Colitis. | Ulcerative Colitis | Drug: Interleukin-2 (aldesleukin). | Scott Snapper | NULL | Completed | 18 Years | 70 Years | All | 26 | Phase 1 | United States |
| 1284 | EUCTR2013-004435-72-NL (EUCTR) | 28/01/2015 | 04/08/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: unknown Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1285 | EUCTR2014-001893-32-PL (EUCTR) | 20/01/2015 | 22/10/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Belgium;Poland;Russian Federation;Germany | ||
| 1286 | EUCTR2013-001205-84-PL (EUCTR) | 20/01/2015 | 22/09/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands | ||
| 1287 | EUCTR2014-001893-32-CZ (EUCTR) | 19/01/2015 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany | ||
| 1288 | EUCTR2013-001682-16-BE (EUCTR) | 15/01/2015 | 22/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Canada;Poland;Spain;Belgium;Israel;Netherlands;Germany;Italy;Japan;Switzerland | ||
| 1289 | EUCTR2013-004282-14-NL (EUCTR) | 13/01/2015 | 04/08/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 720 | Phase 3 | Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of | ||
| 1290 | EUCTR2013-001205-84-DE (EUCTR) | 13/01/2015 | 08/08/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1291 | ChiCTR-IPR-15005760 | 2015-01-12 | 2015-01-02 | Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study | Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study | ulcerative colitis | TCM Group:Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule;Control:Azathioprine; | Affiliated Hospital of Nanjing University of Chinese Medicine | NULL | Pending | 18 | 65 | Both | TCM Group:60;Control:60; | I (Phase 1 study) | China |
| 1292 | EUCTR2013-004279-11-BG (EUCTR) | 12/01/2015 | 06/10/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 1293 | EUCTR2013-004277-27-BG (EUCTR) | 12/01/2015 | 06/10/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 1294 | EUCTR2013-004282-14-PT (EUCTR) | 09/01/2015 | 23/07/2014 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of | ||
| 1295 | EUCTR2013-004435-72-PT (EUCTR) | 09/01/2015 | 23/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1296 | NCT02289417 (ClinicalTrials.gov) | January 8, 2015 | 10/11/2014 | Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis | A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 170 | Phase 2 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic |
| 1297 | NCT03441893 (ClinicalTrials.gov) | January 1, 2015 | 8/2/2018 | Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis | Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis | Ulcerative Colitis;Ulcerative Colitis Exacerbation;Protozoan Infections;Helminth Infection | Diagnostic Test: parasitological diagnostics (coproscopy);Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg | Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan | NULL | Active, not recruiting | 18 Years | 90 Years | All | 300 | Phase 1/Phase 2 | NULL |
| 1298 | NCT04276649 (ClinicalTrials.gov) | January 1, 2015 | 17/2/2020 | A Retrospective Analysis: the Influence of Caltrate Supplement on the Effect of Mesalazine in Ulcerative Colitis | A Retrospective Analysis on the Influence of Caltrate Supplement on the Clinical Effect of Mesalazine in Ulcerative Colitis | Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement | Drug: Caltrate | Second Affiliated Hospital of Wenzhou Medical University | NULL | Completed | 18 Years | N/A | All | 74 | China | |
| 1299 | NCT02335281 (ClinicalTrials.gov) | January 2015 | 7/1/2015 | Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Procedure: FMT;Drug: Mesalazine | Yanling Wei | NULL | Recruiting | 16 Years | 70 Years | Both | 40 | Phase 2 | China |
| 1300 | NCT02261636 (ClinicalTrials.gov) | January 2015 | 7/10/2014 | Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment | Ulcerative Colitis | Drug: mesalazine | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 150 | Netherlands | ||
| 1301 | NCT02136069 (ClinicalTrials.gov) | December 24, 2014 | 15/4/2014 | A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors | Ulcerative Colitis | Drug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection) | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 397 | Phase 3 | Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam |
| 1302 | EUCTR2013-004435-72-BE (EUCTR) | 22/12/2014 | 27/08/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1303 | EUCTR2013-004435-72-ES (EUCTR) | 22/12/2014 | 11/08/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: - Other descriptive name: ETROLIZUMAB | Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2568 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1304 | JPRN-JapicCTI-142649 | 22/12/2014 | 03/09/2014 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290] | Ulcerateive Colotis | Intervention name : abalimumab INN of the intervention : Adalimumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : subcutaneous injection | AbbVie GK | NULL | complete | 4 | 17 | BOTH | 9 | Phase 3 | Japan, North America, Europe |
| 1305 | EUCTR2014-004740-35-DK (EUCTR) | 19/12/2014 | 25/11/2014 | Loperamide vs. Placebo's effect on Ileostomy output | Loperamide vs. Placebo's effect on ileostomy output: A clincal randomized patientblinded crossover study | Patients with ileostomy because of ulcerative colitis, rectal cancer or short bowel syndrom MedDRA version: 17.1;Level: LLT;Classification code 10012727;Term: Diarrhea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imolope Product Name: Imolope Product Code: A07DA03 INN or Proposed INN: LOPERAMIDE | Department of surgery, Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 1306 | EUCTR2013-004280-31-DK (EUCTR) | 17/12/2014 | 29/07/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - Laurel | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Denmark;South Africa;Israel;Germany | ||
| 1307 | EUCTR2014-001893-32-DE (EUCTR) | 15/12/2014 | 24/09/2014 | Placebo-controlled study to assess efficacy, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany | ||
| 1308 | JPRN-UMIN000015912 | 2014/12/15 | 15/12/2014 | Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus | ulcerative colitis | Tacrolimus will be decreased gradually three months after it was administered. Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually. | Osaka Medical College | NULL | Recruiting | 16years-old | 70years-old | Male and Female | 50 | Not applicable | Japan | |
| 1309 | EUCTR2014-003262-25-PT (EUCTR) | 12/12/2014 | 20/11/2014 | Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab | An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 37 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal | ||
| 1310 | NCT02093663 (ClinicalTrials.gov) | December 12, 2014 | 17/3/2014 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases | Ulcerative Colitis | Drug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose) | Shire | NULL | Completed | 5 Years | 17 Years | All | 107 | Phase 3 | United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands |
| 1311 | EUCTR2013-004282-14-BE (EUCTR) | 11/12/2014 | 27/08/2014 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 1312 | EUCTR2013-001682-16-PL (EUCTR) | 08/12/2014 | 22/09/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 1313 | EUCTR2014-001893-32-HU (EUCTR) | 08/12/2014 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany | ||
| 1314 | EUCTR2013-004277-27-GR (EUCTR) | 08/12/2014 | 08/12/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 1315 | EUCTR2013-003032-77-HU (EUCTR) | 04/12/2014 | 30/12/2013 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;New Zealand | ||
| 1316 | EUCTR2013-004435-72-FR (EUCTR) | 02/12/2014 | 22/06/2015 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2568 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1317 | NCT02337608 (ClinicalTrials.gov) | December 2014 | 9/1/2015 | Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: GLPG1205;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 75 Years | Both | 64 | Phase 2 | Belgium;Czech Republic;Germany;Hungary;Poland;Russian Federation |
| 1318 | NCT02442960 (ClinicalTrials.gov) | December 2014 | 23/4/2015 | Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis | An Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild, Moderate or Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Herbal treatment (SA100) | Stanford University | NULL | Completed | 13 Years | 75 Years | All | 15 | Phase 1 | United States |
| 1319 | EUCTR2013-001682-16-NL (EUCTR) | 28/11/2014 | 01/05/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan | ||
| 1320 | EUCTR2013-004282-14-ES (EUCTR) | 25/11/2014 | 06/08/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 720 | Phase 3 | Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of | ||
| 1321 | EUCTR2013-004280-31-DE (EUCTR) | 24/11/2014 | 30/07/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany | ||
| 1322 | EUCTR2014-001893-32-BE (EUCTR) | 24/11/2014 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany | ||
| 1323 | EUCTR2013-004278-88-BE (EUCTR) | 21/11/2014 | 10/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | Denmark;Netherlands;Germany;Korea, Republic of;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia | ||
| 1324 | EUCTR2013-004278-88-NL (EUCTR) | 19/11/2014 | 23/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta 7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1325 | NCT02171429 (ClinicalTrials.gov) | November 14, 2014 | 20/6/2014 | A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors | Ulcerative Colitis | Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 358 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Czechia;France;Greece;Hungary;Latvia;Lithuania;Malaysia;New Zealand;Poland;Russian Federation;Turkey;Ukraine |
| 1326 | EUCTR2013-004435-72-SK (EUCTR) | 13/11/2014 | 20/10/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1327 | EUCTR2013-004279-11-SK (EUCTR) | 13/11/2014 | 08/10/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 1328 | EUCTR2013-004282-14-DE (EUCTR) | 10/11/2014 | 18/07/2014 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of | ||
| 1329 | EUCTR2013-004282-14-IT (EUCTR) | 10/11/2014 | 16/09/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 720 | Phase 3 | Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 1330 | EUCTR2013-004435-72-DK (EUCTR) | 07/11/2014 | 21/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1331 | EUCTR2013-003032-77-CZ (EUCTR) | 06/11/2014 | 31/07/2014 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand | ||
| 1332 | EUCTR2013-004435-72-SE (EUCTR) | 05/11/2014 | 16/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Phase 3 | Bulgaria;Norway;Germany;New Zealand;Sweden;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico | ||
| 1333 | NCT02163759 (ClinicalTrials.gov) | November 4, 2014 | 12/6/2014 | A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors | Ulcerative Colitis | Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 358 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Estonia;France;Hong Kong;Mexico;Poland;Russian Federation;Serbia;Slovakia;Ukraine |
| 1334 | JPRN-JapicCTI-142704 | 01/11/2014 | 14/11/2014 | Phase III study of AJG511 in patients with active ulcerative colitis | Phase III study of AJG511 in patients with active ulcerative colitis | ulcerative colitis | Intervention name : AJG511 INN of the intervention : budesonide Dosage And administration of the intervention : intrarectal Control intervention name : Placebo Dosage And administration of the control intervention : intrarectal | EA Pharma Co.,Ltd. | NULL | 16 | BOTH | 120 | Phase 3 | NULL | ||
| 1335 | NCT02361957 (ClinicalTrials.gov) | November 2014 | 15/1/2015 | The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients | The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Ecologic 825;Dietary Supplement: Placebo | Wageningen University | NULL | Suspended | 18 Years | 65 Years | Both | 40 | N/A | Netherlands |
| 1336 | NCT02246686 (ClinicalTrials.gov) | November 2014 | 19/9/2014 | Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients | A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: STW5-II (Iberogast N, BAY98-7410);Drug: Placebo | Bayer | NULL | Terminated | 18 Years | 80 Years | Both | 3 | Phase 2 | Germany |
| 1337 | EUCTR2013-003032-77-GB (EUCTR) | 30/10/2014 | 19/12/2013 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand | ||
| 1338 | EUCTR2013-004282-14-HU (EUCTR) | 29/10/2014 | 30/10/2014 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of | ||
| 1339 | EUCTR2013-004435-72-HU (EUCTR) | 29/10/2014 | 30/10/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1340 | EUCTR2013-004435-72-GB (EUCTR) | 24/10/2014 | 15/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1341 | EUCTR2013-001744-65-GB (EUCTR) | 22/10/2014 | 31/03/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 1342 | ChiCTR1800016668 | 2014-10-22 | 2018-06-14 | A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome) | A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome) | Active ulcerative colitis | test group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets Simulator;Positive control group:Mesalazine enteric-coated tablets+Hudi Enteric-coated Capsule Simulator;Combined group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets; | Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Province Traditional Chinese Medicine Hospital) | NULL | Completed | 18 | 65 | Both | test group:120;Positive control group:120;Combined group:120; | China | |
| 1343 | EUCTR2012-003702-27-BE (EUCTR) | 21/10/2014 | 04/02/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia | ||
| 1344 | EUCTR2013-004278-88-DE (EUCTR) | 20/10/2014 | 06/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1345 | EUCTR2013-001744-65-PL (EUCTR) | 20/10/2014 | 19/08/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 1346 | EUCTR2013-004435-72-NO (EUCTR) | 17/10/2014 | 06/08/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Vietnam;Switzerland;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Estonia;Hong Kong;Philippines;United States;Portugal;Serbia | ||
| 1347 | EUCTR2013-004282-14-NO (EUCTR) | 17/10/2014 | 04/08/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 720 | Phase 3 | Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of;Canada;Belgium;Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary | ||
| 1348 | NCT02065557 (ClinicalTrials.gov) | October 13, 2014 | 17/2/2014 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Biological: Adalimumab;Biological: Placebo | AbbVie | NULL | Completed | 4 Years | 17 Years | All | 101 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Hungary;Israel;Japan;New Zealand;Poland;Slovakia;Spain;United Kingdom;Czech Republic;Italy;Sweden |
| 1349 | EUCTR2013-004280-31-CZ (EUCTR) | 07/10/2014 | 21/07/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany | ||
| 1350 | EUCTR2013-004279-11-EE (EUCTR) | 03/10/2014 | 09/09/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 1351 | EUCTR2013-004435-72-CZ (EUCTR) | 02/10/2014 | 21/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Vietnam;Switzerland;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Estonia;Hong Kong;Philippines;United States;Portugal;Serbia | ||
| 1352 | NCT02280629 (ClinicalTrials.gov) | October 1, 2014 | 29/10/2014 | Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) | Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: LT-02;Drug: Placebo;Drug: Mesalamine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | All | 150 | Phase 3 | Germany |
| 1353 | NCT02217722 (ClinicalTrials.gov) | October 2014 | 20/7/2014 | Use of the Ulcerative Colitis Diet for Induction of Remission | An Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission. | Ulcerative Colitis (UC) | Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail | Prof. Arie Levine | NULL | Terminated | 5 Years | 18 Years | Both | 9 | N/A | Israel |
| 1354 | NCT02266849 (ClinicalTrials.gov) | October 2014 | 8/10/2014 | Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study | Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study | Rectal Cancer;Ulcerative Colitis;Short Bowel Syndrome | Drug: Loperamide;Drug: Placebo | Odense University Hospital | NULL | Terminated | 18 Years | N/A | Both | 12 | Phase 3 | Denmark |
| 1355 | EUCTR2013-004435-72-LT (EUCTR) | 30/09/2014 | 22/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1356 | EUCTR2013-004277-27-LT (EUCTR) | 30/09/2014 | 22/07/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 1357 | EUCTR2012-003702-27-NL (EUCTR) | 30/09/2014 | 14/04/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia | ||
| 1358 | EUCTR2013-004435-72-GR (EUCTR) | 30/09/2014 | 20/08/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2568 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1359 | EUCTR2013-004282-14-GB (EUCTR) | 29/09/2014 | 15/07/2014 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of | ||
| 1360 | EUCTR2013-001744-65-HU (EUCTR) | 24/09/2014 | 15/07/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom | ||
| 1361 | EUCTR2013-002042-36-NL (EUCTR) | 24/09/2014 | 13/06/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany | ||
| 1362 | EUCTR2013-001682-16-DE (EUCTR) | 22/09/2014 | 10/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 1363 | EUCTR2013-004278-88-GR (EUCTR) | 22/09/2014 | 03/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1364 | EUCTR2013-004280-31-HU (EUCTR) | 19/09/2014 | 31/07/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Ukraine;Israel;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany | ||
| 1365 | EUCTR2013-004435-72-EE (EUCTR) | 19/09/2014 | 29/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1366 | EUCTR2013-004282-14-CZ (EUCTR) | 16/09/2014 | 18/07/2014 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania | ||
| 1367 | NCT02118584 (ClinicalTrials.gov) | September 15, 2014 | 16/4/2014 | Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies | An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies | Ulcerative Colitis | Drug: Etrolizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 1822 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic;Philippines;Sweden;Vietnam |
| 1368 | EUCTR2013-002042-36-BG (EUCTR) | 11/09/2014 | 30/04/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 1369 | EUCTR2013-001744-65-SK (EUCTR) | 11/09/2014 | 17/07/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 1370 | EUCTR2013-003032-77-IT (EUCTR) | 10/09/2014 | 19/12/2013 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand | ||
| 1371 | JPRN-UMIN000015068 | 2014/09/05 | 05/09/2014 | An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis | Ulcerative colitis | Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks GMA will be administrated 10 times | Hiroshima University Hospital, Department of Endoscopy | NULL | Enrolling by invitation | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan | |
| 1372 | EUCTR2013-004435-72-LV (EUCTR) | 05/09/2014 | 22/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1373 | EUCTR2013-004278-88-FR (EUCTR) | 04/09/2014 | 22/06/2015 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1374 | EUCTR2013-004435-72-AT (EUCTR) | 03/09/2014 | 22/07/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1375 | EUCTR2013-000263-88-RO (EUCTR) | 03/09/2014 | 30/05/2014 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not available Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not available Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not available Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 1376 | EUCTR2013-004282-14-AT (EUCTR) | 03/09/2014 | 22/07/2014 | A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of | ||
| 1377 | EUCTR2013-001682-16-IT (EUCTR) | 02/09/2014 | 23/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 1378 | EUCTR2013-004278-88-IT (EUCTR) | 01/09/2014 | 01/07/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1379 | EUCTR2013-003032-77-BE (EUCTR) | 25/08/2014 | 02/01/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand | ||
| 1380 | EUCTR2013-001682-16-CZ (EUCTR) | 21/08/2014 | 18/06/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 1381 | EUCTR2013-004278-88-DK (EUCTR) | 21/08/2014 | 10/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Hungary;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Korea, Republic of | ||
| 1382 | NCT02165215 (ClinicalTrials.gov) | August 12, 2014 | 13/6/2014 | A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors | Colitis, Ulcerative | Drug: Etrolizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 359 | Phase 3 | United States;Brazil;Canada;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Slovakia;South Africa;Ukraine;Czech Republic |
| 1383 | EUCTR2013-004435-72-HR (EUCTR) | 12/08/2014 | 05/09/2014 | An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies | AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1384 | EUCTR2013-004277-27-HR (EUCTR) | 12/08/2014 | 05/09/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 1385 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 1386 | EUCTR2013-004278-88-HU (EUCTR) | 04/08/2014 | 10/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 605 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1387 | NCT02209987 (ClinicalTrials.gov) | August 2014 | 4/8/2014 | Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults | A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects | Ulcerative Colitis | Drug: GS-5745 SC;Drug: GS-5745 IV | Gilead Sciences | NULL | Completed | 18 Years | 45 Years | Both | 28 | Phase 1 | New Zealand |
| 1388 | EUCTR2013-002042-36-DE (EUCTR) | 31/07/2014 | 27/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 1389 | EUCTR2012-003702-27-PL (EUCTR) | 29/07/2014 | 20/05/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands | ||
| 1390 | EUCTR2013-004282-14-FR (EUCTR) | 28/07/2014 | 22/06/2015 | A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 720 | Phase 3 | Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 1391 | EUCTR2013-004277-27-LV (EUCTR) | 28/07/2014 | 21/07/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;New Zealand;Latvia;Bulgaria;Australia;Croatia;Malaysia | ||
| 1392 | EUCTR2013-004278-88-ES (EUCTR) | 25/07/2014 | 13/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: - Other descriptive name: ETROLIZUMAB | Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1393 | EUCTR2013-001682-16-ES (EUCTR) | 25/07/2014 | 08/05/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 525 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan | ||
| 1394 | JPRN-JapicCTI-142648 | 22/7/2014 | 03/09/2014 | Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033] | Ulcerative Colitis | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : subcutaneous injection | AbbVie GK | NULL | complete | 18 | 75 | BOTH | 100 | Phase 3 | Japan, North America, Europe |
| 1395 | EUCTR2013-000891-13-DE (EUCTR) | 21/07/2014 | 24/06/2014 | Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease) | A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Iberogast N Product Name: Iberogast N Product Code: STW5-II INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml Other descriptive name: BITTER CANDYTUFT FRESH PLANT EXTRACT INN or Proposed INN: Kümmel 2ml/10ml Other descriptive name: CARVI EXTRACTUM FLUIDUM INN or Proposed INN: Pfefferminzblätter 1ml/10ml Other descriptive name: MENTHA × PIPERITA L. FOLIUM INN or Proposed INN: Süßholzwurzel 1ml/10ml Other descriptive name: GLYCYRRHIZA GLABRA ROOT INN or Proposed INN: Kamillenblüten 3ml/10ml Other descriptive name: MATRICARIA RECUTITA L. FLOS INN or Proposed INN: Melissenblätter 15ml/10ml Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT | Steigerwald Arzneimittelwerk GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1396 | NCT02142725 (ClinicalTrials.gov) | July 21, 2014 | 15/5/2014 | Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis | Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine | Ulcerative Colitis | Drug: LT-02;Drug: Placebo | Dr. Falk Pharma GmbH | NULL | Terminated | 18 Years | 70 Years | All | 468 | Phase 3 | Germany |
| 1397 | EUCTR2013-002042-36-BE (EUCTR) | 10/07/2014 | 20/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 1398 | EUCTR2013-004278-88-CZ (EUCTR) | 09/07/2014 | 09/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1399 | EUCTR2013-001682-16-AT (EUCTR) | 03/07/2014 | 16/06/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 1400 | EUCTR2013-004278-88-AT (EUCTR) | 02/07/2014 | 11/06/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Greece;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of;Spain | ||
| 1401 | NCT02155335 (ClinicalTrials.gov) | July 1, 2014 | 2/6/2014 | Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027) | Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Prefilled Syringe delivery of Golimumab;Drug: Smartject Device delivery of Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | Belgium |
| 1402 | NCT02227342 (ClinicalTrials.gov) | July 2014 | 22/7/2014 | Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis | A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbiota Transplant | University of Alberta | NULL | Completed | 18 Years | 65 Years | Both | 3 | Phase 1/Phase 2 | Canada |
| 1403 | NCT02049502 (ClinicalTrials.gov) | July 2014 | 27/1/2014 | FMT in Ulcerative Colitis-Associated Pouchitis | The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis | Ulcerative Colitis Associated Pouchitis | Biological: biologically active human fecal microbiota;Procedure: sigmoidoscopy | Virginia O. Shaffer | NULL | Completed | 18 Years | 65 Years | All | 8 | Phase 2 | United States |
| 1404 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 1405 | JPRN-UMIN000014275 | 2014/06/24 | 24/06/2014 | Efficacy of infliximab for refractory pouchitis with complexed anal fistula | ulcerative colitis | infliximab | Hyogo College of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 10 | Phase 1 | Japan | |
| 1406 | EUCTR2013-000366-11-SK (EUCTR) | 19/06/2014 | 21/05/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 1407 | EUCTR2013-004278-88-LT (EUCTR) | 19/06/2014 | 24/04/2014 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1408 | EUCTR2013-001682-16-HU (EUCTR) | 18/06/2014 | 22/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 1409 | EUCTR2013-003060-31-BG (EUCTR) | 18/06/2014 | 10/04/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1410 | EUCTR2014-000656-29-BE (EUCTR) | 13/06/2014 | 05/03/2014 | Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device | Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi | MSD Belgium BVBA/SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 1411 | EUCTR2013-003060-31-PL (EUCTR) | 11/06/2014 | 19/03/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1412 | EUCTR2012-003702-27-SK (EUCTR) | 10/06/2014 | 06/03/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1413 | EUCTR2013-001682-16-SK (EUCTR) | 10/06/2014 | 29/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan | ||
| 1414 | EUCTR2013-002042-36-PL (EUCTR) | 09/06/2014 | 06/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands | ||
| 1415 | JPRN-UMIN000014152 | 2014/06/04 | 04/06/2014 | A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitis | ulcerative colitis | Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks | Juntendo university school of medicine Department of gastroenterology | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 1416 | EUCTR2013-002042-36-CZ (EUCTR) | 04/06/2014 | 21/03/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 1417 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | |
| 1418 | NCT02186886 (ClinicalTrials.gov) | June 2014 | 1/7/2014 | Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab | Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi) | Ulcerative Colitis | Drug: Golimumab | Kliniken im Naturpark Altmuehltal | NULL | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | Germany |
| 1419 | NCT02179372 (ClinicalTrials.gov) | June 2014 | 29/6/2014 | Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases | Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases | Ulcerative Colitis;Crohn's Disease | Dietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo) | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | NULL | Completed | 18 Years | 80 Years | Both | 60 | N/A | Italy |
| 1420 | NCT02100696 (ClinicalTrials.gov) | May 21, 2014 | 27/3/2014 | A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors | Ulcerative Colitis | Drug: Etrozulimab;Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 609 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Spain;Switzerland;United Kingdom;Czech Republic;New Zealand |
| 1421 | EUCTR2012-003702-27-LV (EUCTR) | 20/05/2014 | 25/03/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany | ||
| 1422 | EUCTR2012-003702-27-HU (EUCTR) | 19/05/2014 | 07/03/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1423 | EUCTR2012-003702-27-CZ (EUCTR) | 15/05/2014 | 24/02/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1424 | JPRN-UMIN000013694 | 2014/05/13 | 11/04/2014 | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs - Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | ulcerative colitis | determine CYP3A5 SNP status increase the initial dosage of tacrolimus | Kitasato University Kitasato Institute Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 1425 | EUCTR2012-003702-27-LT (EUCTR) | 12/05/2014 | 19/03/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia | ||
| 1426 | EUCTR2013-002042-36-HU (EUCTR) | 12/05/2014 | 21/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany | ||
| 1427 | ChiCTR-OCH-14004615 | 2014-05-12 | 2014-05-07 | Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis. | Prospective cohort study of qingchangwenzhong decoction in the treatment of patients with mild and moderate ulcerative colitis. | ulcerative colitis | clinical group:Qing Chang Wen Zhong decoction;control:Mesalazine Enteric-coated Tablets or Medichemie Ettingen; | Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine | NULL | Completed | 18 | 65 | Both | clinical group:60;control:60; | China | |
