96. クローン病 [臨床試験数:890,薬物数:832(DrugBank:211),標的遺伝子数:161,標的パスウェイ数:201]
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | NCT04151225 | March 3, 2020 | 11 November 2019 | Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease | A Multicentre, Randomised, Double-blind, Placebo-controlled, Repeat Dose, Dose-ranging Phase 2a/2b Study to Evaluate the Safety, Tolerability and Efficacy of an Anti-oncostatin M Monoclonal Antibody (GSK2330811) in Patients With Moderate to Severe Crohn's Disease | Crohns Disease | Drug: GSK2330811;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 280 | Phase 2 | ||
2 | NCT04118088 | January 1, 2020 | 22 October 2019 | Postauthorization Safety Study of Darvadstrocel Repeat Administration | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula (ASPIRE) | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | All | 50 | Phase 4 | ||
3 | NCT02677350 | December 1, 2019 | 15 July 2019 | AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE) | A Phase I, Pilot Trial to Evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn's Disease. | Crohn's Disease;Fistulizing Crohn's Disease;Stem Cells | Drug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs) | Joshua M Hare | Not recruiting | 18 Years | N/A | All | 0 | Phase 1 | United States | |
4 | NCT04134065 | December 1, 2019 | 4 November 2019 | the Effect of Vitamin D in Crohn's Disease | the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease | Vitamin D Deficiency;Crohn Disease | Drug: Vitamin D;Drug: Placebo oral capsule | Nanjing University School of Medicine | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not recruiting | 20 Years | 60 Years | All | 30 | Early Phase 1 | |
5 | NCT03992469 | December 2019 | 4 November 2019 | Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's Disease | Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease | Crohn's Disease | Drug: BFAHF-2;Drug: Placebo | Icahn School of Medicine at Mount Sinai | Not recruiting | 18 Years | 30 Years | All | 28 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | NCT03943446 | November 4, 2019 | 4 November 2019 | TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence | Crohn Disease | Drug: TAK-018;Drug: TAK-018 Placebo | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | All | 75 | Phase 2 | United States;Austria;France;Germany;Netherlands;United Kingdom | |
7 | NCT03961815 | November 1, 2019 | 26 August 2019 | Open-label Extension Study of Brazikumab in Crohn's Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Brazikumab | Allergan | Recruiting | 16 Years | 80 Years | All | 1000 | Phase 3 | United States | |
8 | NCT04073472 | November 1, 2019 | 9 September 2019 | Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's | A Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch | Crohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, Ileoanal | Drug: mesenchymal stem cells (MSCs) | The Cleveland Clinic | Not recruiting | 18 Years | 75 Years | All | 15 | Phase 1 | United States | |
9 | NCT04154735 | November 2019 | 11 November 2019 | Autologous Transplant Targeted Against Crohn's | Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease | Crohn's Disease | Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: Tacrolimus | Northwestern University | Not recruiting | 18 Years | 49 Years | All | 0 | Phase 2 | United States | |
10 | NCT04075825 | October 30, 2019 | 16 September 2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | All | 150 | Phase 3 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | NCT04131504 | October 16, 2019 | 11 November 2019 | Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION) | A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF | Crohn's Disease;IBD | Drug: Infliximab;Drug: Adalimumab | Children's Hospital Medical Center, Cincinnati | The Leona M. and Harry B. Helmsley Charitable Trust | Recruiting | 1 Year | 22 Years | All | 240 | Phase 3 | United States |
12 | NCT04014517 | October 1, 2019 | 29 July 2019 | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients | Crohn Disease | Other: Standard of Care;Dietary Supplement: Immunonutrition | Istituto Clinico Humanitas | Not recruiting | 18 Years | N/A | All | 350 | N/A | ||
13 | NCT04112212 | October 1, 2019 | 14 October 2019 | NIR FME of Labelled Vedolizumab to Elucidate the Mechanism of Action and Predicting Response in IBD Patients. | Near-infrared Fluorescence Molecular Endoscopy Imaging of Labelled Vedolizumab-800CW to Elucidate the Mechanism of Action and Predicting Response in IBD Patients. A Prospective Pilot Intervention Study: | Crohn Disease;Colitis, Ulcerative | Drug: Vedolizumab-800CW;Device: Fluorescence endoscopy and spectroscopy | University Medical Center Groningen | Not recruiting | 18 Years | N/A | All | 35 | Phase 1 | ||
14 | NCT04131322 | October 2019 | 28 October 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 | Not recruiting | 18 Years | N/A | All | 216 | Phase 4 | ||
15 | JPRN-jRCT1031190056 | 30/09/2019 | 5 November 2019 | E6011-CS1 study | Research for medicinal predictive marker on Crohn's disease - E6011-CS1 study | Crohn's disease Crohn's disease;D003424 | Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit. 1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination 2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination 3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination Study2:None. | Kousaku Nanki | EA Pharma Co.,Ltd.(Utilize AMED's funds) | Recruiting | >= 16age old | Not applicable | Both | 28 | N/A | none |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | NCT04102111 | September 23, 2019 | 11 November 2019 | A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: JNJ-67864238;Drug: Placebo | Janssen Research & Development, LLC | Recruiting | 18 Years | 75 Years | All | 90 | Phase 2 | United States;Argentina;France;Germany;Italy;Poland;Russian Federation;Ukraine | |
17 | NCT03847467 | September 20, 2019 | 22 October 2019 | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Drug: 2'-Fucosyllactose;Other: Placebo | Children's Hospital Medical Center, Cincinnati | Broad Institute;University of Cincinnati;Connecticut Children's Medical Center | Recruiting | 11 Years | 25 Years | All | 216 | Phase 1/Phase 2 | United States |
18 | ChiCTR1900026091 | 2019-09-19 | 30 September 2019 | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study | Crohn's disease | Case series:infliximab; | The First Affiliated Hospital of Sun Yat-sen University | Not Recruiting | 9 | 58 | Both | Case series:343; | Retrospective study | China | |
19 | NCT03870334 | September 15, 2019 | 16 September 2019 | Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: BT-11 1,000 mg;Drug: Placebo | Landos Biopharma Inc. | Not recruiting | 18 Years | 75 Years | All | 130 | Phase 2 | ||
20 | NCT03885713 | September 10, 2019 | 4 November 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 | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
21 | NCT03917303 | September 2019 | 26 August 2019 | Control Crohn Safe Trial | Control Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study. | Crohn Disease;Inflammatory Bowel Diseases | Drug: Adalimumab;Drug: standard step-up care | Maastricht University Medical Center | Not recruiting | 18 Years | 70 Years | All | 158 | Phase 4 | ||
22 | NCT03962998 | September 2019 | 7 October 2019 | Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability | A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's Disease | Crohn Disease | Drug: Lactulose/Rhamnose solution;Drug: MB-102 | MediBeacon | Recruiting | 18 Years | N/A | All | 20 | Early Phase 1 | United States | |
23 | NCT03945019 | August 2019 | 29 July 2019 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease | 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 Crohn's Disease | Crohn's Disease | Biological: CT-P13 SC (Infliximab);Other: Placebo SC | Celltrion | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | United States | |
24 | NCT03999580 | August 2019 | 15 July 2019 | The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 ) | A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in Children | Crohn Disease | Drug: vitamin D3 | Jantchou Prevost | Not recruiting | 4 Years | 18 Years | All | 316 | Phase 3 | Canada | |
25 | NCT03926130 | July 23, 2019 | 11 November 2019 | A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Mirikizumab;Drug: Ustekinumab;Drug: Placebo | Eli Lilly and Company | Recruiting | 18 Years | 80 Years | All | 1100 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
26 | NCT04018599 | July 15, 2019 | 30 September 2019 | Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS | A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects | Rheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious Uveitis | Drug: 40 mg MSB11022 | Fresenius Kabi SwissBioSim GmbH | PRA Health Sciences | Recruiting | 18 Years | 55 Years | All | 216 | Phase 1 | United States |
27 | ChiCTR1900023696 | 2019-07-01 | 11 June 2019 | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Chron's disease | Group 1:EBD;Group 2:EBD combined with local injection of betamethasone; | The Sixth Affiliated Hospital of Sun Yat-sen University | Not Recruiting | 18 | 75 | Both | Group 1:45;Group 2:45; | N/A | China | |
28 | JPRN-JapicCTI-194830 | 01/7/2019 | 22 July 2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] | Crohn's disease | Intervention name : Vedolizumab (Genetical Recombination) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, 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 | Not Recruiting | BOTH | 300 | NA | Japan | |||
29 | NCT03905109 | July 1, 2019 | 23 April 2019 | Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease | A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid Treatment | Crohn Disease | Drug: ABX464;Drug: Placebo | Abivax S.A. | Not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Belgium | |
30 | NCT03935451 | July 1, 2019 | 13 May 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 | Not recruiting | 18 Years | N/A | All | 180 | Early Phase 1 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
31 | NCT04002180 | July 1, 2019 | 29 July 2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] | Crohn's Disease | Drug: Vedolizumab (Genetical Recombination) | Takeda | Recruiting | N/A | N/A | All | 300 | Phase 3 | Japan | |
32 | NCT03950336 | July 2019 | 27 May 2019 | Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease Patients | Influence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's Patients | Healthy First Degree Relatives of Crohn's Disease Patients | Dietary Supplement: Prebiotics;Other: Low n-6 PUFA Diet;Dietary Supplement: Maltodextrin;Other: Control Diet | University of Alberta | Not recruiting | 15 Years | 50 Years | All | 32 | N/A | ||
33 | NCT04089514 | June 30, 2019 | 28 October 2019 | A Real-world Study of Imraldi® Use | Pan-EU Real-World Experience With Imraldi® | Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC) | Drug: Adalimumab | Biogen | Recruiting | 18 Years | N/A | All | 1400 | N/A | Germany;United Kingdom | |
34 | NCT03656627 | June 27, 2019 | 22 October 2019 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 72 | Phase 1 | United States |
35 | NCT03850509 | June 4, 2019 | 4 March 2019 | Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation | Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | Crohn's Disease | Drug: OPS-2071 150 mg;Drug: OPS-2071 300 mg;Drug: OPS-2071 600 mg;Drug: Matching Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | IQVIA | Not recruiting | 18 Years | 70 Years | All | 240 | Phase 2 | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
36 | NCT03941418 | June 1, 2019 | 11 June 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 recruiting | 18 Years | 80 Years | All | 150 | N/A | |
37 | NCT03915262 | June 2019 | 23 April 2019 | Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease | Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy | Crohn Disease | Biological: Search for exocrine pancreatic insufficiency at week 0 and 12 | Hospices Civils de Lyon | Not recruiting | 18 Years | N/A | All | 50 | N/A | France | |
38 | NCT03798691 | May 28, 2019 | 15 July 2019 | Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab | A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Herpes Zoster | Biological: Shingrix | University of Wisconsin, Madison | Boston Medical Center | Recruiting | 50 Years | 70 Years | All | 30 | Phase 4 | United States |
39 | NCT03747718 | May 1, 2019 | 25 February 2019 | Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children | A Study for Evaluation of Clinical Response to Single vs. Maintenance Fecal Microbiota Transplantation in Pediatric Patients With Refractory Crohn's Disease | Crohn Disease | Biological: Fecal Microbiota Transplantation;Other: Placebo | Children's Mercy Hospital Kansas City | Not recruiting | 2 Years | 25 Years | All | 30 | Phase 1 | United States | |
40 | NCT03808103 | May 1, 2019 | 13 May 2019 | Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease | A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD) | Crohn Disease | Biological: Placebo;Biological: Bacteriophage preparation | Intralytix, Inc. | MOUNT SINAI HOSPITAL | Recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
41 | NCT03733314 | April 25, 2019 | 22 July 2019 | A Study of E6011 in Participants With Active Crohn's Disease | Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: E6011;Drug: Placebo | EA Pharma Co., Ltd. | Recruiting | 18 Years | 64 Years | All | 40 | Phase 2 | Japan;Poland | |
42 | NCT03942120 | April 8, 2019 | 11 November 2019 | Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab) | Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA | Crohn Disease | Drug: Ustekinumab | Janssen Korea, Ltd., Korea | Recruiting | 18 Years | N/A | All | 70 | Phase 3 | Korea, Republic of | |
43 | NCT03816345 | April 4, 2019 | 11 November 2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States | |
44 | NCT03712826 | April 2019 | 25 March 2019 | Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease | Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease | Crohn Disease | Drug: Anti-TNF Drug;Drug: Ustekinumab | Hospices Civils de Lyon | Recruiting | 18 Years | N/A | All | 60 | N/A | France | |
45 | NCT03914261 | April 2019 | 23 April 2019 | Expanded Access to Risankizumab | Expanded Access to Risankizumab | Crohn's Disease | Drug: Risankizumab | AbbVie | Not recruiting | 18 Years | N/A | All | N/A | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
46 | NCT03884439 | March 18, 2019 | 4 November 2019 | Infliximab Biosimilar Pfizer Drug Use 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 | Recruiting | N/A | N/A | All | 300 | Phase 3 | Japan | |
47 | NCT03706456 | March 6, 2019 | 11 November 2019 | Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease | A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease | Complex Perianal Fistulas in Adult Patients With Crohn's Disease | Biological: Darvadstrocel | Takeda | Recruiting | 18 Years | N/A | All | 20 | Phase 3 | Japan | |
48 | NCT03901937 | March 1, 2019 | 15 April 2019 | The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease | Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China | Crohn Disease | Drug: ?-3 polyunsaturated fatty acid;Procedure: Intestinal surgery for Crohn's Disease | Sir Run Run Shaw Hospital | Recruiting | 18 Years | 75 Years | All | 158 | Phase 4 | China | |
49 | EUCTR2017-000574-11-GR | 26/02/2019 | 28 February 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
50 | NCT03681067 | February 20, 2019 | 15 April 2019 | A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease | A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients With Moderate-to-Severe Crohn's Disease | Crohn Disease | Drug: GSK1070806;Drug: Placebo- sodium chloride | University of Birmingham | GlaxoSmithKline;University Hospital Birmingham | Recruiting | 16 Years | N/A | All | 30 | Phase 1/Phase 2 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
51 | NCT03681652 | February 11, 2019 | 25 February 2019 | Post-Operative Crohn's Disease Outcome in Children | Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study | Crohn Disease | Drug: Azathioprine;Drug: Anti-TNF Drug | Schneider Children's Medical Center, Israel | Recruiting | 6 Years | 18 Years | All | 100 | N/A | Israel | |
52 | NCT03718182 | February 11, 2019 | 5 November 2018 | Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? | Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial | Crohn Disease;Vitamin D Deficiency | Dietary Supplement: Cholecalciferol | University Hospital Birmingham NHS Foundation Trust | National Institute for Health Research, United Kingdom;University of Birmingham;Clinical Trials Research Centre | Not recruiting | 18 Years | N/A | All | 50 | Phase 4 | |
53 | NCT03627091 | February 6, 2019 | 11 November 2019 | Efficacy and Safety Study of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307) | 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 Crohn's Disease (CARMEN CD 307) | Crohn's Disease | Drug: SHP647;Other: Placebo | Shire | Recruiting | 16 Years | 80 Years | All | 983 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Bosnia and Herzegovina | |
54 | NCT03752970 | February 5, 2019 | 28 October 2019 | A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease | Crohn Disease | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | Recruiting | 18 Years | 75 Years | All | 28 | Phase 2 | Austria;Belgium;Germany;Hungary | |
55 | NCT03650413 | January 14, 2019 | 11 November 2019 | 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. | Recruiting | 18 Years | 80 Years | All | 320 | Phase 2 | United States;Bulgaria;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
56 | EUCTR2018-002629-51-NL | 08/01/2019 | 28 February 2019 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease 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] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International N.V. | Authorised | Female: yes Male: yes | 200 | Phase 3 | France;United States;Spain;Germany;Netherlands;Sweden | |||
57 | NCT03773237 | December 31, 2018 | 21 January 2019 | Intralipid Versus SMOFlipid in HPN Patients | Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients. | Short Bowel Syndrome;Intestinal Fistula;Crohn Disease;Intestinal Obstruction | Dietary Supplement: SMOFLipid;Dietary Supplement: Intralipid | Mayo Clinic | Recruiting | 18 Years | 75 Years | All | 100 | N/A | United States | |
58 | EUCTR2018-002925-47-ES | 28/12/2018 | 28 February 2019 | 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 Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Infliximab Pharmaceutical Form: Infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Trade Name: Golimumab Pharmaceutical Form: Injection INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Ustekinumab Pharmaceutical Form: Injection INN or Proposed INN: USTEKINUMAB CAS Number: 815610-63-0 Other descriptive name: USTEKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Trade Name: Vedolizumab Pharmaceutical Form: Infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Fundación de Investigación Biomédica del Hospital Universitario de La Princesa | Authorised | Female: yes Male: yes | 180 | Phase 4 | Spain | |||
59 | NCT03677648 | December 28, 2018 | 14 October 2019 | A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease | A Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's Disease | Crohn's Disease | Drug: Placebos;Drug: SHR0302 | Reistone Biopharma Company Limited | Recruiting | 18 Years | 75 Years | All | 144 | Phase 2 | United States;China;Poland;Ukraine | |
60 | JPRN-jRCT1051190043 | 20/12/2018 | 10 September 2019 | Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis | Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 | Crohn's disease | At the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week. | Tetsuo Takehara | Hideki Iijima | Recruiting | 20age | Not applicable | Both | 15 | Phase 2 | none |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
61 | NCT03782376 | December 20, 2018 | 11 November 2019 | A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab approximately 6 mg/kg (IV);Drug: Placebo (SC);Drug: Placebo (IV);Drug: Ustekinumab 90 mg (SC) Group 1;Drug: Ustekinumab 90 mg (SC) Group 2 | Janssen-Cilag Ltd. | Recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States;Austria;France;Germany;Italy;Netherlands;Spain;Sweden | |
62 | ChiCTR1800019958 | 2018-12-16 | 18 December 2018 | Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease | Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease | Crohn's disease | Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy; | Daping Hospital, Army Medical University (Third Military Medical University) | Recruiting | 18 | 65 | Both | Case series:60; | New Treatment Measure Clinical Study | China | |
63 | EUCTR2018-002629-51-ES | 12/12/2018 | 28 February 2019 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease 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] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International N.V. | Authorised | Female: yes Male: yes | 200 | Phase 3 | France;United States;Spain;Netherlands;Germany;Sweden | |||
64 | NCT03759288 | December 7, 2018 | 26 August 2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease;IBD | Drug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira®;Drug: Placebo | Allergan | Recruiting | 16 Years | 80 Years | All | 1140 | Phase 2/Phase 3 | United States | |
65 | NCT03574948 | December 6, 2018 | 11 June 2019 | 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 | Recruiting | 18 Years | 60 Years | All | 180 | Phase 2 | Belgium | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
66 | EUCTR2018-001272-37-DE | 04/12/2018 | 7 January 2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not Assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | Theravance Biopharma Ireland Limited | Authorised | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | |||
67 | NCT02834754 | December 1, 2018 | 18 December 2018 | Vedolizumab Post Op Study | A Randomized, Double-blind, Placebo Controlled Study of Vedolizumab for the Prevention of Post-operative Crohn's Disease Recurrence | Crohn's Disease | Drug: Vedolizumab;Drug: placebo | Marc Schwartz | Takeda | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
68 | NCT03378167 | December 1, 2018 | 30 September 2019 | PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial | PediCRaFT: Pediatric Crohn's Disease Fecal Microbiota Transplant Pilot Study | Crohn Disease;Pediatric Crohns Disease;Inflammatory Bowel Diseases;Colitis | Biological: MICROBIOTA;Biological: PLACEBO | McMaster Children's Hospital | Hamilton Health Sciences Corporation;McMaster University | Recruiting | 3 Years | 17 Years | All | 45 | Phase 1 | Canada |
69 | NCT03944447 | December 1, 2018 | 7 October 2019 | Outcomes Mandate National Integration With Cannabis as Medicine | Outcomes Mandate National Integration With Cannabis as Medicine | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder | Drug: Cannabis, Medical | OMNI Medical Services, LLC | Recruiting | 7 Years | N/A | All | 100000 | Phase 2 | United States | |
70 | EUCTR2017-003090-34-BE | 28/11/2018 | 7 January 2019 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 Pharmaceutical Form: Solution for infusion Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | SCS Boehringer Ingelheim Comm.V | Authorised | Female: yes Male: yes | 28 | Phase 2 | Belgium | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
71 | NCT03729674 | November 26, 2018 | 3 December 2018 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease | Drug: Biosimilar;Drug: Originator (legacy) drug | McGill University Health Center | Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group | Not recruiting | 18 Years | N/A | All | 800 | Phase 3 | |
72 | NCT03635112 | November 19, 2018 | 30 September 2019 | Efficacy and Safety of TD-1473 in Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: TD-1473 | Theravance Biopharma | Recruiting | 18 Years | N/A | All | 160 | Phase 2 | United States;Austria;Bulgaria;Croatia;France;Georgia;Germany;Greece;Hungary;Israel;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom | |
73 | EUCTR2017-005151-83-DE | 26/10/2018 | 6 November 2018 | Treatment of Crohn's disease with Ustekinumab in clinical practice | INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUS | Crohn's disease 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: STELARA Product Name: Stelara Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Trade Name: STELARA Product Name: Stelara Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- | Charité Universitätsmedizin Berlin | Authorised | Female: yes Male: yes | 100 | Phase 4 | Germany | |||
74 | NCT03833596 | October 25, 2018 | 25 February 2019 | Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD) | Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms | Crohn's Disease | Dietary Supplement: Exclusive Enteral Nutrition;Drug: Prednisone | McMaster University | Nestlé | Recruiting | 18 Years | 75 Years | All | 100 | Phase 4 | Canada |
75 | NCT03723447 | October 23, 2018 | 11 November 2019 | Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®) | A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial | Pain, Postoperative;Crohn Disease;Inflammatory Bowel Diseases;Colorectal Cancer;Gastrointestinal Cancer;Gastrointestinal Disease;Digestive System Disease;Pain;Pain, Neuropathic;Intestinal Disease | Drug: Liposomal bupivacaine;Drug: Bupivacaine/epinephrine/dexamethasone | Cedars-Sinai Medical Center | Not recruiting | 18 Years | 90 Years | All | 100 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
76 | EUCTR2017-000617-23-BE | 08/10/2018 | 28 February 2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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. | 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 Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 983 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;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;Japan | |||
77 | NCT03606499 | September 26, 2018 | 22 July 2019 | Real-world Effectiveness of Ustekinumab in Participants Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases | Effectiveness of Ustekinumab in Patients Suffering From Crohn's Disease With Extra-intestinal Manifestations or Immune-Mediated Inflammatory Diseases in a Real-world Setting | Crohn Disease | Drug: Ustekinumab | Janssen Cilag S.A.S. | Recruiting | 18 Years | N/A | All | 125 | Phase 2 | France | |
78 | JPRN-JapicCTI-183950 | 20/9/2018 | 16 July 2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | Crohn's Disease | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion. Control intervention name : Ustekinumab INN of the control intervention : Ustekinumab Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion. | Janssen Pharmaceutical K.K. | Recruiting | 18 | BOTH | 2000 | Phase 2-3 | Japan, North America | ||
79 | EUCTR2017-000617-23-NL | 17/09/2018 | 1 October 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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. | 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 Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 983 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
80 | EUCTR2017-001976-48-HU | 13/09/2018 | 4 December 2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | 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 10011398 Term: Crohn's System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 Pharmaceutical Form: Capsule INN or Proposed INN: BMS-986165 CAS Number: 1609392-28-0 Other descriptive name: BMS986165 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Bristol-Myers Squibb international Corporation | Authorised | Female: yes Male: yes | 144 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
81 | NCT03623932 | September 1, 2018 | 20 August 2018 | Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease | Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease | Crohn Disease | Drug: immunosuppressor/TNFalpha;Behavioral: Hypnosis | University Hospital, Grenoble | Not recruiting | 18 Years | 65 Years | All | 40 | N/A | ||
82 | NCT03615378 | August 30, 2018 | 26 August 2019 | Maintenance Dosing of Vitamin D in Crohn's Disease | A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission | Crohns Disease;Vitamin D Deficiency | Dietary Supplement: 5000 IU D3;Dietary Supplement: 1000 IU D3;Dietary Supplement: Placebo | Cedars-Sinai Medical Center | Not recruiting | 18 Years | N/A | All | 10 | Early Phase 1 | United States | |
83 | EUCTR2017-004294-14-DE | 23/08/2018 | 28 February 2019 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | |||
84 | NCT03467958 | August 22, 2018 | 4 November 2019 | An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod | Celgene | Recruiting | 12 Years | 75 Years | All | 1040 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom | |
85 | NCT03546868 | August 14, 2018 | 3 September 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 | Recruiting | 19 Years | 79 Years | All | 20 | Phase 2 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
86 | NCT03492944 | August 6, 2018 | 20 August 2018 | Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason | Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography | Crohn Disease | Drug: Ultrasound Microbubble Contrast Agent;Device: Ultrasound Imaging | Children's Hospital Medical Center, Cincinnati | Recruiting | 10 Years | 18 Years | All | 25 | Phase 1 | United States | |
87 | NCT03196427 | July 30, 2018 | 15 July 2019 | Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Recruiting | 2 Years | 17 Years | All | 80 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom | |
88 | EUCTR2017-000576-29-HU | 24/07/2018 | 19 November 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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)(CARMEN CD 306). | 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 Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 1032 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina | |||