| 1428 | NCT02092285 (ClinicalTrials.gov) | May 9, 2014 | 18/3/2014 | Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) | Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis | Ulcerative Colitis | Drug: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 205 | Phase 4 | United Kingdom |
| 1429 | EUCTR2012-003702-27-DE (EUCTR) | 08/05/2014 | 30/12/2013 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 1430 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 1431 | EUCTR2013-004599-36-DE (EUCTR) | 23/04/2014 | 03/02/2014 | SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily | SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE | Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: SB012 INN or Proposed INN: hgd40 | sterna biologicals GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 1432 | EUCTR2013-000366-11-BG (EUCTR) | 23/04/2014 | 06/03/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1433 | JPRN-UMIN000013716 | 2014/04/15 | 15/04/2014 | A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis | ulcerative colitis | After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy | Yokohama City University Medical Center | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 40 | Phase 2 | Japan | |
| 1434 | EUCTR2013-000263-88-BG (EUCTR) | 14/04/2014 | 17/02/2014 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 1435 | EUCTR2013-003060-31-CZ (EUCTR) | 10/04/2014 | 04/02/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy.(NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1436 | EUCTR2012-002030-37-HR (EUCTR) | 09/04/2014 | 14/10/2014 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1437 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 1438 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 1439 | EUCTR2012-003702-27-AT (EUCTR) | 02/04/2014 | 10/02/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia | ||
| 1440 | EUCTR2013-003060-31-HU (EUCTR) | 02/04/2014 | 31/01/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1441 | ChiCTR-IOR-15006812 | 2014-04-01 | 2015-07-26 | Effect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitis | Effect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitis | ulcerative colitis | intervetion group:wind-dispelling and damp-eliminating glanules;control group:Mesalazine; | Department of anorectal surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine | NULL | Recruiting | 18 | 70 | Both | intervetion group:30;control group:30; | China | |
| 1442 | NCT02913508 (ClinicalTrials.gov) | April 2014 | 22/9/2016 | Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease | A Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab intravenous injection;Drug: Vedolizumab subcutaneous injection | Takeda | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 2 | NULL |
| 1443 | NCT02129439 (ClinicalTrials.gov) | April 2014 | 30/4/2014 | Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients | SB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered OD | Colitis, Ulcerative | Drug: SB012;Drug: Placebo | Sterna Biologicals GmbH & Co. KG | NULL | Completed | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | Germany |
| 1444 | EUCTR2011-005251-13-EE (EUCTR) | 31/03/2014 | 15/01/2014 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Germany;Netherlands;Norway;New Zealand | ||
| 1445 | NCT02065622 (ClinicalTrials.gov) | March 27, 2014 | 17/2/2014 | Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Adalimumab;Other: Placebo | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 952 | Phase 3 | United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic |
| 1446 | EUCTR2013-003032-77-ES (EUCTR) | 25/03/2014 | 27/02/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand | ||
| 1447 | EUCTR2013-000366-11-LV (EUCTR) | 14/03/2014 | 07/02/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1448 | EUCTR2013-003032-77-SK (EUCTR) | 13/03/2014 | 23/01/2014 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand | ||
| 1449 | EUCTR2013-000366-11-LT (EUCTR) | 10/03/2014 | 22/01/2014 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1450 | EUCTR2013-002651-15-NL (EUCTR) | 03/03/2014 | 18/09/2013 | Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood. | Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study | Crohns diseaseUlcerative colitis MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade (infliximab) Product Name: infliximab | Zon MW | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 1451 | EUCTR2011-005251-13-LV (EUCTR) | 03/03/2014 | 16/01/2014 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Netherlands;Norway;Germany;New Zealand | ||
| 1452 | ChiCTR-TRC-14004153 | 2014-03-01 | 2014-01-03 | Research on Quality of Life in Patients with Ulcerative Colitis of type of sificiency of spleen and retention of damp-heat receiving Jian Pi Qing Chang [JPQC] decoction | Research on Quality of Life in Patients with Ulcerative Colitis of type of sificiency of spleen and retention of damp-heat receiving Jian Pi Qing Chang [JPQC] decoction | Ulcerative colitis | Western Medicine:5-ASA;TCM:Jian Pi Qing Chang [JPQC] decoction ; | Department of Gastroenterology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China | NULL | Completed | 18 | 75 | Both | Western Medicine:60;TCM:60; | I (Phase 1 study) | NULL |
| 1453 | EUCTR2013-000366-11-HU (EUCTR) | 24/02/2014 | 28/11/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1454 | EUCTR2013-003060-31-LV (EUCTR) | 17/02/2014 | 16/12/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1455 | EUCTR2013-003060-31-LT (EUCTR) | 11/02/2014 | 30/12/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1456 | JPRN-JapicCTI-142403 | 04/2/2014 | 27/12/2013 | Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis | Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitis | Ulcerative colitis | Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | complete | 15 | 80 | BOTH | 292 | Phase 3 | Japan |
| 1457 | NCT02039505 (ClinicalTrials.gov) | February 4, 2014 | 16/1/2014 | Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis | Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab;Drug: Vedolizumab placebo | Takeda | NULL | Completed | 15 Years | 80 Years | All | 292 | Phase 3 | Japan |
| 1458 | JPRN-UMIN000013033 | 2014/02/01 | 01/02/2014 | Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. | Ulcerative colitis | Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks) | Department of Internal Medicine,Juntendo University | NULL | Pending | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 1459 | NCT01947101 (ClinicalTrials.gov) | February 2014 | 13/9/2013 | Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children | A Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC) | Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Baylor College of Medicine | NULL | Completed | 12 Years | 20 Years | Both | 6 | Phase 1 | United States |
| 1460 | EUCTR2013-000263-88-PL (EUCTR) | 29/01/2014 | 26/11/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands | ||
| 1461 | EUCTR2013-003032-77-AT (EUCTR) | 29/01/2014 | 08/01/2014 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand | ||
| 1462 | EUCTR2013-004583-56-GB (EUCTR) | 28/01/2014 | 23/12/2013 | Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis | Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: golimumab | MSD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 1463 | EUCTR2013-000263-88-NL (EUCTR) | 23/01/2014 | 21/11/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands | ||
| 1464 | EUCTR2013-001012-30-DE (EUCTR) | 20/01/2014 | 07/10/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Belgium;Austria;Germany;Italy | |||
| 1465 | EUCTR2013-000263-88-HU (EUCTR) | 16/01/2014 | 21/11/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 1466 | EUCTR2013-000263-88-BE (EUCTR) | 08/01/2014 | 29/10/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Ukraine;Russian Federation;Israel;France;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands | ||
| 1467 | EUCTR2012-004366-18-BE (EUCTR) | 08/01/2014 | 27/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 1468 | EUCTR2013-000263-88-DE (EUCTR) | 07/01/2014 | 14/10/2013 | A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC). | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany | ||
| 1469 | NCT02069561 (ClinicalTrials.gov) | January 2014 | 19/2/2014 | Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer | Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: Eicosapentaenoic Acid | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | NULL | Completed | 18 Years | 70 Years | Both | 25 | N/A | Italy |
| 1470 | NCT02033408 (ClinicalTrials.gov) | January 2014 | 3/12/2013 | Manipulating the Microbiome in IBD by Antibiotics and FMT | Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial | Exacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's Colitis | Drug: AB (antibiotics);Drug: CS (corticosteroids) Only | Shaare Zedek Medical Center | NULL | Completed | 2 Years | 75 Years | All | 28 | N/A | Canada;Finland;Israel;Italy;Poland;Spain |
| 1471 | NCT02227602 (ClinicalTrials.gov) | January 2014 | 4/6/2014 | Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease | The Mango Consumption Improves Biomarkers for Inflammation in Inflammatory Bowel Disease Patients | Intestinal Diseases;Ulcerative Colitis;Crohn Disease | Drug: Mango polyphenolics | Texas A&M University | NULL | Completed | 18 Years | 72 Years | All | 20 | N/A | United States |
| 1472 | JPRN-JapicCTI-142475 | 24/12/2013 | Phase 3 Clinical Trial with MD-0901 | Phase 3 Clinical Trial with MD-0901 | Mild to moderate active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks. Control intervention name : Asacol tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | NULL | 16 | BOTH | 250 | Phase 3 | NULL | |||
| 1473 | EUCTR2011-002411-29-PL (EUCTR) | 19/12/2013 | 17/10/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 1474 | EUCTR2013-002116-27-BG (EUCTR) | 19/12/2013 | 16/10/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 1475 | EUCTR2012-004366-18-DE (EUCTR) | 17/12/2013 | 29/07/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany | ||
| 1476 | EUCTR2013-000366-11-PL (EUCTR) | 12/12/2013 | 05/09/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 1477 | EUCTR2012-004366-18-DK (EUCTR) | 11/12/2013 | 03/12/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands | ||
| 1478 | JPRN-UMIN000004201 | 2013/12/02 | 14/09/2010 | The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis | The patients with moderate to severe active refractory ulcerative colitis | Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus, Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus, | Osaka City University, Graduate School of Medicine,Department of Gastroenterology | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 50 | Not selected | Japan | |
| 1479 | EUCTR2011-001332-29-AT (EUCTR) | 02/12/2013 | 07/11/2013 | The degradation and elimination of Infliximab | Pharmacokinetics of Infliximab | Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 1480 | NCT01988961 (ClinicalTrials.gov) | December 2013 | 14/11/2013 | A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Golimumab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 103 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine |
| 1481 | EUCTR2012-004366-18-NL (EUCTR) | 28/11/2013 | 16/08/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands | ||
| 1482 | NCT01959165 (ClinicalTrials.gov) | November 21, 2013 | 8/10/2013 | MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients | Ulcerative Colitis | Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo | AstraZeneca | NULL | Completed | 18 Years | 65 Years | All | 44 | Phase 2 | Japan | |
| 1483 | NCT01959282 (ClinicalTrials.gov) | November 15, 2013 | 7/10/2013 | A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Placebo;Drug: JNJ-54781532 25 mg once daily;Drug: JNJ-54781532 75 mg once daily;Drug: JNJ-54781532 150 mg once daily;Drug: JNJ-54781532 75 mg twice daily | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 219 | Phase 2 | United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Ukraine |
| 1484 | EUCTR2011-002411-29-CZ (EUCTR) | 15/11/2013 | 16/09/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 1485 | EUCTR2013-002116-27-LT (EUCTR) | 14/11/2013 | 06/08/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 1486 | EUCTR2011-002411-29-SK (EUCTR) | 11/11/2013 | 14/10/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden;Czech Republic;France;Italy;Switzerland;United Kingdom;Israel;Austria;Turkey;Ireland;Spain;Finland;Greece;Slovakia;Portugal | |||
| 1487 | EUCTR2012-002031-28-DE (EUCTR) | 05/11/2013 | 22/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1488 | NCT01896635 (ClinicalTrials.gov) | November 2013 | 6/7/2013 | Faecal Microbiota Transplantation in Ulcerative Colitis | Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety | Ulcerative Colitis;Inflammatory Bowel Disease | Biological: FMT infusions;Other: Placebo infusion | The University of New South Wales | NULL | Completed | 18 Years | 75 Years | Both | 81 | Phase 2 | Australia |
| 1489 | NCT01971814 (ClinicalTrials.gov) | November 2013 | 17/10/2013 | Early Serum Infliximab Levels in Severe Ulcerative Colitis. | Early Serum Infliximab Levels in Severe Ulcerative Colitis | Ulcerative Colitis (UC);Inflammatory Bowel Disease | Drug: Infliximab | University of California, San Francisco | NULL | Completed | 18 Years | N/A | Both | 11 | Phase 1 | United States |
| 1490 | NCT03268213 (ClinicalTrials.gov) | November 2013 | 22/3/2016 | Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis | Fecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate Colitis | Clostridium Difficile Infection;Ulcerative Colitis;Indeterminate Colitis | Biological: Fecal Microbial Transplantation | Stony Brook University | NULL | Completed | 7 Years | N/A | All | 12 | Early Phase 1 | United States |
| 1491 | EUCTR2012-003123-38-NL (EUCTR) | 29/10/2013 | 27/05/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 1492 | EUCTR2013-002116-27-LV (EUCTR) | 28/10/2013 | 26/06/2013 | A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 1493 | EUCTR2013-002116-27-HU (EUCTR) | 24/10/2013 | 24/07/2013 | A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 1494 | EUCTR2013-001012-30-PL (EUCTR) | 17/10/2013 | 05/09/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Austria;Germany;Italy | |||
| 1495 | EUCTR2012-002031-28-SE (EUCTR) | 09/10/2013 | 27/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1496 | EUCTR2013-002116-27-CZ (EUCTR) | 09/10/2013 | 08/08/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 1497 | EUCTR2013-001012-30-BE (EUCTR) | 09/10/2013 | 12/08/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Canada;Poland;Belgium;Austria;Germany;Italy | ||
| 1498 | EUCTR2013-000366-11-ES (EUCTR) | 07/10/2013 | 12/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden | |||
| 1499 | EUCTR2012-002031-28-BG (EUCTR) | 03/10/2013 | 13/08/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapie, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1500 | EUCTR2012-002030-37-BG (EUCTR) | 03/10/2013 | 24/09/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1501 | ChiCTR-TRC-13003530 | 2013-10-01 | 2013-08-08 | Effect of hydrogen rich water on ulcerative colitis: a randomized controlled trial | Effect of hydrogen rich water on ulcerative colitis: a randomized controlled trial | ulcerative colitis | one:hydrogen rich water;two:pure water; | 411th Hospital of PLA | NULL | Completed | 18 | 60 | Both | one:20;two:20; | China | |
| 1502 | EUCTR2013-001012-30-IT (EUCTR) | 30/09/2013 | 02/07/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Austria;Germany;Italy | |||
| 1503 | EUCTR2012-002030-37-DE (EUCTR) | 27/09/2013 | 22/05/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: not available Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1504 | EUCTR2012-002013-19-DE (EUCTR) | 25/09/2013 | 17/05/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | France;United States;Canada;Belgium;Poland;Austria;Germany;Italy | |||
| 1505 | JPRN-UMIN000010127 | 2013/09/24 | 01/04/2013 | Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis | ulcerative colitis | Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not applicable | Japan | |
| 1506 | EUCTR2013-000366-11-CZ (EUCTR) | 12/09/2013 | 05/06/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1507 | EUCTR2012-002013-19-PL (EUCTR) | 12/09/2013 | 14/06/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | France;United States;Canada;Belgium;Poland;Austria;Germany;Italy | |||
| 1508 | EUCTR2011-003208-19-CZ (EUCTR) | 05/09/2013 | 03/04/2013 | GWP42003 symptomatic treatment of ulcerative colitis. | A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis. | Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GWP42003 INN or Proposed INN: Not Applicable Other descriptive name: CANNABIDIOL | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | Czech Republic;United Kingdom | ||
| 1509 | EUCTR2013-001012-30-AT (EUCTR) | 04/09/2013 | 12/07/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Austria;Germany;Italy | |||
| 1510 | EUCTR2013-000366-11-BE (EUCTR) | 02/09/2013 | 11/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1511 | NCT02306798 (ClinicalTrials.gov) | September 2013 | 15/10/2014 | TP0502-B-Pharmaco-Scintigraphic-Study | An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profile | Ulcerative Colitis | Drug: TP05 | Tillotts Pharma AG | NULL | Completed | 18 Years | 55 Years | Both | 9 | Phase 1 | NULL |
| 1512 | NCT01941589 (ClinicalTrials.gov) | September 2013 | 30/8/2013 | Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis | Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids only | Sheba Medical Center | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 1513 | EUCTR2013-000366-11-GB (EUCTR) | 30/08/2013 | 09/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1514 | EUCTR2011-004579-35-HR (EUCTR) | 27/08/2013 | 28/08/2014 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1515 | EUCTR2011-004578-27-HR (EUCTR) | 26/08/2013 | 28/08/2014 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1516 | EUCTR2011-004581-14-HR (EUCTR) | 26/08/2013 | 28/08/2014 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 725 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1517 | EUCTR2011-004580-79-HR (EUCTR) | 26/08/2013 | 28/08/2014 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1518 | EUCTR2013-000366-11-FI (EUCTR) | 20/08/2013 | 05/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1519 | NCT01900574 (ClinicalTrials.gov) | August 9, 2013 | 12/7/2013 | A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 35 | Phase 1 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland |
| 1520 | NCT01929668 (ClinicalTrials.gov) | August 2013 | 23/8/2013 | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study | Ulcerative Colitis | Drug: polyethylene glycol;Drug: Ascorbic Acid | Kyungpook National University | NULL | Completed | 18 Years | 80 Years | Both | 114 | N/A | Korea, Republic of |
| 1521 | EUCTR2012-004366-18-AT (EUCTR) | 30/07/2013 | 12/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 1522 | EUCTR2012-002013-19-BE (EUCTR) | 19/07/2013 | 19/02/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 2 | France;United States;Canada;Poland;Belgium;Austria;Germany;Italy | ||
| 1523 | EUCTR2013-000366-11-IE (EUCTR) | 17/07/2013 | 16/05/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1524 | EUCTR2012-002031-28-HU (EUCTR) | 11/07/2013 | 15/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1525 | EUCTR2012-001653-13-IT (EUCTR) | 10/07/2013 | 27/03/2013 | New Therapeutic Strategy in Ulcerative Colitis | New Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in PediatricPatients | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: AZAFOR 50mg Product Name: AZATIOPRINA Product Code: AZA INN or Proposed INN: AZATHIOPRINE Other descriptive name: AZATHIOPRINE | Dipartimento di Pediatria Università Federico II di Napoli | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Italy | |||
| 1526 | EUCTR2013-000366-11-DK (EUCTR) | 10/07/2013 | 10/07/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1527 | EUCTR2012-002030-37-ES (EUCTR) | 04/07/2013 | 10/06/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: . Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1528 | EUCTR2012-002031-28-ES (EUCTR) | 04/07/2013 | 10/06/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: . Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1529 | JPRN-UMIN000013892 | 2013/07/01 | 06/05/2014 | A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy | Ulcerative colitis and so on | AJG522 PEG plus E (Niflec®) | Gunma University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 80 | Phase 4 | Japan | |
| 1530 | NCT01861249 (ClinicalTrials.gov) | July 2013 | 21/5/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: SAR339658 | Sanofi | NULL | Terminated | 18 Years | N/A | Both | 6 | Phase 2 | United States;Canada |
| 1531 | NCT01903252 (ClinicalTrials.gov) | July 2013 | 9/7/2013 | TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) | A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis | Acute Ulcerative Colitis | Drug: TP05;Drug: Asacol 400 mg | Tillotts Pharma AG | NULL | Completed | 18 Years | N/A | All | 817 | Phase 3 | Switzerland;Netherlands |
| 1532 | EUCTR2013-000366-11-SE (EUCTR) | 28/06/2013 | 13/05/2013 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 1533 | EUCTR2012-002030-37-HU (EUCTR) | 27/06/2013 | 15/05/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1534 | EUCTR2012-003123-38-GR (EUCTR) | 25/06/2013 | 10/05/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Greece;Russian Federation;Israel;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 1535 | EUCTR2012-002031-28-PL (EUCTR) | 18/06/2013 | 10/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1536 | EUCTR2012-004768-23-DE (EUCTR) | 12/06/2013 | 06/02/2013 | A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis | A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis | Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: STNM01 1.84 mg Product Code: STNM01 INN or Proposed INN: STNM01 | STELIC INSTITUTE & CO. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 1537 | EUCTR2012-002030-37-AT (EUCTR) | 11/06/2013 | 29/05/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: not available Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1538 | EUCTR2012-002031-28-AT (EUCTR) | 11/06/2013 | 29/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1539 | JPRN-UMIN000010906 | 2013/06/10 | 10/06/2013 | The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. | Ulcerative Colitis | A 24-week administration of 4.8g/day of Asacol A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy | Chiba University Hospital | NULL | Complete: follow-up complete | 15years-old | 70years-old | Male and Female | 60 | Phase 2 | Japan | |
| 1540 | JPRN-UMIN000013370 | 2013/06/07 | 07/03/2014 | Efficacy of infliximab therapy for refractory pouchitis | ulcerative colitis, pouchitis | infliximab | Inflammatory bowel disease center, Hyogo college of medicine | NULL | Complete: follow-up complete | 18years-old | 80years-old | Male and Female | 10 | Phase 1 | Japan | |
| 1541 | JPRN-UMIN000013371 | 2013/06/05 | 07/03/2014 | Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis | ulcerative colitis | infliximab | Hyogo college of medicine | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 10 | Not selected | Japan | |
| 1542 | EUCTR2012-002013-19-IT (EUCTR) | 02/06/2013 | 08/04/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | United States;France;Canada;Poland;Belgium;Austria;Germany;Italy | |||
| 1543 | JPRN-UMIN000010776 | 2013/06/01 | 01/06/2013 | An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis | Ulcerative colitis | tacrolimus (Prograf) cyclosporine (Sandimmune) | Chiba University Hospital | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 40 | Not selected | Japan | |
| 1544 | NCT02058524 (ClinicalTrials.gov) | June 2013 | 27/8/2013 | A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis | A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis | Biological: fecal microbiota transplantation | University of Chicago | NULL | Terminated | 18 Years | 65 Years | Both | 1 | Phase 1 | United States |
| 1545 | NCT01716039 (ClinicalTrials.gov) | June 2013 | 15/10/2012 | Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC) | A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: MTX 12.5;Drug: MTX 25;Drug: Adalimumab | University of Western Ontario, Canada | Abbott | Unknown status | 18 Years | N/A | All | 25 | Phase 4 | NULL |
| 1546 | EUCTR2012-002030-37-SE (EUCTR) | 31/05/2013 | 27/05/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1547 | EUCTR2012-002030-37-CZ (EUCTR) | 30/05/2013 | 16/05/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1548 | EUCTR2012-002031-28-CZ (EUCTR) | 30/05/2013 | 16/05/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1549 | EUCTR2012-005521-73-CZ (EUCTR) | 16/05/2013 | 01/03/2013 | Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis | Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study | Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0974 INN or Proposed INN: GLPG0974 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Latvia | ||
| 1550 | EUCTR2012-002030-37-NL (EUCTR) | 15/05/2013 | 12/02/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1551 | EUCTR2012-002031-28-NL (EUCTR) | 15/05/2013 | 22/02/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1552 | EUCTR2012-002031-28-IT (EUCTR) | 08/05/2013 | 01/07/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 1553 | EUCTR2012-002030-37-PL (EUCTR) | 07/05/2013 | 12/04/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1554 | EUCTR2012-002030-37-SK (EUCTR) | 02/05/2013 | 09/05/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1555 | EUCTR2012-002031-28-SK (EUCTR) | 02/05/2013 | 05/02/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: PF-00547659 | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 1556 | JPRN-UMIN000010340 | 2013/05/01 | 01/04/2013 | Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) | Ulcerative colitis | Randomized treatment with mesalazine suppository or oral mesalazine for 2 weeks Switch from oral mesalazine to mesalazine suppository for 2 weeks | Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 1557 | JPRN-UMIN000013266 | 2013/05/01 | 25/02/2014 | Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy | ulcerative colitis, familial adenomatous polyposis | 1% of Dermacrin A ointment 0.033% of Guaiazulene ointment | Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery | NULL | Pending | 20years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| 1558 | JPRN-UMIN000010612 | 2013/05/01 | 01/05/2013 | A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis | Ulcerative colitis | Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period. Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks. | Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 130 | Phase 4 | Japan | |
| 1559 | JPRN-JapicCTI-132135 | 01/5/2013 | Phase III Study of Z-206 | Phase III Study of Z-206 | Ulcerative Colitis | Intervention name : Z-206 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine at the dose 2.4g/day is administered once a day or three times a day. Control intervention name : null | Zeria Pharmaceutical Co., Ltd. | Kyowa Hakko Kirin Co., Ltd. | 16 | 64 | BOTH | 600 | Phase 3 | NULL | ||
| 1560 | NCT02073526 (ClinicalTrials.gov) | May 2013 | 9/1/2014 | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Infliximab, adalimumab, certolizumab pegol | Oslo University Hospital | NULL | Completed | 18 Years | N/A | Both | 1230 | N/A | Norway |
| 1561 | EUCTR2012-005521-73-LV (EUCTR) | 29/04/2013 | 13/03/2013 | Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis | Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study | Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0974 INN or Proposed INN: GLPG0974 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Latvia | ||
| 1562 | EUCTR2012-003123-38-BG (EUCTR) | 24/04/2013 | 05/03/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 1563 | EUCTR2011-005251-13-PL (EUCTR) | 23/04/2013 | 10/01/2013 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 1564 | EUCTR2012-002030-37-IT (EUCTR) | 20/04/2013 | 02/04/2013 | Study to test whether PF-00547659 is safe and improves symptoms in patients with UC | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: NA Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1565 | EUCTR2012-002013-19-AT (EUCTR) | 16/04/2013 | 21/03/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | France;United States;Canada;Belgium;Poland;Austria;Germany;Italy | |||
| 1566 | EUCTR2012-002031-28-BE (EUCTR) | 02/04/2013 | 01/02/2013 | Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 331 | Phase 2 | Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Sweden;New Zealand;Norway;Germany;Bulgaria;Croatia | ||
| 1567 | NCT01829321 (ClinicalTrials.gov) | April 2013 | 9/4/2013 | Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis | Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of GLPG0974 in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: GLPG0974;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 75 Years | Both | 45 | Phase 2 | Belgium;Czech Republic;Latvia;Slovakia |
| 1568 | NCT01846026 (ClinicalTrials.gov) | April 2013 | 30/4/2013 | Ulcerative Colitis and Vitamin D Supplementation | Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab. | Ulcerative Colitis | Drug: Vitamin D;Drug: placebo | University Hospital of North Norway | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | Norway |
| 1569 | NCT01804166 (ClinicalTrials.gov) | March 21, 2013 | 1/2/2013 | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | Hepatosplenic T-Cell Lymphoma | Drug: Infliximab;Drug: Golimumab | Janssen Scientific Affairs, LLC | NULL | Completed | N/A | N/A | All | 1 | Phase 4 | United States |