89 | NCT03449069 | July 23, 2018 | 26 August 2019 | Pediatric MSC-AFP Sub-study for Crohn's Fistula | A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study | Fistula in Ano;Crohn Disease | Drug: MSC-AFP | Mayo Clinic | Recruiting | 12 Years | 17 Years | All | 5 | Phase 1 | United States | |
90 | EUCTR2017-001737-85-NL | 17/07/2018 | 20 August 2018 | Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy | Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy - ADD UP | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: albendazole (Eskazole) Product Name: albendazole Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | academic medical centre | Authorised | Female: yes Male: yes | 110 | Phase 4 | Netherlands | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
91 | NCT03476317 | July 12, 2018 | 30 September 2019 | Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Crohn Disease | Drug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: Fluconazole | Children's Hospital of Philadelphia | University of Pennsylvania;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | 6 Years | 18 Years | All | 30 | Phase 2 | United States |
92 | EUCTR2017-000575-88-AT | 06/07/2018 | 26 November 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, 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) | 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 Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease 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 Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | |||
93 | EUCTR2017-000617-23-AT | 06/07/2018 | 26 November 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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. | 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 Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 983 | Phase 3 | Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina | |||
94 | NCT03860571 | July 6, 2018 | 11 March 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. | Not recruiting | 18 Years | 65 Years | All | 70 | Phase 1 | United States | |
95 | EUCTR2017-002195-13-DE | 03/07/2018 | 7 January 2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease 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: guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for infusion in pre-filled syringe INN or Proposed INN: GUSELKUMAB Current Sponsor code: CNTO 1959 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe Route of administration of the placebo: Intravenous use Product Name: guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Guselkumab Current Sponsor code: CNTO 1959 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe Route of administration of the placebo: Intravenous use Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Janssen-Cilag International NV | Authorised | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;Portugal;United States;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
96 | NCT03662919 | July 2, 2018 | 17 September 2018 | One-year Persistence to Treatment of Participants Receiving Flixabi: a French Cohort Study | PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi®: a French Cohort Study | Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, Ulcerative | Drug: Infliximab | Biogen | Recruiting | 6 Years | N/A | All | 1500 | N/A | France | |
97 | NCT03467620 | July 2018 | 11 June 2018 | Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease | Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study | Crohn Disease;Inflammatory Bowel Diseases;Cannabis | Drug: Cannabidiol;Drug: Placebo oral capsule | University of Illinois at Chicago | Not recruiting | 18 Years | N/A | All | 36 | Phase 2/Phase 3 | ||
98 | NCT03472690 | June 25, 2018 | 23 July 2018 | QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease | A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's Disease | Crohn Disease | Biological: QBECO-SSI;Other: Placebo | Qu Biologics Inc. | Recruiting | 18 Years | N/A | All | 170 | Phase 2 | Canada | |
99 | NCT03559517 | June 25, 2018 | 11 November 2019 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305) | 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 Crohn's Disease (CARMEN CD 305) | Crohn's Disease | Biological: SHP647;Other: Placebo | Shire | Recruiting | 16 Years | 80 Years | All | 1032 | Phase 3 | United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom | |
100 | NCT03559660 | June 25, 2018 | 28 October 2019 | CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) | Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) | Crohn's Disease | Drug: Certolizumab Pegol | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | Phase 3 | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
101 | NCT03599622 | June 25, 2018 | 4 November 2019 | An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease | Granulomatous Colitis;Crohn's Disease;Crohn's Enteritis;Granulomatous Enteritis | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | Recruiting | 18 Years | 75 Years | All | 240 | Phase 2 | United States;Australia;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom | |
102 | EUCTR2017-000617-23-LT | 15/06/2018 | 23 July 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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. | 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 Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 983 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
103 | NCT03566823 | June 11, 2018 | 11 November 2019 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306) | 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 Crohn's Disease (CARMEN CD 306) | Crohn's Disease | Biological: SHP647;Other: Placebo | Shire | Recruiting | 16 Years | 80 Years | All | 1032 | Phase 3 | United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Mexico;New Zealand;Portugal;Slovakia;Spain;Ukraine | |
104 | NCT03142321 | June 8, 2018 | 15 July 2019 | Defining Predictors of RT Response to Vedolizumab in IBD | Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers | Crohn Disease of Small Intestine | Drug: Vedolizumab 300 MG Injection [Entyvio] | Washington University School of Medicine | Recruiting | 18 Years | N/A | All | 80 | Phase 4 | United States | |
105 | NCT03477032 | June 1, 2018 | 11 June 2019 | 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 | Recruiting | 18 Years | 65 Years | All | 50 | Phase 2 | Australia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
106 | EUCTR2017-004292-31-LV | 21/05/2018 | 30 April 2019 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 600 | Phase 3 | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | |||
107 | EUCTR2017-004295-55-LV | 21/05/2018 | 30 April 2019 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | |||
108 | ChiCTR1800015174 | 2018-05-01 | 19 March 2018 | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Crohn's disease | control group:placebo;Vitamin D:800IU Vitamin D; | Gudangdong General Hospital, Guangdong Academy of Medical Sciences | Not Recruiting | 18 | 75 | Both | control group:32;Vitamin D:32; | New Treatment Measure Clinical Study | China | |
109 | EUCTR2017-003649-10-DE | 30/04/2018 | 28 February 2019 | 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 Level: PT 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: ETROLIZUMAB CAS Number: 1044758-60-2 Current Sponsor code: RO5490261/F02-01 Other descriptive name: ETROLIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Poland;Belgium;Spain;Germany;United Kingdom | |||
110 | EUCTR2017-000574-11-DE | 10/04/2018 | 7 January 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
111 | NCT03105102 | April 9, 2018 | 4 November 2019 | A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | 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 Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | Crohn's Disease | Drug: placebo for risankizumab SC;Drug: risankizumab IV;Drug: placebo for risankizumab IV;Drug: risankizumab SC | AbbVie | Recruiting | 18 Years | 80 Years | All | 912 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Turkey | |
112 | EUCTR2016-004112-35-SE | 04/04/2018 | 30 April 2018 | 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 Pharmaceutical Form: Tablet Trade Name: Allopurinol Product Name: Allopurinol Product Code: NA Pharmaceutical Form: Tablet | SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) | Authorised | Female: yes Male: yes | 120 | Phase 4 | Sweden | |||
113 | JPRN-UMIN000031839 | 2018/04/01 | 23 April 2019 | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients | Crohn's disease | At the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week. | Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology | Japan Community Health care Organizationi Osaka Hospital, Gastroenterology and Hepatology National Hospital Organization Osaka National Hospital, Gastroenterology and Hepatology Osaka Rosai Hospital , Gastroenterology and Hepatology Kansai Rosai Hospital, Gastroenterology and Hepatology Itami City Hospital, Gastroenterology and Hepatology Hyogo Prefectural Nishinomiya Hospital, Gastroenterology and Hepatology | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not selected | Japan |
114 | NCT03452501 | April 2018 | 11 June 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 Including Crohn's Disease, Fistulizing Crohn's Disease and Ulcerative Colitis | Drug: Infliximab | Hikma Pharmaceuticals LLC | Not recruiting | 18 Years | N/A | All | 150 | Phase 3 | Saudi Arabia | |
115 | NCT03464136 | March 29, 2018 | 11 November 2019 | Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn Disease | Biological: Placebo for Ustekinumab;Biological: Placebo for Adalimumab;Biological: Ustekinumab (6 mg/kg);Biological: Ustekinumab (90 mg);Biological: Adalimumab (40 mg) | Janssen Scientific Affairs, LLC | Recruiting | 18 Years | N/A | All | 350 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
116 | NCT03478956 | March 27, 2018 | 28 October 2019 | 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 | Not recruiting | 4 Years | 17 Years | All | 24 | Phase 1 | United States;Belgium;Germany;Poland;Spain;United Kingdom | |
117 | NCT03345823 | March 21, 2018 | 25 March 2019 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | Crohn's Disease | Drug: Placebo for Upadacitinib;Drug: Upadacitinib | AbbVie | Recruiting | 18 Years | 75 Years | All | 738 | Phase 3 | United States;American Samoa;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus | |
118 | NCT03597971 | March 20, 2018 | 20 August 2018 | HMPL004-6599 Phase I Dose-escalating Study | A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers | Ulcerative Colitis;Crohn Disease | Drug: HMPL004-6599;Drug: Placebo | Nutrition Science Partners Limited | Hutchison Medipharma Limited;Nestlé | Recruiting | 18 Years | 45 Years | Male | 56 | Phase 1 | Australia |
119 | NCT03854305 | March 20, 2018 | 6 May 2019 | Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease | Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's | Crohn's Disease | Drug: PRV-6527;Drug: Placebo | Provention Bio, Inc. | Not recruiting | 18 Years | 75 Years | All | 93 | Phase 2 | Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine | |
120 | EUCTR2017-004294-14-SK | 16/03/2018 | 7 January 2019 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
121 | EUCTR2017-004295-55-SK | 16/03/2018 | 7 January 2019 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | |||
122 | EUCTR2017-000574-11-IE | 13/03/2018 | 23 July 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
123 | EUCTR2017-004294-14-LT | 12/03/2018 | 30 April 2019 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | |||
124 | EUCTR2017-004295-55-LT | 12/03/2018 | 30 April 2019 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | |||
125 | NCT03440385 | March 7, 2018 | 4 November 2019 | Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | Recruiting | 12 Years | 75 Years | All | 675 | Phase 3 | United States;Australia;Austria;Brazil;Bulgaria;Canada;China;Finland;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
126 | NCT03709628 | March 7, 2018 | 26 November 2018 | A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients | An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients | Crohn Disease | Drug: EB8018 (First-in-class FimH blocker) | Enterome | Recruiting | 18 Years | N/A | All | 8 | Phase 1 | Austria;France;Germany;Italy | |
127 | EUCTR2017-004293-33-HU | 06/03/2018 | 30 April 2019 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease 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 Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | |||
128 | NCT03329209 | March 5, 2018 | 10 September 2018 | A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants | An Open-Label, Single-Center, Phase 1 Study to Determine the Pharmacokinetics of Single Intravenous Dose of Vedolizumab 300 mg in Healthy Adult Chinese Subjects | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab | Takeda | Not recruiting | 18 Years | 45 Years | All | 16 | Phase 1 | China | |
129 | JPRN-UMIN000030884 | 2018/02/27 | 2 April 2019 | A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. | Crohn's disease | Ustekinumab monotherapy for 32 weeks. Combination of Budesonide and Ustekinumab for 32 weeks. | Tohoku University Hospital, Division of Gastroenterology | Recruiting | 18years-old | 75years-old | Male and Female | 80 | Not selected | Japan | ||
130 | NCT03221166 | February 27, 2018 | 22 July 2019 | Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors | Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network | Crohn Disease | Drug: Thalidomide;Drug: Infliximab | IRCCS Burlo Garofolo | Centro di Riferimento Oncologico - Aviano;Azienda Ospedaliera Spedali Civili di Brescia | Recruiting | 6 Years | 17 Years | All | 124 | Phase 3 | Italy |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
131 | NCT03440372 | February 27, 2018 | 22 October 2019 | Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | Recruiting | 12 Years | 75 Years | All | 675 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Germany;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Moldova, Republic of;Norway;Poland;Romania;Russian Federation;Saudi Arabia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom | |
132 | NCT03801928 | February 23, 2018 | 21 January 2019 | 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 | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States | |
133 | NCT03351647 | February 14, 2018 | 5 March 2018 | Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease | Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies | Crohn Disease | Biological: Evaluation of biological predictive factors of clinical response to ustekinumab | Hospices Civils de Lyon | Recruiting | 18 Years | 18 Years | All | 50 | N/A | France | |
134 | EUCTR2017-003017-25-AT | 06/02/2018 | 7 January 2019 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527 (JNJ-40346527) Pharmaceutical Form: Capsule, hard CAS Number: 1142364-35-9 Current Sponsor code: PRV-6527 (JNJ-40346527) Other descriptive name: JNJ-40346527-AAC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Provention Bio, Inc. | Authorised | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | |||
135 | EUCTR2017-002258-36-BE | 05/02/2018 | 4 December 2018 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR Pharmaceutical Form: Coated tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaximin-EIR Other descriptive name: RIFAXIMINA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1600- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | ALFASIGMA S.P.A. | Authorised | Female: yes Male: yes | 180 | Phase 2 | Spain;Belgium;Netherlands;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
136 | NCT03358706 | February 2, 2018 | 11 November 2019 | A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Moderate to Severe Crohn's Disease | 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 Moderate to Severe Crohn's Disease. | Crohn Disease | 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 | Recruiting | 18 Years | 75 Years | All | 51 | Phase 1 | United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark | |
137 | NCT03395184 | February 2, 2018 | 4 November 2019 | Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease | A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE | Crohn's Disease | Drug: Placebo PF-06651600;Drug: Placebo PF-06700841;Drug: PF-06651600;Drug: PF-06700841 | Pfizer | Recruiting | 18 Years | 75 Years | All | 250 | Phase 2 | United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Georgia;Germany;Hungary;Italy;Korea, Republic of;Lebanon;Poland;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Turkey;Ukraine;United Arab Emirates | |
138 | NCT03185000 | February 2018 | 16 December 2017 | Treg Immunotherapy in Crohn's Disease | A Double-blind, Placebo Controlled, First Into Human Clinical Trial of T Regulatory Cells (TR004) for Inflammatory Bowel Disease Using (ex Vivo) Treg Expansion | Crohn Disease | Drug: TR004 (Treg immunotherapy);Other: Placebo | King's College London | Guy's and St Thomas' NHS Foundation Trust;Medical Research Council;Imperial College London;St. George's Hospital, London;Miltenyi biotech | Not recruiting | 18 Years | 80 Years | All | 24 | Phase 1/Phase 2 | |
139 | NCT03901235 | January 15, 2018 | 15 April 2019 | MSC Intratissular Injection in Crohn Disease Patients | Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells | Efficacy and Safety | Biological: Mesenchymal Stromal Cells | University Hospital of Liege | Laboratoire de Thérapie Cellulaire et Génétique from CHU de Liège | Recruiting | 18 Years | N/A | All | 60 | Phase 1/Phase 2 | Belgium |
140 | EUCTR2017-002231-41-BE | 10/01/2018 | 20 August 2018 | 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 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Takeda Development Centre Europe, Ltd. | Authorised | Female: yes Male: yes | 80 | Phase 2 | United Kingdom;Germany;Netherlands;Israel;Ukraine;Belgium;Poland;Canada;Hungary;United States;France | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
141 | EUCTR2017-003017-25-HU | 08/01/2018 | 22 January 2018 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527(JNJ-40346527) Pharmaceutical Form: Capsule, hard CAS Number: 1142364-35-9 Current Sponsor code: PRV-6527(JNJ-40346527) Other descriptive name: JNJ-40346527-AAC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Provention Bio, Inc. | Authorised | Female: yes Male: yes | 90 | Phase 2 | Germany;Russian Federation;Austria;Ukraine;Spain;Poland;Hungary | |||
142 | EUCTR2016-003179-23-DE | 19/12/2017 | 28 February 2019 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease 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 Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Gilead Sciences, Inc. | Authorised | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | |||
143 | NCT03104413 | December 18, 2017 | 22 October 2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's Disease | Drug: risankizumab SC;Drug: placebo for risankizumab IV;Drug: risankizumab IV | AbbVie | Recruiting | 16 Years | 80 Years | All | 579 | Phase 3 | United States;American Samoa;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom;Brazil;Turkey | |
144 | NCT03345849 | December 7, 2017 | 4 November 2019 | A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease | Drug: Upadacitinib;Drug: Placebo for Upadacitinib | AbbVie | Recruiting | 18 Years | 75 Years | All | 501 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus | |
145 | EUCTR2017-002258-36-ES | 04/12/2017 | 26 March 2018 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR Pharmaceutical Form: Coated tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaximin-EIR Other descriptive name: RIFAXIMINA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1600- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | ALFASIGMA S.P.A. | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Spain;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
146 | NCT03362736 | December 4, 2017 | 22 October 2019 | An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease | An Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab | Janssen Research & Development, LLC | Not recruiting | 18 Years | N/A | All | Phase 1 | Brazil | ||
147 | NCT02974322 | December 1, 2017 | 16 December 2017 | A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | Not recruiting | 12 Years | N/A | All | 0 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic | |
148 | NCT02559713 | November 29, 2017 | 11 March 2019 | 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 Disease | Drug: Vedolizumab | Takeda | Not recruiting | 18 Years | N/A | Female | 11 | Phase 4 | United States | |
149 | NCT03345836 | November 29, 2017 | 11 November 2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy | Crohn's Disease | Other: Matching placebo for upadacitinib;Drug: upadacitinib | AbbVie | Recruiting | 18 Years | 75 Years | All | 645 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus | |
150 | EUCTR2017-002258-36-DE | 21/11/2017 | 28 February 2019 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR Pharmaceutical Form: Coated tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaximin-EIR Other descriptive name: RIFAXIMINA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | ALFASIGMA S.P.A. | Authorised | Female: yes Male: yes | 180 | Phase 2 | Spain;Belgium;Netherlands;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
151 | NCT03537157 | November 16, 2017 | 24 September 2018 | A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention | A Phase II, Multicentre, Double-blind, Randomised, Placebo-controlled Study of Rifaximin Delayed Release 400 mg Tablet: Clinical Efficacy and Safety in the Prevention of Post-operative Endoscopic Crohn's Disease Recurrence | Crohn Disease | Drug: Rifaximin delayed release tablets;Other: Placebo | Alfasigma S.p.A. | Cromsource | Recruiting | 18 Years | 75 Years | All | 156 | Phase 2 | Italy |
152 | NCT03266484 | November 13, 2017 | 18 March 2019 | Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease | Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo | Massachusetts General Hospital | Winclove Bio Industries BV | Recruiting | 18 Years | 75 Years | All | 100 | N/A | United States |
153 | NCT03357471 | November 3, 2017 | 10 September 2018 | Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease | Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease | Drug: e-Device | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 70 | Phase 3 | United States | |
154 | NCT03755583 | November 1, 2017 | 21 January 2019 | Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease | Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease | Crohn Disease;Enteral Nutrition;Gastrointestinal Microbiome | Dietary Supplement: Exclusive Enteral Nutrition | Children's Hospital of Fudan University | Recruiting | 1 Year | 17 Years | All | 40 | N/A | China | |
155 | NCT03167437 | October 30, 2017 | 8 April 2019 | Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn s Disease | An Open-Label, Phase I/II Pilot Study to Assess the Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn s Disease | Crohn's Disease | Drug: Vorinostat | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | 18 Years | 65 Years | All | 35 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
156 | NCT03495973 | October 25, 2017 | 22 October 2019 | Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease | Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE) | Crohn Disease | Drug: Ustekinumab | Janssen-Cilag Ltd. | Not recruiting | 18 Years | N/A | All | 110 | Phase 2 | Sweden | |
157 | NCT03171246 | October 23, 2017 | 11 June 2018 | CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease | An Open Label Pilot Study of the CD-TREAT Diet as a Novel Therapy for Active Luminal Crohn's Disease | Crohn Disease | Dietary Supplement: Solid food-based intervention | NHS Greater Glasgow and Clyde | University of Glasgow | Recruiting | 6 Years | 65 Years | All | 20 | N/A | United Kingdom |
158 | NCT03220243 | October 19, 2017 | 26 August 2019 | Stem Cell Coated Fistula Plug in Patients With Crohn's RVF | A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Rectovaginal Fistulizing Crohn's Disease | Fistula Vagina;Crohn Disease | Drug: MSC-AFP | Mayo Clinic | Not recruiting | 18 Years | 65 Years | Female | 5 | Phase 1 | United States | |
159 | NCT03220841 | October 9, 2017 | 16 September 2019 | Stricture Definition and Treatment (STRIDENT) Drug Therapy Study | Stricture Definition and Treatment (STRIDENT) Drug Therapy Study | Crohn Disease;Inflammatory Bowel Diseases;Stricture; Bowel | Drug: Adalimumab Injection;Drug: Thiopurine;Procedure: Endoscopic balloon dilatation | St Vincent's Hospital Melbourne | Australasian Gastro Intestinal Research Foundation;AbbVie | Recruiting | 18 Years | N/A | All | 78 | Phase 4 | Australia |
160 | NCT03279081 | September 15, 2017 | 7 October 2019 | Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) | A Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow up Period up to 52 Weeks | Crohn's Disease | Drug: Cx601;Other: Placebo | Tigenix S.A.U. | Recruiting | 18 Years | N/A | All | 600 | Phase 3 | United States;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
161 | EUCTR2016-003191-50-CZ | 13/09/2017 | 28 February 2019 | 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 Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | 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 Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg milligram(s) Concentration type: equal | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 959 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
162 | JPRN-JapicCTI-184152 | 01/9/2017 | 16 July 2019 | Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease | Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease | Crohn's disease | Intervention name : Budesonide ( Zentacort Capsules 3mg ) INN of the intervention : Budesonide Dosage And administration of the intervention : Oral | ZERIA Pharmaceutical Co., Ltd. | Recruiting | BOTH | 200 | NA | ||||
163 | EUCTR2017-000725-12-CZ | 08/08/2017 | 23 July 2018 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0 Level: PT Classification code 10002156 Term: Anal fistula System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 Pharmaceutical Form: Suspension for injection INN or Proposed INN: nap Current Sponsor code: Allogenic eASCs Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) Concentration unit: Other Concentration type: equal Concentration number: 5000000- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intralesional use | TiGenix, S.A.U. | Authorised | Female: yes Male: yes | 326 | Phase 3 | Italy;Israel;Spain;Belgium;Poland;Canada;Czech Republic;Hungary;United States;France | |||
164 | NCT03234907 | August 3, 2017 | 11 June 2019 | Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease | 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 Crohn's Disease | Crohn's Disease | Drug: Vedolizumab IV;Drug: Placebo | Takeda | Not recruiting | 18 Years | 80 Years | All | 215 | Phase 3 | China | |
165 | NCT03162432 | August 1, 2017 | 30 September 2019 | 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 | Recruiting | 7 Years | 25 Years | All | 50 | Phase 3 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
166 | NCT03185624 | July 25, 2017 | 16 December 2017 | Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease | Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial | Crohn Disease | Drug: Rifaximin | Sixth Affiliated Hospital, Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw Hospital | Not recruiting | 18 Years | 65 Years | All | 80 | Phase 3 | China |
167 | NCT02330211 | July 17, 2017 | 21 January 2019 | Fecal Microbiota Transplant (FMT) in 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 Crohn's Colitis | Inflammatory Bowel Diseases;Crohn Disease | Biological: Fecal Microbiota Transplant;Biological: Placebo | Stacy A. Kahn | Not recruiting | 5 Years | 30 Years | All | 4 | Phase 1/Phase 2 | United States | |
168 | NCT03169894 | July 14, 2017 | 18 March 2019 | Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease | Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFa Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFa-Resistant Crohn's Disease [TRaCk LIGHT]) | Crohn Disease | Drug: MDGN-002 | Aevi Genomic Medicine | Recruiting | 18 Years | 65 Years | All | 8 | Phase 1 | United States | |
169 | NCT03219359 | July 12, 2017 | 23 April 2019 | Autologous Stem Cell Transplant for Crohn's Disease | Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD) | Crohn Disease | Drug: Vedolizumab;Drug: Methylprednisolone;Drug: Thymoglobulin;Drug: Cyclophosphamide;Procedure: Autologous stem cell transplant | Icahn School of Medicine at Mount Sinai | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States | |
170 | JPRN-UMIN000028139 | 2017/07/04 | 2 April 2019 | Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease | Crohn's disease | Treatment with Ustekinumab | Graduate School of Medical Sciences, Kyushu University | Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
171 | NCT03014219 | July 2017 | 16 December 2017 | Phase 1 Crohn's Pediatric Sub-study of MSC AFP | A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study | Perianal Fistula | Drug: Only 1 arm: treatment with MSC-AFP | William A. Faubion, M.D. | Not recruiting | 12 Years | 17 Years | All | 0 | Phase 1 | United States | |
172 | NCT03235180 | June 16, 2017 | 14 October 2019 | Ultrasound Evaluation of Crohn's Disease | Ultrasound Evaluation of Crohn's Disease | Crohn Disease | Drug: Sulfur Hexafluoride;Device: Ultrasound Elastography;Device: Ultrasound Vascularity;Device: Magnetic Resonance Enterography (MRE) | Mayo Clinic | Recruiting | 18 Years | N/A | All | 100 | Phase 4 | United States | |