| 1570 | EUCTR2012-005521-73-BE (EUCTR) | 20/03/2013 | 08/02/2013 | Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis | Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study | Mild to moderate Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0974 INN or Proposed INN: GLPG0974 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Latvia | ||
| 1571 | NCT01771809 (ClinicalTrials.gov) | March 18, 2013 | 8/1/2013 | Long-Term Safety Of PF-00547659 In Ulcerative Colitis | A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II) | Ulcerative Colitis | Drug: 75mg SHP647 (PF-00547659);Drug: 225mg SHP647 (PF-00547659) | Shire | NULL | Completed | 18 Years | 66 Years | All | 330 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Czech Republic;Switzerland |
| 1572 | NCT01863771 (ClinicalTrials.gov) | March 15, 2013 | 23/5/2013 | A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. | A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Other: Placebo | Janssen Pharmaceutical K.K. | NULL | Completed | 18 Years | 70 Years | All | 144 | Phase 3 | Japan |
| 1573 | EUCTR2011-004578-27-NL (EUCTR) | 04/03/2013 | 12/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada | |||
| 1574 | NCT01810185 (ClinicalTrials.gov) | March 2013 | 11/3/2013 | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Low dose naltrexone;Drug: Placebo | Santa Barbara Cottage Hospital | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 1575 | NCT01805791 (ClinicalTrials.gov) | March 2013 | 4/3/2013 | A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: HMPL-004 1800 mg/day;Drug: Placebo;Drug: HMPL-004 2400 mg/day | Hutchison Medipharma Limited | NULL | Terminated | 18 Years | 75 Years | All | 201 | Phase 3 | United States |
| 1576 | NCT01831427 (ClinicalTrials.gov) | March 2013 | 8/4/2013 | Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis | A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: GS-5745;Drug: Placebo to match GS-5745 | Gilead Sciences | NULL | Completed | 18 Years | 65 Years | All | 74 | Phase 1 | United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania |
| 1577 | EUCTR2012-003123-38-HU (EUCTR) | 12/02/2013 | 04/12/2012 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 113 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 1578 | EUCTR2012-003123-38-PL (EUCTR) | 10/02/2013 | 15/01/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Korea, Republic of | ||
| 1579 | EUCTR2012-001830-32-LT (EUCTR) | 04/02/2013 | 04/10/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 1580 | EUCTR2012-001830-32-PL (EUCTR) | 01/02/2013 | 18/10/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 1581 | NCT01658605 (ClinicalTrials.gov) | February 2013 | 24/5/2012 | A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis | A Phase II, 20-week, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Proof of Concept Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK1605786;Other: Placebo | GlaxoSmithKline | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | Belgium;Netherlands;United Kingdom |
| 1582 | NCT01759056 (ClinicalTrials.gov) | February 2013 | 24/12/2012 | Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis | A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: AVX 470;Drug: Placebo | Avaxia Biologics, Incorporated | NULL | Completed | 18 Years | 75 Years | Both | 33 | Phase 1 | United States;Belgium;Canada;Hungary |
| 1583 | EUCTR2012-003123-38-SK (EUCTR) | 28/01/2013 | 04/03/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 1584 | JPRN-UMIN000009811 | 2013/01/23 | 21/01/2013 | Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis | Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitis | Ulcerative colitis | One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint). Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months. | Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 40 | Phase 3 | Japan |
| 1585 | EUCTR2011-004580-79-IT (EUCTR) | 18/01/2013 | 07/08/2012 | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | ulcerative colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib | PFIZER LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;New Zealand;Japan | ||
| 1586 | EUCTR2011-004581-14-IT (EUCTR) | 18/01/2013 | 07/08/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib | PFIZER LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 725 | United States;Estonia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;India;Hungary;Czech Republic;Canada;Brazil;Denmark;Australia;South Africa;Germany;Netherlands;Latvia;Japan;Korea, Republic of | |||
| 1587 | EUCTR2012-003974-18-BG (EUCTR) | 18/01/2013 | 07/11/2012 | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VB-201 INN or Proposed INN: Not applicable | Vascular Biogenics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Hungary;Bulgaria | |||
| 1588 | EUCTR2011-004578-27-IT (EUCTR) | 18/01/2013 | 07/08/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulverative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan | |||
| 1589 | EUCTR2011-001568-22-HU (EUCTR) | 15/01/2013 | 18/07/2012 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation | |||
| 1590 | EUCTR2012-001830-32-DE (EUCTR) | 15/01/2013 | 14/08/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 1591 | EUCTR2012-002030-37-BE (EUCTR) | 08/01/2013 | 05/09/2012 | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Crohn’s Disease (CD) and Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden | |||
| 1592 | EUCTR2011-005251-13-NL (EUCTR) | 08/01/2013 | 23/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 1593 | EUCTR2011-000164-10-GB (EUCTR) | 04/01/2013 | 19/09/2012 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SPD476 INN or Proposed INN: mesalazine Product Code: SPD476 INN or Proposed INN: mesalazine Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1 | United States;Slovakia;Poland;Australia;United Kingdom | ||
| 1594 | NCT01839214 (ClinicalTrials.gov) | January 2013 | 21/4/2013 | A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: VB-201 160mg;Drug: Placebo | Vascular Biogenics Ltd. operating as VBL Therapeutics | NULL | Completed | 18 Years | N/A | Both | 112 | Phase 2 | Bulgaria;Hungary;Poland |
| 1595 | NCT01745770 (ClinicalTrials.gov) | January 2013 | 5/12/2012 | TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC) | Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: Mesalazine - TID 1000 mg;Drug: Mesalazine - TID 2x 500 mg | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 306 | Phase 3 | Germany |
| 1596 | NCT02922374 (ClinicalTrials.gov) | January 2013 | 28/9/2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | N/A | Both | 117 | Phase 1/Phase 2 | China |
| 1597 | NCT01771224 (ClinicalTrials.gov) | January 2013 | 16/1/2013 | Effect of FAn-7 in UC Activity | Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4? and Ulcerative Colitis (UC) Activity | Inflammatory Bowel Disease;Ulcerative Colitis | Dietary Supplement: Palmitoleic acid | National Institute of Medical Sciences and Nutrition, Salvador Zubiran | NULL | Recruiting | 18 Years | 59 Years | Both | 20 | Phase 0 | Mexico |
| 1598 | NCT01647516 (ClinicalTrials.gov) | December 26, 2012 | 19/7/2012 | Efficacy and Safety Study of Ozanimod in Ulcerative Colitis | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Ozanimod;Drug: Placebo | Celgene | NULL | Completed | 18 Years | 73 Years | All | 199 | Phase 2 | United States;Australia;Belgium;Bulgaria;Canada;Greece;Hungary;Israel;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Ukraine |
| 1599 | EUCTR2011-005251-13-DE (EUCTR) | 21/12/2012 | 09/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Latvia;Germany | ||
| 1600 | EUCTR2012-004851-35-FI (EUCTR) | 19/12/2012 | 07/12/2012 | Mesalalazine in pediatric ulcerative colitis | Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: MESALAZINE Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: MESALAZINE | Children´s Hospital, University of Helsinki | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Israel | ||
| 1601 | EUCTR2012-003123-38-BE (EUCTR) | 11/12/2012 | 10/10/2012 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 1602 | EUCTR2012-003974-18-HU (EUCTR) | 10/12/2012 | 28/09/2012 | Study to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VB-201 INN or Proposed INN: Not applicable | Vascular Biogenics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Hungary;Bulgaria | |||
| 1603 | NCT01078935 (ClinicalTrials.gov) | December 2012 | 1/3/2010 | The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation | The Effect of Probiotics on Bowel Disease | Crohn's Disease;Ulcerative Colitis | Dietary Supplement: probiotics;Dietary Supplement: placebo | The Baruch Padeh Medical Center, Poriya | Ministry of Health, Israel | Not yet recruiting | 18 Years | 80 Years | Both | 100 | Phase 4 | NULL |
| 1604 | NCT04032652 (ClinicalTrials.gov) | December 2012 | 4/12/2012 | Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol | Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol | Ulcerative Colitis | Procedure: Rectal dialysis;Drug: Rectal dialysis | NorthShore University HealthSystem | NULL | Terminated | 18 Years | 45 Years | All | 2 | Phase 2 | NULL |
| 1605 | EUCTR2010-023798-20-ES (EUCTR) | 29/11/2012 | 10/05/2012 | A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS | A PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU | MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ASC INN or Proposed INN: adipose tissue-derived mesenchymal stem cells Other descriptive name: aloASC | Fundacion para la Investigacion Biomedica Hospital Universitario La Paz | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 1606 | JPRN-UMIN000009364 | 2012/11/24 | 24/11/2012 | Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis | ulcerative colitis | Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years. | Graduate School of Medical Science, KyotoPrefectural University of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 2 | Japan | |
| 1607 | EUCTR2011-002462-20-SK (EUCTR) | 19/11/2012 | 27/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | ||||
| 1608 | NCT01694485 (ClinicalTrials.gov) | November 16, 2012 | 24/9/2012 | Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Biological: Abrilumab;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 359 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Switzerland;United Kingdom;Czech Republic |
| 1609 | NCT01620255 (ClinicalTrials.gov) | November 2, 2012 | 13/6/2012 | A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis | A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot) | Ulcerative Colitis | Drug: Placebo;Drug: PF-00547659 SC Injection | Shire | NULL | Completed | 18 Years | 65 Years | All | 357 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Croatia;Czech Republic;Norway;Sweden;United Kingdom |
| 1610 | EUCTR2011-004581-14-NL (EUCTR) | 10/10/2012 | 12/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand | ||
| 1611 | EUCTR2011-004579-35-NL (EUCTR) | 10/10/2012 | 12/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | |||
| 1612 | EUCTR2011-001568-22-BG (EUCTR) | 05/10/2012 | 16/08/2012 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Russian Federation;Bulgaria | |||
| 1613 | EUCTR2012-001830-32-HU (EUCTR) | 04/10/2012 | 16/08/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Salofalk® 500 mg tablets INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 1614 | EUCTR2011-006084-22-GB (EUCTR) | 04/10/2012 | 15/08/2012 | Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment | Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab | Royal Liverpool University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 0 | United Kingdom | |||
| 1615 | EUCTR2012-001830-32-LV (EUCTR) | 02/10/2012 | 05/09/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia | ||
| 1616 | NCT01470612 (ClinicalTrials.gov) | October 1, 2012 | 21/10/2011 | Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | N/A | All | 944 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic;India |
| 1617 | NCT01706159 (ClinicalTrials.gov) | October 2012 | 9/10/2012 | A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis | A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis | Inflammation;Ulcerative Colitis | Drug: catridecacog;Drug: placebo | Novo Nordisk A/S | NULL | Terminated | 18 Years | 64 Years | All | 20 | Phase 2 | Bulgaria;Croatia;Denmark;Hungary;Poland;Russian Federation;Ukraine |
| 1618 | NCT02306785 (ClinicalTrials.gov) | October 2012 | 15/10/2014 | TP0502-Pharmaco-Scintigraphic-Study and Amendment | An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects and Patients With Active Ulcerative Colitis With Radio-labelled TP05-tablets to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations (and Amendment) | Ulcerative Colitis | Drug: TP05 Coating D;Drug: TP05 Coating E;Drug: TP05 Coating H | Tillotts Pharma AG | NULL | Completed | 18 Years | 55 Years | Both | 26 | Phase 1 | NULL |
| 1619 | EUCTR2012-002023-15-AT (EUCTR) | 21/09/2012 | 04/09/2012 | Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis | Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis - Mesacol | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten INN or Proposed INN: MESALAZINE Other descriptive name: 5-aminosalicylic acid | Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Austria | ||
| 1620 | JPRN-UMIN000015297 | 2012/09/19 | 01/10/2014 | The feasibility study of accelated infliximab infusion from initial administration | The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | NULL | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan |
| 1621 | EUCTR2011-004578-27-PL (EUCTR) | 18/09/2012 | 20/06/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan | |||
| 1622 | EUCTR2011-004579-35-PL (EUCTR) | 17/09/2012 | 28/06/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand | |||
| 1623 | EUCTR2011-004581-14-PL (EUCTR) | 17/09/2012 | 22/06/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc., 235 East 42nd Street, New York, New York 10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1624 | EUCTR2011-005251-13-IT (EUCTR) | 16/09/2012 | 27/08/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG181 Product Code: AMG181 | AMGEN INC. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Poland;Belgium;Australia | ||
| 1625 | EUCTR2011-005251-13-BE (EUCTR) | 14/09/2012 | 18/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Latvia;Germany;Netherlands;Norway | ||
| 1626 | EUCTR2011-005115-82-LT (EUCTR) | 12/09/2012 | 24/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1627 | EUCTR2011-005251-13-HU (EUCTR) | 11/09/2012 | 18/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Germany;Norway | ||
| 1628 | EUCTR2011-005251-13-AT (EUCTR) | 10/09/2012 | 23/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 1629 | EUCTR2011-005251-13-GB (EUCTR) | 06/09/2012 | 13/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Greece;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 1630 | EUCTR2011-004765-32-NL (EUCTR) | 27/08/2012 | 25/04/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE HYDROCHLORIDE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Belgium;Israel;Russian Federation;Netherlands;Italy | ||
| 1631 | EUCTR2011-001568-22-DK (EUCTR) | 23/08/2012 | 02/08/2012 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation | |||
| 1632 | EUCTR2011-005251-13-DK (EUCTR) | 16/08/2012 | 11/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Latvia;Norway;Netherlands;Germany | ||
| 1633 | EUCTR2011-002411-29-ES (EUCTR) | 10/08/2012 | 18/10/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 1634 | EUCTR2011-004580-79-PL (EUCTR) | 05/08/2012 | 12/06/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1635 | JPRN-UMIN000008352 | 2012/08/01 | 01/08/2012 | Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis | Ulcerative Colitis | Switch from several times to once daily oral mesalazine administration | Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 15years-old | 70years-old | Male and Female | 50 | Not selected | Japan | |
| 1636 | NCT03079700 (ClinicalTrials.gov) | August 1, 2012 | 9/3/2017 | Immune Modulation From Trichuris Suis | Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual | Crohn Disease;Ulcerative Colitis;Intestinal Helminthiasis | Biological: Trichuris suis eggs | University of Aarhus | NULL | Completed | 18 Years | 70 Years | Male | 1 | N/A | NULL |
| 1637 | NCT01678911 (ClinicalTrials.gov) | August 2012 | 31/8/2012 | Efficacy of Gralise® for Chronic Pelvic Pain | Efficacy of Gralise® for Chronic Pelvic Pain | Irritable Bowel Syndrome;Ulcerative Colitis;Interstitial Cystitis;Prostatitis;Pelvic Pain | Drug: Gralise | Shirley Ryan AbilityLab | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 4 | United States |
| 1638 | NCT01433471 (ClinicalTrials.gov) | August 2012 | 6/9/2011 | Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova | Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova | Ulcerative Colitis | Drug: Trichuris suis ova | New York University School of Medicine | NULL | Completed | 18 Years | 72 Years | All | 4 | N/A | United States |
| 1639 | NCT01783119 (ClinicalTrials.gov) | August 2012 | 31/1/2013 | Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis | Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Aloe Barbadensis Miller;Dietary Supplement: placebo water | National Institute of Medical Sciences and Nutrition, Salvador Zubiran | NULL | Recruiting | 18 Years | 59 Years | Both | 60 | Phase 0 | Mexico |
| 1640 | NCT01659138 (ClinicalTrials.gov) | August 2012 | 3/8/2012 | Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: SAR339658;Other: Placebo | Sanofi | NULL | Terminated | 18 Years | 70 Years | Both | 28 | Phase 2 | United States;Austria;Canada;France;Germany;Italy;Poland;Belgium |
| 1641 | EUCTR2011-005251-13-CZ (EUCTR) | 26/07/2012 | 17/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Norway;Germany | ||
| 1642 | NCT01458574 (ClinicalTrials.gov) | July 20, 2012 | 21/10/2011 | A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: CP690,550;Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | N/A | All | 593 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 1643 | EUCTR2011-004578-27-ES (EUCTR) | 11/07/2012 | 09/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | |||
| 1644 | EUCTR2011-004579-35-ES (EUCTR) | 11/07/2012 | 09/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | |||
| 1645 | NCT01612039 (ClinicalTrials.gov) | July 2012 | 1/6/2012 | Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: ASP3291;Drug: Placebo | Telsar Pharma Inc. | NULL | Completed | 18 Years | 65 Years | Both | 112 | Phase 2 | United States |
| 1646 | EUCTR2011-002411-29-FI (EUCTR) | 29/06/2012 | 11/06/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 1647 | EUCTR2011-004581-14-CZ (EUCTR) | 29/06/2012 | 08/02/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed) Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;New Zealand | ||
| 1648 | EUCTR2011-004770-28-AT (EUCTR) | 26/06/2012 | 15/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia | ||
| 1649 | EUCTR2011-004580-79-CZ (EUCTR) | 26/06/2012 | 08/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy | ||
| 1650 | EUCTR2011-002411-29-AT (EUCTR) | 26/06/2012 | 01/02/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 1651 | EUCTR2011-000164-10-SK (EUCTR) | 21/06/2012 | 13/04/2016 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Slovakia;United Kingdom | ||
| 1652 | EUCTR2011-005115-82-LV (EUCTR) | 15/06/2012 | 21/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1653 | EUCTR2010-022766-27-SK (EUCTR) | 11/06/2012 | 27/01/2012 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Italy;Sweden | ||
| 1654 | EUCTR2011-004579-35-BE (EUCTR) | 08/06/2012 | 08/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand | |||
| 1655 | EUCTR2011-004580-79-BE (EUCTR) | 08/06/2012 | 07/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1656 | EUCTR2011-004581-14-BE (EUCTR) | 07/06/2012 | 07/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 1657 | EUCTR2011-004580-79-DE (EUCTR) | 06/06/2012 | 28/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia | ||
| 1658 | EUCTR2011-004578-27-BE (EUCTR) | 06/06/2012 | 07/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1659 | EUCTR2011-004581-14-DE (EUCTR) | 05/06/2012 | 29/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (Phase III Formulation) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercialFormulation - debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1660 | EUCTR2011-005115-82-EE (EUCTR) | 05/06/2012 | 09/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1661 | EUCTR2011-005251-13-GR (EUCTR) | 05/06/2012 | 14/05/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway | ||
| 1662 | EUCTR2011-002411-29-PT (EUCTR) | 01/06/2012 | 03/01/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 1663 | JPRN-UMIN000007806 | 2012/06/01 | 01/05/2012 | The feasibility study of accelated infliximab infusion during maintenance phase | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | |
| 1664 | NCT01586533 (ClinicalTrials.gov) | June 2012 | 25/4/2012 | Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis | A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis | Ulcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative Colitis | Drug: Zoenasa-1:4;Drug: Mesalamine Enema | Altheus Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 64 Years | Both | 120 | Phase 2 | United States |
| 1665 | NCT01458951 (ClinicalTrials.gov) | June 2012 | 21/10/2011 | A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis. | Ulcerative Colitis | Drug: tofacitinib;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 547 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 1666 | EUCTR2011-004578-27-HU (EUCTR) | 30/05/2012 | 10/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1667 | EUCTR2011-004579-35-DE (EUCTR) | 29/05/2012 | 21/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | ||
| 1668 | EUCTR2011-004579-35-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1669 | EUCTR2011-004580-79-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1670 | EUCTR2011-004581-14-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 725 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1671 | EUCTR2011-004578-27-LV (EUCTR) | 23/05/2012 | 01/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1672 | EUCTR2011-004578-27-DE (EUCTR) | 23/05/2012 | 05/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not availble Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 1673 | EUCTR2011-004578-27-AT (EUCTR) | 18/05/2012 | 27/03/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1674 | EUCTR2011-004580-79-AT (EUCTR) | 18/05/2012 | 27/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1675 | EUCTR2011-004581-14-AT (EUCTR) | 18/05/2012 | 27/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand | ||
| 1676 | EUCTR2011-004579-35-AT (EUCTR) | 18/05/2012 | 21/03/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1677 | EUCTR2011-004580-79-ES (EUCTR) | 18/05/2012 | 09/03/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States | ||
| 1678 | EUCTR2011-004581-14-ES (EUCTR) | 18/05/2012 | 14/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 725 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | |||
| 1679 | EUCTR2011-002411-29-DE (EUCTR) | 11/05/2012 | 11/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Sweden;Norway;Germany;Denmark;Belgium;Poland;Canada;Czech Republic;France;Switzerland;Italy;United Kingdom;Israel;Austria;Turkey;Ireland;Spain;Finland;Greece;Slovakia;Portugal | |||
| 1680 | EUCTR2011-005115-82-BG (EUCTR) | 11/05/2012 | 11/04/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1681 | EUCTR2011-004579-35-HU (EUCTR) | 10/05/2012 | 10/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1682 | EUCTR2011-004581-14-HU (EUCTR) | 10/05/2012 | 10/02/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1683 | EUCTR2011-004580-79-HU (EUCTR) | 10/05/2012 | 10/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1684 | NCT01562314 (ClinicalTrials.gov) | May 9, 2012 | 21/3/2012 | A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160) | A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis | Ulcerative Colitis | Drug: GWP42003;Drug: Placebo | GW Research Ltd | NULL | Completed | 18 Years | N/A | All | 60 | Phase 2 | United Kingdom;Czech Republic |
| 1685 | EUCTR2011-004580-79-SK (EUCTR) | 03/05/2012 | 10/04/2013 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1686 | EUCTR2011-004770-28-DE (EUCTR) | 03/05/2012 | 09/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Propionylcarnitinhydrochlorid Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany | ||
| 1687 | EUCTR2011-002411-29-GB (EUCTR) | 03/05/2012 | 07/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 1688 | EUCTR2011-004578-27-SK (EUCTR) | 02/05/2012 | 12/04/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Japan;Germany;Croatia;Romania;Belgium;Brazil;Poland;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;France;India | |||
| 1689 | EUCTR2011-004581-14-SK (EUCTR) | 02/05/2012 | 13/04/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand | ||
| 1690 | EUCTR2011-004579-35-SK (EUCTR) | 02/05/2012 | 13/04/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1691 | JPRN-UMIN000007593 | 2012/05/01 | 02/04/2012 | Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial | Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial - B-FLORA | ulcerative colitis | Bifidobacterium breve fermented milk placebo | Public Health Research foundation | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 600 | Not applicable | Japan |
| 1692 | EUCTR2011-004581-14-GB (EUCTR) | 01/05/2012 | 01/03/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand | ||
| 1693 | EUCTR2011-004579-35-GB (EUCTR) | 01/05/2012 | 12/01/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1694 | NCT01550965 (ClinicalTrials.gov) | May 2012 | 8/3/2012 | A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting | Ulcerative Colitis | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 463 | Phase 3 | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 1695 | NCT01387594 (ClinicalTrials.gov) | May 2012 | 30/6/2011 | Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs | A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA) | Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis | Procedure: lumbar puncture;Drug: lumbar puncture | Shire | NULL | Completed | 18 Years | 75 Years | All | 49 | Phase 1 | Austria;Belgium;France;Germany;Netherlands |
| 1696 | EUCTR2011-004580-79-GB (EUCTR) | 30/04/2012 | 14/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1697 | EUCTR2011-004579-35-EE (EUCTR) | 26/04/2012 | 14/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | |||
| 1698 | EUCTR2011-004765-32-IT (EUCTR) | 26/04/2012 | 23/07/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | SIGMA-TAU | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Belgium;Netherlands;Italy | ||
| 1699 | EUCTR2011-004578-27-GB (EUCTR) | 26/04/2012 | 12/01/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1700 | EUCTR2011-002411-29-SE (EUCTR) | 26/04/2012 | 13/10/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 1701 | EUCTR2011-004581-14-EE (EUCTR) | 26/04/2012 | 13/02/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 1702 | EUCTR2011-004580-79-EE (EUCTR) | 26/04/2012 | 13/02/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1703 | EUCTR2011-004578-27-EE (EUCTR) | 26/04/2012 | 14/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| 1704 | EUCTR2010-023762-49-BE (EUCTR) | 23/04/2012 | 21/11/2011 | A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study | Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Spain;Poland;Belgium;Romania;Austria;Bulgaria;Germany;Netherlands | ||
| 1705 | EUCTR2011-005115-82-CZ (EUCTR) | 18/04/2012 | 08/02/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1706 | EUCTR2011-004770-28-LT (EUCTR) | 12/04/2012 | 15/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany | ||
| 1707 | EUCTR2011-004812-40-GB (EUCTR) | 12/04/2012 | 21/03/2012 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;Italy;United Kingdom | ||
| 1708 | EUCTR2011-005115-82-PL (EUCTR) | 10/04/2012 | 16/03/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1709 | EUCTR2010-023588-16-DE (EUCTR) | 10/04/2012 | 05/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 1710 | NCT01551290 (ClinicalTrials.gov) | April 2012 | 7/3/2012 | A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab;Drug: Placebo | Xian-Janssen Pharmaceutical Ltd. | NULL | Completed | 18 Years | 65 Years | Both | 99 | Phase 3 | China |
| 1711 | NCT01465763 (ClinicalTrials.gov) | April 2012 | 21/10/2011 | A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis | Ulcerative Colitis | Drug: tofacitinib;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 614 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Brazil |
| 1712 | NCT01538251 (ClinicalTrials.gov) | April 2012 | 20/2/2012 | Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis | Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment | Ulcerative Colitis | Drug: Propionyl-L-Carnitine;Drug: Placebo | sigma-tau i.f.r. S.p.A. | NULL | Terminated | 18 Years | 75 Years | Both | 147 | Phase 3 | Belgium;Czech Republic;Israel;Italy;Netherlands;Romania;Russian Federation;Slovakia |
| 1713 | NCT01877577 (ClinicalTrials.gov) | April 2012 | 11/6/2013 | Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D | Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. | Crohn's Disease (CD);Ulcerative Colitis (UC) | Dietary Supplement: Vitamin D3 | University of California, San Francisco | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | United States |
| 1714 | EUCTR2011-002411-29-IE (EUCTR) | 30/03/2012 | 09/02/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 1715 | EUCTR2011-002411-29-DK (EUCTR) | 30/03/2012 | 28/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 1716 | EUCTR2010-022766-27-IT (EUCTR) | 28/03/2012 | 27/04/2012 | Study of safety and effectiveness of human-derived stem cells (multistem, also know as PF-05285401) in the treatment of ulcerative colitis. | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Multistem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: Multistem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten INN or Proposed INN: DEXTRAN 1 FOR INJECTION | PFIZER LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Canada;Belgium;Italy;Sweden | ||