173 | NCT03267238 | June 16, 2017 | 4 November 2019 | Fecal Microbial Transplantation in Patients With Crohn's Disease | Fecal Microbial Transplantation in Patients With Crohn's Disease | Crohn Disease | Biological: Fecal Microbial Transplantation | Stony Brook University | Not recruiting | 7 Years | N/A | All | 9 | Early Phase 1 | United States | |
174 | NCT02764762 | June 12, 2017 | 11 November 2019 | Triple Combination Therapy in High Risk Crohn's Disease (CD) | An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications | Crohn Disease | Drug: Vedolizumab;Drug: Adalimumab;Drug: Methotrexate | Takeda | Recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | United States;Canada | |
175 | NCT03393247 | June 1, 2017 | 18 January 2018 | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study | Crohn Disease | Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14 | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | 14 Years | 60 Years | All | 160 | N/A | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
176 | JPRN-UMIN000025961 | 2017/05/21 | 10 September 2019 | The study of effect of Alfacalcidol treatment on Crohn's disease | The study of effect of Alfacalcidol treatment on Crohn's disease - The study of effect of Alfacalcidol treatment on Crohn's disease | Crohn's disease | Oral treatment of Alfacalcidol 1 microgram/day for 3 month | Nagoya University Hospital | Recruiting | 18years-old | Not applicable | Male and Female | 31 | Not selected | Japan | |
177 | JPRN-jRCTs041180126 | 21/05/2017 | 10 September 2019 | CD Alfacalcidol study | The study of effect of Alfacalcidol treatment on Crohn's disease | Crohn's disease | administration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level. | Masanao Nakamura | Recruiting | 18age | Not applicable | Both | 36 | Phase 2 | none | |
178 | NCT03155945 | May 18, 2017 | 16 September 2019 | Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain | A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain | Crohn's Disease;Abdominal Pain | Drug: APD371 | Arena Pharmaceuticals | Not recruiting | 18 Years | 80 Years | All | 14 | Phase 2 | United States | |
179 | NCT03185611 | May 18, 2017 | 16 December 2017 | Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease | Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial | Crohn Disease | Drug: Rifaximin;Drug: Azathioprine | Sixth Affiliated Hospital, Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw Hospital | Recruiting | 18 Years | 65 Years | All | 120 | Phase 3 | China |
180 | NCT03105128 | May 10, 2017 | 4 November 2019 | A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SC | AbbVie | Recruiting | 16 Years | 80 Years | All | 940 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Finland;France;Turkey | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
181 | NCT03172377 | May 3, 2017 | 24 September 2018 | Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients | Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients | Crohn Disease in Remission;Crohn Disease | Other: Lengthening adalimumab dosing interval | Radboud University | Erasmus Medical Center | Recruiting | 18 Years | N/A | All | 174 | Phase 4 | Netherlands |
182 | NCT03059849 | May 1, 2017 | 16 December 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 | Not recruiting | 18 Years | 80 Years | All | 290 | Phase 4 | ||
183 | NCT02994836 | April 21, 2017 | 27 May 2019 | 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 | Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus);Biological: Anti-TNF: Infliximab (Infusion) | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Recruiting | 18 Years | N/A | All | 194 | Phase 4 | Spain | |
184 | NCT03107793 | April 19, 2017 | 11 November 2019 | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab | Crohn Disease | Drug: Ustekinumab | Janssen-Cilag Ltd. | Not recruiting | 18 Years | N/A | All | 500 | Phase 3 | Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Portugal;Slovakia;Spain;Sweden;United Kingdom | |
185 | NCT03108326 | April 15, 2017 | 23 July 2018 | Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease | Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome | Crohn Disease | Biological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra | Ced Service GmbH | Recruiting | 18 Years | 80 Years | All | 900 | Phase 1 | Germany | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
186 | NCT02953275 | April 13, 2017 | 22 July 2019 | Synergistic Effect of Vedolizumab and Pentoxifylline | Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease | Crohn Disease | Drug: vedolizumab;Drug: Pentoxifylline;Drug: placebo | University of Miami | Takeda | Not recruiting | 18 Years | 80 Years | All | 37 | Early Phase 1 | United States |
187 | NCT03046056 | April 11, 2017 | 11 November 2019 | Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) | Small Bowel Crohn's Disease | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | United States;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Spain;Ukraine;United Kingdom |
188 | NCT03077412 | April 6, 2017 | 14 October 2019 | Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease | Fistulizing Crohn's Disease | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Recruiting | 18 Years | 75 Years | All | 75 | Phase 2 | United States;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Spain;United Kingdom;Poland |
189 | EUCTR2016-002939-15-DE | 05/04/2017 | 30 April 2019 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease 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 Name: V565 Product Code: V565 Pharmaceutical Form: Capsule INN or Proposed INN: not applied for Current Sponsor code: V565 Other descriptive name: V565 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 185- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | VHsquared Ltd | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | |||
190 | NCT03078803 | March 28, 2017 | 25 February 2019 | Fecal Transplant for Crohn's Disease | A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease | Crohn Disease | Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo | University of Alberta | University of Calgary;McMaster University | Recruiting | 18 Years | N/A | All | 126 | Phase 2 | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
191 | NCT03090139 | March 28, 2017 | 2 July 2018 | 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 | Not recruiting | 18 Years | N/A | All | 1731 | Phase 3 | Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey | |
192 | NCT03009396 | March 18, 2017 | 11 March 2019 | Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease | An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study | Crohn Disease | Drug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine | RedHill Biopharma Limited | Not recruiting | 18 Years | 76 Years | All | 331 | Phase 3 | United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia | |
193 | NCT02914600 | March 17, 2017 | 22 October 2019 | Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease | Crohn's Disease | Drug: Filgotinib;Drug: Placebo | Gilead Sciences | Galapagos NV | Recruiting | 18 Years | N/A | All | 1000 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic |
194 | NCT03027193 | March 15, 2017 | 11 November 2019 | A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers | A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult Volunteers | Crohn Disease;Mycobacterium Avium Subspecies Paratuberculosis | Biological: ChAdOx2 HAV;Biological: MVA HAV | University of Oxford | Recruiting | 18 Years | 50 Years | All | 28 | Phase 1 | United Kingdom | |
195 | EUCTR2016-002918-43-GB | 28/02/2017 | 26 February 2018 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease 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] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 130- Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- | Janssen-Cilag International N.V. | Authorised | Female: yes Male: yes | 650 | Phase 3 | United Kingdom;Germany;Netherlands;Spain;Belgium;Portugal | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
196 | JPRN-UMIN000026330 | 2017/02/27 | 10 September 2019 | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients | Crohn disease | Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) | University of Toyama | Not Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
197 | EUCTR2016-003797-40-BE | 23/02/2017 | 23 October 2017 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet available CAS Number: 1206123 97 8 Current Sponsor code: APD334 Other descriptive name: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | |||
198 | EUCTR2015-001924-40-AT | 21/02/2017 | 6 November 2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Celgene Corporation | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Austria;Turkey;Finland;Bosnia and Herzegovina;Korea, Republic of;Latvia;Netherlands;Denmark;Australia;Malaysia;France;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Taiwan;United States;Portugal | |||
199 | EUCTR2016-003797-40-DE | 21/02/2017 | 15 October 2018 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet available CAS Number: 1206123 97 8 Current Sponsor code: APD334 Other descriptive name: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | |||
200 | JPRN-UMIN000025846 | 2017/02/01 | 2 April 2019 | 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 medicine Department of gastroenterology | Recruiting | 16years-old | Not applicable | Male and Female | 60 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
201 | JPRN-jRCTs031180415 | 01/02/2017 | 22 July 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. | Dai Ishikawa | Recruiting | >=6 age old | Both | 120 | N/A | none | ||
202 | EUCTR2015-001179-36-CZ | 30/01/2017 | 28 February 2019 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 | Moderately to Severely Active Crohn's Disease 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: RHB-104 Pharmaceutical Form: Capsule INN or Proposed INN: Clarithromycin CAS Number: 81103-11-9 Other descriptive name: CLARITHROMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 95- INN or Proposed INN: Rifabutin CAS Number: 72559-06-9 Other descriptive name: RIFABUTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- INN or Proposed INN: Clofazimine CAS Number: 2030-63-9 Other descriptive name: CLOFAZIMINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | RedHill Biopharma Ltd. | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | |||
203 | EUCTR2016-002939-15-CZ | 24/01/2017 | 3 September 2018 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease. | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - English A six week efficacy, safety and tolerability study of V565 in Crohn’s disease (HarbOR study) | Active Crohn's Disease 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 Name: V565 Product Code: V565 Pharmaceutical Form: Capsule INN or Proposed INN: not applied for Current Sponsor code: V565 Other descriptive name: V565 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 185- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | VHsquared Ltd | Authorised | Female: yes Male: yes | 126 | Phase 2 | United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom | |||
204 | NCT03000101 | January 19, 2017 | 21 January 2019 | Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease | New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE) | Crohn's Disease;Ulcerative Colitis | Other: placebo beverage;Other: 100% pomegranate juice | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | University of Bologna;Conserve Italia;GAT Foods | Not recruiting | 18 Years | 80 Years | All | 18 | N/A | Italy |
205 | EUCTR2016-003321-42-NL | 18/01/2017 | 10 April 2017 | Stepwise extention of the adalimumab injection interval in patients with stable Crohn's disease. | Lengthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients: the LADI study. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira (adalimumab) Product Name: Adalimumab Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Radboud University Medical Centre | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
206 | NCT02968108 | January 18, 2017 | 27 May 2019 | A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease | A Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab | Janssen Research & Development, LLC | Not recruiting | 2 Years | 17 Years | All | 45 | Phase 1 | United States;Belgium;Canada;France;Germany;Poland | |
207 | NCT03261102 | January 17, 2017 | 25 March 2019 | TDM Guided Early Optimization of ADAL in Crohn's Disease | Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study | Crohn Disease;Drug Monitoring;Inflammatory Bowel Diseases | Biological: Adalimumab | waqqas.afif | AbbVie | Recruiting | 18 Years | N/A | All | 200 | N/A | Canada |
208 | EUCTR2015-001179-36-SK | 13/01/2017 | 28 February 2019 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 | Moderately to Severely Active Crohn's Disease 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: RHB-104 Pharmaceutical Form: Capsule INN or Proposed INN: Clarithromycin CAS Number: 81103-11-9 Other descriptive name: CLARITHROMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 95- INN or Proposed INN: Rifabutin CAS Number: 72559-06-9 Other descriptive name: RIFABUTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- INN or Proposed INN: Clofazimine CAS Number: 2030-63-9 Other descriptive name: CLOFAZIMINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | RedHill Biopharma Ltd. | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | |||
209 | EUCTR2016-002763-34-GB | 04/01/2017 | 28 February 2019 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Gilead Sciences, Inc. | Authorised | Female: yes Male: yes | 1000 | Phase 3 | 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 | |||
210 | NCT02862132 | January 2017 | 28 January 2019 | 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 | Recruiting | N/A | 18 Years | All | 120 | N/A | United States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
211 | NCT03012542 | January 2017 | 11 June 2018 | Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease | Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome | Crohn Disease | Dietary Supplement: Diet 1;Dietary Supplement: Diet 2 | University of Washington | Recruiting | 18 Years | N/A | All | 32 | N/A | United States | |
212 | NCT03056664 | January 2017 | 16 December 2017 | The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease | The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease | Crohn's Disease;Fistula | Procedure: Routine drainage surgery;Biological: MSC injection 01;Biological: MSC injection 02;Other: placebo | Sixth Affiliated Hospital, Sun Yat-sen University | Not recruiting | 18 Years | 65 Years | All | 3 | Phase 2/Phase 3 | ||
213 | EUCTR2017-000576-29-IE | 18 June 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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)(CARMEN CD 306). | 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 Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Not Available | Female: yes Male: yes | 1032 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina | ||||
214 | EUCTR2017-000617-23-IE | 18 June 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, 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. | 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 Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: SHP647 Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Not Available | Female: yes Male: yes | 983 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||||
215 | EUCTR2017-003649-10-PL | 28 February 2019 | 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 Level: PT 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: ETROLIZUMAB CAS Number: 1044758-60-2 Current Sponsor code: RO5490261/F02-01 Other descriptive name: ETROLIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | F. Hoffmann-La Roche Ltd | Not Available | Female: yes Male: yes | 60 | Phase 1 | United States;Belgium;Spain;Poland;Germany;United Kingdom | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
216 | NCT02891226 | December 14, 2016 | 9 September 2019 | A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY) | Crohn's Disease | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | 75 Years | All | 180 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France | |
217 | NCT02231814 | December 2016 | 24 September 2018 | Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease | Dietary Therapy Using Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet (CDED) for Induction and Maintenance of Remission in Mild to Moderate Crohn's Disease in Adults- A Pilot Study | Crohn's Disease | Dietary Supplement: Crohns Disease Exclusion Diet + PEN;Other: Crohns Disease Exclusion Diet | Prof. Arie Levine | Recruiting | 18 Years | 55 Years | All | 40 | N/A | Israel | |
218 | NCT02704624 | December 2016 | 9 July 2018 | Effects of Supplementation of Vitamin D in Patients With Crohn`s Disease | The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial | Crohn Disease;Vitamin D Deficiency;Fatigue;Sarcopenia;Muscle Weakness;Disorder of Bone Density and Structure, Unspecified | Dietary Supplement: Vitamin D;Other: Placebo | Federal University of Juiz de Fora | Fundação de Amparo à Pesquisa do estado de Minas Gerais | Recruiting | 18 Years | 50 Years | All | 110 | Phase 4 | Brazil |
219 | NCT03183661 | November 16, 2016 | 16 December 2017 | A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial | Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101) | Crohn Disease | Biological: ALLO-ASC-CD | Anterogen Co., Ltd. | Recruiting | 18 Years | 65 Years | All | 9 | N/A | ||
220 | EUCTR2016-000634-21-DE | 08/11/2016 | 3 September 2018 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease | Active Crohn's Disease 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 Code: JNJ-64304500 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: JNJ-64304500 Current Sponsor code: JNJ-64304500 Other descriptive name: JNJ-64304500-AAA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB CAS Number: 815610-63-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for infusion INN or Proposed INN: USTEKINUMAB CAS Number: 815610-63-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International NV | Authorised | Female: yes Male: yes | 693 | Phase 2 | United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
221 | JPRN-UMIN000024566 | 2016/11/01 | 2 April 2019 | Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. | Crohn'disease | Dose escalation group Administration of Adalimumab 80 mg every other week Non-dose escalation group Administration of Adalimumab 40 mg every other week | Toho University Medical Center Sakura Hospital | Not Recruiting | 16years-old | Not applicable | Male and Female | 60 | Not applicable | Japan | ||
222 | NCT02760615 | November 1, 2016 | 10 December 2018 | 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 | Recruiting | 18 Years | 55 Years | All | 60 | Phase 4 | United States | |
223 | NCT02998827 | November 2016 | 9 January 2017 | Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients | Crohn Disease | Drug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutrition | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | N/A | N/A | Female | 90 | N/A | |||
224 | JPRN-UMIN000023735 | 2016/10/31 | 23 April 2019 | Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study | Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study - TRADE study | Crohn's disease | EW or EOW injection of adalimumab | Saitama Medical Center, Saitama Medical University | Not Recruiting | 15years-old | 75years-old | Male and Female | 10 | Not selected | Japan | |
225 | NCT02914561 | October 31, 2016 | 22 October 2019 | Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease | Combined Phase 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 Crohn's Disease | Crohn's Disease | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Recruiting | 18 Years | 75 Years | All | 1320 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sri Lanka;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
226 | EUCTR2016-002061-54-IT | 13/10/2016 | 7 January 2019 | 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 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT 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 Pharmaceutical Form: Powder for solution for infusion | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | |||
227 | NCT02772965 | October 2016 | 28 October 2019 | Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy | Pediatric Crohn's Disease | Drug: Methotrexate;Other: Sugar pill (placebo) | University of North Carolina, Chapel Hill | Patient-Centered Outcomes Research Institute;ImproveCareNow (ICN);The Leona M. and Harry B. Helmsley Charitable Trust;Children's Hospital Medical Center, Cincinnati;Grifols Diagnostics Solutions, Inc;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | N/A | 20 Years | All | 425 | Phase 3 | United States |
228 | NCT02956538 | October 2016 | 14 November 2016 | Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide | Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study | Crohn Disease | Drug: Thalidomide;Drug: placebo(for thalidomide) | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | 18 Years | 50 Years | Both | 72 | Phase 0 | China | |
229 | EUCTR2016-003073-18-GB | 29/09/2016 | 3 April 2017 | 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 Level: LLT 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 Pharmaceutical Form: Oral solution INN or Proposed INN: Ozanimod hydrochloride CAS Number: 1618636-37-5 Current Sponsor code: RPC1063HCL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.1- | Celgene International II Sàrl | Authorised | Female: no Male: yes | 6 | Phase 1 | United Kingdom | |||
230 | NCT02871635 | September 28, 2016 | 27 May 2019 | BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity | BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity | Crohn Disease | Drug: BI 695501;Drug: HUMIRA | Boehringer Ingelheim | Not recruiting | 18 Years | 80 Years | All | 147 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Israel;Poland;Russian Federation;Serbia;Turkey;Ukraine;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
231 | EUCTR2014-004904-31-BE | 21/09/2016 | 20 August 2018 | 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) Pharmaceutical Form: Powder for concentrate for solution for injection/infusion | Mundipharma Pharmaceuticals B.V. | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | |||
232 | NCT02883452 | September 12, 2016 | 26 August 2019 | A Phase I Study to Evaluate PK, Efficacy and Safety of CT-P13 SC in Patients With Active CD and UC | 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 | Biological: Infliximab | Celltrion | Not recruiting | 18 Years | 75 Years | All | 170 | Phase 1 | Korea, Republic of | |
233 | JPRN-UMIN000023871 | 2016/09/01 | 2 April 2019 | Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) | Crohn's disease | Administration of Adalimumab 80 mg every 2 weeks. Administration of Adalimumab 40 mg every week. | Fukuoka University Chikushi Hospital | Recruiting | 16years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | ||
234 | NCT02820493 | September 2016 | 11 June 2018 | Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF | Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression | Crohn Disease | Drug: vedolizumab | Universita degli Studi di Genova | Not recruiting | 18 Years | 80 Years | All | 0 | Phase 4 | ||
235 | NCT02630966 | August 10, 2016 | 3 December 2018 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE) | Crohn Disease | Drug: Vedolizumab;Drug: Placebo | Takeda | Not recruiting | 18 Years | 80 Years | All | 34 | Phase 4 | United States;Canada;France;Italy;Netherlands;Spain;United Kingdom;Belgium | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
236 | NCT02743806 | August 1, 2016 | 11 November 2019 | 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 | 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 | |
237 | NCT02765256 | August 2016 | 26 August 2019 | Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Crohn's Disease | Drug: Fluconazole;Drug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: Promethazine | University of Pennsylvania | Children's Hospital of Philadelphia;Crohn's and Colitis Foundation | Not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United States |
238 | NCT02897661 | August 2016 | 16 December 2017 | Fecal Microbiota Transplantation Improves Nutritional State of Patients With Crohn's Disease | Fecal Microbiota Transplantation Combined Enteral Nutrition Therapy Contribute to Nutritional Improvement of Patients With Crohns' Disease | Crohn's Diseases | Procedure: FMT;Drug: Metronidazole;Dietary Supplement: EN | The Second Hospital of Nanjing Medical University | Recruiting | 18 Years | 65 Years | All | 60 | Phase 2/Phase 3 | China | |
239 | NCT02641392 | July 25, 2016 | 11 February 2019 | A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | Crohn's Disease | Drug: GED-0301;Other: Placebo | Celgene | Not recruiting | 12 Years | N/A | All | 310 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Estonia;Finland;Malaysia;New Zealand;South Africa | |
240 | EUCTR2016-000205-36-DE | 11/07/2016 | 14 November 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 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: FE 999301 Pharmaceutical Form: Concentrate for solution for infusion | University Hospital Schleswig-Holstein (UKSH) | Authorised | Female: yes Male: yes | Phase 2 | Germany | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
241 | EUCTR2016-001638-84-NL | 08/07/2016 | 23 October 2017 | Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study | Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study - ThiLDA-study | Crohn's disease & Colitis Ulcerosa;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Allopurinol Sandoz 100 mg, tabletten Pharmaceutical Form: Tablet INN or Proposed INN: ALLOPURINOL CAS Number: 315-30-0 Current Sponsor code: allopurinol Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50- INN or Proposed INN: ALLOPURINOL CAS Number: 315-30-0 Current Sponsor code: allopurinol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Meander Medical Center | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | ||||
242 | JPRN-UMIN000019958 | 2016/07/02 | 2 April 2019 | 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 University Kochi Medical School Hospital Keio University School of Medicine | Not Recruiting | 15years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | ||
243 | NCT02768532 | July 1, 2016 | 26 August 2019 | Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease | VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease | Crohn Disease | Drug: Vedolizumab | Centre Hospitalier Universitaire de Saint Etienne | Theradiag;Takeda | Recruiting | 18 Years | N/A | All | 93 | Phase 4 | France |
244 | NCT02793778 | July 2016 | 15 July 2019 | Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF Therapy | Crohn's Disease | Drug: CROWN;Drug: CROWN Placebo | Prometheus Laboratories | Nestlé Health Science Spain;Nestec Ltd. | Not recruiting | 18 Years | 85 Years | All | 42 | Phase 2 | United States |
245 | NCT02806206 | July 2016 | 8 August 2016 | Prucalopride Prior to Small Bowel Capsule Endoscopy | The Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled Trial | Gastrointestinal Hemorrhage;Crohn Disease;Celiac Disease;Intestinal Diseases;Inflammatory Bowel Diseases | Drug: Prucalopride;Drug: Placebo | University of British Columbia | Not recruiting | 19 Years | N/A | Both | 122 | Phase 4 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
246 | JPRN-UMIN000022270 | 2016/06/30 | 23 April 2019 | Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease | Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease - ADA2 study | Crohn's disease | double dose of adalimumab | Saitama Medical Center | Not Recruiting | 15years-old | 80years-old | Male and Female | 20 | Not selected | Japan | |
247 | EUCTR2016-000678-40-CZ | 27/06/2016 | 28 February 2019 | 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 Level: LLT 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Takeda Development Centre Europe Limited | Authorised | Female: yes Male: yes | 385 | Phase 4 | 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 | |||
248 | EUCTR2015-000555-24-NL | 16/06/2016 | 8 August 2016 | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel. | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Concentrate and solvent for solution for infusion Route of administration of the placebo: Intravenous use | Academic Medical Center Amsterdam | Authorised | Female: yes Male: yes | 80 | Phase 4 | Netherlands | |||
249 | EUCTR2016-001278-13-FI | 08/06/2016 | 27 June 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 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10057035 Term: Crohn's ileocolitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10011405 Term: Crohn's enteritis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10011406 Term: Crohn's ileitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10076318 Term: Crohn's disease relapse System Organ Class: 10017947 - Gastrointestinal disorders 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 10011402 Term: Crohn's disease (colon) System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10075466 Term: Fistulising Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT 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 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 | Taina Sipponen | Authorised | Female: yes Male: yes | Phase 4 | Finland | ||||
250 | NCT02782663 | May 18, 2016 | 1 April 2019 | A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease | Crohn's Disease (CD) | Drug: ABT-494 | AbbVie | Not recruiting | 18 Years | 75 Years | All | 107 | Phase 2 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Romania;Slovakia;Spain;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
251 | ChiCTR-OPC-16008655 | 2016-05-01 | 18 April 2017 | Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China | Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China | Crohn‘s Disease | 1:Thalidomide 75-100mg qd;2:Thalidomide 150-200mg qd;3:Thalidomide 75-100mg qd+MTX 20-25mg /W; | Peking Union Medical College Hospital | Recruiting | 16 | 70 | Both | 1:90;2:90;3:90; | Post-market | China | |
252 | NCT02538341 | May 2016 | 15 April 2019 | Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) | Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial) | Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Not recruiting | 50 Years | N/A | All | 617 | Phase 2 | United States |
253 | EUCTR2015-004618-10-BE | 19/04/2016 | 8 August 2016 | 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 CAS Number: 170277-31-3 Other descriptive name: Remsima Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remicade Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 Trade Name: Inflectra Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Inflectra Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 | CUB- Hopital Erasme | Authorised | Female: yes Male: yes | Phase 4 | Belgium | ||||
254 | NCT02620046 | April 15, 2016 | 20 May 2019 | Vedolizumab Subcutaneous 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 | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab SC | Takeda | Recruiting | 18 Years | 80 Years | All | 692 | Phase 3 | Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;United States;Colombia;Czech Republic;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 | |
255 | EUCTR2015-001963-37-SK | 14/04/2016 | 19 November 2018 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Celgene Corporation | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
256 | NCT02749630 | April 11, 2016 | 11 November 2019 | 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. | Not recruiting | 18 Years | 80 Years | All | 90 | Phase 1 | Germany;United Kingdom;Canada | |
257 | NCT02685683 | April 4, 2016 | 20 August 2018 | Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease | A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: GED-0301 | Celgene | Not recruiting | 18 Years | N/A | All | 18 | Phase 2 | Italy | |
258 | JPRN-UMIN000020029 | 2016/04/01 | 22 July 2019 | 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. | Saitama Medical University | Recruiting | 16years-old | Not applicable | Male and Female | 300 | Not selected | Japan | |
259 | NCT02324699 | April 2016 | 3 September 2018 | Corticosteroids With Vedolizumab in Crohn's Disease | Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial | Crohn's Disease | Drug: Prednisone;Drug: Placebo;Drug: Vedolizumab | Icahn School of Medicine at Mount Sinai | Takeda | Not recruiting | 18 Years | 70 Years | All | 1 | Phase 4 | United States |
260 | NCT02538354 | March 2016 | 13 June 2016 | The Effect of Riboflavin in Crohn's Disease | The Effect of Riboflavin Supplementation on Faecalibacterium Prausnitzii in Crohn's Disease | Crohn Disease | Dietary Supplement: Riboflavin supplementation | University Medical Center Groningen | Recruiting | 18 Years | 65 Years | Both | 84 | N/A | Netherlands | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
261 | NCT02769494 | March 2016 | 23 May 2016 | The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer | The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease | Crohn's Disease;Oral Ulcer | Drug: Mesalazine Sustained-Release Tablets;Drug: Riboflavin Sodium Phosphate Injection | Xijing Hospital of Digestive Diseases | Recruiting | 18 Years | 65 Years | Both | 40 | Phase 3 | China | |
262 | EUCTR2015-001925-18-GB | 24/02/2016 | 2 October 2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety o | Active Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Celgene Corporation | Authorised | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
263 | EUCTR2015-001963-37-LV | 18/02/2016 | 29 January 2018 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Celgene Corporation | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
264 | NCT02186275 | February 2016 | 16 December 2017 | The Vitamin D in Pediatric Crohn's Disease | Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses | Crohn's Disease | Drug: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day;Drug: Vitamin D3 800 UI/day then 800 UI/day | St. Justine's Hospital | Canadian Institutes of Health Research (CIHR) | Recruiting | 9 Years | 18 Years | All | 316 | Phase 3 | Canada |
265 | EUCTR2015-002025-19-PL | 28/01/2016 | 28 February 2019 | An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.1 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod CAS Number: 1306760-87-1 Other descriptive name: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: 1mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod CAS Number: 1306760-87-1 Other descriptive name: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene Corporation | Authorised | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
266 | NCT02925351 | January 25, 2016 | 11 November 2019 | Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases | The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases | Autoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu Arteritis | Procedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission Tomography | Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI) | Not recruiting | 18 Years | N/A | All | 8 | N/A | United States |
267 | NCT02742597 | January 12, 2016 | 8 January 2018 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital | Not recruiting | 18 Years | 80 Years | All | 1980 | N/A | Canada |
268 | NCT02574637 | January 5, 2016 | 20 August 2018 | Evaluation of Efficacy and Safety of MEDI2070 in Subjects With Active, Moderate to Severe Crohn's Disease | A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | Crohn's Disease | Drug: MEDI2070 High dose;Drug: MEDI2070 High-Med dose;Drug: MEDI2070 Low-Med dose;Drug: MEDI2070 Low dose;Drug: Placebo | Allergan | Not recruiting | 18 Years | 80 Years | All | 29 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Russian Federation;Spain;Bulgaria;Czech Republic;Korea, Republic of;Poland;Turkey;United Kingdom | |
269 | NCT02611817 | January 4, 2016 | 1 July 2019 | Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease | Drug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mg | Takeda | Not recruiting | 18 Years | 80 Years | All | 644 | Phase 3 | United States;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic;Spain | |
270 | ChiCTR-IIR-16007751 | 2016-01-01 | 18 April 2017 | Clinical study of acupuncture and moxibustion treatment for Cohn's disease | Molecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease | Crohn's disease | Acupuncture Group:Acupuncture, Moxibustion, Prednisone and azathioprine;Placebo acupuncture group:Placebo acupuncture, moxibustion, Prednisone and azathioprine;Drug Group:Prednisone and azathioprine; | Shanghai Research Institute of Acupuncture and Meridian | Recruiting | 16 | 70 | Both | Acupuncture Group:40;Placebo acupuncture group:40;Drug Group:40; | Phase 1 study | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
271 | ChiCTR1800020305 | 2016-01-01 | 14 January 2019 | A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease | Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI | crohn's disease;K50.900 | Group 2:infliximab + azathioprine;Group 1:infliximab alone; | Department of Gastroenterology, Nanfang Hospital, Southern Medical University | Recruiting | 12 | 80 | Both | Group 2:41;Group 1:45; | Retrospective study | China | |
272 | NCT02465944 | January 2016 | 5 September 2016 | A Pilot Study of FFP104 in Subjects With Crohn's Disease | A Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects With Moderate to Severely Active Crohn's Disease | Crohn's Disease | Drug: FFP104;Drug: Placebo | Fast Forward Pharmaceuticals | Recruiting | 18 Years | 75 Years | Both | 24 | Phase 1/Phase 2 | Belgium;Netherlands | |
273 | NCT02532738 | January 2016 | 7 September 2015 | The Efficiency of MSC in Refractory Crohn's Disease | A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease | Crohn's Disease | Drug: Routine Treatment of CD;Biological: MSC treatment 01;Biological: MSC treatment 02;Other: NS | Sixth Affiliated Hospital, Sun Yat-sen University | Third Affiliated Hospital, Sun Yat-Sen University;Nanfang Hospital of Southern Medical University | Not recruiting | 18 Years | 65 Years | Both | 3 | Phase 2/Phase 3 | |
274 | NCT02680756 | January 2016 | 18 June 2018 | Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD | A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease | Anemia, Iron-Deficiency;Inflammatory Bowel Disease;Crohn's Disease | Drug: Ferric Maltol;Drug: Ferric Carboxy Maltose | Shield Therapeutics | Recruiting | 18 Years | N/A | All | 242 | Phase 3 | United States;Belgium;France;Germany;Hungary;Spain | |
275 | EUCTR2016-000522-18-FR | 2 October 2017 | Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy | Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL | Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: humira Pharmaceutical Form: Solution for infusion INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- Product Name: Imurel Pharmaceutical Form: Coated tablet INN or Proposed INN: azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 2.5- Trade Name: Methotrexate Product Name: methotrexate Pharmaceutical Form: Solution for injection | PIBDNet | Not Available | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
276 | EUCTR2016-000786-24-IT | 5 March 2018 | Efficacy and safety of thalidomide in pediatric patients with Crohn's disease | Thalidomide, a novel immunological treatment to modify the natural history of paediatric Crohn's disease: a new proposal from a well-established paediatric research network - Talidomide in Crohn disease in Pediatrics | Crohn's Disease MedDRA version: 19.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: THALIDOMIDE CELGENE - 50 MG CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PE/ACLAR/ALU) 28 CAPSULE Pharmaceutical Form: Capsule, hard Product Name: INFLIXIMAB Pharmaceutical Form: Powder for infusion | IRCCS Burlo Garofolo | Not Available | Female: yes Male: yes | 124 | Phase 3 | Italy | ||||
277 | EUCTR2016-003190-17-CZ | 28 February 2019 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal | AbbVie Deutschland GmbH & Co. KG | Not Available | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||||
278 | NCT02596893 | December 8, 2015 | 2 September 2019 | Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | Not recruiting | 18 Years | N/A | All | 701 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Former Serbia and Montenegro;South Africa | |
279 | NCT02678052 | December 1, 2015 | 26 August 2019 | OTIS Vedolizumab Pregnancy Exposure Registry | Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab;Biological: Other Biological Agent | Takeda | Recruiting | 18 Years | 44 Years | Female | 200 | N/A | United States;Canada | |
280 | NCT02620007 | December 2015 | 4 March 2019 | Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease | Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease | Crohn Disease;Adherent-invasive E. Coli | Drug: Ciprofloxacin;Drug: Rifaximin;Drug: Ciprofloxacin Placebo;Drug: Rifaximin Placebo | Assistance Publique - Hôpitaux de Paris | Recruiting | 18 Years | 80 Years | All | 62 | Phase 2 | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
281 | NCT02636517 | December 2015 | 18 December 2018 | 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 | Recruiting | 3 Years | 21 Years | All | 50 | N/A | United States | |
282 | NCT02597829 | November 2015 | 17 November 2015 | Does Clinical Response Correlate With Serum Certolizumab Levels? | Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO) | Crohn's Disease | Drug: Certolizumab Pegol | Shafran Gastroenterology Center | UCB Pharma;UCB Pharma | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 4 | United States |
283 | NCT02622763 | November 2015 | 25 February 2019 | Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment | Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease | Crohn's Disease | Biological: Tolerogenic Dendritic Cells | Fundacion Clinic per a la Recerca Biomédica | Recruiting | 18 Years | 65 Years | All | 20 | Phase 1 | Spain | |
284 | NCT02926300 | November 2015 | 16 December 2017 | Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD) | Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease | Crohn's Disease | Biological: stem cells | Kang Stem Biotech Co., Ltd. | Recruiting | 19 Years | 70 Years | All | 24 | N/A | Korea, Republic of | |
285 | EUCTR2014-005666-29-GB | 16/10/2015 | 21 August 2017 | A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's disease | A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease. - A study of Thetanix in young people with stable Crohn's disease | Crohn's disease in young persons 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 Name: Thetanix Product Code: B. theta Pharmaceutical Form: Capsule INN or Proposed INN: Colony-purified Bacteroides thetaiotaomicron (B.theta) Current Sponsor code: MRx1233 (previously LBP001) Other descriptive name: B. theta Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: range Concentration number: 1E+7 to 1E+10-CFU/g Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | 4D Pharma | Authorised | Female: yes Male: yes | Phase 1 | United Kingdom | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
286 | NCT02531113 | October 9, 2015 | 30 September 2019 | Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease | A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy | Crohn's Disease | Drug: RPC1063 | Celgene | Not recruiting | 18 Years | 75 Years | All | 69 | Phase 2 | United States;Canada;Hungary;Poland;Ukraine;Italy | |
287 | NCT02177071 | October 2015 | 21 January 2019 | A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy | A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy | Crohn's Disease | Drug: INFLIXIMAB;Drug: AZATHIOPRINE;Drug: MERCAPTOPURINE;Drug: Methotrexate | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Saint-Louis Hospital, Paris, France | Recruiting | 18 Years | 65 Years | All | 300 | Phase 4 | Australia;Belgium;France |
288 | NCT02520843 | October 2015 | 28 January 2019 | An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF | An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction | Crohn Disease | Drug: stromal vascular fraction (SVF) | Assistance Publique Hopitaux De Marseille | Not recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | France | |
289 | NCT02847884 | October 2015 | 11 June 2019 | IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study | IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study | Inflammatory Bowel Disease;Crohn's Disease | Biological: Infliximab | University of Alberta | The Hospital for Sick Children;The Children's Hospital of Winnipeg;Alberta Children's Hospital;Provincial Health Services Authority;Children's Hospital of Eastern Ontario | Not recruiting | 2 Years | 17 Years | All | 28 | Phase 2 | Canada |
290 | EUCTR2013-003199-11-BE | 25/09/2015 | 28 May 2018 | CURE | Changing the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURE | Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Adalimumab Product Name: Humira Pharmaceutical Form: Injection | GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives | Authorised | Female: yes Male: yes | 200 | Phase 4 | France;Belgium | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
291 | EUCTR2015-001834-15-ES | 24/09/2015 | 12 October 2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 18.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not available yet Current Sponsor code: BI 655066 Other descriptive name: BI 655066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Product Code: BI 655066 90 mg/ml Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: not available yet Current Sponsor code: BI 655066 Other descriptive name: BI 655066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- | Boehringer Ingelheim España, S.A. | Authorised | Female: yes Male: yes | 62 | United States;Canada;Spain;Germany;Korea, Republic of | ||||
292 | NCT02513459 | September 16, 2015 | 15 July 2019 | A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab) in Patients With Moderately to Severely Active Crohn's Disease | An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: ABBV-066 | AbbVie | Boehringer Ingelheim | Not recruiting | 18 Years | 75 Years | All | 65 | Phase 2 | United States;Belgium;Canada;Germany;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom |
293 | NCT02417974 | September 2015 | 24 June 2019 | Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) | Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) | Crohn's Disease | Biological: Fecal Microbiota Transplant (FMT) | Beth Israel Deaconess Medical Center | Brigham and Women's Hospital;Boston Medical Center;Massachusetts Institute of Technology | Recruiting | 18 Years | N/A | All | 44 | Phase 2 | United States |
294 | NCT02522169 | September 2015 | 24 August 2015 | TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease | Verbessertes Therapiemanagement für pädiatrische CED-Patienten Mit Chronisch-entzündlicher Darmerkrankung: Eine Randomisierte Multizentrische Studie, Welche Die Effektivität Einer Talspiegel-gesteuerten Infliximab-Erhaltungsphase Mit Dem herkömmlichen Dosierungsregime Vergleicht Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Randomized Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease | Pediatric Crohns Disease | Drug: Infliximab | Klinikum Westbrandenburg GmbH | Not recruiting | 6 Years | 17 Years | Both | 120 | N/A | ||
295 | NCT03010787 | September 2015 | 16 December 2017 | A First Time in Human Study in Healthy Volunteers and Patients | A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy | Crohn's Disease | Drug: V565;Drug: Placebo | VHsquared Ltd. | Not recruiting | 18 Years | 65 Years | All | 47 | Phase 1 | United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
296 | EUCTR2014-004108-31-HU | 27/08/2015 | 29 August 2016 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU | Moderately Active Crohn's Disease MedDRA version: 18.0 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: RHB-104 Pharmaceutical Form: Capsule INN or Proposed INN: Clarithromycin CAS Number: 81103-11-9 Other descriptive name: CLARITHROMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 95- INN or Proposed INN: Rifabutin CAS Number: 72559-06-9 Other descriptive name: RIFABUTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- INN or Proposed INN: Clofazimine CAS Number: 2030-63-9 Other descriptive name: CLOFAZIMINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | RedHill Biopharma Ltd. | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Slovakia;Belgium;Spain;Ukraine;Ireland;Russian Federation;Netherlands;Germany;United Kingdom | |||
297 | EUCTR2014-003824-36-SE | 12/08/2015 | 17 September 2018 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease 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 Name: Etrolizumab Product Code: Ro 549-0261/F04-02 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 210- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | |||
298 | EUCTR2014-003855-76-SE | 12/08/2015 | 17 September 2018 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease 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 Name: Etrolizumab Product Code: Ro 549-0261/F04-02 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | |||
299 | NCT02538679 | August 7, 2015 | 16 December 2017 | A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques | A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal Surgery | Crohn's Disease;Inflammatory Bowel Disease;Postoperative Pain | Other: Placebo;Drug: US TAP Bupivacaine/Epinephrine;Drug: Lap TAP Bupivacaine/Epinephrine | Cedars-Sinai Medical Center | Not recruiting | 18 Years | 90 Years | All | 127 | N/A | ||
300 | NCT02193750 | August 2015 | 11 June 2018 | Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease | Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial | Crohn's Disease | Dietary Supplement: Placebo;Dietary Supplement: Moderate Oligosaccharide Group;Dietary Supplement: High Oligosaccharide Group | University of British Columbia | The Alfred;Melbourne Health | Recruiting | 19 Years | N/A | All | 48 | N/A | Australia;Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
301 | NCT02389790 | August 2015 | 16 December 2017 | Extension Study of MT-1303 in Subjects With Crohn's Disease | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study | Crohn's Disease | Drug: MT-1303 | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 18 Years | 65 Years | All | 46 | Phase 2 | Czechia;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine;Czech Republic | |
302 | NCT02452151 | August 2015 | 1 June 2015 | Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial | Santeon InflixMab biosimILAr Research A 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. | Colitis, Ulcerative;Crohn's Disease | Drug: Infliximab-Biosimilar;Drug: Infliximab-Innovator | Onze Lieve Vrouwe Gasthuis | Santeon | Not recruiting | 18 Years | N/A | Both | 300 | Phase 4 | |
303 | NCT02499783 | July 27, 2015 | 29 January 2018 | Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein | Crohn's Disease | Biological: Adalimumab;Other: Placebo | AbbVie | Not recruiting | 18 Years | 70 Years | All | 205 | Phase 3 | China | |
304 | EUCTR2015-001179-36-PL | 24/07/2015 | 30 April 2019 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn's Disease 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: RHB-104 Pharmaceutical Form: Capsule INN or Proposed INN: Clarithromycin CAS Number: 81103-11-9 Other descriptive name: CLARITHROMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 95- INN or Proposed INN: Rifabutin CAS Number: 72559-06-9 Other descriptive name: RIFABUTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- INN or Proposed INN: Clofazimine CAS Number: 2030-63-9 Other descriptive name: CLOFAZIMINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | RedHill Biopharma Ltd. | Not Recruiting | Female: yes Male: yes | 324 | Phase 3 | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | |||
305 | NCT02646683 | July 2015 | 13 May 2019 | A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study | An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study (LOw Countries VEdolizumab in CD Study) | Crohn Disease | Drug: vedolizumab | Geert D'Haens | Takeda | Recruiting | 18 Years | 80 Years | All | 260 | Phase 4 | Belgium;Hungary;Netherlands |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
306 | EUCTR2014-005376-29-NL | 29/06/2015 | 4 August 2015 | An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease. | An open-label observational phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Pharmaceutical Form: Powder for concentrate for dispersion for infusion | Academic Medical Center, Gastroenterology | Authorised | Female: yes Male: yes | 260 | Phase 4 | Netherlands | |||
307 | EUCTR2014-001050-41-DE | 12/06/2015 | 28 February 2019 | Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2 | A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease - REACT2 | Crohn's Disease MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection | Robarts Clinical Trials | Authorised | Female: yes Male: yes | 1200 | Phase 4 | United States;Canada;Germany;United Kingdom | |||
308 | NCT02403323 | June 8, 2015 | 4 November 2019 | Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn Disease | Drug: etrolizumab | Hoffmann-La Roche | Recruiting | 18 Years | N/A | All | 900 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic | |
309 | EUCTR2014-004904-31-NL | 19/05/2015 | 5 September 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) Pharmaceutical Form: Powder for concentrate for solution for injection/infusion | Mundipharma Pharmaceuticals B.V. | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
310 | NCT02256462 | May 1, 2015 | 25 February 2019 | Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial | Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial | Crohn's Disease | Drug: Adalimumab | Schneider Children's Medical Center, Israel | Not recruiting | 6 Years | 17 Years | All | 82 | Phase 4 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
311 | NCT02413047 | May 2015 | 16 December 2017 | 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 | Recruiting | 18 Years | 80 Years | All | 20 | N/A | United States | |
312 | NCT02423460 | May 2015 | 19 November 2018 | Threonine Requirement in IBD Adults and Healthy Adult Controls | Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology | Ulcerative Colitis;Crohn's Disease;Healthy | Other: Threonine | Nestlé | The Hospital for Sick Children;Mount Sinai Hospital, Canada | Not recruiting | 18 Years | 40 Years | Male | 86 | N/A | Canada |
313 | NCT02575040 | May 2015 | 26 October 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 | Recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Turkey | |
314 | NCT02405442 | April 30, 2015 | 23 April 2019 | Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Andecaliximab;Drug: Placebo | Gilead Sciences | Not recruiting | 18 Years | 75 Years | All | 187 | Phase 2 | United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Czech Republic;Iceland | |
315 | NCT02539368 | April 22, 2015 | 26 August 2019 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease | POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD) | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease | Drug: CT-P13;Drug: Remicade | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 2565 | Phase 3 | Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
316 | NCT02425111 | April 13, 2015 | 16 December 2017 | Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV | Crohn's Disease | Drug: Vedolizumab | Takeda | Not recruiting | 18 Years | 80 Years | All | 101 | Phase 3 | United States;Belgium;Canada;Czechia;France;Hungary;Italy;Poland;Czech Republic | |
317 | NCT02367183 | April 8, 2015 | 21 January 2019 | A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease | A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease. | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | Not recruiting | 18 Years | N/A | All | 64 | Phase 1 | United States;Australia;Canada;Hungary;Slovakia | |
318 | NCT02208310 | April 2015 | 16 December 2017 | Trial of High Dose Vitamin D in Patient's With Crohn's Disease | A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease | Crohn's Disease;Vitamin D Deficiency | Drug: Cholecalciferol 10,000 IU;Drug: Cholecalciferol 400 IU | University of Michigan | Crohn's and Colitis Foundation | Not recruiting | 18 Years | 75 Years | All | 11 | Phase 4 | United States |
319 | NCT02517684 | April 2015 | 25 February 2019 | Top-down Infliximab Study in Kids With Crohn's Disease | Top-down Infliximab Study in Kids With Crohn's Disease | Crohn's Disease | Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine | Erasmus Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer | Not recruiting | 3 Years | 17 Years | All | 100 | Phase 4 | Belgium;Finland;Netherlands;Denmark;Italy;Poland |
320 | NCT02580617 | April 2015 | 22 January 2018 | A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease | A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease | Crohn's Disease | Biological: ALLO-ASC | Anterogen Co., Ltd. | Recruiting | 18 Years | 65 Years | All | 9 | Phase 1 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
321 | NCT02851134 | April 2015 | 11 March 2019 | Search for New Genetic Mutations Major Effect in Crohn's Disease | Search for New Genetic Mutations Major Effect in Crohn's Disease | Crohn Disease | Genetic: genetic analysis;Biological: blood and stools samples | University Hospital, Lille | Not recruiting | 5 Years | 80 Years | All | 20 | N/A | France | |
322 | NCT02674308 | March 31, 2015 | 14 October 2019 | 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 | Not recruiting | 18 Years | N/A | All | 5302 | N/A | United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom | |
323 | NCT02394028 | March 20, 2015 | 4 November 2019 | A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants With Moderately to Severely Active Crohn's Disease (CD) | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Etrolizumab;Drug: Placebo | Hoffmann-La Roche | Recruiting | 18 Years | 80 Years | All | 1150 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic | |
324 | NCT02365649 | March 17, 2015 | 16 December 2017 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy | Crohn's Disease | Drug: ABT-494;Drug: Placebo | AbbVie | Not recruiting | 18 Years | 75 Years | All | 219 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Romania;Slovakia;Spain;United Kingdom;Czech Republic;Sweden | |
325 | NCT03306446 | March 17, 2015 | 8 April 2019 | Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab | Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab | CD | Drug: Start adalimumab in monotherapy | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Not recruiting | 18 Years | 75 Years | All | 203 | Phase 4 | Belgium;France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
326 | NCT02675153 | March 1, 2015 | 16 December 2017 | To Evaluate the Efficacy and Safety of Sirolimus for Crohn's Disease With Stenosis | Efficacy and Safety of Sirolimus in the Treatment of Crohn's Disease With Stenosis | Crohn's Diseases | Drug: Sirolimus;Drug: 5-ASA, Prednisone, Azathioprine or Remicade | The Second Hospital of Nanjing Medical University | Xijing Hospital of Digestive Diseases | Recruiting | 18 Years | 70 Years | All | 50 | Phase 4 | China |