| 1717 | EUCTR2011-005115-82-HU (EUCTR) | 26/03/2012 | 07/02/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 1718 | EUCTR2011-004770-28-HU (EUCTR) | 21/03/2012 | 23/01/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia | ||
| 1719 | EUCTR2011-004581-14-DK (EUCTR) | 20/03/2012 | 09/02/2012 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand | ||
| 1720 | EUCTR2011-004770-28-PL (EUCTR) | 17/03/2012 | 16/02/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 15.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany | ||
| 1721 | EUCTR2011-003130-14-IT (EUCTR) | 12/03/2012 | 05/03/2012 | Clinical Trial to assess the efficacy and safety of Kappaproct | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients” - CSUC-01/10 | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Product Code: DIMS0150 INN or Proposed INN: NA Other descriptive name: NA | INDEX PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 132 | Czech Republic;Hungary;Poland;Germany;United Kingdom;Italy | |||
| 1722 | EUCTR2011-002411-29-BE (EUCTR) | 07/03/2012 | 23/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 1723 | ChiCTR1900023689 | 2012-03-01 | 2019-06-07 | Comparison of white light endoscopy vs chromoendoscopy in the detection rate of dysplasia and colorectal cancer in ulcerative colitis: A Multicenter Long-term Follow-up Randomized Controlled Trial in China | Comparison of white light endoscopy vs chromoendoscopy in the detection rate of dysplasia and colorectal cancer in ulcerative colitis: A Multicenter Long-term Follow-up Randomized Controlled Trial in China | Ulcerative colitis | Gold Standard:Pathological examination;Index test:1. targeted biopsies were taken from all visible lesions when using white light endoscopy 2. using white light endoscopy, sequential 4-quadrantic random biopsies were taken at every 10-cm intervals colon from disease segments defined by the endoscopist in addition to targeted biopsies from all visible lesions; 3. tar; | Xijing Hospital of Digestive Diseases, Fourth Military Medical University | NULL | Completed | 18 | 70 | Both | Target condition:141;Difficult condition:0 | N/A | China |
| 1724 | NCT01506362 (ClinicalTrials.gov) | March 2012 | 3/1/2012 | Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis | An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: BL-7040 | BioLineRx, Ltd. | NULL | Completed | 18 Years | 70 Years | All | 22 | Phase 2 | Israel |
| 1725 | EUCTR2011-004770-28-LV (EUCTR) | 29/02/2012 | 24/01/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Spain;Poland;Lithuania;Austria;Germany;Latvia | ||
| 1726 | EUCTR2011-004770-28-ES (EUCTR) | 28/02/2012 | 11/01/2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | France;Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany | ||
| 1727 | EUCTR2011-004578-27-DK (EUCTR) | 24/02/2012 | 09/02/2012 | A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 1728 | EUCTR2011-004579-35-DK (EUCTR) | 24/02/2012 | 24/02/2012 | A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to severe active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand | ||
| 1729 | EUCTR2011-004580-79-DK (EUCTR) | 24/02/2012 | 23/01/2012 | A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis. | A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 Other descriptive name: tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan | ||
| 1730 | EUCTR2011-004765-32-CZ (EUCTR) | 21/02/2012 | 15/12/2011 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Belgium;Netherlands;Italy | ||
| 1731 | EUCTR2011-002411-29-IT (EUCTR) | 20/02/2012 | 07/03/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB | ABBOTT GMBH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden | |||
| 1732 | EUCTR2011-002818-37-BE (EUCTR) | 15/02/2012 | 03/10/2011 | A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis. | A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis. | Subjects with Active Ulcerative Colitis. MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Belgium;Netherlands;United Kingdom | ||
| 1733 | EUCTR2011-003532-32-LT (EUCTR) | 14/02/2012 | 28/11/2011 | A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis | Acute mild to moderate ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LX1606 Product Code: LX1606 INN or Proposed INN: Telotristat etiprate Other descriptive name: telotristat etiprate | Lexicon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovakia;Poland;Belgium;Lithuania | ||
| 1734 | EUCTR2010-022766-27-BE (EUCTR) | 09/02/2012 | 08/11/2011 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 INN or Proposed INN: N/A Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 INN or Proposed INN: N/A Other descriptive name: Multistem Trade Name: Promiten INN or Proposed INN: Dextran Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Germany;Italy;Sweden | ||
| 1735 | EUCTR2011-003409-36-DE (EUCTR) | 09/02/2012 | 17/11/2011 | A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease) | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1736 | EUCTR2011-002818-37-GB (EUCTR) | 08/02/2012 | 07/11/2011 | A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis. | A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis. | Subjects with Active Ulcerative Colitis. MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Netherlands;United Kingdom | ||
| 1737 | EUCTR2010-022766-27-HU (EUCTR) | 07/02/2012 | 05/12/2011 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden | ||
| 1738 | JPRN-UMIN000007341 | 2012/02/01 | 21/02/2012 | The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab | The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab | ulcerative colitis | Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54). Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54). | Tohoku University Graduate School of Medicine (Tohoku University Hospital) | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 90 | Not applicable | Japan |
| 1739 | NCT01585155 (ClinicalTrials.gov) | February 2012 | 24/4/2012 | Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis | Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis. | Pediatric Ulcerative Colitis | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 6 Years | 17 Years | All | 21 | Phase 3 | Japan |
| 1740 | NCT01456052 (ClinicalTrials.gov) | January 30, 2012 | 17/10/2011 | A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Telotristat Etiprate;Drug: Placebo | Lexicon Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 59 | Phase 2 | United States;Lithuania;Poland;Slovakia |
| 1741 | NCT01532648 (ClinicalTrials.gov) | January 27, 2012 | 13/12/2011 | Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis | Drug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASA | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic |
| 1742 | EUCTR2011-004812-40-DE (EUCTR) | 26/01/2012 | 25/11/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;United Kingdom;Italy | ||
| 1743 | EUCTR2011-004812-40-NL (EUCTR) | 25/01/2012 | 22/12/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;United Kingdom;Italy | ||
| 1744 | EUCTR2011-004812-40-CZ (EUCTR) | 24/01/2012 | 29/12/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;United Kingdom;Italy | ||
| 1745 | EUCTR2010-022766-27-SE (EUCTR) | 19/01/2012 | 03/11/2011 | Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden | ||
| 1746 | EUCTR2011-004765-32-SK (EUCTR) | 19/01/2012 | 09/12/2011 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Slovakia;Belgium;Netherlands;Italy | ||
| 1747 | EUCTR2011-003130-14-CZ (EUCTR) | 13/01/2012 | 14/10/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct INN or Proposed INN: DIMS0150 Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;Czech Republic;Poland;Germany;Italy;United Kingdom | |||
| 1748 | EUCTR2011-003409-36-CZ (EUCTR) | 11/01/2012 | 18/11/2011 | A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease) | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: RO5490261/F02 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;New Zealand;United Kingdom | ||
| 1749 | EUCTR2011-004765-32-BE (EUCTR) | 10/01/2012 | 06/12/2011 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Slovakia;Belgium;Netherlands;Italy | ||
| 1750 | EUCTR2011-005693-36-IT (EUCTR) | 09/01/2012 | 02/03/2012 | Evaluation of the number of colon intraephitelial tumours in patients with ulcerative colitis after oral administration of the vital dye methylene blue | Intraepithelial neoplasia detection rate after single oral dose of methylene blue MMX modified release tablets administered to patients with long standing ulcerative colitis undergoing colonoscopy - NA | Patients affecetd by Long standing ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Methylene blue 25mg tablets Product Code: NA INN or Proposed INN: METHYLENE BLUE Other descriptive name: NA | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1751 | EUCTR2011-002411-29-GR (EUCTR) | 09/01/2012 | 07/12/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 1752 | EUCTR2011-003283-78-IT (EUCTR) | 09/01/2012 | 01/03/2012 | A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS | A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS | Active Ulcerative Colitis Patients MedDRA version: 14.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: GED-0507-34-Levo INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid Other descriptive name: NA | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1753 | EUCTR2010-023762-49-PL (EUCTR) | 06/01/2012 | 05/07/2011 | A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Spain;Belgium;Poland;Romania;Austria;Bulgaria;Germany;Netherlands | ||
| 1754 | EUCTR2011-002818-37-NL (EUCTR) | 03/01/2012 | 16/02/2012 | A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis. | A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis. | Subjects with Active Ulcerative Colitis. MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Netherlands;United Kingdom | ||
| 1755 | EUCTR2011-002462-20-IT (EUCTR) | 02/01/2012 | 08/03/2012 | Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis. | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis:PoC study | mild to moderate ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Lysine-D-proline-threonine Product Code: K(D)PT INN or Proposed INN: NA Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate | DR. AUGUST WOLFF GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | |||
| 1756 | NCT01494857 (ClinicalTrials.gov) | January 2012 | 15/12/2011 | Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis | Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Adalimumab | Clalit Health Services | NULL | Recruiting | 18 Years | N/A | Both | 200 | Phase 3 | Israel |
| 1757 | EUCTR2011-003130-14-DE (EUCTR) | 30/12/2011 | 19/09/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct INN or Proposed INN: DIMS0150 Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | |||
| 1758 | EUCTR2011-002462-20-PL (EUCTR) | 27/12/2011 | 20/10/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Poland;Germany;Italy | |||
| 1759 | EUCTR2011-003409-36-ES (EUCTR) | 23/12/2011 | 18/11/2011 | A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease) | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1760 | EUCTR2011-003130-14-PL (EUCTR) | 22/12/2011 | 10/10/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | |||
| 1761 | EUCTR2010-020448-37-NL (EUCTR) | 21/12/2011 | 16/09/2010 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE | Enceladus Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Belgium;Netherlands | ||
| 1762 | EUCTR2011-003532-32-SK (EUCTR) | 19/12/2011 | 10/11/2011 | A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis | Acute mild to moderate ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LX1606 Product Code: LX1606 INN or Proposed INN: Non as of yet Other descriptive name: telotristat etiprate | Lexicon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovakia;Belgium;Poland;Lithuania | ||
| 1763 | EUCTR2011-004268-31-DK (EUCTR) | 13/12/2011 | 21/11/2011 | Adalimumab (Humira) in the treatment of chronic pouchitis | Adalimumab (Humira) in the treatment of chronic pouchitis | Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringes Product Name: Humira Product Code: EMEA/H/C/000481 | Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Denmark | ||
| 1764 | EUCTR2011-004812-40-IT (EUCTR) | 12/12/2011 | 02/03/2012 | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab Other descriptive name: NA | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;United Kingdom;Italy | ||
| 1765 | EUCTR2011-002462-20-HU (EUCTR) | 07/12/2011 | 22/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Czech Republic;Hungary;Poland;Germany;Italy | ||||
| 1766 | EUCTR2011-003409-36-GB (EUCTR) | 02/12/2011 | 06/12/2011 | A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease) | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: RO5490261 / F02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;New Zealand;United Kingdom | ||
| 1767 | NCT01991314 (ClinicalTrials.gov) | December 2011 | 18/11/2013 | Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate | Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue | Ulcerative Colitis;Crohn's Disease | Drug: Ferrous sulphate | Queen Mary University of London | NULL | Completed | 13 Years | 80 Years | All | 90 | Phase 4 | United Kingdom |
| 1768 | NCT01434576 (ClinicalTrials.gov) | December 2011 | 1/9/2011 | Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative Colitis | Ulcerative Colitis | Biological: HGS1025;Drug: Placebo | Human Genome Sciences Inc. | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1 | NULL |
| 1769 | NCT01493960 (ClinicalTrials.gov) | December 2011 | 12/12/2011 | The Efficacy and Safety of Kappaproct in Chronic Active Treatment Refractory Ulcerative Colitis Patients | A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Kappaproct as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients | Colitis, Ulcerative | Drug: Kappaproct;Drug: Placebo | InDex Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 131 | Phase 3 | Czech Republic;France;Germany;Hungary;Italy;Poland;United Kingdom |
| 1770 | NCT02306772 (ClinicalTrials.gov) | December 2011 | 15/10/2014 | TP0501 - Pharmaco-Scintigraphic-Study | An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations. | Ulcerative Colitis | Drug: TP05 Coating A;Drug: TP05 Coating B | Tillotts Pharma AG | NULL | Completed | 18 Years | 55 Years | Both | 18 | Phase 1 | NULL |
| 1771 | NCT01461317 (ClinicalTrials.gov) | November 29, 2011 | 12/10/2011 | Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Etrolizumab | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom;Czech Republic |
| 1772 | EUCTR2010-023762-49-DE (EUCTR) | 29/11/2011 | 17/08/2011 | A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study | Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Spain;Romania;Austria;Bulgaria;Netherlands;Germany | ||
| 1773 | EUCTR2011-002462-20-CZ (EUCTR) | 24/11/2011 | 20/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Czech Republic;Poland;Germany;Italy | ||||
| 1774 | EUCTR2011-003208-19-GB (EUCTR) | 16/11/2011 | 28/09/2011 | GWP42003 symptomatic treatment of ulcerative colitis. | A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis. | Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GWP42003 INN or Proposed INN: Not applicable Other descriptive name: CANNABIDIOL | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;United Kingdom | ||
| 1775 | EUCTR2011-003409-36-BE (EUCTR) | 14/11/2011 | 14/11/2011 | A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease) | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1776 | EUCTR2010-023762-49-HU (EUCTR) | 09/11/2011 | 13/05/2011 | A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study | Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Hungary;Germany;Canada;Netherlands;Belgium;Romania;France;Bulgaria;Spain;United States;Poland;Austria | ||
| 1777 | EUCTR2011-002462-20-DE (EUCTR) | 25/10/2011 | 13/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Poland;Germany;Italy | |||
| 1778 | EUCTR2010-022506-41-PL (EUCTR) | 24/10/2011 | 05/09/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 | Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany | ||
| 1779 | EUCTR2011-000897-80-DE (EUCTR) | 19/10/2011 | 15/07/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Israel;Germany;United States;Hungary;Czech Republic;Canada;Spain;Australia;United Kingdom;New Zealand | ||
| 1780 | EUCTR2011-003130-14-HU (EUCTR) | 14/10/2011 | 01/09/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | |||
| 1781 | EUCTR2011-003130-14-GB (EUCTR) | 06/10/2011 | 11/08/2011 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Other descriptive name: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom | ||
| 1782 | JPRN-UMIN000006141 | 2011/10/01 | 12/08/2011 | Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis | ulcerative colitis | Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54). Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54). | Department of Gastroenterology and Hepatology, Kyoto University Hospital | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 50 | Not applicable | Japan | |
| 1783 | EUCTR2011-000897-80-ES (EUCTR) | 23/09/2011 | 04/07/2011 | A clinical study to investigate the safety and efficacy of the productrhuMAb BETA7 in treating patients with ulcerative colitis, a form ofinflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDYTO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 INPATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1784 | EUCTR2011-000897-80-CZ (EUCTR) | 14/09/2011 | 29/06/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1785 | EUCTR2011-000897-80-GB (EUCTR) | 06/09/2011 | 29/06/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;New Zealand;United Kingdom | ||
| 1786 | EUCTR2011-000897-80-HU (EUCTR) | 05/09/2011 | 07/09/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1787 | NCT01336465 (ClinicalTrials.gov) | September 2011 | 14/4/2011 | Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis | Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: placebo;Drug: rhuMAb Beta7 | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 124 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom |
| 1788 | EUCTR2010-022506-41-BE (EUCTR) | 23/08/2011 | 17/06/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05 | Colitis, Ulcerative MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Austria;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Australia;South Africa;Netherlands;Germany | ||
| 1789 | EUCTR2011-000897-80-BE (EUCTR) | 16/08/2011 | 27/06/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 1790 | EUCTR2010-023797-39-GB (EUCTR) | 12/08/2011 | 16/07/2011 | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Iron sulphate 200mg coated tablets Product Name: Ferrous sulphate Product Code: Ferrous sulphate INN or Proposed INN: Iron sulphate Trade Name: CosmoFer Product Name: CosmoFer 50mg/ml solution for infusion or injection INN or Proposed INN: iron(III)- hydroxide dextran complex | Barts Health NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1791 | EUCTR2010-023588-16-HU (EUCTR) | 11/08/2011 | 27/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 1792 | EUCTR2010-023588-16-GB (EUCTR) | 02/08/2011 | 11/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 16.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Austria;Germany;United Kingdom | ||
| 1793 | NCT01340872 (ClinicalTrials.gov) | August 2011 | 19/4/2011 | Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) | A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1) | Iron Deficiency Anaemia;Inflammatory Bowel Disease;Ulcerative Colitis | Drug: ST10-021;Drug: Placebo Comparator | Shield Therapeutics | NULL | Completed | 18 Years | N/A | All | 128 | Phase 3 | Austria;United Kingdom |
| 1794 | EUCTR2010-023762-49-AT (EUCTR) | 22/07/2011 | 26/04/2011 | A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands | ||
| 1795 | EUCTR2010-022506-41-DE (EUCTR) | 18/07/2011 | 28/02/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Germany;Netherlands | ||
| 1796 | JPRN-UMIN000005824 | 2011/07/01 | 21/06/2011 | Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis | ulcerative colitis | Tacrolimus (12weeks) | Juntendo University | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 20 | Not applicable | Japan | |
| 1797 | NCT01320436 (ClinicalTrials.gov) | July 2011 | 21/3/2011 | Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: 5-aminosalicylic acid | Sheba Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 50 | Phase 3 | Israel |
| 1798 | EUCTR2011-002061-38-BE (EUCTR) | 29/06/2011 | 08/06/2011 | Treating patients with infliximab based on their trough levels | A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT | 2) Crohn's disease and ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade Product Code: Remicade INN or Proposed INN: INFLIXIMAB | Katholieke Universiteit Leuven | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Belgium | |||
| 1799 | EUCTR2010-023588-16-AT (EUCTR) | 22/06/2011 | 16/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 1800 | EUCTR2010-023762-49-BG (EUCTR) | 06/06/2011 | 31/05/2011 | A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands | ||
| 1801 | EUCTR2010-022506-41-HU (EUCTR) | 31/05/2011 | 13/04/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05 | Colitis, Ulcerative MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany | ||
| 1802 | EUCTR2010-022506-41-IT (EUCTR) | 16/05/2011 | 28/12/2011 | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC) | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC) - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Hungary;Mexico;Canada;Poland;Brazil;Austria;Australia;South Africa;Germany;Italy | ||
| 1803 | EUCTR2010-023762-49-ES (EUCTR) | 16/05/2011 | 11/02/2011 | ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS | ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS | Colitis ulcerosa MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer, S.L.U. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Belgium;Poland;Spain;Bulgaria;Germany | ||
| 1804 | EUCTR2010-022506-41-AT (EUCTR) | 05/05/2011 | 01/03/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Netherlands;Germany | ||
| 1805 | JPRN-UMIN000011236 | 2011/05/02 | 20/07/2013 | Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - | Ulcerative colitis | Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding. | Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine | NULL | Complete: follow-up complete | 15years-old | 65years-old | Male and Female | 200 | Not selected | Japan | |
| 1806 | NCT01772615 (ClinicalTrials.gov) | May 2011 | 17/1/2013 | Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle | Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle | Ulcerative Colitis | Drug: Ciprofloxacin;Dietary Supplement: E. coli Nissle | Hvidovre University Hospital | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 4 | Denmark |
| 1807 | NCT01346826 (ClinicalTrials.gov) | May 2011 | 2/5/2011 | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD) | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial | Crohn's Disease;Ulcerative Colitis | Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion | Asan Medical Center | NULL | Completed | 16 Years | 80 Years | Both | 145 | Phase 4 | Korea, Republic of |
| 1808 | NCT01287195 (ClinicalTrials.gov) | April 7, 2011 | 28/1/2011 | Oral OKT3 for the Treatment of Active Ulcerative Colitis | Oral Anti-CD3 for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: Oral OKT3;Drug: Omeprazole | Brigham and Women's Hospital | NULL | Completed | 18 Years | 65 Years | All | 6 | Phase 1/Phase 2 | United States |
| 1809 | NCT01341808 (ClinicalTrials.gov) | April 2011 | 25/4/2011 | Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients | Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis A | Biological: Epaxal Berna (virosomal hepatitis A vaccine) | Asan Medical Center | NULL | Completed | 18 Years | 40 Years | Both | 493 | Phase 4 | Korea, Republic of |
| 1810 | JPRN-UMIN000005033 | 2011/03/01 | 01/03/2011 | Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis | ulcerative colitis | Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks)) Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week. | Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 12years-old | 75years-old | Male and Female | 50 | Not applicable | Japan | |
| 1811 | NCT01284062 (ClinicalTrials.gov) | March 2011 | 25/1/2011 | Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients | A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Anrukinzumab;Other: placebo | Pfizer | NULL | Completed | 18 Years | 65 Years | All | 84 | Phase 2 | United States;Austria;Bulgaria;Canada;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Belgium |
| 1812 | NCT01294410 (ClinicalTrials.gov) | March 2011 | 10/2/2011 | Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC) | Colitis, Ulcerative | Drug: Placebo;Drug: Anti-IP-10 Antibody | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 305 | Phase 2 | United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Mexico;Netherlands;Poland;South Africa |
| 1813 | NCT00895336 (ClinicalTrials.gov) | March 2011 | 27/4/2009 | Lactobacillus GG in Pediatric Ulcerative Colitis (UC) | An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative Colitis | Ulcerative Colitis | Biological: Lactobacillus GG | Children's Hospital Medical Center, Cincinnati | NULL | Withdrawn | 5 Years | 18 Years | All | 0 | Phase 2 | United States |
| 1814 | EUCTR2010-019558-42-SK (EUCTR) | 23/02/2011 | 27/10/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Hungary;Czech Republic;Slovakia;Belgium | ||
| 1815 | EUCTR2010-023494-19-SE (EUCTR) | 10/02/2011 | 27/12/2010 | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Lysine-D-Proline-Threonine Product Code: K(D)PT | Dr. August Wolff GmbH & Co. KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 1816 | EUCTR2010-019970-33-GB (EUCTR) | 01/02/2011 | 13/10/2010 | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis - | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: KRP203A Product Code: KRP203A Product Code: KRP203A | Novartis Services AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;United Kingdom;Belgium;Sweden | ||||
| 1817 | NCT01408810 (ClinicalTrials.gov) | February 2011 | 20/7/2011 | Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis | Histological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis Patients | Ulcerative Colitis | Drug: Infliximab | Grupo de Estudo da Doença Inflamatória Intestinal | NULL | Completed | 18 Years | 64 Years | Both | 21 | Phase 4 | Portugal |
| 1818 | NCT01290042 (ClinicalTrials.gov) | February 2011 | 27/1/2011 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. | A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease. | Ulcerative Colitis;Crohn's Disease | Drug: AMG 181;Other: Placebo for AMG 181 | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia |
| 1819 | EUCTR2010-019558-42-HU (EUCTR) | 20/01/2011 | 10/11/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | |||
| 1820 | EUCTR2010-019558-42-CZ (EUCTR) | 10/01/2011 | 25/10/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | |||
| 1821 | EUCTR2010-019558-42-BE (EUCTR) | 23/12/2010 | 13/10/2010 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | |||
| 1822 | EUCTR2010-019970-33-DE (EUCTR) | 22/12/2010 | 15/10/2010 | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis - | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: KRP203 Product Code: KRP203 Product Name: KRP203 Product Code: KRP203 Product Name: KRP203 Product Code: KRP203 | Novartis Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;United Kingdom;Germany;Belgium;Sweden | ||||
| 1823 | EUCTR2010-020448-37-BE (EUCTR) | 10/12/2010 | 22/12/2010 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE | Enceladus Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Belgium;Netherlands | ||
| 1824 | EUCTR2010-019970-33-BE (EUCTR) | 07/12/2010 | 20/09/2010 | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Product Code: KRP203A Product Code: KRP203A Product Code: KRP203A | Novartis Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | Hungary;Belgium;Germany;United Kingdom;Sweden | ||
| 1825 | NCT01375179 (ClinicalTrials.gov) | December 2010 | 12/5/2011 | Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients | A Multi-centre, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of KRP203 in Subjects With Moderately Active Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: KRP203;Drug: Placebo matching KRP203 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 27 | Phase 2 | Belgium;Germany;Hungary;Sweden;Switzerland;United Kingdom |
| 1826 | JPRN-JapicCTI-101380 | 15/11/2010 | Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis- | Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis- | Mild to moderate active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 2.4 g/d or 4.8 g/d are administrated orally once daily after breakfast for 8 weeks. Control intervention name : Mesalazine tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 2.25 g/d are administrated orally 3 times daily after each meal for 8 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | NULL | 16 | BOTH | 228 | Phase 3 | NULL | |||
| 1827 | JPRN-JapicCTI-101381 | 15/11/2010 | Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase- | Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase- | Ulcerative colitis in remission phase | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 2.4 g/d are administrated orally once daily after breakfast for 48 weeks. Control intervention name : Mesalazine tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 2.25g/d are administrated orally 3 times daily after each meal for 48 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | NULL | 16 | BOTH | 190 | Phase 3 | NULL | |||