327 | NCT01836289 | March 2015 | 20 August 2018 | High-dose Cyclophosphamide for Severe Refractory Crohn Disease | High-dose Cyclophosphamide for Severe Refractory Crohn Disease | Crohn's Disease;Crohn Disease | Drug: High-dose Cyclophosphamide | Johns Hopkins University | Not recruiting | 18 Years | 100 Years | All | 0 | Phase 1/Phase 2 | United States | |
328 | NCT02378688 | March 2015 | 24 October 2016 | Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease | Crohn's Disease | Drug: MT-1303;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 18 Years | 65 Years | Both | 78 | Phase 2 | Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine | |
329 | NCT02392286 | March 2015 | 18 January 2018 | Corticosteroid Dosage for Crohn's Disease Flare | A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares | Crohn's Disease;Inflammatory Bowel Disease | Drug: Corticosteroid | Yale University | Recruiting | 18 Years | N/A | All | 182 | Phase 4 | United States | |
330 | EUCTR2014-001645-24-DE | 09/02/2015 | 28 February 2019 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaxmin DR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Salix Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
331 | EUCTR2014-001644-38-DE | 02/02/2015 | 28 February 2019 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) Pharmaceutical Form: Tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaxmin DR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Salix Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | |||
332 | NCT02061163 | February 2015 | 29 June 2015 | Contrast-Enhanced Ultrasound in Human Crohn's Disease | Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease | Crohn's Disease | Device: Contrast Enhanced Ultrasound;Drug: Optison | University of Michigan | Not recruiting | 10 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States | |
333 | NCT02321280 | February 2015 | 22 October 2018 | The Efficacy of Denosumab in Active Crohn's Disease | Denosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's Disease | Crohn Disease | Drug: Denosumab | University of Manitoba | University of Toronto;McMaster University | Not recruiting | 18 Years | 80 Years | All | 2 | Phase 1/Phase 2 | Canada |
334 | JPRN-UMIN000032485 | 2015/01/01 | 2 April 2019 | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease | Cron's disease | adalimumab azathiopurine | Sakura medical center, Toho university | Recruiting | 20years-old | 70years-old | Male and Female | 20 | Not selected | Japan | ||
335 | NCT02272868 | January 2015 | 11 June 2018 | Fecal Microbial Transplant in Pediatric Crohn's Disease | Fecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control Study | Crohn's Disease | Biological: Fecal Microbial transplant;Drug: Normal Saline;Drug: rifaximin+omeprazole+miralax | Seattle Children's Hospital | Not recruiting | 12 Years | 21 Years | All | 7 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
336 | NCT02335281 | January 2015 | 19 February 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 | Recruiting | 16 Years | 70 Years | Both | 40 | Phase 2 | China | |
337 | EUCTR2015-002882-41-AT | 1 February 2016 | A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease | Sono-Response-Study A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease | Inflammatory bowel disease (Crohn's disease) MedDRA version: 18.1 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: SonoVue Product Name: SonoVue Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion INN or Proposed INN: sulphur hexafluoride CAS Number: 2551-62-4 Other descriptive name: SULFUR HEXAFLUORIDE Concentration unit: µl/ml microlitre(s)/millilitre Concentration type: equal Concentration number: 8- | Medical University of Vienna (MUW) | Authorised | Female: yes Male: yes | Austria | ||||||
338 | NCT02201693 | December 12, 2014 | 29 April 2019 | Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease | Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease | Crohn's Disease | Dietary Supplement: MODULEN IBD | Assistance Publique - Hôpitaux de Paris | GETAID Pediatric | Not recruiting | 6 Years | 18 Years | All | 100 | N/A | France |
339 | EUCTR2014-001295-65-AT | 01/12/2014 | 14 November 2016 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 18.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave Pharmaceutical Form: Suspension for injection INN or Proposed INN: Ova-Treg CAS Number: - Current Sponsor code: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population Concentration unit: Other Concentration type: equal Concentration number: 10e6- Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Intravenous use | TxCell | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Belgium;Austria;Germany;Italy | |||
340 | NCT02249078 | December 2014 | 17 November 2015 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease | A Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: E6011;Drug: Placebo | Eisai Inc. | Not recruiting | 18 Years | N/A | Both | 0 | Phase 1 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
341 | NCT02255370 | December 2014 | 8 August 2016 | Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease | Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease | Crohn's Disease | Drug: Curcumin | University Hospital, Clermont-Ferrand | 3i nature;Naturopôle Nutrition santé | Recruiting | 18 Years | N/A | Both | 122 | Phase 3 | France |
342 | NCT02539849 | December 2014 | 12 February 2018 | Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease | Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease | Crohn Disease | Dietary Supplement: FOS;Drug: Adalimumab | Hospital Universitari Vall d'Hebron Research Institute | AbbVie | Not recruiting | 18 Years | 65 Years | All | 38 | N/A | Spain |
343 | EUCTR2014-001295-65-BE | 28/11/2014 | 31 October 2016 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and parallel-group study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn's Disease (Crohn's And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave Pharmaceutical Form: Suspension for injection INN or Proposed INN: Ova-Treg CAS Number: - Current Sponsor code: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population Concentration unit: Other Concentration type: equal Concentration number: 10e6- Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Intravenous use | TxCell | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | Belgium;Austria;Germany;Italy | |||
344 | EUCTR2014-002556-77-CZ | 27/11/2014 | 21 November 2016 | A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 Pharmaceutical Form: Capsule, hard INN or Proposed INN: MT-1303 Current Sponsor code: MT-1303 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.4- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Mitsubishi Tanabe Pharma Corporation (MTPC) | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | |||
345 | EUCTR2014-002557-19-CZ | 27/11/2014 | 6 November 2017 | A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 Pharmaceutical Form: Capsule, hard INN or Proposed INN: MT-1303 Current Sponsor code: MT-1303 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.4- | Mitsubishi Tanabe Pharma Corporation (MTPC) | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
346 | EUCTR2014-001892-30-BE | 24/11/2014 | 17 August 2015 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's disease | 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 Crohn’s Disease | Crohn’s Disease MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Pharmaceutical Form: Capsule, hard Current Sponsor code: G321605 Other descriptive name: GLPG1205 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Russian Federation;Germany;United Kingdom | |||
347 | EUCTR2014-001644-38-HU | 18/11/2014 | 28 February 2019 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 17.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) Pharmaceutical Form: Tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaxmin DR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Salix Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany | |||
348 | EUCTR2014-001645-24-HU | 18/11/2014 | 28 February 2019 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 17.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) Pharmaceutical Form: Tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: Rifaxmin DR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Salix Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany | |||
349 | NCT02453607 | November 17, 2014 | 16 December 2017 | The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease | The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease | Inflammatory Bowel Disease;Crohn's Disease | Drug: Infliximab;Drug: thiopurine | Ernest Seidman | University of Toronto;University of Calgary;University of Alberta | Recruiting | 18 Years | 70 Years | All | 225 | N/A | Canada |
350 | NCT02240108 | October 28, 2014 | 30 September 2019 | One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: Rifaximin EIR;Drug: Placebo | Bausch Health Americas, Inc. | Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | Not recruiting | 18 Years | N/A | All | 81 | Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
351 | EUCTR2013-001746-33-DK | 23/10/2014 | 28 February 2019 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease 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: Humira 40 mg solution for injection in pre-filled syringe Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands | |||
352 | EUCTR2013-001746-33-DE | 08/10/2014 | 28 February 2019 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease 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: Humira 40 mg solution for injection in pre-filled syringe Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | |||
353 | NCT02148640 | October 2014 | 16 December 2017 | The NOR-SWITCH Study | 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 DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY | Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic | Drug: Innovator infliximab;Drug: Biosimilar infliximab | Diakonhjemmet Hospital | South-Eastern Norway Regional Health Authority | Not recruiting | 18 Years | N/A | All | 482 | Phase 4 | Norway |
354 | EUCTR2014-003141-10-BE | 29/09/2014 | 6 January 2015 | Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie. | Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie. | Crohn's disease or colitis ulcerosa MedDRA version: 17.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.1 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: UrsoFalk® 250 mg tabletten. Product Name: UrsoFalk Pharmaceutical Form: Tablet INN or Proposed INN: ursodeoxycholic acid CAS Number: 128-13-2 Other descriptive name: URSODEOXYCHOLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Ghent University Hospital | Authorised | Female: yes Male: yes | Belgium | |||||
355 | NCT02096861 | September 19, 2014 | 11 June 2018 | Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease | Crohn's Disease | Biological: CT-P13;Biological: Remicade | Celltrion | Pfizer | Not recruiting | 18 Years | 75 Years | All | 220 | Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
356 | JPRN-UMIN000015770 | 2014/09/01 | 7 October 2019 | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. | Crohn's disease (180 <= CDAI < 450) CDAI: Crohn's disease Activity Index | Standard therapy for Crohn's disease (Pentasa 3 g/day) Patients take curcumin or placebo | Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research | Not Recruiting | 20years-old | 70years-old | Male and Female | 30 | Not selected | Japan | |
357 | NCT02108821 | September 2014 | 16 December 2017 | Fecal Microbiota Transplantation in Pediatric Patients | A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease. | Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Children's Mercy Hospital Kansas City | University of Pittsburgh | Not recruiting | 2 Years | 22 Years | All | 23 | Phase 1 | United States |
358 | NCT02154425 | September 2014 | 11 June 2018 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers | A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Breast milk sampling;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Not recruiting | 18 Years | N/A | Female | 17 | Phase 1 | United States;Netherlands;Switzerland;France |
359 | NCT02332356 | September 2014 | 23 April 2019 | Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Crohn Disease | Drug: azathioprine or adalimumab and infliximab | Tokyo Medical and Dental University | Recruiting | 16 Years | 65 Years | All | 100 | Phase 3 | Japan | |
360 | NCT02240121 | August 21, 2014 | 30 September 2019 | One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: Rifaximin EIR;Drug: Placebo | Bausch Health Americas, Inc. | Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | Not recruiting | 18 Years | N/A | All | 80 | Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
361 | EUCTR2013-005629-21-HU | 14/08/2014 | 28 August 2014 | Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease | Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease | Crohn’s disease MedDRA version: 17.0 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: Remicade Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | First Department of Medicine, University of Szeged | Authorised | Female: yes Male: yes | Hungary | |||||
362 | NCT02185014 | August 12, 2014 | 16 December 2017 | Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab | AbbVie | Not recruiting | 18 Years | 75 Years | All | 246 | Phase 3 | United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic | |
363 | JPRN-UMIN000014006 | 2014/08/01 | 2 April 2019 | Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease | Crohn's disease | dose escalation of infliximab | IBD Center, Sapporo Kosei General Hospital | Recruiting | 18years-old | Not applicable | Male and Female | 20 | Not selected | Japan | ||
364 | NCT02000362 | August 2014 | 16 December 2017 | Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD) | An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease | Crohn's Disease | Biological: Stem cells | Kang Stem Biotech Co., Ltd. | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/Phase 2 | Korea, Republic of | |
365 | NCT02199561 | July 2014 | 9 January 2017 | Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease | A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease | Crohn's Disease | Biological: Fecal Microbiota Transplant | University of Alberta | Not recruiting | 18 Years | 65 Years | Both | 3 | Phase 1/Phase 2 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
366 | EUCTR2013-001746-33-ES | 23/06/2014 | 28 February 2019 | A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 16.1 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | AbbVie Deutschland GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | |||
367 | NCT02164877 | June 2014 | 11 June 2018 | Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease | A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease | Crohn's Disease | Drug: pectin | Jinling Hospital, China | Not recruiting | 17 Years | 40 Years | All | 3 | Phase 2 | China | |
368 | NCT02179372 | June 2014 | 12 December 2016 | 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 | Not recruiting | 18 Years | 80 Years | Both | 60 | N/A | Italy | |
369 | NCT01881464 | May 2014 | 19 February 2015 | Anti TNF a Improves Endothelial Dysfunction in IBD Patients | Anti TNF a Improves Endothelial Dysfunction in IBD Patients | Crohn's Disease | Device: Endopath from Itamar medical - FDA approved device.;Drug: Anti TNF Alfa. | Carmel Medical Center | Recruiting | 18 Years | 40 Years | Both | 20 | Phase 4 | Israel | |
370 | NCT02148185 | May 2014 | 19 February 2015 | Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease | A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: MT-1303 | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 20 Years | 65 Years | Both | 1 | Phase 1 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
371 | EUCTR2013-004781-34-ES | 16/04/2014 | 13 February 2017 | Rapidity of response to adalimumab treatment in patients with Crohn´s Disease. | Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study. | Crohn's disease MedDRA version: 16.1 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: ADALIMUMAB Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Product Name: ADALIMUMAB Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Product Name: ADALIMUMAB Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | AbbVie Farmacéutica S.L.U. | Not Recruiting | Female: yes Male: yes | Phase 4 | Spain | ||||
372 | NCT02065570 | April 9, 2014 | 18 December 2018 | Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's Disease | Drug: Adalimumab | AbbVie | Not recruiting | 18 Years | 75 Years | All | 514 | Phase 3 | Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;United States;Czech Republic | |
373 | EUCTR2013-005013-13-LT | 08/04/2014 | 16 November 2015 | 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 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: SB5 Other descriptive name: SB5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Humira® Product Name: Humira® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: not applicable Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Samsung Bioepis Co., Ltd. | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||||
374 | EUCTR2013-001029-17-NL | 01/04/2014 | 14 April 2014 | Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentration | Efficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX | Crohn's disease MedDRA version: 16.0 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: Remicade Product Name: Infliximab Pharmaceutical Form: Powder for concentrate for solution for infusion | Academic Medical Center | Authorised | Female: yes Male: yes | Netherlands | |||||
375 | JPRN-UMIN000013369 | 2014/04/01 | 2 April 2019 | Efficacy of preoperative oral antibiotics prophylaxis for prevention of surgical site infections in patients with Crohn's disease | Crohn's disease | Oral antibiotics will be administrated on the day before surgery (500mg of kanamycin and 500mg of metronidazole at 14:00, 15:00, and 21:00) without oral antibiotics | Hyogo college of medicine | Not Recruiting | 20years-old | 70years-old | Male and Female | 240 | Phase 2 | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
376 | NCT01960426 | April 2014 | 23 May 2016 | Evaluation of Health Costs and Resource Utilization | A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease. | Ulcerative Colitis;Crohn's Disease | Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug | University of Western Ontario, Canada | Prometheus Laboratories | Not recruiting | 18 Years | N/A | Both | 51 | Phase 4 | United States |
377 | NCT02913508 | April 2014 | 3 October 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 subcutaneous injection;Drug: Vedolizumab intravenous injection | Takeda | Not recruiting | 18 Years | 80 Years | Both | 0 | Phase 2 | ||
378 | ChiCTR-DDT-14004402 | 2014-03-28 | 18 April 2017 | The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fasting | The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fasting | Obscure gastrointestinal bleeding, iron deficiency anemia , Suspected Crohn’s disease, Suspected small bowel tumors, Surveillance of polyposis syndromes, malabsorption? Celiac disease, nonsteroidal a | Group A:20%Mannitol, 0.9% saline;Group B:20%Mannitol, 0.9% saline?simethicone;Group C:20%Mannitol, 0.9% saline?simethicone; | Sanming First Affiliated Hospital of Fujian Medical University | Not Recruiting | 10 | 85 | Both | Group A:60;Group B:60;Group C:60; | Phase 4 study | China | |
379 | JPRN-UMIN000014205 | 2014/03/25 | 16 July 2019 | Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient | Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient - Validity of pancrelipase in patients with inflammatory bowel disease | Crohn's disease Ulcerative colitis | Administration of pancrelipase | Department of Gastroenterology Osaka City University Graduate School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
380 | NCT02039063 | March 14, 2014 | 21 January 2019 | A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease | A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease | Crohn's Disease | Drug: E6011 2 mg/kg;Drug: E6011 5 mg/kg;Drug: E6011 10 mg/kg;Drug: E6011 15 mg/kg | EA Pharma Co., Ltd. | Not recruiting | 20 Years | 64 Years | All | 28 | Phase 1/Phase 2 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
381 | NCT01908283 | March 2014 | 9 January 2017 | Induction of Immunity Against Streptococcus Pneumoniae in Adults With Inflammatory Bowel Disease | Influence of Immunosuppressive Treatment on Immunological Response to Pneumococcal Conjugated Vaccine (PCV13) in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Diseases;Crohn Disease;Colitis, Ulcerative | Biological: 13-valent pneumococcal conjugated vaccine (PCV13) | Klara M. Pósfay Barbe | Swiss IBD Cohort Study;Foundation for liver and gut studies (FLAGS);Schweizerische Morbus Crohn / Colitis ulcerosa Vereinigung (SMCCV) | Not recruiting | 18 Years | 99 Years | Both | 300 | Phase 4 | Switzerland |
382 | NCT02088944 | March 2014 | 19 February 2015 | a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease | Serological C Reactive Protein or Erythrocyte Sedimentation Rate | Drug: Infliximab | Nanfang Hospital of Southern Medical University | Not recruiting | 18 Years | 75 Years | Both | 142 | N/A | |||
383 | NCT02281916 | March 2014 | 18 June 2018 | Safety Study of P28GST Treatment in Crohn's Disease Patients | Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial | Crohn's Ileocolitis | Drug: P28GST | University Hospital, Lille | National Research Agency, France;Institut National de la Santé Et de la Recherche Médicale, France | Not recruiting | 18 Years | N/A | All | 10 | Phase 2 | France |
384 | EUCTR2013-002857-32-DE | 20/02/2014 | 28 November 2016 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 18.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB CAS Number: 1206161-97-8 Current Sponsor code: GLPG0634 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom | |||
385 | NCT01986127 | February 14, 2014 | 18 December 2018 | Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients | A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients | Crohn's Disease | Drug: Adalimumab;Drug: placebo | Sara Varea | Hospital Clinic of Barcelona | Not recruiting | 18 Years | N/A | All | 26 | Phase 3 | Spain |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
386 | NCT02060318 | February 11, 2014 | 16 December 2017 | Regulatory T-cells and Crohn's Disease | The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells | Crohn Disease | Drug: Infliximab | Hvidovre University Hospital | Not recruiting | 18 Years | N/A | All | 47 | N/A | Denmark | |
387 | JPRN-UMIN000012790 | 2014/02/01 | 2 April 2019 | Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease | Crohn's disease | dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months | Saitama Medical center | Not Recruiting | 20years-old | 65years-old | Male and Female | 20 | Not selected | Japan | ||
388 | NCT01783106 | February 1, 2014 | 4 November 2019 | Antibiotics and Hydroxychloroquine in Crohn's | A Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's Disease | Crohn's Disease | Drug: Ciprofloxacin;Drug: Doxycycline;Drug: Hydroxychloroquine;Drug: Budesonide | Royal Liverpool University Hospital | National Association for Colitis and Crohn's Disease;National Institute for Health Research, United Kingdom | Not recruiting | 18 Years | N/A | All | 59 | Phase 2 | United Kingdom |
389 | NCT01765439 | February 2014 | 20 August 2018 | The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | The Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Dietary Supplement: VSL#3 (Original De Simone formulation) | Charles University, Czech Republic | Iscare i.v.f., Czech Republic;CD Investments srl;University Of Perugia;University of Roma La Sapienza | Recruiting | N/A | N/A | All | 80 | N/A | Czechia;Czech Republic |
390 | NCT01932658 | February 2014 | 25 April 2016 | Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment | Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment | Crohn's Disease | Biological: Hematopoietic stem cell transplantation | University of California, Los Angeles | Not recruiting | 7 Years | 70 Years | Both | 0 | Phase 0 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
391 | JPRN-JapicCTI-142402 | 28/1/2014 | 16 July 2019 | Phase III study of MLN0002 (300 mg) in treatment of Crohn's disease | 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 Crohn's disease | Crohn's disease | Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab (300 mg) administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Vedolizumab Placebo administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter. | Takeda Pharmaceutical Company Limited | Not Recruiting | 15 | 80 | BOTH | 157 | Phase 3 | Japan | |
392 | EUCTR2013-002902-29-BE | 09/01/2014 | 9 January 2017 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: BI 655066 Other descriptive name: BI 655066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Code: BI 655066 90 mg/ml Pharmaceutical Form: Solution for injection in pre-filled syringe Current Sponsor code: BI 655066 Other descriptive name: BI 655066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- | SCS Boehringer Ingelheim Comm.V | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
393 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
394 | NCT02019602 | January 2014 | 16 December 2017 | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta | A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Not recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States;France;Netherlands;Switzerland |
395 | NCT02044952 | January 2014 | 19 February 2015 | Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission | Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission | Inflammatory Bowel Diseases;Crohn's Disease;Gastrointestinal Diseases;Digestive System Diseases;Intestinal Diseases | Drug: Mesalazine, Tripterygium glycosides | Zhu Weiming | Recruiting | 18 Years | 75 Years | Both | 40 | Phase 2/Phase 3 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
396 | NCT02056418 | January 2014 | 19 February 2015 | Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult | A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult | Crohn Disease | Dietary Supplement: enteral nutrition;Drug: corticosteroid | Jinling Hospital, China | Not recruiting | 18 Years | 75 Years | Both | 30 | Phase 4 | China | |
397 | NCT02615288 | January 2014 | 7 December 2015 | High Dose Vitamin D3 in Crohn's Disease | Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study | Crohn's Disease | Dietary Supplement: Vitamin D3 | McMaster University | Canadian Association of Gastroenterology | Not recruiting | 18 Years | 70 Years | Both | 40 | N/A | |
398 | EUCTR2011-001332-29-AT | 02/12/2013 | 27 October 2014 | 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 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remicade Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie | Authorised | Female: yes Male: yes | Austria | |||||
399 | NCT02015793 | December 2013 | 11 June 2018 | Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease | A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein | Crohn's Disease | Biological: Adalimumab;Biological: Placebo for adalimumab | AbbVie | Not recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | China | |
400 | EUCTR2012-004222-25-BE | 26/11/2013 | 16 August 2016 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease | Crohn's disease MedDRA version: 18.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Other descriptive name: not applicable Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Other descriptive name: not applicable Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AB Science | Authorised | Female: yes Male: yes | 450 | Phase 3 | United States;Central African Republic;Slovakia;Greece;Spain;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Netherlands;Tunisia;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
401 | EUCTR2013-002838-20-NL | 12/11/2013 | 29 January 2018 | The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease | The effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT | Crohn's Disease MedDRA version: 18.0 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: InVita D3 Pharmaceutical Form: Oral solution INN or Proposed INN: Colecalciferol Other descriptive name: CHOLECALCIFEROL CONCENTRATE Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 25000- Pharmaceutical form of the placebo: Oral drops, solution Route of administration of the placebo: Oral use | Academic Medical Center | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | Belgium;Netherlands | |||
402 | EUCTR2012-001723-12-ES | 07/10/2013 | 4 December 2018 | adalimumab intralesional in intestinal strictures of Crohn's disease patients | A randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients | Crohn disease MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Humira Product Name: Adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intralesional use | Fundació Clínic per a la Recerca Biomèdica | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | Spain | |||
403 | NCT02859675 | October 7, 2013 | 26 August 2019 | Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease | Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease | Crohn's Disease;Olfactogustatory Perception | Other: triangular test;Biological: blood sampling;Other: Questionnaires | Centre Hospitalier Universitaire Dijon | Recruiting | 18 Years | 60 Years | Female | 75 | N/A | France | |