| 1828 | EUCTR2010-019970-33-HU (EUCTR) | 11/11/2010 | 07/09/2010 | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis - | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: n.a. Product Code: KRP203A Product Name: n.a Product Code: KRP203A Product Name: n.a Product Code: KRP203A | Novartis Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Germany;United Kingdom;Belgium;Sweden | ||||
| 1829 | EUCTR2010-018557-35-NL (EUCTR) | 08/11/2010 | 11/02/2010 | Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine | Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine | Ulcerative colitis | Trade Name: Mesalazine Product Name: Mesalazine Product Code: Salofalk | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Netherlands | |||
| 1830 | EUCTR2009-017044-13-DE (EUCTR) | 03/11/2010 | 16/06/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 1831 | EUCTR2010-019970-33-SE (EUCTR) | 29/10/2010 | 10/09/2010 | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis | A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: KRP203 Product Code: KRP203A Product Name: KRP203 Product Code: KRP203A Product Name: KRP203 Product Code: KRP203A | Novartis Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Belgium;Germany;United Kingdom;Sweden | |||
| 1832 | NCT01130844 (ClinicalTrials.gov) | October 8, 2010 | 20/5/2010 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | NULL | Completed | 5 Years | 17 Years | All | 52 | Phase 1 | United States;Australia;Poland;Slovakia;United Kingdom |
| 1833 | NCT01111292 (ClinicalTrials.gov) | October 2010 | 24/4/2010 | Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia | Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia | Colon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal Carcinoma | Drug: Inositol;Other: Placebo | National Cancer Institute (NCI) | NULL | Terminated | 18 Years | N/A | All | 5 | Phase 1/Phase 2 | United States |
| 1834 | EUCTR2009-017044-13-BE (EUCTR) | 14/09/2010 | 06/05/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany | ||
| 1835 | NCT01221428 (ClinicalTrials.gov) | September 2010 | 14/10/2010 | Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis | Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis | Ulcerative Colitis;Mesenchymal Stem Cells;Umbilical Cord | Biological: Umbilical Cord Mesenchymal Stem Cells | Qingdao University | NULL | Active, not recruiting | 18 Years | 70 Years | Both | 50 | Phase 1/Phase 2 | China |
| 1836 | NCT01201122 (ClinicalTrials.gov) | September 2010 | 12/9/2010 | Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis | Multi Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC. | Mild to Moderate Ulcerative Colitis | Drug: Mesalamine | Wolfson Medical Center | NULL | Completed | 6 Years | 18 Years | Both | 86 | Phase 4 | Israel |
| 1837 | EUCTR2009-017044-13-IE (EUCTR) | 10/08/2010 | 20/04/2010 | A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 1838 | EUCTR2009-017044-13-CZ (EUCTR) | 05/08/2010 | 28/05/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic | ||
| 1839 | NCT01320332 (ClinicalTrials.gov) | August 2010 | 15/3/2011 | A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis | A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: ASP3291;Drug: Placebo | Telsar Pharma Inc. | NULL | Completed | 18 Years | 65 Years | Both | 16 | Phase 1 | United States |
| 1840 | EUCTR2009-017044-13-FR (EUCTR) | 27/07/2010 | 22/06/2010 | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 1841 | EUCTR2009-017044-13-HU (EUCTR) | 21/07/2010 | 26/04/2010 | A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 1842 | JPRN-UMIN000003785 | 2010/07/01 | 01/07/2010 | Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. | Ulcerative colitis | 5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). 5-aminosalicylic acid monotherapy and tacrolimus arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule. | Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan | |
| 1843 | NCT01164904 (ClinicalTrials.gov) | July 2010 | 1/7/2010 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Amg 181 | Amgen | NULL | Terminated | 18 Years | 55 Years | Both | 72 | Phase 1 | United States;Australia;New Zealand |
| 1844 | NCT01216280 (ClinicalTrials.gov) | July 2010 | 2/9/2010 | Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis | Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: placebo capsule;Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule;Drug: 2 x 10 mg Natura-alpha capsules | Natrogen Therapeutics International, Inc | NULL | Active, not recruiting | 18 Years | 70 Years | Both | 75 | Phase 2 | United States |
| 1845 | EUCTR2009-017044-13-GB (EUCTR) | 30/06/2010 | 17/03/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany | ||
| 1846 | NCT01124149 (ClinicalTrials.gov) | June 29, 2010 | 13/5/2010 | Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis | A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: MMX mesalamine/ mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 759 | Phase 4 | United States;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;India;Ireland;Poland;Romania;South Africa;Spain;United Kingdom;Brazil;Czech Republic |
| 1847 | EUCTR2009-017044-13-ES (EUCTR) | 25/06/2010 | 19/04/2010 | Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Colitis UlcerosaUlcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 1848 | NCT01149707 (ClinicalTrials.gov) | June 1, 2010 | 22/6/2010 | Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis | A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis | Left-Sided Ulcerative Colitis;Proctosigmoiditis | Drug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo Enema | PurGenesis Technologies Inc. | NULL | Completed | 18 Years | 75 Years | All | 34 | Phase 2 | Germany |
| 1849 | EUCTR2009-013890-16-PT (EUCTR) | 28/05/2010 | 21/12/2009 | Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica | Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica | This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 | Trade Name: Remicade Product Name: Remicade | GEDII - Grupo de Estudo da Doença inflamatória Intestinal | NULL | Not Recruiting | Female: yes Male: yes | 20 | Portugal | |||
| 1850 | EUCTR2006-003398-28-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden | ||
| 1851 | EUCTR2006-003399-37-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 1852 | EUCTR2009-017839-18-DE (EUCTR) | 14/05/2010 | 16/02/2010 | A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS | A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS | Active mild-to-moderate distal ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) | PurGenesis Techonologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Germany | |||
| 1853 | EUCTR2008-005903-25-BG (EUCTR) | 23/04/2010 | 14/04/2010 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Bulgaria | |||
| 1854 | NCT00572585 (ClinicalTrials.gov) | April 2010 | 12/12/2007 | Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: AEB071;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 2 | United States;Denmark;Germany;Poland |
| 1855 | EUCTR2008-002784-14-GB (EUCTR) | 26/03/2010 | 28/06/2010 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1856 | NCT04753775 (ClinicalTrials.gov) | March 10, 2010 | 9/2/2021 | RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS. | RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS. | Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC) | Drug: Aloe vera gel | Ospedale Sandro Pertini, Roma | NULL | Completed | 18 Years | N/A | All | 44 | N/A | NULL |
| 1857 | EUCTR2008-003169-19-GB (EUCTR) | 04/03/2010 | 17/09/2009 | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CyCol Product Code: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) | Sigmoid Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Ireland;United Kingdom | ||
| 1858 | NCT01033305 (ClinicalTrials.gov) | March 2010 | 15/12/2009 | Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™) | A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: CyCol™;Drug: Placebo | Sigmoid Pharma | NULL | Completed | 18 Years | N/A | Both | 118 | Phase 2 | Ireland;United Kingdom |
| 1859 | EUCTR2008-002784-14-SE (EUCTR) | 12/02/2010 | 23/01/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1860 | NCT01037322 (ClinicalTrials.gov) | January 2010 | 20/12/2009 | Cannabidiol for Inflammatory Bowel Disease | Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis | Drug: cannabidiol;Drug: placebo in drops | Meir Medical Center | NULL | Completed | 20 Years | 80 Years | Both | 20 | Phase 1/Phase 2 | Israel |
| 1861 | NCT01040910 (ClinicalTrials.gov) | January 2010 | 29/12/2009 | Cannabis for Inflammatory Bowel Disease | A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis | Drug: smoking of cannabis;Drug: smoking cigarettes with placebo | Meir Medical Center | NULL | Recruiting | 20 Years | 70 Years | Both | 20 | Phase 1/Phase 2 | Israel |
| 1862 | EUCTR2008-002782-32-DK (EUCTR) | 18/12/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1863 | EUCTR2008-005237-30-NL (EUCTR) | 01/12/2009 | 18/08/2009 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP | Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima and Inflectra | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6000 | United States;Canada;Netherlands;Sweden | |||
| 1864 | NCT01039597 (ClinicalTrials.gov) | December 2009 | 23/12/2009 | Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: ORE1001;Drug: Placebo | Ore Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 1/Phase 2 | Canada;India |
| 1865 | NCT01011322 (ClinicalTrials.gov) | December 2009 | 10/11/2009 | A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis | Ulcerative Colitis;Large Intestine;Diarrhea;Abdominal Pain | Drug: LT-02;Drug: placebo | Lipid Therapeutics GmbH | NULL | Active, not recruiting | 18 Years | N/A | Both | 156 | Phase 2 | Germany;Lithuania;Romania | |
| 1866 | EUCTR2009-015077-12-GB (EUCTR) | 23/11/2009 | 17/09/2009 | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1867 | EUCTR2008-007952-90-LT (EUCTR) | 23/11/2009 | 15/09/2009 | A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. | A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. | Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit. MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine | Lipid Therapeutics GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | Germany;Lithuania | ||
| 1868 | EUCTR2009-015136-14-BE (EUCTR) | 20/11/2009 | 12/10/2009 | Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study | Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study | Pouchitis MedDRA version: 12.0;Level: LLT;Classification code 10036463;Term: Pouchitis | Product Name: Metronidazole capsule 50 mg Product Code: FP-110 INN or Proposed INN: Metronidazole Trade Name: Flagyl INN or Proposed INN: Metronidazole | FORMAC Pharmaceuticals NV | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 1869 | EUCTR2008-007952-90-DE (EUCTR) | 17/11/2009 | 04/08/2009 | A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010 | A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010 | Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit. MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine | Lipid Therapeutics GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Germany;Lithuania | ||
| 1870 | EUCTR2008-003169-19-IE (EUCTR) | 09/11/2009 | 05/06/2008 | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) Product Name: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) | Sigmoid Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom;Ireland | |||
| 1871 | NCT00984568 (ClinicalTrials.gov) | November 2009 | 24/9/2009 | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553) | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study | Colitis, Ulcerative | Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | All | 28 | Phase 3 | Germany |
| 1872 | NCT01059344 (ClinicalTrials.gov) | November 2009 | 28/1/2010 | Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis | A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamin | Tillotts Pharma AG | NULL | Completed | 18 Years | N/A | All | 281 | Phase 3 | Belarus;India;Turkey;Ukraine |
| 1873 | NCT01020708 (ClinicalTrials.gov) | November 2009 | 20/11/2009 | Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis | A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis | Ulcerative Colitis | Drug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4 | Altheus Therapeutics, Inc. | NULL | Completed | 18 Years | 64 Years | Both | 9 | Phase 1 | United States |
| 1874 | EUCTR2007-004157-28-SE (EUCTR) | 22/10/2009 | 06/05/2009 | Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 1875 | EUCTR2009-015649-21-NO (EUCTR) | 21/10/2009 | 16/09/2009 | Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab. | Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab. | Ulcerative colitis | Trade Name: Dekristol Product Name: cholecalciferol Product Code: na | Medical clinic, University Hospital of North Norway | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Norway | |||
| 1876 | NCT03747068 (ClinicalTrials.gov) | October 9, 2009 | 12/11/2018 | The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease. | Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis | Ulcerative Colitis;Anti TNF Therapy;Ileal Pouch Anal Anastomosis (IPAA) | Drug: Anti-TNF Drug | HaEmek Medical Center, Israel | Mount Sinai Hospital, Canada;University of Toronto | Completed | N/A | N/A | All | 130 | NULL | |
| 1877 | EUCTR2009-011608-51-DE (EUCTR) | 09/10/2009 | 21/07/2009 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | |||
| 1878 | NCT01004185 (ClinicalTrials.gov) | October 2009 | 27/10/2009 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Terminated | 5 Years | 17 Years | All | 39 | Phase 3 | United States;Canada;Croatia;Poland;Romania;Russian Federation |
| 1879 | EUCTR2004-004184-29-DK (EUCTR) | 10/09/2009 | 10/10/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 1880 | EUCTR2009-010921-38-NL (EUCTR) | 08/09/2009 | 02/03/2009 | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Ulcerative Colitis and the risk of developing colorectal cancer. MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Salofalk INN or Proposed INN: mesalazine Trade Name: Ursofalk INN or Proposed INN: ursodeoxycholic acid | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 1881 | EUCTR2008-002784-14-DE (EUCTR) | 02/09/2009 | 02/06/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia | ||
| 1882 | NCT01036022 (ClinicalTrials.gov) | September 1, 2009 | 17/12/2009 | Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK1399686 | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 120 | Phase 2 | Belgium;Canada;Germany;Norway;Sweden |
| 1883 | NCT02322008 (ClinicalTrials.gov) | September 2009 | 17/12/2014 | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Biological: infliximab and adalimumab | Regionshospitalet Viborg, Skive | NULL | Completed | 18 Years | N/A | Both | 1035 | N/A | NULL |
| 1884 | EUCTR2008-002782-32-DE (EUCTR) | 24/08/2009 | 23/04/2009 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 995 | Phase 3 | Portugal;Serbia;Taiwan;Estonia;Hong Kong;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand | ||
| 1885 | EUCTR2009-010065-23-DE (EUCTR) | 17/08/2009 | 14/04/2009 | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone | Essex Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 1886 | EUCTR2009-011608-51-SE (EUCTR) | 17/08/2009 | 22/06/2009 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | |||
| 1887 | EUCTR2008-002782-32-AT (EUCTR) | 13/08/2009 | 28/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Other descriptive name: LDP-02 | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1888 | EUCTR2008-002784-14-AT (EUCTR) | 13/08/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1889 | EUCTR2009-011608-51-BE (EUCTR) | 03/08/2009 | 23/06/2009 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belgium;Germany;Sweden | ||
| 1890 | NCT00963287 (ClinicalTrials.gov) | August 2009 | 11/6/2009 | Trial of Chinese Prescription on Ulcerative Colitis | Ulcerative Colitis | Drug: bascial prescription plus or minus herbs depend on symptoms | Shanghai University of Traditional Chinese Medicine | NULL | Completed | 18 Years | 65 Years | Both | 200 | N/A | China | |
| 1891 | EUCTR2007-003815-30-PT (EUCTR) | 31/07/2009 | 05/03/2009 | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis | Mild or Moderately Active Steroid Dependent Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Dacortin Product Name: prednisone INN or Proposed INN: Prednisone INN or Proposed INN: Prednisone Trade Name: Dacortin Product Name: prednisone Product Code: H02AB INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Spain | ||||
| 1892 | EUCTR2008-002784-14-IT (EUCTR) | 22/07/2009 | 17/03/2009 | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND | Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD) MedDRA version: 9.1;Level: LLT;Classification code 10045282 MedDRA version: 9.1;Level: PT;Classification code 10011401 | Product Name: Vedolizumab Product Code: MLN0002 | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1893 | EUCTR2008-002782-32-IT (EUCTR) | 22/07/2009 | 22/01/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND | Patients with Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1894 | EUCTR2008-002782-32-GB (EUCTR) | 20/07/2009 | 27/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1895 | EUCTR2008-002782-32-CZ (EUCTR) | 13/07/2009 | 31/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1896 | NCT01149694 (ClinicalTrials.gov) | June 2009 | 22/6/2010 | A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers | A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers | Ulcerative Colitis | Drug: PUR 0110 Rectal Enema or Placebo Enema | PurGenesis Technologies Inc. | NULL | Completed | 18 Years | 55 Years | Male | 24 | Phase 1 | Germany |
| 1897 | EUCTR2008-003913-28-IT (EUCTR) | 25/05/2009 | 16/04/2009 | Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND | Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND | Mild to moderate ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 150 | Italy | |||
| 1898 | EUCTR2007-004867-22-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Avonex Product Name: Avonex | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Czech Republic;Hungary;Slovakia | ||
| 1899 | NCT00790933 (ClinicalTrials.gov) | May 22, 2009 | 5/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | N/A | All | 2243 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic |
| 1900 | EUCTR2008-004564-40-GB (EUCTR) | 20/05/2009 | 14/10/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1901 | NCT00889161 (ClinicalTrials.gov) | May 2009 | 24/4/2009 | Curcumin in Pediatric Inflammatory Bowel Disease | Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Curcumin | Seattle Children's Hospital | NULL | Completed | 8 Years | 18 Years | Both | 11 | Phase 1 | United States |
| 1902 | EUCTR2008-002784-14-EE (EUCTR) | 28/04/2009 | 27/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia | ||
| 1903 | EUCTR2006-003607-40-FI (EUCTR) | 23/04/2009 | 26/02/2009 | METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Trexan inj 25 mg/ml INN or Proposed INN: Methotrexate | GETAID, Jean Minjoz Hospital | NULL | Not Recruiting | Female: yes Male: yes | 110 | Finland;Belgium;Austria;Netherlands | |||
| 1904 | EUCTR2008-002784-14-BE (EUCTR) | 21/04/2009 | 14/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1905 | EUCTR2008-002784-14-HU (EUCTR) | 20/04/2009 | 27/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1906 | EUCTR2008-007519-34-SE (EUCTR) | 17/04/2009 | 02/03/2009 | Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION | Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION | This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with | Trade Name: Remicade | University of Leuven Hospitals, Division of Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Sweden | |||
| 1907 | EUCTR2008-002782-32-HU (EUCTR) | 14/04/2009 | 27/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1908 | EUCTR2008-002782-32-GR (EUCTR) | 07/04/2009 | 05/11/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1909 | EUCTR2008-002784-14-GR (EUCTR) | 07/04/2009 | 05/11/2009 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1910 | EUCTR2008-004610-27-SK (EUCTR) | 06/04/2009 | 09/02/2009 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Slovakia;Spain;Belgium | ||
| 1911 | EUCTR2008-002784-14-ES (EUCTR) | 02/04/2009 | 18/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) | Ulcerative Colitis and Crohn?s DiseaseColitis ulcerosa (CU) y enfermedad de Crohn (EC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1912 | EUCTR2008-004564-40-NL (EUCTR) | 24/03/2009 | 11/11/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1913 | EUCTR2008-007292-25-IT (EUCTR) | 24/03/2009 | 16/03/2009 | AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 | AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 | Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure) MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis | Trade Name: MEZAVANT INN or Proposed INN: Mesalazine Trade Name: ASACOL INN or Proposed INN: Mesalazine | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 1914 | EUCTR2008-002784-14-FR (EUCTR) | 23/03/2009 | 14/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1915 | EUCTR2007-004157-28-PT (EUCTR) | 17/03/2009 | 12/12/2008 | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 1916 | EUCTR2008-000045-59-GB (EUCTR) | 17/03/2009 | 15/07/2008 | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS | Patients with mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode | Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE | Ferring Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 398 | United Kingdom;Netherlands;Belgium;France | |||
| 1917 | EUCTR2008-002782-32-FR (EUCTR) | 13/03/2009 | 14/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1918 | EUCTR2008-002782-32-PT (EUCTR) | 09/03/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1919 | EUCTR2008-002784-14-PT (EUCTR) | 06/03/2009 | 06/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1920 | EUCTR2008-002782-32-ES (EUCTR) | 02/03/2009 | 23/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave | Moderate to Severe Ulcerative ColitisColitis ulcerosa moderada o grave MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1921 | NCT00820365 (ClinicalTrials.gov) | March 2009 | 9/1/2009 | SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease | Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) | Inflammatory Bowel Disease (IBD) | Drug: SC12267 (4SC-101) | 4SC AG | NULL | Completed | 18 Years | 70 Years | Both | 34 | Phase 2 | Bulgaria;Germany;Romania |
| 1922 | EUCTR2008-004610-27-HU (EUCTR) | 26/02/2009 | 15/12/2008 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 1923 | EUCTR2008-002784-14-CZ (EUCTR) | 20/02/2009 | 31/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1924 | EUCTR2008-002784-14-NL (EUCTR) | 18/02/2009 | 05/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1925 | EUCTR2008-002782-32-NL (EUCTR) | 18/02/2009 | 05/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland | ||
| 1926 | EUCTR2008-002782-32-BE (EUCTR) | 08/02/2009 | 14/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1927 | EUCTR2008-004564-40-CZ (EUCTR) | 05/02/2009 | 23/01/2009 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Slovakia;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1928 | JPRN-JapicCTI-090718 | 01/2/2009 | A Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis. | Ulcerative colitis | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : 160/80 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50 Control intervention name : Placebo Dosage And administration of the control intervention : Placebo eow starting at Week 0 to Week 50 | AbbVie GK | Eisai Co., Ltd. | 15 | BOTH | 255 | Phase 2-3 | NULL | |||
| 1929 | EUCTR2008-002783-33-AT (EUCTR) | 29/01/2009 | 28/10/2008 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden | ||
| 1930 | EUCTR2008-002783-33-MT (EUCTR) | 28/01/2009 | 25/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece | ||
| 1931 | EUCTR2008-002782-32-MT (EUCTR) | 28/01/2009 | 02/02/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece | ||
| 1932 | EUCTR2008-002784-14-MT (EUCTR) | 28/01/2009 | 25/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece | ||
| 1933 | EUCTR2008-002784-14-IS (EUCTR) | 27/01/2009 | 06/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden | ||
| 1934 | EUCTR2008-004564-40-FR (EUCTR) | 26/01/2009 | 16/03/2009 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden | ||
| 1935 | EUCTR2008-004564-40-IT (EUCTR) | 23/01/2009 | 29/09/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Product Name: CP-690,550 Product Name: CP-690,550 Product Name: CP-690,550 | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1936 | NCT00748410 (ClinicalTrials.gov) | January 22, 2009 | 5/9/2008 | Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis | An Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis. | Colitis, Ulcerative | Drug: SB-656933 | GlaxoSmithKline | NULL | Terminated | N/A | N/A | All | 3 | Phase 2 | Netherlands |
| 1937 | EUCTR2008-004564-40-SE (EUCTR) | 16/01/2009 | 01/10/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1938 | EUCTR2008-002784-14-BG (EUCTR) | 16/01/2009 | 12/01/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1939 | EUCTR2008-002784-14-SK (EUCTR) | 15/01/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1940 | EUCTR2008-004564-40-BE (EUCTR) | 13/01/2009 | 14/11/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1941 | EUCTR2008-002782-32-IE (EUCTR) | 09/01/2009 | 28/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1942 | EUCTR2008-002784-14-IE (EUCTR) | 09/01/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden | ||
| 1943 | EUCTR2008-002782-32-IS (EUCTR) | 09/01/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands | ||
| 1944 | EUCTR2008-002782-32-EE (EUCTR) | 09/01/2009 | 24/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1945 | EUCTR2008-002782-32-BG (EUCTR) | 08/01/2009 | 12/01/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1946 | EUCTR2008-005903-25-DE (EUCTR) | 08/01/2009 | 03/11/2008 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 35 | Bulgaria;Germany | |||
| 1947 | JPRN-UMIN000008967 | 2009/01/01 | 24/09/2012 | Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis | Ulcerative Colitis | Polaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week Placebo group: 100 mL tap water enema daily for one week | The Jikei University School of MedicineDivision of Gastroenterology and Hepatology | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| 1948 | NCT00790478 (ClinicalTrials.gov) | January 2009 | 12/11/2008 | Melatonin and Ulcerative Colitis: A Pilot Clinical Trial | Melatonin and Ulcerative Colitis: A Pilot Clinical Trial | Ulcerative Colitis | Drug: Melatonin;Other: Placebo | Emory University | NULL | Terminated | 18 Years | 69 Years | All | 3 | Phase 2 | United States |
| 1949 | NCT00783718 (ClinicalTrials.gov) | January 2009 | 31/10/2008 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 895 | Phase 3 | United States;Canada;Puerto Rico |
| 1950 | EUCTR2008-000045-59-BE (EUCTR) | 23/12/2008 | 22/09/2008 | Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS | Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS | Patients with mild to moderate ulcerative colitis | Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE | Ferring SAS | NULL | Not Recruiting | Female: yes Male: yes | 398 | Phase 3 | France;Belgium;Netherlands;United Kingdom | ||
| 1951 | EUCTR2008-002782-32-LV (EUCTR) | 19/12/2008 | 31/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 1952 | EUCTR2008-002784-14-LV (EUCTR) | 19/12/2008 | 31/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1953 | EUCTR2008-004564-40-ES (EUCTR) | 15/12/2008 | 17/10/2008 | ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP 690,550 es un fármaco en desarrollo para el tratamiento de los pacientes con colitis ulcerosa de moderada a grave.CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer S.A | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden | ||
| 1954 | EUCTR2006-003607-40-BE (EUCTR) | 09/12/2008 | 27/10/2008 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml | Besancon University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Finland;Belgium;Austria;Netherlands | |||
| 1955 | EUCTR2007-004157-28-NL (EUCTR) | 09/12/2008 | 10/12/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1956 | JPRN-JapicCTI-090739 | 08/12/2008 | 10/04/2009 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | NULL | 18 | BOTH | Phase 2-3 | NULL | |||
| 1957 | JPRN-JapicCTI-090740 | 08/12/2008 | 10/04/2009 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | NULL | 18 | BOTH | Phase 3 | NULL | |||
| 1958 | EUCTR2008-004610-27-BE (EUCTR) | 02/12/2008 | 24/07/2008 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 1959 | NCT00787202 (ClinicalTrials.gov) | December 2008 | 6/11/2008 | A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis. | A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis. | Ulcerative Colitis | Drug: CP- 690 550;Other: placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 195 | Phase 2 | Belgium;Brazil;Chile;Czech Republic;Denmark;France;Hungary;Israel;Italy;Mexico;Netherlands;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Turkey |
| 1960 | NCT00801723 (ClinicalTrials.gov) | December 2008 | 2/12/2008 | (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis. | Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis. | Ulcerative Colitis | Drug: Budesonide MMX 6 mg Tablet;Drug: Placebo Tablet | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 123 | Phase 3 | United States;Canada |
| 1961 | NCT00808977 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis | A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis | Ulcerative Colitis | Drug: Dersalazine sodium;Drug: Mesalazine;Drug: Placebo | Palau Pharma S.A. | NULL | Completed | 18 Years | 65 Years | Both | 80 | Phase 2 | Belgium;Hungary;Slovakia;Spain |
| 1962 | NCT00713310 (ClinicalTrials.gov) | December 2008 | 9/7/2008 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis | Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Completed | 5 Years | 17 Years | All | 83 | Phase 3 | United States;Canada;Croatia;Poland;Romania |
| 1963 | EUCTR2006-003607-40-AT (EUCTR) | 26/11/2008 | 10/11/2008 | A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR | A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml | Besancon University Hospitaö | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Finland;Netherlands;Austria | ||||
| 1964 | EUCTR2008-004610-27-ES (EUCTR) | 25/11/2008 | 26/09/2008 | Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazina sodica INN or Proposed INN: dersalazine sodium Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE | Palau Pharma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 1965 | EUCTR2008-004564-40-HU (EUCTR) | 20/11/2008 | 17/10/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1966 | EUCTR2006-003607-40-NL (EUCTR) | 13/11/2008 | 13/08/2008 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml | Besancon University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 110 | Finland;Netherlands;Austria | |||
| 1967 | EUCTR2008-004564-40-SK (EUCTR) | 11/11/2008 | 24/10/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550 | Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden | ||
| 1968 | EUCTR2008-000967-40-NL (EUCTR) | 03/11/2008 | 30/05/2008 | A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis | A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis | Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 | ActoGeniX NV. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Netherlands;Belgium;Sweden | ||
| 1969 | NCT00737789 (ClinicalTrials.gov) | November 2008 | 19/8/2008 | Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. | Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalazine slow-release granules;Drug: Mesalazine liquid enema | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 206 | Phase 3 | Belgium;France;Netherlands;United Kingdom |
| 1970 | NCT00793130 (ClinicalTrials.gov) | November 2008 | 16/11/2008 | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | Ulcerative Colitis | Dietary Supplement: Coltect | Tel-Aviv Sourasky Medical Center | NULL | Recruiting | 18 Years | 75 Years | Both | 30 | N/A | Israel |
| 1971 | EUCTR2006-003397-94-SE (EUCTR) | 23/10/2008 | 21/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden | ||
| 1972 | EUCTR2007-002544-25-CZ (EUCTR) | 21/10/2008 | 07/01/2008 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | ||
| 1973 | EUCTR2006-004776-12-IT (EUCTR) | 15/10/2008 | 20/03/2009 | Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02 | Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02 | Patients with mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide Trade Name: ENTOCORT CR INN or Proposed INN: Budesonide Product Name: Budesonide MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 1974 | EUCTR2007-004867-22-CZ (EUCTR) | 07/10/2008 | 26/02/2008 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Avonex Product Name: Avonex | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;Czech Republic | |||
| 1975 | EUCTR2008-000045-59-NL (EUCTR) | 06/10/2008 | 13/08/2008 | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS | Patients with mild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode | Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE | Ferring SAS | NULL | Not Recruiting | Female: yes Male: yes | 398 | United Kingdom;Netherlands;Belgium;France | |||
| 1976 | EUCTR2007-005520-32-NL (EUCTR) | 01/10/2008 | 05/08/2008 | An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis. | An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis. | ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: SB-656933 Tablets Product Code: SB-656933 | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 1977 | NCT00805285 (ClinicalTrials.gov) | October 2008 | 8/12/2008 | The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis | Oral Budesonide and Rectal Hydrocortisone for the Treatment of Extensive Ulcerative Colitis: A Pilot Study | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Combination Oral Budesonide and Rectal Hydrocortisone | University of Maryland, Baltimore | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 1978 | EUCTR2006-003399-37-DK (EUCTR) | 25/09/2008 | 10/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1979 | EUCTR2006-003398-28-DK (EUCTR) | 25/09/2008 | 04/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 1980 | EUCTR2006-004776-12-SK (EUCTR) | 18/09/2008 | 16/07/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden | ||
| 1981 | ChiCTR-TRC-08000145 | 2008-09-01 | 2008-08-25 | The study of the treatment and rehabilitation of ulcerative colitis | The study of the treatment and rehabilitation of ulcerative colitis | Ulcerative Colitis | 1:5-ASA and low residue diet;2:5-ASA and EN;3:5-ASA and low residue diet and microecology prepar;4:5-ASA and low residue diet ang Gln;5:5-ASA and EN and Gln and microecology preparation; | Friendship Hospital of Capital Medical University | NULL | Completed | 18 | 70 | Both | 1:60;2:60;3:60;4:60;5:60; | I (Phase 1 study) | China |
| 1982 | NCT00694980 (ClinicalTrials.gov) | September 2008 | 7/6/2008 | A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis | A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: placebo;Drug: rhuMAb Beta7 | Genentech, Inc. | NULL | Completed | 18 Years | 70 Years | Both | 48 | Phase 1 | United States;Belgium;Canada;Germany;Netherlands;United Kingdom |
| 1983 | EUCTR2008-000967-40-SE (EUCTR) | 29/08/2008 | 04/06/2008 | A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis | A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis | Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 | ActoGeniX NV. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Netherlands;Belgium;Sweden | ||
| 1984 | EUCTR2008-001968-36-GB (EUCTR) | 27/08/2008 | 15/07/2008 | Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT | Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT | Acute severe steroid resistant ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade Trade Name: Sandimmun Trade Name: Neoral Soft Gelatin Capsules | Swansea University | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 1985 | EUCTR2006-003399-37-SE (EUCTR) | 26/08/2008 | 21/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 1986 | EUCTR2006-003398-28-SE (EUCTR) | 26/08/2008 | 21/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden | ||
| 1987 | EUCTR2007-004157-28-DE (EUCTR) | 07/08/2008 | 25/03/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 1988 | EUCTR2006-004776-12-EE (EUCTR) | 04/08/2008 | 11/06/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden | |||
| 1989 | EUCTR2007-004157-28-SK (EUCTR) | 04/08/2008 | 09/04/2008 | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 1990 | EUCTR2007-005166-12-DE (EUCTR) | 29/07/2008 | 15/01/2008 | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) | Hutchison MediPharma Enterprises Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Germany | ||
| 1991 | EUCTR2006-004776-12-GB (EUCTR) | 23/07/2008 | 25/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden | ||
| 1992 | EUCTR2007-004157-28-FR (EUCTR) | 10/07/2008 | 14/04/2008 | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 1993 | EUCTR2007-004157-28-HU (EUCTR) | 09/07/2008 | 28/03/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia | ||
| 1994 | EUCTR2006-004776-12-FR (EUCTR) | 07/07/2008 | 09/05/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 492 | Sweden;Lithuania;Latvia;Italy;France;Estonia;Belgium;United Kingdom | |||
| 1995 | EUCTR2006-004776-12-BE (EUCTR) | 01/07/2008 | 18/06/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 1996 | NCT00729872 (ClinicalTrials.gov) | July 2008 | 4/8/2008 | A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis | A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects With Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis | Biological: AG011;Other: Placebo | ActoGeniX N.V. | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 1/Phase 2 | Belgium;Canada;Netherlands;Sweden |
| 1997 | EUCTR2005-003471-20-LT (EUCTR) | 26/06/2008 | 12/02/2008 | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment | Ulcerative Colitis MedDRA version: 9.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Propionyl-L-carnitine Product Code: ST261 INN or Proposed INN: Propionyl-L-Carnitine | SIGMA-TAU | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Italy;Lithuania | ||
| 1998 | EUCTR2007-004157-28-BE (EUCTR) | 23/06/2008 | 13/12/2007 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Germany;Norway;New Zealand;Sweden;Netherlands;Australia;Denmark;Poland;Belgium;Canada;Puerto Rico;Czech Republic;Hungary;France;Switzerland;Italy;Israel;Austria;Spain;Slovakia;Portugal | ||
| 1999 | EUCTR2007-004867-22-HU (EUCTR) | 18/06/2008 | 21/02/2008 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis. | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Avonex Product Name: Avonex | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;Czech Republic | |||
| 2000 | EUCTR2007-004157-28-IT (EUCTR) | 17/06/2008 | 01/10/2008 | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Ulcerative Colitis - ND | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Ulcerative Colitis - ND | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 2001 | EUCTR2006-004776-12-LT (EUCTR) | 17/06/2008 | 22/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania | |||
| 2002 | EUCTR2008-000967-40-BE (EUCTR) | 13/06/2008 | 05/08/2008 | A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis | A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 | ActoGeniX N.V | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Netherlands;Belgium;Sweden | ||
| 2003 | EUCTR2006-002670-22-GB (EUCTR) | 11/06/2008 | 01/08/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 2004 | EUCTR2006-003398-28-BG (EUCTR) | 10/06/2008 | 30/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania | ||
| 2005 | EUCTR2007-004157-28-CZ (EUCTR) | 09/06/2008 | 10/04/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 2006 | EUCTR2007-007928-18-DE (EUCTR) | 04/06/2008 | 12/11/2008 | Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU | Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU | ulcerative colitis patients in clinical remission MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Myrrhinil-Intest® INN or Proposed INN: MATRICARIA FLOWER Other descriptive name: MATRICARIA FLOWER INN or Proposed INN: MYRRH Other descriptive name: MYRRH INN or Proposed INN: COFFEE COAL Other descriptive name: COFFEE COAL Trade Name: Salofalk® 500mg INN or Proposed INN: MESALAZINE | REPHA GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 2007 | EUCTR2008-000045-59-FR (EUCTR) | 04/06/2008 | 22/04/2008 | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS | Patients with mild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode | Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE | Ferring SAS | NULL | Not Recruiting | Female: yes Male: yes | 398 | Phase 3 | France;Belgium;Netherlands;United Kingdom | ||
| 2008 | EUCTR2006-004776-12-SE (EUCTR) | 02/06/2008 | 10/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 2009 | NCT00679432 (ClinicalTrials.gov) | June 2008 | 14/5/2008 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg. | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Canada;India;Mexico |
| 2010 | EUCTR2006-003399-37-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 2011 | EUCTR2006-003397-94-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania | ||
| 2012 | EUCTR2006-004776-12-LV (EUCTR) | 29/05/2008 | 29/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 2013 | EUCTR2007-002544-25-LV (EUCTR) | 29/05/2008 | 18/02/2008 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 | Bristol-Myers Squibb Company | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | ||
| 2014 | EUCTR2007-002544-25-HU (EUCTR) | 23/05/2008 | 07/01/2008 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | ||
| 2015 | EUCTR2006-002781-20-SE (EUCTR) | 23/05/2008 | 04/03/2008 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 2016 | EUCTR2006-005299-42-BE (EUCTR) | 20/05/2008 | 07/03/2008 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | |||
| 2017 | EUCTR2006-005299-42-ES (EUCTR) | 19/05/2008 | 03/03/2008 | Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF | Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF | Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis) | Trade Name: Sandimmum Product Name: ciclosporina Trade Name: Remicade Product Name: infliximab | GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | |||
| 2018 | EUCTR2007-004732-23-PL (EUCTR) | 05/05/2008 | 12/05/2008 | A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) | A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 2019 | NCT00676832 (ClinicalTrials.gov) | May 2008 | 9/5/2008 | Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: Placebo;Drug: COLAL-PRED | Prometheus Laboratories | NULL | Completed | 18 Years | 75 Years | Both | 190 | Phase 2 | United States |
| 2020 | NCT00616434 (ClinicalTrials.gov) | May 2008 | 5/2/2008 | A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis | Active Ulcerative Colitis | Drug: BG9418 (Interferon beta-1a);Drug: Placebo | Biogen | NULL | Completed | 18 Years | 65 Years | All | 123 | Phase 2 | United States;Canada;Czech Republic;Hungary;Poland;Russian Federation;Slovakia |
| 2021 | EUCTR2008-001467-10-GB (EUCTR) | 30/04/2008 | 28/03/2008 | Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3 | Ulcerative colitis - in remissionCrohn's Disease - in remission MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom | ||||
| 2022 | EUCTR2007-004157-28-AT (EUCTR) | 30/04/2008 | 08/04/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 2023 | EUCTR2007-006692-37-GB (EUCTR) | 10/04/2008 | 25/01/2008 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 2024 | EUCTR2007-007702-30-IT (EUCTR) | 03/04/2008 | 08/07/2008 | Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND | Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND | Ulcerative colitis MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: no Male: yes | Italy | ||||
| 2025 | NCT00656890 (ClinicalTrials.gov) | April 2008 | 4/4/2008 | A Study of MDX-1100 in Subjects With Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Biological: sterile saline for injection;Biological: MDX-1100 | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 110 | Phase 2 | United States;Canada;Czech Republic;Hungary;Latvia;Romania;Russian Federation;Ukraine |
| 2026 | EUCTR2006-002782-40-AT (EUCTR) | 16/03/2008 | 20/03/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 2027 | EUCTR2006-002781-20-AT (EUCTR) | 27/02/2008 | 23/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 475 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 2028 | EUCTR2007-004732-23-LV (EUCTR) | 27/02/2008 | 28/02/2008 | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 2029 | EUCTR2006-003604-19-PL (EUCTR) | 27/02/2008 | 07/11/2007 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date 06-Dec-2006), 03 (Version 1.0, Date 05-Mar-2007) and Administrative Letter 01. | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date 06-Dec-2006), 03 (Version 1.0, Date 05-Mar-2007) and Administrative Letter 01. | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland | ||
| 2030 | EUCTR2006-005299-42-FI (EUCTR) | 25/02/2008 | 27/12/2007 | A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY | A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY | Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten INN or Proposed INN: INFLIXIMAB | Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.) | NULL | Not Recruiting | Female: yes Male: yes | 100 | France;Finland;Belgium;Spain | |||
| 2031 | EUCTR2006-002782-40-DE (EUCTR) | 20/02/2008 | 18/04/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria | |||
| 2032 | EUCTR2006-002670-22-SK (EUCTR) | 08/02/2008 | 15/04/2008 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 2033 | NCT00659802 (ClinicalTrials.gov) | February 7, 2008 | 8/4/2008 | Phase II Study of HMPL-004 in Patients With Ulcerative Colitis | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine | Ulcerative Colitis | Drug: HMPL-004 low dose;Drug: Placebo;Drug: HMPL-004 high dose | Hutchison Medipharma Limited | NULL | Completed | 18 Years | N/A | All | 224 | Phase 2 | United States |
| 2034 | NCT00628433 (ClinicalTrials.gov) | February 2008 | 25/2/2008 | Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis | A Phase I/II, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Activity of HE3286 When Administered Orally to Patients With Active, Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: HE3286 | Harbor Therapeutics | NULL | Completed | 18 Years | 65 Years | Both | 27 | Phase 1/Phase 2 | United States |
| 2035 | EUCTR2006-003397-94-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2036 | EUCTR2006-003399-37-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2037 | EUCTR2006-003398-28-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2038 | EUCTR2006-003397-94-NL (EUCTR) | 17/01/2008 | 07/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2039 | EUCTR2006-003399-37-NL (EUCTR) | 17/01/2008 | 08/10/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 2040 | EUCTR2006-003398-28-NL (EUCTR) | 17/01/2008 | 08/10/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2041 | EUCTR2004-004184-29-NL (EUCTR) | 15/01/2008 | 17/10/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 2042 | NCT01045018 (ClinicalTrials.gov) | January 2008 | 17/12/2009 | A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis | BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: Placebo;Drug: Mesalamine | EMET Pharmaceuticals, LLC | Eagle Pharmaceuticals, Inc. | Completed | 18 Years | N/A | Both | Phase 3 | NULL | |
| 2043 | EUCTR2006-004230-32-BE (EUCTR) | 21/12/2007 | 04/12/2007 | Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study | Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study | Ulcerative colitis extending proximally beyond the rectum. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper 30 cpr 5mg R.M. INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene 20 cpr 5mg INN or Proposed INN: PREDNISONE Trade Name: Deltacortene 10 cpr 25mg INN or Proposed INN: PREDNISONE | CHIESI Farmaceutici S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland | |||
| 2044 | EUCTR2004-004184-29-PT (EUCTR) | 14/12/2007 | 11/10/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 2045 | EUCTR2006-005377-22-ES (EUCTR) | 12/12/2007 | 29/10/2007 | Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa | Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa | Tratamiento de colitis ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany | ||
| 2046 | EUCTR2006-003398-28-BE (EUCTR) | 10/12/2007 | 18/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2047 | EUCTR2006-004230-32-PL (EUCTR) | 07/12/2007 | 05/09/2007 | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper INN or Proposed INN: Beclomethasone diproprionate Trade Name: Deltacortene INN or Proposed INN: Prednisone Trade Name: Deltacortene INN or Proposed INN: Prednisone | Chiesi Farmaceutici SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Spain;Poland;Italy | ||
| 2048 | NCT00619489 (ClinicalTrials.gov) | December 2007 | 11/2/2008 | Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: vedolizumab | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 72 | Phase 2 | Canada |
| 2049 | EUCTR2007-002542-38-DK (EUCTR) | 28/11/2007 | 08/11/2007 | A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis | A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210 | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Sotrastaurin Product Code: AEB071 INN or Proposed INN: Sotrastaurin (INN) acetate Product Name: Vitamin B2 INN or Proposed INN: Riboflavin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;Denmark | ||
| 2050 | NCT00573794 (ClinicalTrials.gov) | November 28, 2007 | 12/12/2007 | Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis | Biological: adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | N/A | All | 592 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Poland;Puerto Rico;Slovakia;Spain;Sweden;Switzerland;United States |
| 2051 | EUCTR2006-003399-37-DE (EUCTR) | 27/11/2007 | 03/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 2052 | EUCTR2007-003815-30-ES (EUCTR) | 27/11/2007 | 24/10/2007 | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Colitis ulcerosa corticodependiente leve o moderada MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: DACORTIN Product Name: PREDNISONE INN or Proposed INN: PREDNISONE Other descriptive name: N/A | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Spain | ||||
| 2053 | EUCTR2006-002670-22-IT (EUCTR) | 27/11/2007 | 04/10/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: Infliximab Trade Name: imuran INN or Proposed INN: azathioprine | SCHERING-PLOUGH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy | |||
| 2054 | EUCTR2004-004184-29-SE (EUCTR) | 22/11/2007 | 27/09/2007 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 2055 | EUCTR2006-003398-28-DE (EUCTR) | 15/11/2007 | 03/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2056 | EUCTR2006-003397-94-BE (EUCTR) | 15/11/2007 | 18/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2057 | EUCTR2006-003397-94-AT (EUCTR) | 15/11/2007 | 16/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2058 | EUCTR2006-003399-37-BE (EUCTR) | 15/11/2007 | 18/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 2059 | EUCTR2006-005377-22-LT (EUCTR) | 13/11/2007 | 14/08/2007 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Germany;Spain;Latvia;Poland;Lithuania | ||
| 2060 | EUCTR2006-000410-20-NL (EUCTR) | 13/11/2007 | 09/08/2007 | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Netherlands;Belgium;Denmark;Italy | ||
| 2061 | EUCTR2006-002670-22-DE (EUCTR) | 31/10/2007 | 12/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 2062 | EUCTR2006-003399-37-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden | ||
| 2063 | EUCTR2006-003397-94-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2;Phase 3 | Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden;France;Hungary;Slovakia;Belgium | ||
| 2064 | EUCTR2006-003398-28-HU (EUCTR) | 29/10/2007 | 10/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2065 | EUCTR2007-002542-38-DE (EUCTR) | 29/10/2007 | 22/02/2008 | A clinical study to explore the safe and effective use of the drugsotrastaurin in patients with ulcerative colitis | A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: AEB071A Trade Name: B2-ASmedic Product Name: B2-ASmedic INN or Proposed INN: RIBOFLAVIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Denmark;Germany | |||
| 2066 | EUCTR2006-005377-22-DE (EUCTR) | 23/10/2007 | 16/07/2007 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Poland;Spain;Lithuania;Latvia;Germany | ||
| 2067 | EUCTR2007-004732-23-EE (EUCTR) | 22/10/2007 | 23/10/2007 | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 2068 | EUCTR2006-002670-22-PT (EUCTR) | 12/10/2007 | 20/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 2069 | EUCTR2006-003397-94-SK (EUCTR) | 04/10/2007 | 16/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden | ||
| 2070 | EUCTR2006-003398-28-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2;Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 2071 | EUCTR2006-003399-37-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 2072 | NCT00603733 (ClinicalTrials.gov) | October 2007 | 16/1/2008 | Canadian Active & Maintenance Modified Pentasa Study | A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks | Active Ulcerative Colitis;Remission of Ulcerative Colitis | Drug: 5-ASA (5-Aminosalicylate) | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 288 | Phase 3 | Canada |
| 2073 | NCT00747110 (ClinicalTrials.gov) | October 2007 | 3/9/2008 | Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC) | Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: budesonide;Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 343 | Phase 3 | Germany |
| 2074 | EUCTR2006-005377-22-LV (EUCTR) | 27/09/2007 | 12/09/2007 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Germany;Spain;Latvia;Poland;Lithuania | ||
| 2075 | EUCTR2006-003399-37-AT (EUCTR) | 27/09/2007 | 17/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 2076 | EUCTR2006-003397-94-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden | ||
| 2077 | EUCTR2006-003399-37-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 2078 | EUCTR2006-003398-28-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 2079 | EUCTR2006-002670-22-ES (EUCTR) | 20/09/2007 | 26/07/2007 | Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). | Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). | Colitis Ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom | ||
| 2080 | EUCTR2006-005377-22-CZ (EUCTR) | 17/09/2007 | 14/09/2007 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-stix® INN or Proposed INN: MESALAZINE Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Germany;Czech Republic;Spain;Latvia;Poland;Lithuania | ||
| 2081 | EUCTR2006-005377-22-SK (EUCTR) | 14/09/2007 | 16/04/2008 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix® INN or Proposed INN: MESALAZINE Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany | ||
| 2082 | EUCTR2006-002782-40-PT (EUCTR) | 07/09/2007 | 18/06/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria | |||
| 2083 | EUCTR2006-002670-22-FR (EUCTR) | 07/09/2007 | 14/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 2084 | EUCTR2006-003398-28-AT (EUCTR) | 06/09/2007 | 17/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2085 | EUCTR2006-003397-94-DE (EUCTR) | 05/09/2007 | 03/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2086 | EUCTR2006-003398-28-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2087 | EUCTR2006-003399-37-LV (EUCTR) | 03/09/2007 | 04/09/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan | ||
| 2088 | EUCTR2006-003397-94-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 2089 | NCT00498589 (ClinicalTrials.gov) | September 2007 | 9/7/2007 | Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: methotrexate;Drug: placebo | Centre Hospitalier Universitaire de Besancon | NULL | Completed | 18 Years | 75 Years | Both | 110 | Phase 2 | Austria;Belgium;France;Israel;Italy;Netherlands |
| 2090 | EUCTR2006-002670-22-CZ (EUCTR) | 29/08/2007 | 20/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy | |||
| 2091 | EUCTR2006-004230-32-ES (EUCTR) | 22/08/2007 | 26/09/2007 | EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA | EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA | Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE | Chiesi Farmaceutici SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland | |||
| 2092 | EUCTR2006-003604-19-GB (EUCTR) | 16/08/2007 | 09/03/2007 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. + Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Protocol amendment 04 - Biopsy substudy - Site specific+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-2006). | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. + Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Protocol amendment 04 - Biopsy substudy - Site specific+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-2006). | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Ireland;Germany | ||
| 2093 | EUCTR2006-003604-19-CZ (EUCTR) | 15/08/2007 | 11/05/2007 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | United Kingdom;Germany;Czech Republic;Belgium;France;Ireland;Italy;Poland | ||
| 2094 | EUCTR2006-000410-20-DK (EUCTR) | 13/08/2007 | 09/01/2007 | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade INN or Proposed INN: infliximab | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Netherlands;Belgium;Denmark;Italy | ||
| 2095 | EUCTR2006-002670-22-HU (EUCTR) | 09/08/2007 | 04/07/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | |||
| 2096 | EUCTR2006-006052-35-IT (EUCTR) | 08/08/2007 | 15/05/2007 | An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND | An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Nicolon | S.L.A. PHARMA (UK) LTD | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 2097 | EUCTR2006-003604-19-DE (EUCTR) | 06/08/2007 | 15/12/2006 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland | ||
| 2098 | EUCTR2006-000410-20-IT (EUCTR) | 02/08/2007 | 08/08/2007 | A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72 | A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72 | Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: REMICADE INN or Proposed INN: Infliximab | CENTOCOR | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Netherlands;Belgium;Denmark;Italy | ||
| 2099 | EUCTR2006-002670-22-BE (EUCTR) | 25/07/2007 | 15/06/2007 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 2100 | EUCTR2006-002781-20-BE (EUCTR) | 16/07/2007 | 10/01/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 475 | Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden | |||
| 2101 | EUCTR2006-002782-40-DK (EUCTR) | 09/07/2007 | 07/03/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 2102 | NCT00537316 (ClinicalTrials.gov) | July 2007 | 28/9/2007 | Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Ulcerative Colitis | Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion | Merck Sharp & Dohme Corp. | NULL | Terminated | 21 Years | N/A | All | 242 | Phase 3 | Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 2103 | NCT00505778 (ClinicalTrials.gov) | July 2007 | 20/7/2007 | A Comparison of Once a Day Dose Compared to 2 Doses/Day | A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine Once-Daily;Drug: Mesalamine Twice-Daily | Warner Chilcott | NULL | Completed | 18 Years | N/A | All | 1027 | Phase 3 | United States;Canada;Puerto Rico |