404 | NCT01674413 | October 2013 | 16 December 2017 | Calprotectin-Directed Humira® Maintenance Therapy (CADHUM) | Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's Disease | Crohn's Disease | Drug: Adalimumab;Drug: Adalimumab PRN;Drug: Placebo | Peter Higgins | AbbVie | Not recruiting | 18 Years | N/A | All | 0 | Phase 3 | United States |
405 | NCT02538757 | October 2013 | 21 August 2017 | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE) | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE) | Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Not recruiting | 50 Years | N/A | All | 125 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
406 | JPRN-JapicCTI-142426 | 01/9/2013 | 2 April 2019 | A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | Crohn's Disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : adalimumab 80mg every other week Control intervention name : null | AbbVie GK | 15 | BOTH | 28 | Phase 3 | ||||
407 | NCT01951326 | September 2013 | 11 March 2019 | Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease | A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: RHB-104;Drug: Placebo | RedHill Biopharma Limited | Not recruiting | 18 Years | 75 Years | All | 330 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;Israel;New Zealand;Poland;Serbia;Slovakia;Czech Republic | |
408 | NCT01958827 | September 2013 | 19 October 2017 | A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: Adalimumab | AbbVie | Not recruiting | 15 Years | N/A | All | 28 | Phase 3 | Japan | |
409 | EUCTR2013-002932-25-NL | 21/08/2013 | 28 February 2019 | A randomized clinical trial: treatment of perianal fistulas in Crohn's disease | Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial | Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Pharmaceutical Form: Powder for concentrate for solution for infusion Trade Name: Humira Product Name: Adalimumab Pharmaceutical Form: Powder for concentrate for solution for infusion | Academic Medical Center | Not Recruiting | Female: yes Male: yes | 126 | Phase 4 | Netherlands | |||
410 | EUCTR2013-000971-34-DK | 01/08/2013 | 30 April 2019 | High dose vitamin D treatment in Crohn's disease affects the gut immune cells | Mucosal immune regulation by high dose vitamin D treatment in Crohn’s disease - MirViDiC | Active Crohn's Disease in colon and/or terminal ileum MedDRA version: 19.0 Level: LLT Classification code 10011408 Term: Crohns disease aggravated System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Dekristol 20.000 ie Pharmaceutical Form: Capsule, soft INN or Proposed INN: cholecalciferol Other descriptive name: CHOLECALCIFEROL Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 20000- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Remsima Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Jørgen Agnholt | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Denmark | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
411 | NCT01523106 | August 2013 | 19 February 2015 | L-carnitine to Treat Fatigue Associated With Crohn's Disease | L-carnitine to Treat Fatigue Associated With Crohn's Disease | Crohn's Disease;Fatigue | Drug: L-carnitine;Other: Placebo | University of California, San Francisco | Not recruiting | 18 Years | 70 Years | Both | 0 | N/A | United States | |
412 | EUCTR2013-001212-30-NL | 04/07/2013 | 4 November 2013 | Immune modulation by parenteral Fish oil in patients with Crohn’s disease | Modulation of immune function by parenteral fish oil in patients with Crohn’s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Omegaven Pharmaceutical Form: Emulsion for infusion Trade Name: Intralipid 10% Pharmaceutical Form: Solution for infusion | Authorised | Female: yes Male: yes | Netherlands | ||||||
413 | NCT01864616 | July 2013 | 11 June 2018 | The Impact of Vitamin D on Disease Activity in Crohn's Disease | Crohn Disease | Dietary Supplement: Vitamin D3 | University of Saskatchewan | Dania Alrefai;Dr.Jennifer Jones;Dr.Hani Jawa;Dr.Wael El-matary;Saudi Arabian Cultural Bureau | Not recruiting | 16 Years | 70 Years | All | 9 | N/A | Canada;Saudi Arabia | |
414 | NCT01915927 | July 2013 | 26 August 2019 | Stem Cell Fistula Plug in Perianal Crohn's Disease | A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease. | Perianal Crohn's Disease | Drug: MSC-AFP | William A. Faubion, M.D. | Not recruiting | 18 Years | 65 Years | All | 20 | Phase 1 | United States | |
415 | NCT01947010 | July 2013 | 19 February 2015 | Pneumococcal Vaccination of Crohn Patients | Pneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's Disease | Crohns Disease | Biological: Prevenar 13;Biological: Pneumovax | Statens Serum Institut | Hvidovre University Hospital;Herlev Hospital | Not recruiting | 18 Years | N/A | Both | 151 | Phase 4 | Denmark |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
416 | EUCTR2013-001503-37-DK | 31/05/2013 | 10 July 2015 | Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease | Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease | Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease) MedDRA version: 14.1 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: Imurel Pharmaceutical Form: Tablet INN or Proposed INN: azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Allopurinol Pharmaceutical Form: Tablet INN or Proposed INN: allopurinol CAS Number: 17795-21-0 Other descriptive name: ALLOPURINOL SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Marianne Kiszka-Kanowitz | Not Recruiting | Female: yes Male: yes | 46 | Denmark | ||||
417 | NCT01827631 | May 27, 2013 | 16 December 2017 | Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects | Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects | Crohn's Disease | Drug: GSK1605786 capsule | GlaxoSmithKline | Not recruiting | 18 Years | 45 Years | All | 21 | Phase 1 | China | |
418 | NCT01847170 | May 2013 | 16 December 2017 | Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease | Crohn's Disease | Biological: Fecal Microbial Transplantation | Beth Israel Deaconess Medical Center | The Broad Foundation;Brigham and Women's Hospital | Not recruiting | 18 Years | N/A | All | 22 | Phase 1 | United States | |
419 | NCT02073526 | May 2013 | 9 January 2017 | 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 | Not recruiting | 18 Years | N/A | Both | 1230 | N/A | Norway | |
420 | NCT02233062 | May 2013 | 19 February 2015 | Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease | Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease | Crohn's Disease | Dietary Supplement: Exclusive Enteral Nutrition Therapy | Jinling Hospital, China | Not recruiting | 18 Years | 40 Years | Male | 12 | N/A | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
421 | NCT02676622 | April 2013 | 16 December 2017 | Autologous Stem Cell Transplant for Refractory Crohn's Disease | A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's Disease | Crohn's Disease | Drug: mobilization of stem cells to prepare for Leukapheresis;Other: Leukapheresis- Collection of stem cells;Drug: Preparative regimen 4-6 weeks after Leukapheresis;Other: Stem Cell Transplant;Drug: Low-dose IL-2 administration | Nationwide Children's Hospital | Not recruiting | 12 Years | 29 Years | All | 0 | Phase 2 | ||
422 | JPRN-UMIN000010524 | 2013/03/29 | 2 April 2019 | Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease -OASISstudy | Crohn's disease | Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician. | Tokyo Medical & Dental University Gastroenterology | Not Recruiting | 15years-old | Not applicable | Male and Female | 20 | Not selected | Japan | ||
423 | NCT01804166 | March 21, 2013 | 30 September 2019 | 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 | Recruiting | N/A | N/A | All | 40 | Phase 4 | United States | |
424 | NCT01769755 | March 2013 | 12 March 2018 | A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease | Crohns Disease | Biological: PDA001;Drug: Vehicle Controlled Placebo | Celularity Incorporated | Not recruiting | 18 Years | 75 Years | All | 14 | Phase 1 | United States | |
425 | NCT01809275 | March 2013 | 29 August 2016 | Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease | A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease;Inflammatory Bowel Disease | Drug: QBECO;Drug: Placebo | Qu Biologics Inc. | Not recruiting | 18 Years | N/A | Both | 68 | Phase 1/Phase 2 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
426 | NCT01810185 | March 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | United States | |
427 | NCT01817972 | March 2013 | 19 February 2015 | Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease | A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Certolizumab pegol;Drug: Azathioprine | Gastroenterology Research of America | UCB Pharma | Not recruiting | 18 Years | 70 Years | Both | 65 | Phase 3 | United States |
428 | NCT01826188 | March 2013 | 18 March 2019 | Combined THC and CBD Drops for Treatment of Crohn's Disease | Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial | Crohn's Disease | Drug: THC 5mg/ml and CBS 50mg/ml;Drug: Placebo | Meir Medical Center | Not recruiting | 20 Years | 85 Years | All | 50 | Phase 1/Phase 2 | Israel | |
429 | NCT01828190 | March 2013 | 19 February 2015 | The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers | Prospective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha Blockers | Crohn's Disease;Perianal Fistulas | Other: Hyperbaric oxygen | Assaf-Harofeh Medical Center | Recruiting | 18 Years | 70 Years | Both | 50 | N/A | Israel | |
430 | EUCTR2012-002867-86-DK | 13/02/2013 | 31 August 2015 | Prevention of serious pneumococcal infections in people with Crohn's disease | Pneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease - PneuVac | Crohn's Disease MedDRA version: 15.1 Level: LLT Classification code 10069594 Term: Pneumococcal immunization System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Pnemovax Product Name: Pneumovax Pharmaceutical Form: Solution for injection/infusion Trade Name: Prevenar 13 Product Name: Prevenar 13 Pharmaceutical Form: Solution for injection | Statens Serum Institut | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
431 | NCT01768858 | February 5, 2013 | 11 February 2019 | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Not recruiting | 18 Years | 99 Years | All | 96 | Phase 2 | Austria |
432 | NCT01714726 | February 1, 2013 | 18 March 2019 | Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease | Drug: MEDI2070;Drug: placebo | Allergan | Not recruiting | 18 Years | 65 Years | All | 121 | Phase 2 | United States;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;Czech Republic | |
433 | NCT01696942 | February 2013 | 16 December 2017 | Cimzia Versus Mesalamine for Crohn's Recurrence | Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine | Crohn's Disease | Drug: Cimzia;Drug: Mesalamine | Milton S. Hershey Medical Center | UCB Pharma | Not recruiting | 18 Years | N/A | All | 10 | Phase 4 | United States |
434 | NCT01765998 | February 2013 | 19 February 2015 | The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) | The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation | Crohn's Disease | Drug: Probiotic;Drug: Placebo | The Baruch Padeh Medical Center, Poriya | Not recruiting | 18 Years | 60 Years | Both | 60 | Phase 4 | Israel | |
435 | NCT01802593 | February 2013 | 4 January 2016 | Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure | Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure | Crohn's Disease | Drug: AZATHIOPRINE or METHOTREXATE | Prof. Arie Levine | Not recruiting | 6 Years | 18 Years | Both | 20 | Phase 4 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
436 | NCT01874015 | February 2013 | 16 December 2017 | Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease | Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease | Crohn's Disease | Biological: mesenchymal cell transplantation;Biological: mesenchymal cell and fibroblast injection | Royan Institute | Recruiting | 18 Years | 65 Years | All | 10 | Phase 1 | Iran, Islamic Republic of | |
437 | NCT02010762 | February 2013 | 16 December 2017 | The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease | The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial | Crohn's Disease | Drug: Vitamin D;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Not recruiting | 18 Years | N/A | All | 142 | Phase 4 | Netherlands | |
438 | EUCTR2012-002432-93-CZ | 18/01/2013 | 24 August 2015 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | Crohns disease MedDRA version: 17.0 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: 0114-0006B Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: N/A Current Sponsor code: NNC0114-0006 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 114 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria | ||||
439 | JPRN-UMIN000009596 | 2013/01/01 | 2 April 2019 | Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). | Crohn`s disease | Withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment. Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment. | Department of Internal Medicine, School of Medicine, Keio University | Not Recruiting | 15years-old | Not applicable | Male and Female | 200 | Not selected | Japan | ||
440 | NCT02501291 | January 2013 | 14 March 2016 | Thalidomide in Treating Crohn's Disease | Thalidomide in Inducing and Maintaining Remission of Crohn's Disease | Crohn's Disease | Drug: Thalidomide | First Affiliated Hospital, Sun Yat-Sen University | Not recruiting | 18 Years | 75 Years | Both | 47 | Phase 2 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
441 | NCT01696396 | December 4, 2012 | 20 August 2018 | AMG 181 in Subjects With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: AMG 181;Other: Placebo | Amgen | Not recruiting | 18 Years | 65 Years | All | 254 | Phase 2 | United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Netherlands;Switzerland;United Kingdom;Czech Republic | |
442 | NCT01078935 | December 2012 | 19 February 2015 | 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 recruiting | 18 Years | 80 Years | Both | 100 | Phase 4 | |
443 | NCT01735461 | December 2012 | 11 June 2018 | Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients | Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection | Kidney Calculi;Crohn's Disease | Dietary Supplement: Calcium Carbonate | University of British Columbia | University of Texas Southwestern Medical Center | Recruiting | 19 Years | N/A | All | 40 | N/A | Canada |
444 | NCT01752790 | December 2012 | 19 February 2015 | Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease | Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial | Pediatric Crohn's Disease | Drug: Top-down;Drug: Step-up | University of Roma La Sapienza | Not recruiting | 6 Years | 18 Years | Both | 0 | Phase 4 | Italy | |
445 | NCT01757964 | December 2012 | 16 December 2017 | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CD | Biological: Bacteriotherapy | David Suskind | Seattle Children's Hospital | Not recruiting | 12 Years | 21 Years | All | 13 | Phase 1 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
446 | NCT01820247 | December 2012 | 19 February 2015 | Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission | Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission | Crohn's Disease | Drug: enteral nutrition;Drug: Tripterygium glycosides | Zhu Weiming | Recruiting | 18 Years | 75 Years | Both | 100 | N/A | China | |
447 | JPRN-UMIN000009284 | 2012/11/20 | 21 May 2019 | The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients | The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients - The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease | Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection) | adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week. | Sakura Medical Center,Toho university | Not Recruiting | 18years-old | 65years-old | Male and Female | 20 | Phase 2 | Japan | |
448 | EUCTR2012-000529-31-BE | 09/11/2012 | 11 June 2018 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 17.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 Pharmaceutical Form: Solution for injection INN or Proposed INN: AMG 181 Current Sponsor code: AMG 181 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | |||
449 | NCT01349920 | November 2012 | 19 October 2017 | Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143) | An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD) | Crohn Disease | Drug: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 60 Years | All | 15 | N/A | Moldova, Republic of;United Kingdom | |
450 | NCT01817426 | November 2012 | 19 February 2015 | Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission | Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study | Crohn Disease | Drug: Infliximab;Other: Placebo | Copenhagen University Hospital at Herlev | Recruiting | 18 Years | N/A | Both | 136 | Phase 4 | Denmark | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
451 | NCT01823029 | November 2012 | 19 February 2015 | Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia | Crohn's Disease | Drug: erythropoietin;Drug: enteral nutrition.;Drug: injection of iron | Jinling Hospital, China | Ministry of Health, China | Not recruiting | 18 Years | 75 Years | Both | 387 | N/A | China | |
452 | EUCTR2012-000645-13-NL | 17/10/2012 | 5 August 2014 | Infliximab as first treatment instead of second line treatment in Crohns disease | Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion | ErasmusMC | Authorised | Female: yes Male: yes | 90 | Belgium;Netherlands;Italy | ||||
453 | EUCTR2011-006084-22-GB | 04/10/2012 | 16 October 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 Pharmaceutical Form: Infusion INN or Proposed INN: Infliximab CAS Number: 170277-31-3 Current Sponsor code: Centocor Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 10mg/kg body wt- Trade Name: Humira Product Name: adalimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Current Sponsor code: EU/1/03/256/001 Concentration unit: mg milligram(s) Concentration type: not less then Concentration number: 40-mg | Royal Liverpool University Hospital | Authorised | Female: yes Male: yes | 0 | United Kingdom | ||||
454 | NCT01562951 | October 2012 | 17 May 2016 | Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants | cAlprotectin and hsCRP as Markers of a New Diagnostic-therapeutic strAtegy That Assesses muCosal Activity to individuaLize Treatment and Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants | Crohn's Disease;Mucosal Inflammation | Drug: ADALIMUMAB;Drug: Placebo | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Abbott;TFS Trial Form Support | Not recruiting | 18 Years | 75 Years | Both | 15 | Phase 3 | Belgium;France;Spain |
455 | NCT01596894 | October 2012 | 16 December 2017 | Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease | A Randomized, Single Blinded, Controlled, Multi Center Phase 4 Study for Induction of Remission in Active Pediatric Crohn's Disease, Using 2 Months Antibiotic Course of Azithromycin Combined With Metronidazole vs. Metronidazole Alone. | Crohn's Disease | Drug: Azithromycin + Metronidazole;Drug: Metronidazole | Prof. Arie Levine | Not recruiting | 5 Years | 17 Years | All | 73 | Phase 4 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
456 | NCT01692808 | October 2012 | 17 November 2015 | Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease | Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease. | Crohn's Disease | Drug: Vitamin D3 3000 UI daily;Drug: Vitamin D3 4000 UI daily | St. Justine's Hospital | Not recruiting | 10 Years | 18 Years | Both | 20 | Phase 2 | Canada | |
457 | NCT01823042 | October 2012 | 19 February 2015 | The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD) | A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD). | Crohn's Disease | Drug: azathioprine+enteral nutrition;Drug: Azathioprine | Jinling Hospital, China | Recruiting | 18 Years | 75 Years | Both | 100 | N/A | China | |
458 | EUCTR2011-006064-43-DE | 27/09/2012 | 22 May 2017 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease. | A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn's disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s disease MedDRA version: 17.1 Level: PT Classification code 10002156 Term: Anal fistula System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601 Product Code: Cx601 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Not applicable Current Sponsor code: Allogenic eASCs Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 5000000 - Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Intralesional use | TiGenix S.A.U. | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | |||
459 | EUCTR2012-000529-31-GB | 27/09/2012 | 28 February 2019 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 17.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 Pharmaceutical Form: Solution for injection INN or Proposed INN: AMG 181 Current Sponsor code: AMG 181 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | |||
460 | EUCTR2012-002702-51-DK | 24/09/2012 | 5 February 2018 | Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study | Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT | Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) 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: Remicade Product Name: Remicade Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use Trade Name: Remsima Product Name: Remsima Pharmaceutical Form: Concentrate for solution for infusion | Department of medical gastroenterology S, Odense University Hospital | Authorised | Female: yes Male: yes | 136 | Phase 4 | Finland;Denmark;Norway;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
461 | JPRN-UMIN000015297 | 2012/09/19 | 23 April 2019 | 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 | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan | |
462 | NCT01632462 | September 2012 | 19 February 2015 | A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease | A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease | Crohn's Disease | Drug: VSL#3 | Federico II University | Recruiting | 5 Years | 17 Years | Both | 30 | Phase 4 | Italy | |
463 | NCT03079700 | August 1, 2012 | 16 December 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 | Not recruiting | 18 Years | 70 Years | Male | 1 | N/A | ||
464 | EUCTR2011-005846-36-DK | 31/07/2012 | 7 April 2015 | Bloodflow measurements in stenotic inflammatory bowel disease. | Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS) - STENOSIS | Crohns Disease undergoing elective surgery for intestinal stenosis. MedDRA version: 14.1 Level: PT Classification code 10058829 Term: Elective surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10059696 Term: Scan with contrast System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10045434 Term: Ultrasound scan System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10022699 Term: Intestinal stenosis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: SonoVue Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: sulphur hexafluoride CAS Number: 2551-62-4 Other descriptive name: SULFUR HEXAFLUORIDE Concentration unit: µl/ml microlitre(s)/millilitre Concentration type: equal Concentration number: 8- | Gastroenterology MIDT | Not Recruiting | Female: yes Male: yes | Denmark | |||||
465 | EUCTR2011-005886-19-DK | 31/07/2012 | 7 April 2015 | Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) | Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) - CONTRAST | Crohns Disease with active disease MedDRA version: 14.1 Level: PT Classification code 10059696 Term: Scan with contrast System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10045434 Term: Ultrasound scan System Organ Class: 10022891 - Investigations ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: SonoVue Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: sulphur hexafluoride CAS Number: 2551-62-4 Other descriptive name: SULFUR HEXAFLUORIDE Concentration unit: µl/ml microlitre(s)/millilitre Concentration type: equal Concentration number: 8- | Gastroenterology MIDT | Not Recruiting | Female: yes Male: yes | Denmark | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
466 | NCT01570348 | July 2012 | 11 March 2019 | Crohn's Allogeneic Transplant Study | Allogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 Study | Crohn Disease | Procedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Drug: Mycophenolic Acid;Other: Quality-of-Life Assessment;Drug: Tacrolimus;Radiation: Total-Body Irradiation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI);National Institutes of Health (NIH) | Not recruiting | 18 Years | 60 Years | All | 2 | Phase 2 | United States |
467 | NCT01576471 | July 2012 | 16 December 2017 | Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo | A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Biological: Trichuris suis ova (TSO);Biological: Placebo | Coronado Biosciences, Inc. | Not recruiting | 18 Years | 65 Years | All | 250 | Phase 2 | United States | |
468 | NCT01629628 | July 2012 | 19 February 2015 | Adalimumab for the Management of Post-operative Crohn's Disease (CD) | An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD Patients | Crohn Disease | Drug: Adalimumab;Drug: 6 Mercaptopurine | Tel-Aviv Sourasky Medical Center | Abbott | Not recruiting | 18 Years | 70 Years | Both | 100 | Phase 3 | Israel |
469 | NCT01659762 | July 2012 | 24 October 2016 | A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease. | A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease. | Crohn's Disease | Biological: autologous mesenchymal stromal cell | Emory University | Atlanta Clinical and Translational Science Institute;Atlanta Clinical and Translational Science Institute | Not recruiting | 18 Years | 65 Years | Both | 16 | Phase 1 | United States |
470 | NCT00692939 | June 26, 2012 | 26 August 2019 | Autologous Stem Cell Transplantation for Crohn's Disease | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease | Crohn's Disease | Biological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: Mesna | Paul Szabolcs | Recruiting | 10 Years | 60 Years | All | 20 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
471 | EUCTR2011-003038-14-NL | 21/06/2012 | 3 July 2012 | A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE | A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX | Luminal active Crohn's Disease MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: INFLIXIMAB Product Name: INFLIXIMAB Pharmaceutical Form: Suspension for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: INFLIXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | GETAID | Authorised | Female: yes Male: yes | 120 | Netherlands | ||||
472 | EUCTR2011-004820-37-ES | 13/06/2012 | 26 June 2012 | Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients | Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients | Perianal fistulas in Crohn's Disease Patients MedDRA version: 14.1 Level: LLT Classification code 10068659 Term: Perianal fistula 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: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) Pharmaceutical Form: Rectal solution INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) Other descriptive name: HUMAN PLASMA FOR FRACTIONATION Concentration unit: % percent Concentration type: equal Concentration number: 100- | Fundación FISEVI | Authorised | Female: yes Male: yes | Phase 2 | Spain | ||||
473 | EUCTR2012-000729-28-ES | 13/06/2012 | 26 June 2012 | Imaging study in patients with Crohn`s Disease | MULTICENTER STUDY IN PATIENTS WITH CROHN?S DISEASE FOR CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY ASSAYS FOR ASSESSMENT OF DISEASE ACTIVITY | Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease MedDRA version: 14.1 Level: HLGT Classification code 10017969 Term: Gastrointestinal inflammatory conditions System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] | Product Name: / Product Code: / Pharmaceutical Form: Solution for injection INN or Proposed INN: ÁCIDO GADOBÉNICO CAS Number: 113662-23-0 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mmol/kg millimole(s)/kilogram Concentration type: equal Concentration number: 0.1- | Genentech, Inc. | Authorised | Female: yes Male: yes | 54 | Belgium;France;Spain;United States | ||||
474 | EUCTR2009-017998-37-BE | 08/06/2012 | 2 May 2016 | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active 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: HLT Classification code 10052775 Term: Spondyloarthropathies System Organ Class: 100000004859 MedDRA version: 19.0 Level: HLT Classification code 10039078 Term: Rheumatoid arthropathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab pegol Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Product Name: 99mTc-S-HYNIC Certolizumab pegol Pharmaceutical Form: Solution for injection INN or Proposed INN: CERTOLIZUMAB PEGOL CAS Number: 428863-50-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- | Ghent University Hospital | Authorised | Female: yes Male: yes | Belgium | |||||
475 | EUCTR2011-001754-28-DE | 05/06/2012 | 8 August 2016 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
476 | EUCTR2011-006127-38-ES | 05/06/2012 | 26 June 2012 | Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment. | Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot in processed with PRGF-system technology, in the treatment of anal fistulas in Crohn's patients with no concomitant therapy with second-line drugs. | Perianal fistulas in Crohn's Disease Patients MedDRA version: 14.1 Level: PT Classification code 10002156 Term: Anal fistula 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: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) Pharmaceutical Form: Rectal solution INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) Other descriptive name: HUMAN PLASMA FOR FRACTIONATION Concentration unit: % percent Concentration type: equal Concentration number: 100- | Fundación FISEVI | Authorised | Female: yes Male: yes | Phase 2 | Spain | ||||