| 2104 | NCT01061996 (ClinicalTrials.gov) | July 2007 | 2/2/2010 | Basiliximab Maintenance in Ulcerative Colitis | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | NULL | Terminated | 18 Years | 75 Years | Both | 88 | Phase 2 | United Kingdom |
| 2105 | EUCTR2006-002781-20-DE (EUCTR) | 27/06/2007 | 04/04/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Hungary;Czech Republic;Germany;Italy;Austria;Sweden | |||
| 2106 | EUCTR2006-003604-19-IE (EUCTR) | 26/06/2007 | 13/02/2007 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01. | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01. | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland | ||
| 2107 | JPRN-JapicCTI-070399 | 22/6/2007 | 21/05/2007 | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | Active ulcerative colitis | Intervention name : Rebamipide INN of the intervention : Rebamipide Dosage And administration of the intervention : Intracolonial (enema) Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Intracolonial (enema) | Otsuka Pharmaceutical Co., Ltd. | NULL | complete | 16 | BOTH | 120 | Phase 2 | Japan | |
| 2108 | EUCTR2006-002782-40-FR (EUCTR) | 19/06/2007 | 06/03/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany | ||
| 2109 | EUCTR2006-002782-40-BE (EUCTR) | 19/06/2007 | 05/01/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany | |||
| 2110 | EUCTR2006-002782-40-CZ (EUCTR) | 18/06/2007 | 10/04/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 2111 | EUCTR2006-004303-19-BE (EUCTR) | 08/06/2007 | 07/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Czech Republic;United Kingdom;Belgium | |||
| 2112 | EUCTR2006-004230-32-IT (EUCTR) | 06/06/2007 | 12/11/2007 | Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA | Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA | Mild moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: CLIPPER*30CPR 5MG R.M. INN or Proposed INN: Beclometasone Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone Trade Name: DELTACORTENE FORTE*10CPR 25MG INN or Proposed INN: Prednisone | CHIESI | NULL | Not Recruiting | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland | |||
| 2113 | JPRN-UMIN000004401 | 2007/06/01 | 18/10/2010 | A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis | Ulcerative colitis (Proctitis type) | Placebo arm: A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks). True arm: A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study period | Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 30 | Phase 2,3 | Japan | |
| 2114 | NCT00463151 (ClinicalTrials.gov) | June 2007 | 19/4/2007 | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: rebamipide | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 16 Years | N/A | Both | 120 | Phase 2 | Japan |
| 2115 | NCT00542152 (ClinicalTrials.gov) | June 2007 | 8/10/2007 | Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis | A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis | Ulcerative Colitis;Steroid Refractory | Drug: CYCLOSPORINE VS INFLIXIMAB | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Completed | 18 Years | N/A | Both | 115 | Phase 4 | Belgium;Finland;France;Italy;Spain |
| 2116 | NCT00606346 (ClinicalTrials.gov) | May 31, 2007 | 21/1/2008 | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases | Biological: Anti TNF therapy including infliximab;Drug: No Biologics | Janssen Biotech, Inc. | NULL | Active, not recruiting | 1 Month | 17 Years | All | 4970 | United States;Canada | |
| 2117 | EUCTR2005-003707-37-BE (EUCTR) | 25/05/2007 | 18/12/2006 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | ||
| 2118 | EUCTR2006-006319-54-BE (EUCTR) | 24/05/2007 | 08/02/2007 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | United Kingdom;Belgium | |||
| 2119 | EUCTR2006-005299-42-FR (EUCTR) | 16/05/2007 | 06/03/2007 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | |||
| 2120 | EUCTR2006-006319-54-CZ (EUCTR) | 14/05/2007 | 20/02/2007 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Belgium;United Kingdom | ||
| 2121 | EUCTR2006-003604-19-BE (EUCTR) | 10/05/2007 | 20/02/2007 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland | ||
| 2122 | EUCTR2005-003707-37-AT (EUCTR) | 09/05/2007 | 03/01/2007 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | ||
| 2123 | EUCTR2006-004303-19-CZ (EUCTR) | 09/05/2007 | 20/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | United Kingdom;Czech Republic;Belgium | |||
| 2124 | EUCTR2006-006319-54-SK (EUCTR) | 07/05/2007 | 08/03/2007 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 2125 | EUCTR2006-002781-20-CZ (EUCTR) | 04/05/2007 | 16/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 2126 | EUCTR2006-004303-19-SK (EUCTR) | 04/05/2007 | 08/03/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 2127 | NCT00446849 (ClinicalTrials.gov) | May 1, 2007 | 12/3/2007 | Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) | A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | NULL | Completed | 18 Years | N/A | All | 290 | Phase 4 | United States |
| 2128 | NCT01177228 (ClinicalTrials.gov) | May 2007 | 5/8/2010 | Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis | A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab;Drug: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 47 | Phase 2 | NULL |
| 2129 | EUCTR2005-004105-28-FR (EUCTR) | 26/04/2007 | 23/02/2007 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 2130 | EUCTR2006-006319-54-GB (EUCTR) | 25/04/2007 | 07/12/2006 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 2131 | EUCTR2006-004303-19-GB (EUCTR) | 25/04/2007 | 06/12/2006 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 2132 | EUCTR2006-002782-40-HU (EUCTR) | 18/04/2007 | 20/03/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany | |||
| 2133 | EUCTR2006-000410-20-BE (EUCTR) | 18/04/2007 | 11/01/2007 | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Remicade INN or Proposed INN: infliximab | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Netherlands;Denmark;Belgium;Italy | ||
| 2134 | EUCTR2006-002781-20-IT (EUCTR) | 17/04/2007 | 07/03/2007 | A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND | A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND | Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: HUMIRA | Abbott GmbH Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 2135 | NCT00403923 (ClinicalTrials.gov) | April 2007 | 24/11/2006 | Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis | A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis | Lactose Intolerance;Ulcerative Colitis | Dietary Supplement: Lactose in water | University Hospitals, Leicester | NULL | Completed | 18 Years | N/A | Both | 48 | United Kingdom | |
| 2136 | EUCTR2006-002781-20-HU (EUCTR) | 26/03/2007 | 28/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 2137 | EUCTR2006-002782-40-ES (EUCTR) | 23/03/2007 | 05/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa. | Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany | |||
| 2138 | EUCTR2006-002781-20-SK (EUCTR) | 19/03/2007 | 01/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden | ||
| 2139 | EUCTR2005-004105-28-GR (EUCTR) | 15/03/2007 | 15/02/2007 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 2140 | EUCTR2006-003604-19-IT (EUCTR) | 09/03/2007 | 14/07/2008 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. | ulcerative colitis, NOS MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Orencia INN or Proposed INN: abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | France;Czech Republic;Poland;Belgium;Ireland;Germany;United Kingdom;Italy | ||
| 2141 | EUCTR2004-005032-35-BE (EUCTR) | 06/03/2007 | 23/11/2006 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden | |||
| 2142 | JPRN-UMIN000013925 | 2007/03/01 | 31/05/2014 | The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection | The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection - KIBDG-Protocol 1 | Ulcerative colitis | A Group: Ganciclovir monotherapy B Group: Ganciclovir and GMAA combination therapy C Group: GMAA monotherapy | Graduate School of Medicine, Kyoto University, Gastroenterology and Hepatology | NULL | Recruiting | 15years-old | 80years-old | Male and Female | 90 | Not applicable | Japan |
| 2143 | EUCTR2006-004162-13-DE (EUCTR) | 27/02/2007 | 06/10/2006 | Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients | Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients | Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano. MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease | Trade Name: Salofalk 4g/60ml Klysma INN or Proposed INN: MESALAZINE | Charité Universitätsmedizin, Campus Charité Mitte | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| 2144 | EUCTR2005-003482-17-GB (EUCTR) | 26/02/2007 | 01/02/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 2145 | EUCTR2006-003604-19-FR (EUCTR) | 14/02/2007 | 29/12/2006 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01. | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01. | ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | France;Czech Republic;Poland;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 2146 | EUCTR2005-003481-42-GR (EUCTR) | 30/01/2007 | 24/11/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 2147 | EUCTR2005-003482-17-GR (EUCTR) | 30/01/2007 | 24/11/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 2148 | EUCTR2005-005363-28-HU (EUCTR) | 25/01/2007 | 25/09/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | |||
| 2149 | EUCTR2005-005363-28-AT (EUCTR) | 08/01/2007 | 10/01/2007 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | |||
| 2150 | NCT00502294 (ClinicalTrials.gov) | January 2007 | 13/7/2007 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis | Drug: Visilizumab (HuM291; Nuvion®) | Facet Biotech | PDL BioPharma, Inc. | Withdrawn | 18 Years | N/A | Both | 150 | Phase 3 | NULL |
| 2151 | NCT00430898 (ClinicalTrials.gov) | January 2007 | 31/1/2007 | Basiliximab in Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 181 | Phase 2 | United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom |
| 2152 | EUCTR2006-001782-42-HU (EUCTR) | 20/12/2006 | 16/08/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Other descriptive name: PARNAPARIN SODIUM | Cosmo Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | |||
| 2153 | EUCTR2006-001846-15-SE (EUCTR) | 06/12/2006 | 20/10/2006 | A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree | A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree | Active ulcerative colitis in steroid refractory or steroid dependent patients | Product Name: Kappaproct Product Code: DIMS0150 | InDex Pharmaceuticals AB | NULL | Not Recruiting | Female: yes Male: yes | 48 | Sweden | |||
| 2154 | NCT00410410 (ClinicalTrials.gov) | December 2006 | 11/12/2006 | A Study of Abatacept in Patients With Active Ulcerative Colitis | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy | Ulcerative Colitis | Drug: abatacept (ABA);Drug: placebo;Drug: abatacept | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 591 | Phase 3 | United Kingdom;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;United States;Argentina;Spain |
| 2155 | EUCTR2006-002036-25-GB (EUCTR) | 09/11/2006 | 15/02/2012 | Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC | Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC | Ulcerative Colitis | Product Name: Epidermal growth factor enema Product Code: EGF enema INN or Proposed INN: Epidermal growth factor Trade Name: Pentasa enema Product Name: Pentasa INN or Proposed INN: mesalazine enema | University Hospitals of Leicester NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United Kingdom | ||
| 2156 | EUCTR2006-001782-42-IT (EUCTR) | 03/11/2006 | 20/12/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND | Patients with mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: CB-01-05-MMX | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | |||
| 2157 | NCT00385736 (ClinicalTrials.gov) | November 2006 | 9/10/2006 | Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis | A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: adalimumab;Biological: placebo | Abbott | NULL | Completed | 18 Years | N/A | All | 576 | Phase 3 | United States;Austria;Belgium;Canada;Czech Republic;Germany;Hungary;Italy;Netherlands;Poland;Puerto Rico;Slovakia;Sweden |
| 2158 | NCT00408629 (ClinicalTrials.gov) | November 2006 | 5/12/2006 | Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: adalimumab;Biological: placebo | Abbott | NULL | Completed | 18 Years | N/A | All | 518 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;New Zealand;Norway;Poland;Portugal;Spain;Switzerland;Sweden |
| 2159 | EUCTR2006-001782-42-GB (EUCTR) | 17/10/2006 | 29/09/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Other descriptive name: PARNAPARIN SODIUM | Cosmo Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Italy;United Kingdom | ||
| 2160 | EUCTR2005-004105-28-DE (EUCTR) | 11/10/2006 | 10/04/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;United Kingdom;Germany;Netherlands;France;Ireland;Greece | |||
| 2161 | ChiCTR-TRC-08000048 | 2006-10-01 | 2008-01-17 | A multicenter, double-blind, randomized controlled trial: Traditional Chinese Medicine treatment for ulcerative colitis | Intervention and efficacy evaluation study of Traditional Chinese Medicine for ulcerative colitis | Ulcerative colitis | Controlled group:Take mesalazine 1g Qid in active stage. Sustain the treatment for another week after the symptoms relieve. Then take 0.5g Tid and adjust the dosage according to the condition. The treatment lasts for 6 months.;Experimental group:Take the intestine-clearing and dissipating dampness formula 2 times a day in the 1st stage. Enema is given once a day for 12 days. Take health-supporting and intestine-clearing formula for spleen and stomach deficiency 2 times a day. The treatment lasts for 6 months; | The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine | NULL | Completed | 18 | 65 | Both | Controlled group:112;Experimental group:112; | I (Phase 1 study) | China |
| 2162 | NCT00951548 (ClinicalTrials.gov) | October 2006 | 2/8/2009 | Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis | Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study | Ulcerative Colitis | Dietary Supplement: VSL#3;Dietary Supplement: Placebo | VSL Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 144 | N/A | Italy |
| 2163 | NCT00486031 (ClinicalTrials.gov) | October 2006 | 11/6/2007 | Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study | A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide Disodium | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 443 | Phase 3 | United States |
| 2164 | NCT00421642 (ClinicalTrials.gov) | October 2006 | 11/1/2007 | Open-Label Adalimumab for Ulcerative Colitis Patients | An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients | Ulcerative Colitis | Drug: Adalimumab | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 1 | United States |
| 2165 | EUCTR2005-004105-28-NL (EUCTR) | 28/09/2006 | 10/08/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 2166 | NCT00355901 (ClinicalTrials.gov) | September 2006 | 21/7/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Visilizumab (Nuvion®; HuM291) | PDL BioPharma, Inc. | NULL | Terminated | 18 Years | N/A | Both | 300 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Ukraine | |
| 2167 | NCT00336492 (ClinicalTrials.gov) | September 2006 | 9/6/2006 | A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE?) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: infliximab | Centocor, Inc. | NULL | Completed | 6 Years | 17 Years | All | 60 | Phase 3 | United States;Belgium;Canada;Denmark;Netherlands |
| 2168 | NCT00643071 (ClinicalTrials.gov) | September 2006 | 20/3/2008 | Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study | Ulcerative Colitis | Drug: Tacrolimus | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 32 | Phase 3 | Japan |
| 2169 | NCT00347048 (ClinicalTrials.gov) | September 2006 | 30/6/2006 | Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Ulcerative Colitis | Drug: tacrolimus;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 62 | Phase 3 | Japan |
| 2170 | EUCTR2005-005363-28-BE (EUCTR) | 22/08/2006 | 27/04/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | |||
| 2171 | EUCTR2006-001310-32-LT (EUCTR) | 17/07/2006 | 15/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 2172 | EUCTR2005-005363-28-GB (EUCTR) | 11/07/2006 | 17/01/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom | ||
| 2173 | EUCTR2006-001310-32-HU (EUCTR) | 29/06/2006 | 23/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 2174 | EUCTR2006-001310-32-CZ (EUCTR) | 26/06/2006 | 17/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 2175 | EUCTR2005-004105-28-IE (EUCTR) | 20/06/2006 | 10/02/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Hungary;Greece;Ireland;Netherlands;Germany;United Kingdom | ||
| 2176 | EUCTR2005-004105-28-GB (EUCTR) | 20/06/2006 | 07/03/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 2177 | EUCTR2006-001310-32-EE (EUCTR) | 16/06/2006 | 27/04/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 2178 | EUCTR2005-003481-42-IT (EUCTR) | 08/06/2006 | 11/07/2007 | A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND | A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND | subjects with IVSR-UC MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: visilizumab INN or Proposed INN: visilizumab | PDL BioPharma, Inc; | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 2179 | EUCTR2005-003482-17-IT (EUCTR) | 08/06/2006 | 04/12/2006 | A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis. | A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis. | Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: visilizumab Product Code: HuM291 Product Name: visilizumab Product Code: HuM291 Product Name: visilizumab Product Code: HuM291 | PDL BioPharma , Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 2180 | NCT00350415 (ClinicalTrials.gov) | June 2006 | 6/7/2006 | A Double Blind Study for the Treatment of Acute Ulcerative Colitis | A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalamine | Warner Chilcott | NULL | Completed | 18 Years | 75 Years | Both | 772 | Phase 3 | United States;Belarus;Canada;Croatia;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro |
| 2181 | EUCTR2006-000197-69-CZ (EUCTR) | 30/05/2006 | 10/03/2006 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis | Inflammatory Bowel Disease | Product Name: Bovine-Calf Alkaline Phosphatase (BIAP) | AM-Pharma B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Czech Republic;Italy | |||
| 2182 | EUCTR2005-003482-17-ES (EUCTR) | 26/05/2006 | 15/03/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Ireland;Spain;Italy;Greece | ||
| 2183 | EUCTR2005-003481-42-ES (EUCTR) | 26/05/2006 | 15/03/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. | Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece | |||
| 2184 | EUCTR2005-005363-28-CZ (EUCTR) | 15/05/2006 | 18/04/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Germany;United Kingdom;Czech Republic;Belgium;Austria | |||
| 2185 | EUCTR2004-005032-35-IT (EUCTR) | 10/05/2006 | 19/01/2007 | A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis | A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Trade Name: PREDNISOLONE INN or Proposed INN: Prednisolone | ALIZYME | NULL | Not Recruiting | Female: yes Male: yes | 890 | Phase 3 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | ||
| 2186 | EUCTR2005-005363-28-DE (EUCTR) | 02/05/2006 | 02/06/2006 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon | Ocera Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Czech Republic;United Kingdom;Germany;Belgium;Austria | |||
| 2187 | NCT00317356 (ClinicalTrials.gov) | May 2006 | 21/4/2006 | A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis | A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: OPC-6535(Tetomilast) | Otsuka Pharmaceutical Co., Ltd. | NULL | Terminated | 18 Years | 65 Years | Both | 160 | Phase 2 | Japan |
| 2188 | NCT01026857 (ClinicalTrials.gov) | May 2006 | 4/12/2009 | Propionyl-L-Carnitine in Ulcerative Colitis | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomised, Multicenter Study to Investigate the Efficacy of Two Dosages of Propionyl-L-Carnitine Colon Release Tablets in Patients Affected by Ulcerative Colitis Under Oral Stable Treatment | Ulcerative Colitis | Drug: Propionyl-L-Carnitine;Drug: Placebo | sigma-tau i.f.r. S.p.A. | NULL | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Italy;Lithuania;Poland;Russian Federation |
| 2189 | NCT00408174 (ClinicalTrials.gov) | May 2006 | 4/12/2006 | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide disodium | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 400 | Phase 3 | United States |
| 2190 | EUCTR2006-001310-32-LV (EUCTR) | 28/04/2006 | 22/08/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III | Ulcerative Colitis | Product Name: Asacol 800mg tablet INN or Proposed INN: mesalazine Product Name: Asacol 400mg tablet INN or Proposed INN: mesalazine | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 470 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 2191 | EUCTR2005-003481-42-SK (EUCTR) | 21/04/2006 | 25/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | ||
| 2192 | EUCTR2005-003481-42-HU (EUCTR) | 04/04/2006 | 28/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 2193 | EUCTR2005-002063-87-HU (EUCTR) | 04/04/2006 | 02/05/2007 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Germany;Czech Republic;Belgium | ||
| 2194 | EUCTR2005-003481-42-IE (EUCTR) | 04/04/2006 | 10/01/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | ||
| 2195 | NCT00307827 (ClinicalTrials.gov) | April 2006 | 24/3/2006 | Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Visilizumab | Abbott | NULL | Terminated | 18 Years | N/A | Both | 38 | Phase 2 | United States;Canada;Croatia;Italy;Russian Federation;Spain;Ireland;Poland;Serbia;Switzerland |
| 2196 | EUCTR2005-003481-42-DE (EUCTR) | 22/03/2006 | 29/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece | |||
| 2197 | EUCTR2005-002063-87-DE (EUCTR) | 22/03/2006 | 29/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Czech Republic;Germany;Belgium | ||
| 2198 | EUCTR2005-002063-87-SK (EUCTR) | 16/03/2006 | 23/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany | ||
| 2199 | EUCTR2006-000197-69-IT (EUCTR) | 16/03/2006 | 05/06/2006 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02 | Inflammatory Blowel Disease MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: Bovine-Calf Alkaline Phosphatase BIAP Product Code: BIAP | AM PHARMA B.V. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 2200 | EUCTR2005-005414-20-IT (EUCTR) | 06/03/2006 | 31/01/2006 | Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD | Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD | Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis MedDRA version: 6.1;Level: PT;Classification code 10021972 | Trade Name: Thalidomide Pharmion INN or Proposed INN: Thalidomide | ISTITUTO PER L INFANZIA BURLO GAROFOLO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Italy | |||
| 2201 | EUCTR2005-003482-17-IE (EUCTR) | 03/03/2006 | 10/01/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Greece;Spain;Ireland;Italy;United Kingdom | ||
| 2202 | NCT00299013 (ClinicalTrials.gov) | March 2006 | 2/3/2006 | Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | Ulcerative Colitis | Drug: COLAL-PRED®;Drug: Prednisolone | Alizyme | NULL | Completed | 18 Years | 75 Years | Both | 796 | Phase 3 | Australia;Belgium;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Russian Federation;South Africa;Spain;Sweden;United Kingdom |
| 2203 | EUCTR2005-002063-87-CZ (EUCTR) | 16/02/2006 | 28/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Germany;Czech Republic;Belgium | ||
| 2204 | EUCTR2005-003481-42-CZ (EUCTR) | 16/02/2006 | 28/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece | |||
| 2205 | EUCTR2005-002063-87-BE (EUCTR) | 09/02/2006 | 24/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Germany;Czech Republic;Belgium | ||
| 2206 | EUCTR2005-002784-91-GB (EUCTR) | 06/02/2006 | 24/11/2005 | A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) | A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Cardiff and Vale NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 630 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 2207 | EUCTR2005-003481-42-AT (EUCTR) | 04/01/2006 | 30/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | |||
| 2208 | NCT00295282 (ClinicalTrials.gov) | January 2006 | 21/2/2006 | A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis | A Phase I, Multicenter, Dose-escalation Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: MDX-1100 (anti-CXCL10 human monoclonal antibody) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 1 | United States |
| 2209 | EUCTR2005-002063-87-AT (EUCTR) | 28/12/2005 | 23/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Czech Republic;Belgium;Austria;Germany | ||
| 2210 | EUCTR2004-001218-15-SI (EUCTR) | 22/12/2005 | 26/10/2005 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Estonia;Hungary;Slovenia;Lithuania;Latvia;Germany | |||
| 2211 | NCT00326209 (ClinicalTrials.gov) | December 22, 2005 | 12/5/2006 | Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission | A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation | Ulcerative Colitis | Drug: Encapsulated Mesalamine Granules (eMG) | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 393 | Phase 3 | United States |
| 2212 | EUCTR2004-001216-31-SI (EUCTR) | 22/12/2005 | 26/10/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany | |||
| 2213 | EUCTR2005-003471-20-IT (EUCTR) | 07/12/2005 | 17/01/2007 | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment | ULCERATIVE COLITIS MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Propionyl-L-carnitine Product Code: ST261 INN or Proposed INN: Levocarnitine | SIGMA-TAU | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Lithuania;Italy | |||
| 2214 | JPRN-C000000289 | 2005/12/01 | 21/11/2005 | Z-206 Phase III Clinical Trial- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - | Patients with ulcerative colitis in remission phase. | Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. | Zeria Pharmaceutical Co.,LTD. | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 120 | Phase 3 | Japan | |
| 2215 | JPRN-C000000288 | 2005/12/01 | 21/11/2005 | Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - | Patients with ulcerative colitis in active phase | Z-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. | Zeria Pharmaceutical Co.,LTD. | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 210 | Phase 3 | Japan | |
| 2216 | NCT00269438 (ClinicalTrials.gov) | December 2005 | 22/12/2005 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 80 Years | All | 225 | Phase 3 | United States |
| 2217 | EUCTR2005-003724-19-CZ (EUCTR) | 21/11/2005 | 05/10/2005 | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | Active Ulcerative Colitis MedDRA version: 8.0;Level: LLT;Classification code 10058816 | Product Name: OPC-6535 Product Code: OPC-6535 INN or Proposed INN: Not applicable Other descriptive name: OPC-6535 | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 3 | Hungary;Czech Republic | ||
| 2218 | EUCTR2004-005032-35-SE (EUCTR) | 17/11/2005 | 14/09/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | |||
| 2219 | EUCTR2004-005032-35-CZ (EUCTR) | 04/11/2005 | 16/09/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden | |||
| 2220 | NCT00309660 (ClinicalTrials.gov) | November 2005 | 30/3/2006 | Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis | Ulcerative Colitis | Drug: Rosiglitazone | Herlev Hospital | NULL | Recruiting | 18 Years | 80 Years | Both | 20 | Phase 1/Phase 2 | Denmark | |
| 2221 | EUCTR2004-005032-35-HU (EUCTR) | 24/10/2005 | 22/09/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | |||
| 2222 | EUCTR2005-003724-19-HU (EUCTR) | 24/10/2005 | 07/09/2005 | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | Active Ulcerative Colitis MedDRA version: 8.0;Level: LLT;Classification code 10058816 | Product Name: OPC-6535 Product Code: OPC-6535 INN or Proposed INN: Not applicable Other descriptive name: OPC-6535 | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 3 | Czech Republic;Hungary | ||
| 2223 | EUCTR2004-005032-35-DK (EUCTR) | 24/10/2005 | 04/10/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | |||
| 2224 | EUCTR2004-005032-35-GB (EUCTR) | 11/10/2005 | 24/02/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Tablets B.P. 5mg Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Belgium;Spain;Denmark;Italy;United Kingdom;Sweden | ||
| 2225 | NCT00254618 (ClinicalTrials.gov) | October 2005 | 14/11/2005 | A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis. | Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis. | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | NULL | Terminated | 5 Years | 17 Years | Both | 34 | Phase 1 | United States |
| 2226 | EUCTR2005-000695-40-GB (EUCTR) | 27/09/2005 | 17/08/2005 | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | The medical condition is Ulcerative Colitis. | Product Name: products containing azathioprine or 6-mercaptopurine INN or Proposed INN: azathioprine INN or Proposed INN: azathioprine INN or Proposed INN: 6-mercaptopurine Product Name: Products containing aminosalicylate INN or Proposed INN: Sulphsalazine, Pentasa, Asacol, Colazide, Depentum | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 2227 | NCT00928681 (ClinicalTrials.gov) | September 2005 | 22/6/2009 | A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis | A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis. | Colitis, Ulcerative | Biological: Single dose-group A;Biological: Multiple dose- Group B;Biological: Multiple dose-Group B | Pfizer | NULL | Completed | 18 Years | 70 Years | Both | 80 | Phase 1 | Belgium;Czech Republic;Denmark;Germany;Norway;Slovakia;Spain |