477 | JPRN-UMIN000007806 | 2012/06/01 | 2 April 2019 | 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 | Not Recruiting | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | ||
478 | JPRN-UMIN000008199 | 2012/06/01 | 2 April 2019 | The investigations for improving successful judgment rate with PillCam Patency Capsule and differential diagnosis in Crohn's disease patients with following capsule endoscopy. | Crohn's disease, Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin more than 3 months | Patients administered with mosapride Patients administered with no mosapride | Department of Gastroenterology, Graduate School of Medicine, Osaka City University | Not Recruiting | 12years-old | 85years-old | Male and Female | 40 | Not selected | Japan | ||
479 | NCT01181765 | June 2012 | 19 February 2015 | The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy | The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study) | Crohn's Disease | Biological: Infliximab 5 mg/kg body weight infused over 2 hours | Janssen Inc. | Not recruiting | 18 Years | N/A | Both | 1 | Phase 4 | Canada | |
480 | NCT01442025 | June 2012 | 24 August 2015 | Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease | A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease | Crohn's Disease | Drug: Infliximab | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Not recruiting | 18 Years | N/A | Both | 121 | Phase 4 | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
481 | NCT01545050 | June 2012 | 11 June 2018 | Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Placebo matching with BMS-945429;Biological: BMS-945429 | Vitaeris INC | Not recruiting | 18 Years | N/A | All | 72 | Phase 2 | United States;Austria;Canada;Czechia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Switzerland;Taiwan;United Kingdom;Australia;Brazil;Czech Republic;Russian Federation;Singapore | |
482 | NCT01564823 | June 2012 | 30 March 2015 | Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease | Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease | Crohn´s Disease | Drug: Metronidazole;Drug: Azathioprine;Drug: Adalimumab | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Effice Servicios Para la Investigacion S.L. | Not recruiting | 18 Years | N/A | Both | 86 | Phase 3 | Spain |
483 | NCT01624376 | June 2012 | 19 February 2015 | Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105. | Fistulizing Crohn's Disease | Drug: DLX105;Drug: Placebo | Delenex Therapeutics AG | Not recruiting | 18 Years | 65 Years | Both | 18 | Phase 2 | Switzerland | |
484 | NCT02445547 | June 2012 | 16 December 2017 | Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease | Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial | Crohn Disease | Other: UC-MSCs by peripheral intravenous infusion;Drug: received hormone maintenance therapy | Fuzhou General Hospital | Shaanxi Provincial People's Hospital | Not recruiting | 18 Years | 70 Years | All | 82 | Phase 1/Phase 2 | China |
485 | JPRN-UMIN000009631 | 2012/05/02 | 2 April 2019 | Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled study | Crohn's disease | In the intervention group, sivelestat sodium will be continuously administered intravenously at 4.8 mg/kg from introduction of anesthesia until a maximum of 2 days after surgery. In the control group, sivelestat sodium will not be administered and conventional treatment will be given. | Department of Surgery 2,Tokyo Women's Medical University | Recruiting | 16years-old | Not applicable | Male and Female | 20 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
486 | JPRN-UMIN000008043 | 2012/05/01 | 22 July 2019 | The influence of medication for Crohn's disease on serological response to the influenza vaccination | The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination | Crohn's disease | Influenza Vaccination to Crohn's disease patients treated with Infliximab Influenza Vaccination to Crohn's disease patients treated with Elemental diet Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control) | The Jikei University School of Medicine Division of Gastroenterology and Hepatology | Not Recruiting | 16years-old | 60years-old | Male and Female | 150 | Phase 4 | Japan | |
487 | NCT01387594 | May 2012 | 16 December 2017 | 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 | Not recruiting | 18 Years | 75 Years | All | 49 | Phase 1 | Austria;Belgium;France;Germany;Netherlands | |
488 | NCT01369667 | April 2012 | 24 August 2015 | Vitamin D Supplementation in Adult Crohn's Disease | Vitamin D and Immunomodulation: Effects in Crohn's Disease | Crohn's Disease | Dietary Supplement: Vitamin D3;Other: Placebo | University of Dublin, Trinity College | Queen Mary University of London | Not recruiting | 18 Years | 75 Years | Both | 117 | Phase 4 | Ireland |
489 | NCT01470599 | April 2012 | 16 December 2017 | A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease | A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease | Crohn's Disease | Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | 76 Years | All | 150 | Phase 2 | United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;Czech Republic | |
490 | NCT01556672 | April 2012 | 11 July 2016 | Adalimumab-psoriasis and Small Bowel Lesions | Open-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With Adalimumab | Plaque Psoriasis;Crohn's Disease | Drug: Adalimumab;Device: Capsule endoscopy | Innovaderm Research Inc. | Abbott;Abbott | Not recruiting | 18 Years | 80 Years | Both | 100 | Phase 4 | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
491 | NCT01877577 | April 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 30 | N/A | United States | |
492 | EUCTR2011-005966-39-BE | 08/03/2012 | 7 October 2014 | Therapeutic effect of mesenchymal cells in patients suffering from a disease characterized by a severe inflammation and/or in whom the immune system attacks their own tissues. | Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders. | Crohn's disease MedDRA version: 14.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0 Level: HLGT Classification code 10003816 Term: Autoimmune disorders System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.0 Level: PT Classification code 10064147 Term: Gastrointestinal inflammation System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mesenchymal stem cells Product Code: MSC Pharmaceutical Form: Infusion | CHU-ULg | Authorised | Female: yes Male: yes | 20 | Belgium | ||||
493 | NCT01393899 | March 2012 | 19 October 2017 | The Safety And Efficacy Of Maintenance Therapy With CP-690,550 | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | 75 Years | All | 180 | Phase 2 | United States;Australia;Austria;Bulgaria;Canada;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;India | |
494 | NCT01540292 | March 2012 | 19 February 2015 | Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders | Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders | Crohn's Disease | Biological: Mesenchymal Stem Cells (MSC) | University Hospital of Liege | Recruiting | 18 Years | 75 Years | Both | 20 | Phase 1/Phase 2 | Belgium | |
495 | NCT01580670 | March 2012 | 15 July 2019 | Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease | Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease | Pediatric Crohn's Disease | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 6 Years | 17 Years | All | 14 | Phase 3 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
496 | NCT01647412 | March 2012 | 20 April 2015 | Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease | Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial | Crohn's Disease | Drug: Growth Hormone;Dietary Supplement: Nutraceutical Combination;Other: Exclusion Diet;Other: Placebo Growth Hormone | Columbia University | Not recruiting | 10 Years | 17 Years | Both | 0 | Phase 2 | United States | |
497 | NCT01957423 | March 2012 | 19 February 2015 | Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients. | Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy. | Crohn's Disease | Dietary Supplement: Whey protein;Dietary Supplement: Soy protein | University of Campinas, Brazil | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | N/A | N/A | Both | 41 | N/A | Brazil |
498 | NCT02450513 | March 2012 | 13 June 2016 | Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study | Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study | Crohn's Disease | Drug: Adalimumab | Universitaire Ziekenhuizen Leuven | Recruiting | 18 Years | 65 Years | Both | 30 | N/A | Belgium | |
499 | EUCTR2011-002517-11-DE | 22/02/2012 | 5 November 2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 15.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 15.0 Level: LLT Classification code 10011403 Term: Crohn's disease aggravated System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 Pharmaceutical Form: Solution for injection INN or Proposed INN: olokizumab CAS Number: 1007223-17-7 Current Sponsor code: CDP6038 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB BIOSCIENCES GmbH | Not Recruiting | Female: yes Male: yes | 96 | Germany;Hungary;Czech Republic;Serbia | ||||
500 | JPRN-UMIN000006882 | 2012/02/01 | 2 April 2019 | Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy | Crohn's disease | Adalimumab therapy (40 mg/dose, every other week) combined with Granulocyte/ Monocyte Apheresis (GMA), once weekly for 5 comsecutive weeks. If responses are noted, GMA is applied for another 5 sessions (once weekly). | Department of Lower Gastroenterology, Hyogo College of Medicine | Hyogo College of Medicine (Hyogo, Japan), Osaka City Univ. (Osaka, Japan), Osaka Medical College (Osaka, Japan), Kyoto Univ. (Kyoto, Japan), Shiga University of Medical Science (Shiga, Japan) | Not Recruiting | 15years-old | Not applicable | Male and Female | 20 | Phase 4 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
501 | JPRN-UMIN000007343 | 2012/02/01 | 10 September 2019 | The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients | The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients | Crohn's disease | Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody). Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy. | Tohoku University Graduate School of Medicine (Tohoku University Hospital) | Not Recruiting | 20years-old | Not applicable | Male and Female | 90 | Not applicable | Japan | |
502 | NCT01514240 | February 2012 | 19 October 2017 | Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan | A Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in Japan | Crohn's Disease | Drug: D9421-C capsule 3 mg;Drug: Mesalazine tablets | AstraZeneca | Not recruiting | 15 Years | 130 Years | All | 123 | Phase 3 | Japan | |
503 | NCT02399683 | February 2012 | 28 November 2016 | Immune Modulation From Trichuris Trichiura | Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual | Crohn Disease;Colitis, Ulcerative;Intestinal Helminthiasis | Biological: Trichuris trichiura eggs | University of Aarhus | Not recruiting | 18 Years | 70 Years | Male | 1 | N/A | ||
504 | EUCTR2011-005678-47-IT | 19/01/2012 | 18 March 2013 | A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. | A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. - IGON 2 | CROHN'S DISEASE IN REMISSION PHASE MedDRA version: 14.1 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: NA Pharmaceutical Form: Modified-release capsule, hard Current Sponsor code: GED-0301 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Modified-release capsule, hard Route of administration of the placebo: Oral use | GIULIANI | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | ||||
505 | EUCTR2011-003966-34-ES | 10/01/2012 | 10 March 2014 | Biomarkers in diagnosis & treatment of patients with Crohn?s disease treated with immunosuppressants | The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn?s disease treated with immunosuppressants - not applicable | Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 40-160 Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | Not Recruiting | Female: yes Male: yes | 180 | Spain | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
506 | EUCTR2011-002817-12-GR | 09/01/2012 | 28 October 2013 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1605786A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | GlaxoSmithKline Research and Development Limited | Not Recruiting | Female: yes Male: yes | 900 | Argentina;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;China;Netherlands;South Africa;Australia;Denmark;France;Italy;Switzerland;Russian Federation;Israel;Spain;Greece;Slovakia;Hong Kong;Taiwan;Estonia;Portugal;United States;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | ||||
507 | JPRN-UMIN000006889 | 2012/01/01 | 2 April 2019 | Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy | Crohn's disease | Repeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion. Repeat 3 infusions of the 10mg/kg/dose infliximab in 8 weeks interval. | Department of Lower Gastroenterology, Hyogo College of Medicine | Not Recruiting | 16years-old | 75years-old | Male and Female | 50 | Phase 4 | Japan | ||
508 | JPRN-UMIN000007514 | 2012/01/01 | 2 April 2019 | Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence | Crohn's disease | Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29. | Nagoya University Gradeate School of Medicine Department of Gastroenterology | Not Recruiting | 20years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan | ||
509 | EUCTR2011-000885-36-ES | 26/12/2011 | 16 February 2015 | Adalimub treatment to prevent recurrency post-surgery in Crohn disease. | Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment - APPRECIA | Compare efficay of Adalimub vs Azatioprina to prevent surgical intervention in Chron disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Current Sponsor code: NA Other descriptive name: Adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- Trade Name: Imurel Product Name: Imurel Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Azatioprina CAS Number: 6336-41-0 Other descriptive name: Imurel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Flagyl Product Name: Flagyl Pharmaceutical Form: Oral suspension INN or Proposed INN: Metronidazol CAS Number: 99616-64-5 Other descriptive name: Flagyl Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | GETECCU | Not Recruiting | Female: yes Male: yes | Spain | |||||
510 | EUCTR2011-003966-34-BE | 06/12/2011 | 21 August 2017 | Biomarkers in diagnosis & treatment of patients with Crohn’s disease treated with immunosuppressants | The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn’s disease treated with immunosuppressants | Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 40-160 Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Spain;Belgium | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
511 | NCT01438151 | December 2011 | 19 October 2017 | Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease | Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease | Crohn's Disease | Drug: Remicade | Shradha Agarwal | Prometheus Laboratories | Not recruiting | 7 Years | N/A | All | 11 | N/A | United States |
512 | NCT01453946 | December 2011 | 19 October 2017 | Safety and Maintenance Study of Entocort for Children With Crohn's Disease | A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease | Drug: Entocort | Perrigo Company | Not recruiting | 5 Years | 17 Years | All | 55 | Phase 3 | Italy;Poland;United States;Canada;Germany | |
513 | NCT01466374 | December 2011 | 28 September 2015 | Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: BMS-936557 (Anti-IP-10 Antibody) | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 121 | Phase 2 | United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa | |
514 | NCT01496053 | December 2011 | 28 April 2015 | Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD) | Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study | Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract | Oslo University Hospital | ImmunoPharma | Recruiting | 18 Years | 60 Years | Both | 100 | Phase 2/Phase 3 | Norway |
515 | NCT01505855 | December 2011 | 19 February 2015 | Efficacy Study of Pneumococcal Vaccination in Crohn's Disease | Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study | Crohn's Disease | Drug: 23-valent polysaccharide pneumococcal vaccine | Kyunghee University Medical Center | Wonju Severance Christian Hospital;Seoul National University Hospital;Asan Medical Center;Soonchunhyang University Hospital;Ewha Womans University;Kosin University Gospel Hospital;Chung-Ang University Hospital;Inje University;The Catholic University of Korea;Keimyung University Dongsan Medical Center;Korea University;Wonkwang University;Severance Hospital;Konkuk University Hospital | Not recruiting | 18 Years | N/A | Both | 197 | Phase 4 | Korea, Republic of |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
516 | NCT01792388 | December 2011 | 19 February 2015 | Vitd and Barrier Function in IBD | Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission | Crohn's Disease | Dietary Supplement: Vitamin D;Dietary Supplement: Soya Bean oil | University of Dublin, Trinity College | University of Calgary;Queen Mary University of London | Not recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Ireland |
517 | NCT01536418 | November 11, 2011 | 5 February 2018 | An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn's Disease | Drug: GSK1605786A | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 255 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;China;Czech Republic;Ireland;South Africa | |
518 | NCT01218360 | November 2011 | 30 March 2015 | Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484) | Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484) | Crohn Disease | Drug: Physician standard-of-care | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | Both | 71 | N/A | Greece | |
519 | NCT01434693 | November 2011 | 19 October 2017 | Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease | A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease | Crohn's Disease | Biological: Trichuris suis ova;Other: Placebo | Coronado Biosciences, Inc. | Not recruiting | 18 Years | 55 Years | All | 36 | Phase 1 | United States | |
520 | NCT01442363 | November 2011 | 19 February 2015 | A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease | Perianal Crohn's Disease | Drug: BLI-1300 low dose;Drug: BLI-1300 high dose;Drug: placebo | Braintree Laboratories | Not recruiting | 18 Years | N/A | Both | 8 | Phase 2 | United States | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
521 | NCT01444092 | November 2011 | 19 October 2017 | Safety Study of Entocort for Children With Crohn's Disease | A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease | Drug: Entocort | Perrigo Company | Not recruiting | 5 Years | 17 Years | All | 123 | Phase 3 | United States;Canada;Germany;Italy;Poland | |
522 | NCT01540942 | November 2011 | 19 February 2015 | Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease | A Randomized, Controlled, Open-label Study to Investigate the Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease | Crohn's Disease | Dietary Supplement: nutrition treat;Other: surgery | Jinling Hospital, China | Not recruiting | 18 Years | 75 Years | Both | 91 | N/A | China | |
523 | JPRN-UMIN000006232 | 2011/10/01 | 2 April 2019 | Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab | Crohn's disease | treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine) treatment with only high dose infliximab | Saitama Medical University | Not Recruiting | 15years-old | 70years-old | Male and Female | 40 | Not selected | Japan | ||
524 | NCT01393626 | October 2011 | 16 December 2017 | A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | 75 Years | All | 280 | Phase 2 | United States;Australia;Austria;Bulgaria;Canada;Croatia;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;India;Romania;Sweden | |
525 | NCT01433432 | October 2011 | 19 February 2015 | Open Label Extension Study to Protocol C2/13/DR-6MP-02 | Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension Study | Crohn's Disease | Drug: 80 mg DR-6MP | Teva GTC | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 2 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
526 | NCT01489943 | September 19, 2011 | 16 December 2017 | A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects | A Single Centre, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects | Crohn's Disease | Drug: GSK1605786 500 mg;Drug: Midazolam 3 mg;Drug: Pioglitazone 15 mg;Drug: Omeprazole 40 mg;Drug: Rosuvastatin 10 mg | GlaxoSmithKline | Not recruiting | 18 Years | 55 Years | All | 24 | Phase 1 | United States | |
527 | EUCTR2010-022760-12-DE | 13/09/2011 | 5 March 2018 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease 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] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 77-104 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Janssen-Cilag International N.V. | Authorised | Female: yes Male: yes | 1310 | Phase 3 | New Zealand;Japan;Germany;Iceland;Bulgaria;Croatia;Belgium;Brazil;Canada;European Union;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;Italy;Russian Federation;Israel;Ireland;Spain;Serbia;United States | |||
528 | NCT01369355 | September 13, 2011 | 22 October 2019 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease;Colitis;IBD;Inflammatory Bowel Disease | Drug: Placebo SC;Drug: Placebo IV;Drug: Ustekinumab 90 mg SC q8w;Drug: Ustekinumab 130 mg IV;Drug: Ustekinumab 90 mg SC q12w | Janssen Research & Development, LLC | Not recruiting | 18 Years | 99 Years | All | 1282 | Phase 3 | Spain;United Kingdom;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;United States;Czech Republic | |
529 | JPRN-UMIN000005689 | 2011/09/01 | 2 April 2019 | GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial | Crohn's disease | Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine. Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine. | Department of Gastroenterology and Hepatology, Kyoto University Hospital | Not Recruiting | 12years-old | 75years-old | Male and Female | 60 | Not applicable | Japan | ||
530 | NCT01388933 | September 2011 | 19 February 2015 | A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease | Crohn's Disease | Drug: TU-100;Drug: Matching Placebo | Tsumura USA | INC Research | Not recruiting | 18 Years | 75 Years | Both | 79 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
531 | EUCTR2010-022759-42-DE | 29/08/2011 | 16 November 2015 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 17.1 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: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Janssen-Cilag International N.V. | Not Recruiting | Female: yes Male: yes | 612 | Phase 3 | United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | |||
532 | EUCTR2010-022758-18-DE | 24/08/2011 | 26 October 2015 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.1 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: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: N/A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Janssen-Cilag International N.V. | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Korea, Republic of;Japan;New Zealand;Iceland;Germany;South Africa;Australia;Denmark;Brazil;Belgium;Canada;European Union;Czech Republic;Hungary;United Kingdom;Italy;Israel;Austria;Ireland;Spain;United States;Serbia | |||
533 | EUCTR2010-023797-39-GB | 12/08/2011 | 28 January 2013 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Iron sulphate CAS Number: 7720-78-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: CosmoFer Product Name: CosmoFer 50mg/ml solution for infusion or injection Pharmaceutical Form: Solution for infusion INN or Proposed INN: iron(III)- hydroxide dextran complex CAS Number: 9004-66-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Barts Health NHS Trust | Authorised | Female: yes Male: yes | Phase 4 | United Kingdom | ||||
534 | NCT01352221 | August 2011 | 16 December 2017 | Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2) | A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2) | Iron Deficiency Anaemia;Inflammatory Bowel Disease;Crohn's Disease | Drug: ST10;Drug: Placebo oral capsule | Shield Therapeutics | Not recruiting | 18 Years | N/A | All | 128 | Phase 3 | Austria;United Kingdom | |
535 | NCT02619552 | August 2011 | 26 August 2019 | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Crohn's Disease;IBD | Drug: Anti-TNF;Drug: Steroids | University of Maryland, Baltimore | Vanderbilt University;Milton S. Hershey Medical Center;Mercy Medical Center | Not recruiting | 18 Years | N/A | All | 50 | Phase 1 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
536 | EUCTR2010-022215-19-GB | 21/07/2011 | 3 December 2012 | Combined growth hormone and IGF1 therapy in paediatric Crohn'd disease | A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s | Impaired growth in Paediatric Crohn's disease MedDRA version: 14.1 Level: LLT Classification code 10011398 Term: Crohn's System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Increlex Product Name: Increlex 10mg/ml solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution CAS Number: 67763-96-6 Other descriptive name: Recombinant human Insulin-like Growth Factor Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: NutropinAq® Product Name: NutropinAq 10mg/2ml solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin(rhGH) CAS Number: 12629-01-5 Other descriptive name: recombinant growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-1 | Greater Glasgow & Clyde NHS | Authorised | Female: yes Male: yes | 24 | United Kingdom | ||||
537 | EUCTR2011-002821-24-IT | 21/07/2011 | 25 March 2013 | Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. | Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011 | Treatment of active, moderate Crohn’s disease 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 Name: Rifaximin-EIR Product Code: NA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIFAXIMIN CAS Number: 80621-81-4 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: range Concentration number: 380-420 | ALFA WASSERMANN | Not Recruiting | Female: yes Male: yes | Italy | |||||
538 | EUCTR2011-002640-27-IT | 14/07/2011 | 28 October 2013 | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis) | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY | ACTIVE CROHN'S DISEASE MedDRA version: 14.1 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: NA Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg/g milligram(s)/gram Concentration type: up to Concentration number: 160- | GIULIANI | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany;Italy | ||||
539 | JPRN-UMIN000005970 | 2011/07/01 | 2 April 2019 | Investigation on the remission maintaining effect of Polaprezinc in patients with Crohn's disease in remission phase. | Patients with Crohn's disease in remission phase | Polaprezinc administration group: patients has Polaprezinc 150mg/day for xxx months with Crohn's disease maintenance therapy. Polaprezinc non administration group: patients treated with Crohn's disease maintenance therapy only. | Kawasaki Medical School | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan | ||
540 | NCT01298492 | July 1, 2011 | 16 December 2017 | A Study To Monitor Long-Term Treatment With PF-00547659 | A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II | Crohn's Disease | Drug: PF-00547659 | Shire | Not recruiting | 18 Years | 75 Years | All | 268 | Phase 2 | United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
541 | EUCTR2011-002061-38-BE | 29/06/2011 | 21 August 2017 | 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 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Katholieke Universiteit Leuven | Not Recruiting | Female: yes Male: yes | Phase 4 | Belgium | ||||
542 | JPRN-UMIN000005251 | 2011/06/01 | 2 April 2019 | A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab | Crohn's disease | Administration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly. | Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University | Not Recruiting | 16years-old | Not applicable | Male and Female | 14 | Not selected | Japan | ||
543 | NCT01345318 | June 2011 | 16 December 2017 | B0151005 Open-Label Extension Study | A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii) | Crohn's Disease | Biological: PF-04236921 | Pfizer | Not recruiting | N/A | N/A | All | 191 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;New Zealand;Switzerland;United Kingdom | |
544 | NCT01582568 | June 2011 | 14 March 2016 | EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment | EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment | Crohns Disease | Drug: Certolizumab | Baylor College of Medicine | UCB Pharma | Not recruiting | 18 Years | 70 Years | Both | 1 | Phase 4 | United States |
545 | EUCTR2011-000854-44-SE | 02/05/2011 | 17 November 2014 | A clinical study for treatment of Crohns Disease with the new drug substance TRK-170. The study consists of two parts and are conducted at servral hopsitals in Europe. Patients in the study may receive placebo (drug with no effect) but either the doctor or the patient will know during the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double Blind Study of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Pharmaceutical Form: Film-coated tablet CAS Number: 894404-71-8 Current Sponsor code: TRK-170 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: TRK-170 Product Code: TRK-170 Pharmaceutical Form: Film-coated tablet CAS Number: 894404-71-8 Current Sponsor code: TRK-170 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Toray Industries Inc | Not Recruiting | Female: yes Male: yes | 609 | Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