| 2228 | EUCTR2004-004565-15-FI (EUCTR) | 26/08/2005 | 28/04/2005 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900 | Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 2229 | EUCTR2004-001216-31-CZ (EUCTR) | 17/08/2005 | 17/08/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania | |||
| 2230 | EUCTR2004-001216-31-HU (EUCTR) | 28/07/2005 | 20/06/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 2231 | EUCTR2004-001216-31-SK (EUCTR) | 28/07/2005 | 23/05/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany | ||
| 2232 | EUCTR2004-001216-31-LV (EUCTR) | 25/07/2005 | 25/07/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 2233 | EUCTR2004-000734-36-CZ (EUCTR) | 13/07/2005 | 08/10/2004 | A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. | A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. | Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study | Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA) | Shire Pharmaceutical Development Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | Czech Republic | ||
| 2234 | NCT00167882 (ClinicalTrials.gov) | July 2005 | 9/9/2005 | The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: 5-aminosalicylate (Pentasa, Ferring) | VU University Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 24 | Phase 4 | Netherlands | |
| 2235 | NCT00449722 (ClinicalTrials.gov) | July 2005 | 20/3/2007 | OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis | Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 380 | Phase 3 | Germany |
| 2236 | EUCTR2004-001218-15-EE (EUCTR) | 07/06/2005 | 27/04/2005 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 2237 | EUCTR2004-001677-26-IT (EUCTR) | 06/06/2005 | 15/02/2006 | Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study | Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study | Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: Nolpitantium Besylate Product Code: SR140333B | SANOFI-SYNTHELABO | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 2238 | EUCTR2004-001216-31-LT (EUCTR) | 06/06/2005 | 28/04/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 2239 | EUCTR2004-004184-29-DE (EUCTR) | 06/06/2005 | 01/03/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis | Product Name: None given Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 3 | Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden | ||
| 2240 | EUCTR2004-004565-15-CZ (EUCTR) | 03/06/2005 | 13/04/2005 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900 | Trade Name: Pentasa sachet 1g Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Finland;Denmark;Germany;Norway;Sweden | ||
| 2241 | EUCTR2004-004184-29-GB (EUCTR) | 31/05/2005 | 23/02/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 2242 | EUCTR2004-001216-31-DE (EUCTR) | 30/05/2005 | 04/04/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 2243 | EUCTR2004-001218-15-LV (EUCTR) | 30/05/2005 | 30/05/2005 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 2244 | EUCTR2004-004565-15-SE (EUCTR) | 24/05/2005 | 09/03/2005 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900 | Trade Name: Pentasa Sachet 1g Product Name: Pentasa Sachet 1 g INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa Sachet 2 g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 2245 | EUCTR2004-004184-29-ES (EUCTR) | 05/05/2005 | 03/04/2006 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. | Ulcerative colitis MedDRA version: 3.2;Level: LLT;Classification code 10045365 | Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 2246 | NCT00746447 (ClinicalTrials.gov) | May 2005 | 3/9/2008 | Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC) | Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis | Colitis, Ulcerative;Recurrence | Drug: mesalamine granules | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 648 | Phase 3 | Germany |
| 2247 | NCT00209300 (ClinicalTrials.gov) | May 2005 | 13/9/2005 | Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission | Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily | Ulcerative Colitis | Drug: Pentasa | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 362 | Phase 3 | Belgium;Czech Republic;Denmark;Finland;Germany;Netherlands;Norway;Sweden |
| 2248 | NCT00829595 (ClinicalTrials.gov) | May 2005 | 23/1/2009 | Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease | Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis | Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM) | Cedars-Sinai Medical Center | NULL | Completed | 18 Years | N/A | Both | 69 | N/A | United States |
| 2249 | NCT00618202 (ClinicalTrials.gov) | May 2005 | 30/1/2008 | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions | Ulcerative Colitis | Drug: Balsalazide | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 52 | N/A | United States |
| 2250 | EUCTR2004-004077-29-SK (EUCTR) | 25/04/2005 | 01/02/2005 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Slovakia;Lithuania;Germany;United Kingdom | ||
| 2251 | EUCTR2004-004184-29-CZ (EUCTR) | 13/04/2005 | 11/04/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden | ||
| 2252 | NCT00151892 (ClinicalTrials.gov) | April 8, 2005 | 7/9/2005 | Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis | A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: SPD476;Drug: Asacol | Shire | NULL | Completed | 18 Years | N/A | All | 829 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czechia;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic |
| 2253 | EUCTR2004-004565-15-NO (EUCTR) | 06/04/2005 | 14/02/2005 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900 | Trade Name: Pentasa sachet 1g Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 2254 | EUCTR2004-001218-15-DE (EUCTR) | 04/04/2005 | 10/12/2004 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 2255 | NCT00232258 (ClinicalTrials.gov) | April 2005 | 3/10/2005 | Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study | Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study | Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Nolpitantium besylate | Sanofi | NULL | Completed | 18 Years | N/A | Both | 307 | Phase 2 | Argentina;Belgium;Brazil;Canada;Chile;Czech Republic;Estonia;Hungary;Italy;Russian Federation;Singapore;South Africa;Spain;Sweden;France;United States |
| 2256 | EUCTR2004-004565-15-DK (EUCTR) | 31/03/2005 | 24/02/2005 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900 | Product Name: Pentasa Sachet INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa Sachet INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 2257 | EUCTR2004-004184-29-HU (EUCTR) | 30/03/2005 | 10/02/2005 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 2258 | EUCTR2004-001218-15-SK (EUCTR) | 24/03/2005 | 02/02/2005 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Estonia;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany | ||
| 2259 | EUCTR2004-001677-26-EE (EUCTR) | 23/03/2005 | 23/03/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 2260 | EUCTR2004-001218-15-HU (EUCTR) | 17/03/2005 | 04/02/2005 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 2261 | EUCTR2004-004077-29-GB (EUCTR) | 18/02/2005 | 23/02/2005 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Technical Centres Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Lithuania;Germany;United Kingdom | |||
| 2262 | EUCTR2004-001218-15-LT (EUCTR) | 09/02/2005 | 27/12/2004 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 2263 | EUCTR2004-004077-29-LT (EUCTR) | 09/02/2005 | 22/12/2004 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | |||
| 2264 | EUCTR2004-001677-26-SE (EUCTR) | 07/02/2005 | 23/12/2004 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 2265 | EUCTR2004-004077-29-DE (EUCTR) | 04/02/2005 | 22/12/2004 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | |||
| 2266 | EUCTR2004-004077-29-CZ (EUCTR) | 03/02/2005 | 03/02/2005 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Czech Republic;Lithuania | |||
| 2267 | EUCTR2004-001677-26-HU (EUCTR) | 25/01/2005 | 03/11/2004 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Estonia;Czech Republic;Hungary;Spain;Italy;Sweden | ||
| 2268 | EUCTR2004-001677-26-ES (EUCTR) | 14/01/2005 | 01/06/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 2269 | EUCTR2004-001216-31-EE (EUCTR) | 11/01/2005 | 20/09/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 2270 | NCT00744016 (ClinicalTrials.gov) | December 2004 | 27/8/2008 | Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Granulated mesalamine;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 305 | Phase 3 | United States |
| 2271 | NCT00457171 (ClinicalTrials.gov) | December 2004 | 4/4/2007 | GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis | A Double-Blind, Placebo-Controlled Phase I/II Study in Patients With Mild to Moderate Ulcerative Colitis Treated With GI-270384X, an Oral ICAM-1 and E-Selectin Inhibitor | Ulcerative Colitis | Drug: GI-270384 | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | Both | 16 | Phase 1 | Netherlands |
| 2272 | NCT00767728 (ClinicalTrials.gov) | December 2004 | 17/9/2008 | Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Granulated mesalamine;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 256 | Phase 3 | United States |
| 2273 | EUCTR2004-000611-25-IE (EUCTR) | 19/10/2004 | 16/08/2004 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 2274 | EUCTR2004-000611-25-HU (EUCTR) | 15/10/2004 | 21/07/2004 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 2275 | EUCTR2004-000916-25-IT (EUCTR) | 28/09/2004 | 18/05/2005 | A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS | A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS | TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION MedDRA version: 6.1;Level: PT;Classification code 10021972 | Product Name: 5-ASA MMx INN or Proposed INN: Mesalazine | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 2276 | EUCTR2004-000733-12-CZ (EUCTR) | 14/07/2004 | 01/07/2004 | A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. | A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. | Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses | Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA) | Shire Pharmaceutical Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | Czech Republic | ||
| 2277 | NCT00092508 (ClinicalTrials.gov) | May 2004 | 22/9/2004 | CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission | Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission | Ulcerative Colitis | Drug: OPC-6535;Drug: Asacol® | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 1725 | Phase 3 | United States |
| 2278 | EUCTR2004-001677-26-CZ (EUCTR) | 09/03/2004 | 10/02/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 2279 | NCT00618228 (ClinicalTrials.gov) | January 2004 | 30/1/2008 | Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions | A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions | Ulcerative Colitis | Drug: Balsalazide | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 52 | N/A | United States |
| 2280 | NCT00548574 (ClinicalTrials.gov) | December 4, 2003 | 23/10/2007 | Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: Mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 343 | Phase 3 | Belgium |
| 2281 | NCT00151944 (ClinicalTrials.gov) | November 26, 2003 | 7/9/2005 | Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. | A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission. | Colitis, Ulcerative | Drug: SPD476 (mesalazine) | Shire | NULL | Completed | 18 Years | N/A | All | 400 | Phase 3 | NULL |
| 2282 | NCT00503243 (ClinicalTrials.gov) | September 30, 2003 | 16/7/2007 | Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: Delayed and extended release mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 280 | Phase 3 | United States |
| 2283 | NCT00063414 (ClinicalTrials.gov) | September 2003 | 25/6/2003 | ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis | ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare) | Ulcerative Colitis | Drug: Alicaforsen | Isis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | Phase 2 | United States | |
| 2284 | NCT00063830 (ClinicalTrials.gov) | June 2003 | 7/7/2003 | ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis. | ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: Alicaforsen | Isis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | Phase 2 | United States | |
| 2285 | NCT00064454 (ClinicalTrials.gov) | May 2003 | 8/7/2003 | FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis | FACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: OPC-6535 Tablets (drug) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 375 | Phase 3 | United States |
| 2286 | NCT00064441 (ClinicalTrials.gov) | May 2003 | 8/7/2003 | FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis | FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: OPC-6535 Tablets (drug) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 375 | Phase 3 | United States |
| 2287 | NCT01171807 (ClinicalTrials.gov) | April 2003 | 28/7/2010 | Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis | PHASE 2 STUDY OF DEXAMETHASONE 21-PHOSPHATE LOADED INTO AUTOLOGOUS ERYTHROCYTES IN STEROID-DEPENDENT ULCERATIVE COLITIS PATIENTS | Ulcerative Colitis | Drug: Dexamethasone 21-phosphate | Casa Sollievo della Sofferenza IRCCS | NULL | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 2 | Italy |
| 2288 | NCT00073047 (ClinicalTrials.gov) | April 2003 | 14/11/2003 | Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis | A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis | Ulcerative Colitis;Gastrointestinal Disease;Inflammatory Bowel Disease | Drug: Daclizumab | Facet Biotech | NULL | Completed | 12 Years | N/A | Both | 150 | Phase 2 | United States;Belgium;Canada |
| 2289 | NCT00545389 (ClinicalTrials.gov) | February 10, 2003 | 16/10/2007 | Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 | A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily | Colitis, Ulcerative | Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 38 | Phase 2 | Belgium |
| 2290 | NCT00048347 (ClinicalTrials.gov) | October 2002 | 29/10/2002 | Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis | An Open-Label, Pilot Study of Type I Interferon (AVONEX) Treatment of Ulcerative Colitis | Ulcerative Colitis | Drug: AVONEX | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | N/A | All | 18 | Phase 2 | United States |
| 2291 | NCT00061282 (ClinicalTrials.gov) | September 30, 2002 | 23/5/2003 | Clotrimazole Enemas for Pouchitis in Children and Adults | Clotrimazole Enemas for Pouchitis in Children and Adults | Ulcerative Colitis;Pouchitis;Ileitis;Inflammatory Bowel Disease | Drug: Clotrimazole | Paul Rufo | NULL | Terminated | 2 Years | N/A | All | 18 | Phase 1/Phase 2 | United States |
| 2292 | NCT00096655 (ClinicalTrials.gov) | May 2002 | 12/11/2004 | A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis | A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 364 | Phase 3 | NULL |
| 2293 | NCT00032305 (ClinicalTrials.gov) | March 2002 | 14/3/2002 | Research Study in Patients With Severe Ulcerative Colitis | A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids | Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 2/Phase 3 | United States |
| 2294 | NCT00036439 (ClinicalTrials.gov) | February 2002 | 10/5/2002 | A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis | A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 364 | Phase 3 | United States;Belgium |
| 2295 | NCT00577473 (ClinicalTrials.gov) | February 2001 | 19/12/2007 | Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) | A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | NULL | Completed | 18 Years | 65 Years | All | 301 | Phase 3 | United States |
| 2296 | NCT00033943 (ClinicalTrials.gov) | January 2001 | 16/4/2002 | Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis | A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: deligoparin | Incara Pharmaceuticals | NULL | Completed | 18 Years | 60 Years | Both | 270 | Phase 2/Phase 3 | United States |
| 2297 | NCT00073021 (ClinicalTrials.gov) | September 2000 | 13/11/2003 | Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis | A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 800 mg (mesalamine);Drug: Asacol 400 mg (mesalamine) | Warner Chilcott | NULL | Completed | 18 Years | 75 Years | All | 386 | Phase 3 | United States;Canada;Puerto Rico |
| 2298 | NCT00463619 (ClinicalTrials.gov) | April 2000 | 18/4/2007 | Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis | Ulcerative Colitis | Drug: Retarded release phosphatidylcholine | Heidelberg University | NULL | Completed | 16 Years | N/A | Both | 132 | N/A | Germany | |
| 2299 | NCT00004810 (ClinicalTrials.gov) | June 1996 | 24/2/2000 | Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis | Ulcerative Colitis | Drug: -aminosalicylic acid | National Center for Research Resources (NCRR) | University of Vermont | Completed | 18 Years | 80 Years | Both | 30 | Phase 2 | NULL | |
| 2300 | NCT00038922 (ClinicalTrials.gov) | September 1994 | 5/6/2002 | Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Disease | Drug: rhIL-11 | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Terminated | 18 Years | N/A | Both | Phase 1 | United States | |
| 2301 | EUCTR2016-000641-31-NO (EUCTR) | 07/11/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | |||
| 2302 | JPRN-JapicCTI-184216 | 22/11/2018 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMAN) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMAN) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection | Eli Lilly Japan K.K. | NULL | recruiting | 18 | 80 | BOTH | Phase 3 | NULL | ||
| 2303 | JPRN-JapicCTI-121943 | 30/08/2012 | Phase II Study of Z-206 | Phase II Study of Z-206 | Ulcerative colitis | Intervention name : Z-206 INN of the intervention : Mesalazine Dosage And administration of the intervention : oral | Zeria Pharmaceutical Co., Ltd. | Kyowa Hakko Kirin Co., Ltd. | BOTH | Phase 2 | NULL | |||||
| 2304 | EUCTR2004-004565-15-DE (EUCTR) | 15/09/2005 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900 | Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Czech Republic;Germany;Denmark;Norway;Sweden | ||||
| 2305 | EUCTR2014-004559-29-Outside-EU/EEA (EUCTR) | 12/11/2014 | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Inc. | NULL | NA | Female: yes Male: yes | 274 | Japan | ||||
| 2306 | EUCTR2017-000572-28-IE (EUCTR) | 04/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Japan;Bulgaria;Belgium;Argentina;Canada;Mexico;Hungary;France;Switzerland;Colombia;Turkey;Lebanon;Ireland;Ukraine;Spain;Greece;Slovakia;Portugal;United States | |||
| 2307 | EUCTR2018-003986-33-CZ (EUCTR) | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 2308 | EUCTR2017-003649-10-PL (EUCTR) | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Germany;Poland;Spain;Belgium;United States | |||
| 2309 | EUCTR2017-000599-27-PL (EUCTR) | 04/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;New Zealand;Japan | |||
| 2310 | EUCTR2019-004224-38-GB (EUCTR) | 25/11/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom | |||
| 2311 | EUCTR2016-001392-78-IT (EUCTR) | 12/02/2021 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis - NA | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden | |||
| 2312 | EUCTR2016-000674-38-DE (EUCTR) | 28/09/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib - Direct compression-yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib -Direct compression-yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib -Direct compression-yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib - Wet Granulation-Yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib - Wet Granulation-Yellow Product Code: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 950 | Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | |||
| 2313 | EUCTR2016-004676-22-PL (EUCTR) | 15/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 942 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | |||
| 2314 | EUCTR2018-002378-30-SK (EUCTR) | 14/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | |||
| 2315 | EUCTR2017-000574-11-PL (EUCTR) | 05/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | NA | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
| 2316 | EUCTR2016-004677-40-GB (EUCTR) | 04/07/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis. | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | |||
| 2317 | EUCTR2020-004457-76-FR (EUCTR) | 27/08/2021 | A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions. | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED | Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Belgium;Poland;Germany;Japan | |||
| 2318 | EUCTR2015-001346-29-AT (EUCTR) | 12/01/2016 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 93 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Japan;New Zealand;Sweden | |||
| 2319 | EUCTR2018-002378-30-BE (EUCTR) | 13/12/2021 | OPEN LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | |||
| 2320 | EUCTR2019-004224-38-BE (EUCTR) | 19/04/2021 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | |||
| 2321 | EUCTR2018-003987-29-PL (EUCTR) | 24/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 2322 | EUCTR2017-002231-41-FR (EUCTR) | 15/12/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | |||
| 2323 | EUCTR2018-003987-29-EE (EUCTR) | 12/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 702 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Latvia;Netherlands;South Africa;Denmark;Australia;France;India;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Lebanon;Ukraine;Spain;Thailand;Slovakia;Estonia;Taiwan;Belarus;United States;Portugal;Serbia | |||
| 2324 | EUCTR2016-004677-40-CZ (EUCTR) | 01/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 1547 | Phase 2;Phase 3 | Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of | |||
| 2325 | EUCTR2017-000573-37-PL (EUCTR) | 01/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;United States | |||
| 2326 | EUCTR2018-003985-15-BE (EUCTR) | 08/05/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 2327 | JPRN-JapicCTI-060298 | 24/08/2006 | Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis | Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion | Mitsubishi Tanabe Pharma Corporation | NULL | 16 | BOTH | Phase 3 | NULL | ||||
| 2328 | EUCTR2018-003986-33-PL (EUCTR) | 15/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany | |||
| 2329 | JPRN-JapicCTI-184217 | 22/11/2018 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection, Subcutaneous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection, Subcutaneous injection | Eli Lilly Japan K.K. | NULL | pending | 18 | 80 | BOTH | Phase 3 | NULL | ||
| 2330 | EUCTR2016-004677-40-IT (EUCTR) | 20/01/2022 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy - na | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | NA | Female: yes Male: yes | 720 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;Hungary;Czech Republic;Egypt;United Kingdom;Austria;Lithuania;Turkey;Slovenia;Czechia;Korea, Republic of;China;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation | |||
| 2331 | JPRN-JapicCTI-101144 | 25/05/2010 | Phase II/III induction study of AJG501 in patients with active ulcerative colitis | Phase II/III induction study of AJG501 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : AJG501 Dosage And administration of the intervention : oral Control intervention name : Mesalazine tablet Dosage And administration of the control intervention : oral | Ajinomoto Pharmaceuticals Co., Ltd. | NULL | 16 | 64 | BOTH | Phase 2-3 | NULL | |||
| 2332 | EUCTR2018-003986-33-EE (EUCTR) | 19/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | |||
| 2333 | EUCTR2018-003986-33-DE (EUCTR) | 19/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 2334 | EUCTR2006-005377-22-PL (EUCTR) | 14/02/2008 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Spain;Poland;Lithuania;Latvia;Germany | |||
| 2335 | EUCTR2015-001346-29-PL (EUCTR) | 21/03/2016 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 20 mg solution for injection in pre-filled syringe (20 mg/0.2mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe (40 mg/0.4 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 80 mg solution for injection in pre-filled syringe (80 mg/0.8 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 59 | Phase 3 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden | |||
| 2336 | EUCTR2015-000319-41-PL (EUCTR) | 16/09/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | |||
| 2337 | EUCTR2018-002378-30-IT (EUCTR) | 27/01/2022 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS - - | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ - Product Name: Tofacitinib citrate Product Code: [CP-690, 550-10] INN or Proposed INN: tofacitinib citrate Trade Name: Xeljanz Product Name: Tofacitinib citrate Product Code: [CP-690, 550-10] INN or Proposed INN: tofacitinib | PFIZER INC | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | |||
| 2338 | EUCTR2016-004676-22-CZ (EUCTR) | 01/06/2018 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | |||
| 2339 | EUCTR2020-004300-34-CZ (EUCTR) | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | |||
| 2340 | EUCTR2007-005702-49-PL (EUCTR) | 17/06/2009 | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II | Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term: | Trade Name: Asacol Product Name: Asacol Product Code: NA INN or Proposed INN: MESALAZINE | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Poland | |||
| 2341 | EUCTR2020-004300-34-BE (EUCTR) | 26/01/2022 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 2342 | EUCTR2017-000574-11-CZ (EUCTR) | 01/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | NA | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Japan | |||
| 2343 | EUCTR2012-004366-18-FR (EUCTR) | 28/09/2015 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | |||
| 2344 | EUCTR2018-002378-30-DE (EUCTR) | 13/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | |||
| 2345 | EUCTR2016-000674-38-NO (EUCTR) | 01/11/2016 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 950 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden | |||
| 2346 | EUCTR2015-000319-41-BG (EUCTR) | 12/08/2015 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | |||
| 2347 | JPRN-JapicCTI-090967 | 09/12/2009 | PS-QD Phase3 Clinical Study -Investigation to find new dosage and administration of mesalazine for the treatment of patients with Ulcerative Colitis in remission phase.- | PS-QD Phase3 Clinical Study -Investigation to find new dosage and administration of mesalazine for the treatment of patients with Ulcerative Colitis in remission phase.- | ulcerative colitis | Intervention name : PS-QD Dosage And administration of the intervention : Mesalazine at the dose 1500mg/day or 2250mg/day is administered once a day or three times a day. Control intervention name : null | Kyorin Pharmaceutical Co.,LTD | NULL | 15 | 64 | BOTH | Phase 3 | NULL | |||
| 2348 | EUCTR2018-002378-30-PL (EUCTR) | 24/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan;Sweden | |||
| 2349 | EUCTR2019-004224-38-PL (EUCTR) | 04/12/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Belgium;Poland;Russian Federation;Germany;United Kingdom;Japan | |||
| 2350 | EUCTR2015-001600-64-PL (EUCTR) | 03/12/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | NA | Female: yes Male: yes | 1350 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | |||
| 2351 | EUCTR2017-000573-37-BE (EUCTR) | 14/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Baxalta Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 772 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | |||
| 2352 | EUCTR2018-003985-15-PL (EUCTR) | 02/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 2353 | EUCTR2016-004677-40-PL (EUCTR) | 20/06/2018 | A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 720 | Phase 2;Phase 3 | Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Korea, Republic of;China;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;Belarus;Portugal;Serbia;United States;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | |||
| 2354 | EUCTR2013-003032-77-FR (EUCTR) | 19/06/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand | |||
| 2355 | JPRN-JapicCTI-132294 | 03/10/2013 | Phase II study of AJG511 in patients with active ulcerative colitis | Phase II study of AJG511 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : AJG511 INN of the intervention : budesonide Dosage And administration of the intervention : intrarectal | Ajinomoto Pharmaceuticals Co., Ltd. | NULL | 16 | 69 | BOTH | Phase 2 | NULL | |||
| 2356 | EUCTR2016-000641-31-DE (EUCTR) | 06/10/2016 | Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan | |||
| 2357 | EUCTR2019-004224-38-Outside-EU/EEA (EUCTR) | 25/01/2021 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - UNIFI-Jr | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | Phase 3 | Japan;Russian Federation;United States;Belgium;Germany;Hungary;Poland;United Kingdom | ||||
| 2358 | EUCTR2015-001346-29-SE (EUCTR) | 30/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 93 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;United Kingdom;New Zealand;Japan;Sweden | |||
| 2359 | EUCTR2018-003985-15-DE (EUCTR) | 01/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Serbia;Belarus;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 2360 | EUCTR2018-003987-29-CZ (EUCTR) | 10/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 912 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 2361 | JPRN-JapicCTI-111421 | PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis. | PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis. | Ulcerative Colitis | Intervention name : PS-SP Dosage And administration of the intervention : PS-SP suppository 1g or placebo is administered rectally once a day. Control intervention name : null | Kyorin Pharmaceutical Co.,LTD | NULL | 15 | 74 | BOTH | Phase 3 | NULL |