546 | ChiCTR-TRC-11001321 | 2011-05-01 | 18 April 2017 | Effect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's Disease | Effect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's Disease | Crohn's disease;ICD:K50.9 | control group:Total parenteral nutrition (TPN) will be administrated to patients from day1 to day7 after the operation. Non-protein energy of the TPN is 120kJ/kg/d, of which 60% is supplied by glucose and 40% by fat emulsion. Amino acid of the TPN is 0.8-1.0g/kg/d. Electrolyte, vitamins, trace elements will be added into the TPN. Glucose/insulin ratio is 5:1. In this group, medium-long chain triglyceride will be used.;?-3 Fat group:Total parenteral nutrition (TPN) will be administrated to patients from day1 to day7 after the operation. Non-protein energy of the TPN is 120kJ/kg/d, of which 60% is supplied by glucose and 40% by fat emulsion. Amino acid of the TPN is 0.8-1.0g/kg/d. Electrolyte, vitamins, trace elements will be added into the TPN. Glucose-insulin ratio is 5:1. In this group, medium-long chain triglyceride and ?-3 fish oil fat (Omegaven); | The First Affiliated Hospital of Sun Yat-sen University | Not Recruiting | 14 | 75 | Both | control group:30;?-3 Fat group:30; | Post-market | China | |
547 | NCT01346826 | May 2011 | 8 August 2016 | 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 | Not recruiting | 16 Years | 80 Years | Both | 145 | Phase 4 | Korea, Republic of | |
548 | NCT01276509 | April 6, 2011 | 16 December 2017 | Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease | A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera) | Crohn's Disease | Drug: PF-00547659 SC injection | Shire | Not recruiting | 18 Years | 75 Years | All | 265 | Phase 2 | United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden | |
549 | NCT01338740 | April 2011 | 19 February 2015 | Switching From Adalimumab to Infliximab | Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to Adalimumab | Crohn's Disease | Drug: Adalimumab and Infliximab | University Hospital, Ghent | Abbott | Recruiting | 18 Years | 75 Years | Both | 40 | N/A | Belgium |
550 | NCT01341808 | April 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | 40 Years | Both | 493 | Phase 4 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
551 | NCT01345799 | April 2011 | 19 February 2015 | A Study of TRK-170 for the Treatment of Crohn's Disease | A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease | Crohn's Disease | Drug: TRK-170;Drug: Placebo | Toray Industries, Inc | Not recruiting | 18 Years | 50 Years | Both | 123 | Phase 2 | Belgium;Bulgaria;Czech Republic;France;Hungary;Latvia;Netherlands;Norway;Poland;Romania;Serbia;Sweden;Ukraine | |
552 | NCT02504255 | April 2011 | 3 August 2015 | Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease | Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort | Crohn Disease | Biological: Biological samplings;Other: Questionnaires | Hospices Civils de Lyon | Not recruiting | 18 Years | N/A | Both | 144 | Phase 3 | France | |
553 | EUCTR2010-023347-14-BE | 02/03/2011 | 17 February 2014 | Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LAR An open pilot study | Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LAR An open pilot study | Crohn Disease refractory diarrhoea MedDRA version: 12.1 Level: LLT Classification code 10066533 Term: Diarrhea recurrent | Trade Name: Sandostatine Product Name: sandostatine Pharmaceutical Form: Injection* Trade Name: Sandostatine Product Name: sandostatine Pharmaceutical Form: Injection* | Gastroenterology CHC Liege | Authorised | Female: yes Male: yes | Belgium | |||||
554 | JPRN-UMIN000005146 | 2011/03/01 | 2 April 2019 | Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) | Crohn's disease | Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks. In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azathioprine up to 4 weeks and not increase in dosage later | Department of Internal Medicine, School of Medicine, Keio University | Not Recruiting | 15years-old | Not applicable | Male and Female | 200 | Phase 4 | Japan | ||
555 | NCT01258205 | February 28, 2011 | 16 December 2017 | Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects | A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease | Crohn's Disease | Drug: AMG 139 | Allergan | Not recruiting | 18 Years | 55 Years | All | 48 | Phase 1 | United States;Australia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
556 | EUCTR2010-022383-12-NL | 16/02/2011 | 12 May 2014 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A Pharmaceutical Form: Capsule, hard INN or Proposed INN: GSK1605786A CAS Number: na Current Sponsor code: GSK1605786A Other descriptive name: na Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Limited | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden | ||||
557 | EUCTR2010-024528-12-DK | 14/02/2011 | 22 July 2013 | Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT | Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT | Morbus Crohn disease with signs of activity in the small bowel. MedDRA version: 12.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: SonoVue Pharmaceutical Form: Powder for solution for injection CAS Number: 2551-62-4 Other descriptive name: SULFUR HEXAFLUORIDE Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 45- | Henning Glerup | Not Recruiting | Female: yes Male: yes | 5 | Denmark | ||||
558 | EUCTR2010-022384-35-DE | 02/02/2011 | 14 April 2014 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1605786A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | 800 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden | ||||
559 | NCT01203631 | February 2011 | 8 August 2016 | Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease | A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease | Inflammation;Crohn's Disease | Drug: NNC 0142-0000-0002;Drug: Placebo | Janssen Research & Development, LLC | Not recruiting | 18 Years | 75 Years | Both | 78 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Poland;Russian Federation | |
560 | NCT01287897 | February 2011 | 19 October 2017 | A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy | A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante) | Crohn's Disease | Drug: PF-04236921 SC injection | Pfizer | Not recruiting | 18 Years | 75 Years | All | 250 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;New Zealand;Romania;Switzerland;United Kingdom;Sweden | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
561 | NCT01290042 | February 2011 | 23 March 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia | |
562 | NCT01291810 | February 2011 | 19 February 2015 | Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's Disease | Crohn's Disease | Biological: TNF Kinoid;Biological: WFI | Neovacs | Not recruiting | 18 Years | 65 Years | Both | 66 | Phase 2 | Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania | |
563 | EUCTR2010-019973-13-DE | 14/01/2011 | 3 September 2012 | A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients | A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease | Treatment of perianal fistulas in patients suffering from Crohn's Disease. MedDRA version: 14.0 Level: PT Classification code 10016717 Term: Fistula System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders | Product Code: QAX576 Pharmaceutical Form: Powder and solvent for solution for infusion Current Sponsor code: QAX576 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 23 | Phase 2 | Germany;Switzerland | |||
564 | EUCTR2010-019996-32-BE | 12/01/2011 | 21 August 2017 | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TNF-Kinoid Product Code: TNF-K Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Not assigned yet Current Sponsor code: TNFa-Kinoid or TNFa-K or Kinoid Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Emulsion for injection Route of administration of the placebo: Intramuscular use | Neovacs SA | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany | |||
565 | EUCTR2010-020836-21-BE | 07/01/2011 | 21 August 2017 | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | Crohn’s disease 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 Name: NNC0142-0000-0002 Product Code: NNC142-0002 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: N/A Current Sponsor code: NNC142-0002 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Hungary;European Union;Canada;Poland;Belgium;Israel;Russian Federation | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
566 | EUCTR2010-022017-26-GB | 07/01/2011 | 28 February 2019 | A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease | A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease | Crohn's disease MedDRA version: 12. Level: LLT Classification code 10013099 Term: Disease Crohns | Product Name: Prednisolone Pharmaceutical Form: Soluble tablet INN or Proposed INN: Prednisolone CAS Number: 125-02-0 Concentration unit: mg milligram(s) Concentration type: equal | Central Manchester University Hospitals Foundation Trust | Not Recruiting | Female: yes Male: yes | 27 | Phase 2 | United Kingdom | |||
567 | EUCTR2010-022382-10-GB | 06/01/2011 | 2 October 2012 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1605786A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 600 | Hungary;Germany;Netherlands;Norway;France;Italy;Austria;Sweden;Australia;United Kingdom;Czech Republic;Canada;Belgium;Denmark;Spain;Japan;United States | ||||
568 | JPRN-UMIN000007047 | 2011/01/01 | 2 April 2019 | Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease | Crohn's disease | Adacolumn and adalimumab combination therapy for 10 weeks. Adalimumab single therapy for remain 94 weeks. Adacolumn single therapy for 104 weeks. | Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology | Recruiting | 12years-old | 75years-old | Male and Female | 40 | Not applicable | Japan | ||
569 | NCT01245088 | January 2011 | 19 February 2015 | Chondroitin Sulfate for Crohn's Disease | A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease | Crohn's Disease | Drug: chondroitin sulfate | University Hospital Case Medical Center | Not recruiting | 18 Years | 80 Years | Both | 0 | Phase 1/Phase 2 | United States | |
570 | NCT01275508 | January 2011 | 19 February 2015 | Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut | Prospective, Monocentric, Open-label, Clinical Phase 1 Study to Demonstrate the Safety and Tolerability of FITC-Adalimumab After Single Topical Administration to the Intestinal Mucosa During Endomicroscopy in Patients With Crohn's Disease | Crohn's Disease | Drug: FITC-Adalimumab | University of Erlangen-Nürnberg Medical School | Abbott | Not recruiting | 18 Years | 70 Years | Both | 25 | Phase 1/Phase 2 | Germany |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
571 | NCT01316601 | January 2011 | 8 June 2015 | A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease | Crohn's Disease | Drug: QAX567 | Gerhard Rogler | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 3 | Phase 2 | Switzerland | |
572 | EUCTR2011-003742-40-DE | 23 February 2015 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Entocort® Kapseln Product Name: budesonide Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 50 | United States;Canada;Poland;Germany;Italy | |||||
573 | EUCTR2011-003743-22-DE | 10 July 2015 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Entocort® Kapseln Product Name: budesonide Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: budesonide CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 110 | United States;Canada;Poland;Germany;Italy | |||||
574 | NCT01277666 | December 20, 2010 | 16 December 2017 | A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease | A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn's Disease | Drug: GSK1605786A;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 608 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Czech Republic | |
575 | NCT01199302 | December 2010 | 11 May 2015 | Safety Study in Subjects With Crohn's Disease | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease | Crohn's Disease | Drug: AMG 827 | Amgen | Not recruiting | N/A | N/A | Both | 67 | Phase 2 | United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
576 | NCT01266785 | December 2010 | 20 May 2019 | Infliximab, Regulatory T Cells, IL2 and Crohn's Disease | Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease | Crohn's Disease | Drug: Infliximab | Oregon Health and Science University | Centocor, Inc. | Not recruiting | 18 Years | 70 Years | All | 0 | N/A | United States |
577 | NCT01094613 | November 2010 | 19 February 2015 | Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease | MultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's Disease | Crohn's Disease | Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine | Teva GTC | Not recruiting | 18 Years | 75 Years | Both | 70 | Phase 1/Phase 2 | Israel | |
578 | NCT01224171 | November 2010 | 19 October 2017 | Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | 80 Years | All | 416 | Phase 3 | United States;Canada;Puerto Rico | |
579 | EUCTR2006-000720-13-DE | 27/10/2010 | 16 November 2015 | Study to evaluate the effectiveness and safety of 3 doses of embryonated eggs of the porcine whipworm compared to placebo (dummy drug) in the treatment of active Crohn's disease. | Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease | Induction of remission in active Crohn´s disease 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 Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 250 Pharmaceutical Form: Oral suspension Current Sponsor code: TSO 250 Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 17- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 2500 Pharmaceutical Form: Oral suspension Current Sponsor code: TSO 2500 Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 167- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 7500 Pharmaceutical Form: Oral suspension Current Sponsor code: TSO 7500 Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Czech Republic;Denmark;Austria;Germany;Switzerland | |||
580 | JPRN-UMIN000005761 | 2010/10/27 | 2 April 2019 | The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab | Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness. | Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29. | Kenji Watanabe | Not Recruiting | Not applicable | Not applicable | Male and Female | 50 | Not selected | Japan | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
581 | JPRN-UMIN000005762 | 2010/10/27 | 2 April 2019 | The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease | Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody. | 1)Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29. 2)Elental(1 kcal/ml; 80g/300ml) | Kenji Watanabe | Not Recruiting | Not applicable | Not applicable | Male and Female | 40 | Not selected | Japan | ||
582 | NCT01111292 | October 2010 | 19 October 2017 | 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) | Not recruiting | 18 Years | N/A | All | 5 | Phase 1/Phase 2 | United States | |
583 | NCT01203254 | October 2010 | 19 February 2015 | Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease | Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease | Crohns Disease;Bile Acid Malabsorption | Drug: Colesevelam;Drug: Placebo | Florian Beigel | Not recruiting | 18 Years | 65 Years | Both | 34 | Phase 4 | Germany | |
584 | NCT01231217 | October 2010 | 19 February 2015 | Green Tea in Crohn's Disease | Crohn's Disease | Other: Green tea (Camellia sinensis);Other: Coffee | University Hospital Heidelberg | Recruiting | 18 Years | N/A | Both | 80 | N/A | Germany | ||
585 | EUCTR2010-020137-10-GB | 20/09/2010 | 30 April 2019 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0 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: Humira 40 mg solution for injection in pre-filled syringe Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Pharmaceutical Form: Tablet INN or Proposed INN: Azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Pharmaceutical Form: Tablet INN or Proposed INN: Azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Decortin 5 mg Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Decortin 20 mg Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | AbbVie Deutschland GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
586 | NCT01187459 | September 2010 | 19 February 2015 | Vitamin D in Pediatric Crohn's Disease | Vitamin D in Pediatric Crohn's Disease | Vitamin D Deficiency | Dietary Supplement: Vitamin D | University of British Columbia | McMaster University | Not recruiting | 8 Years | 18 Years | Both | 87 | Phase 4 | Canada |
587 | NCT01215890 | September 2010 | 19 February 2015 | Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease | A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients | Crohn's Disease;Low Bone Mineral Density | Drug: risedronate;Drug: placebo | University of Alberta | Not recruiting | 18 Years | N/A | Both | Phase 4 | Canada | ||
588 | NCT01233570 | September 2010 | 19 February 2015 | Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease | Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease | Crohn Disease | Drug: Tacrolimus | University of Aberdeen | Not recruiting | 12 Years | N/A | Both | 20 | Phase 2 | United Kingdom | |
589 | NCT01233960 | September 2010 | 16 December 2017 | Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease | A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease | Crohn's Disease | Drug: adult human mesenchymal stem cells | Mesoblast International Sàrl | Not recruiting | 18 Years | 70 Years | All | 120 | Phase 3 | United States;Australia;New Zealand | |
590 | EUCTR2010-018431-18-DE | 23/08/2010 | 16 February 2015 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1 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: REMICADE Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: INFLIXIMAB Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Janssen Biologics B.V. | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
591 | NCT01155362 | August 2010 | 4 March 2019 | A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease | A Phase 2a, Randomized, Double Blind, Placebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease | Crohn's Disease | Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion;Drug: Vehice Control | Celularity Incorporated | Celgene Corporation | Not recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States |
592 | NCT01190410 | August 2010 | 23 July 2018 | Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol | An Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035 | Crohn's Disease | Drug: certolizumab pegol | UCB Pharma | Not recruiting | 6 Years | 17 Years | All | 16 | Phase 2 | United States;Canada;Australia | |
593 | NCT01261286 | August 2010 | 19 February 2015 | Drug-Disease Interaction in Crohn's Disease | Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients | Crohn's Disease | Drug: verapamil | University of Alberta | Not recruiting | 18 Years | 65 Years | Both | Phase 1 | Canada | ||
594 | NCT01611805 | July 22, 2010 | 16 December 2017 | Japanese Phase I of GSK1605786 | A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject | Crohn's Disease | Drug: GSK1605786;Drug: GSK1605786 Placebo | GlaxoSmithKline | Not recruiting | 20 Years | 55 Years | Male | 30 | Phase 1 | Australia | |
595 | NCT01150890 | July 2010 | 25 May 2015 | AMG 827 in Subjects With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: AMG 827 350 MG;Drug: AMG 827 210 MG;Drug: AMG 827 700 MG;Drug: Placebo | Amgen | Not recruiting | 18 Years | 65 Years | Both | 130 | Phase 2 | United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
596 | EUCTR2009-015680-14-NL | 18/05/2010 | 16 February 2015 | Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients with Refractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | single or multiple draining perianal fistulas as a result of Crohn's Disease MedDRA version: 12.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: Bone Marrow Derived Mesenchymal Stem cells (MSCs) Product Code: NA Pharmaceutical Form: Injection* | Leiden University Medical Center | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
597 | NCT01114607 | May 5, 2010 | 16 December 2017 | A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects | A Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female Subjects | Crohn's Disease | Drug: GSK1605786 ChemoCentryx: formulation A;Drug: GSK1605786 GSK: formulation B;Drug: GSK1605786 GSK direct-fill: formulation C;Drug: GSK1605786 GSK modified-process: formulation D;Drug: GSK1605786 GSK tablet: formulation E | GlaxoSmithKline | Not recruiting | 18 Years | 55 Years | All | 24 | Phase 1 | United States | |
598 | NCT00737932 | May 2010 | 30 March 2015 | Laquinimod Phase IIa Study in Active Crohn's Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease. | Crohn's Disease | Drug: Laquinimod;Other: placebo | Teva Pharmaceutical Industries | Not recruiting | 18 Years | 75 Years | Both | 180 | Phase 2 | Belgium;France;Israel;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom | |
599 | NCT00988832 | February 2010 | 19 October 2017 | An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066) | A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab | Crohn's Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 380 | N/A | United Kingdom | |
600 | NCT01037322 | January 2010 | 19 February 2015 | 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 | Not recruiting | 20 Years | 80 Years | Both | 20 | Phase 1/Phase 2 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
601 | NCT01040910 | January 2010 | 19 February 2015 | 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 | Recruiting | 20 Years | 70 Years | Both | 20 | Phase 1/Phase 2 | Israel | |
602 | NCT01046773 | January 2010 | 19 February 2018 | Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease | Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease | Crohn's Disease;Vitamin D Deficiency | Drug: Cholecalciferol | University of California, Los Angeles | The Broad Foundation | Not recruiting | 8 Years | 18 Years | All | 3 | Phase 1 | United States |
603 | NCT01053559 | January 2010 | 19 February 2015 | Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy | Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy | Crohn's Disease | Drug: certolizumab pegol | Shafran Gastroenterology Center | UCB Pharma | Not recruiting | 18 Years | 70 Years | Both | 15 | N/A | United States |
604 | NCT01090817 | January 2010 | 29 June 2015 | An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease | A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease | Crohn Disease | Drug: Mesenchymal stromal cells (MSC) for infusion | R.P.Herrmann | The Queen Elizabeth Hospital;Concord Hospital;Sir Charles Gairdner Hospital;The Alfred | Not recruiting | 18 Years | 55 Years | Both | 21 | Phase 2 | Australia |
605 | NCT01288053 | January 2010 | 20 August 2018 | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease | Crohn's Disease | Biological: Allogeneic Stem Cell Therapy | Northwestern University | Not recruiting | 18 Years | 45 Years | All | 9 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
606 | NCT01548014 | January 2010 | 19 February 2015 | The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease | Reduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot Study | Crohn's Disease | Dietary Supplement: VSL#3 | Samsung Medical Center | Recruiting | 13 Years | 17 Years | Both | 1 | Phase 3 | Korea, Republic of | |
607 | JPRN-UMIN000010293 | 2009/12/19 | 2 April 2019 | Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy | Crohn's disease | Infliximab maintenance therapy for 48 weeks in, Racol daily nutritional interventions during the study period as a target intake of 800kcal per day, in the implementation group nutrition therapy is used in conjunction with a diet and Racol. In the group of non-nutritional therapy is carried out aggressive nutritional intervention is not performed, and only the normal diet | Graduate School of Medical Sciences, Kyushu University | Oita Red Cross Hospital Takano Hospital | Recruiting | 20years-old | Not applicable | Male and Female | 80 | Not applicable | Japan | |
608 | EUCTR2008-005237-30-NL | 01/12/2009 | 7 December 2015 | 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remsima and Inflectra Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Janssen Biologics B.V. | Authorised | Female: yes Male: yes | 6000 | United States;Canada;Netherlands;Sweden | ||||
609 | NCT01024647 | December 2009 | 19 February 2015 | Optimizing Cimzia in Crohn's Patients | Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy | Crohn's Disease | Biological: certolizumab pegol | Atlanta Gastroenterology Associates | UCB Pharma | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | United States |
610 | EUCTR2009-011621-14-AT | 12/11/2009 | 19 March 2012 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’s disease - A2202E1 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’s disease - A2202E1 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Not available CAS Number: None Current Sponsor code: AIN457 Other descriptive name: None Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
611 | JPRN-UMIN000002796 | 2009/11/01 | 2 April 2019 | Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial. | Crohn's disease | We randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks. For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml). placebo control | Department of Gastroenterology and Hepatology, Kyoto University | Recruiting | 16years-old | 65years-old | Male and Female | 50 | Phase 2 | Japan | ||
612 | NCT01015391 | November 2009 | 19 February 2015 | Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease | A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection | Crohn's Disease | Drug: T2;Drug: Azathioprine | Jinling Hospital, China | Recruiting | 18 Years | N/A | Both | 100 | N/A | China | |
613 | EUCTR2008-006957-42-DE | 30/10/2009 | 11 March 2013 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.1 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode 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 | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Gastro-resistant capsule, hard Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany | |||
614 | EUCTR2009-011220-62-NL | 26/10/2009 | 19 March 2012 | A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study | A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study | 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year. MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: mesalazine Pharmaceutical Form: Tablet INN or Proposed INN: mesalazine CAS Number: 65-49-6 Other descriptive name: AMINOSALICYLIC ACID Concentration unit: mg milligram(s) Concentration type: range Concentration number: 3000-3200 | University Medical Center Utrecht | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
615 | NCT00989573 | October 2009 | 19 February 2015 | A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease | A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: OPC-6535 | Otsuka Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 64 Years | Both | 191 | Phase 2/Phase 3 | Japan;Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
616 | NCT01661257 | October 2009 | 19 February 2015 | Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy | Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy | Crohn's Disease | Drug: Infliximab | Samsung Medical Center | Not recruiting | 13 Years | 17 Years | Both | 20 | Phase 3 | Korea, Republic of | |
617 | NCT00999115 | September 2009 | 19 February 2015 | Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA) | Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease | Rectovaginal Fistula;Crohn Disease | Drug: Expanded allogenic adipose-derived adult stem cells | Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz | Not recruiting | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | Spain | |
618 | NCT02322008 | September 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 1035 | N/A | ||
619 | EUCTR2009-013348-35-NL | 04/08/2009 | 19 March 2012 | (Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease | (Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease | Patients with quiescent Crohn’s colitis, defined as a Crohn’s Disease Activity Index <150 ; non-IBD patients will serve as disease controls. MedDRA version: 9.1 Level: LLT Classification code 10011400 Term: Crohn's colitis MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) | Trade Name: Chenofalk Product Name: Chenofalk Product Code: RVG 07151 Pharmaceutical Form: Capsule* INN or Proposed INN: CHENODEOXYCHOLIC ACID CAS Number: 474259 Other descriptive name: Chenodiol Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 15- | University Medical Center Utrecht | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
620 | NCT00367705 | August 2009 | 19 February 2015 | VSL#3 Treatment in Children With Crohn's Disease | Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease | Crohn's Disease | Dietary Supplement: VSL#3®;Dietary Supplement: Placebo | Hadassah Medical Organization | Not recruiting | 6 Years | 18 Years | Both | 300 | Phase 4 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
621 | NCT01012570 | August 2009 | 19 February 2015 | The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients | Crohn's Disease | Drug: Application of Adalimumab | Gerhard Rogler | Not recruiting | 18 Years | 65 Years | Both | 34 | Phase 2 | Switzerland | ||
622 | EUCTR2009-011763-37-IT | 22/07/2009 | 28 August 2012 | THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB IN CROHN`S DISEASE - ND | THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB IN CROHN`S DISEASE - ND | Crohn`s Disease MedDRA version: 9.1 Level: LLT Classification code 10038283 Term: Regional enteritis of small intestine with large intestine | Pharmaceutical Form: Solution for injection INN or Proposed INN: Adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | ISTITUTO CLINICO HUMANITAS | Not Recruiting | Female: yes Male: yes | Italy | |||||
623 | JPRN-UMIN000002074 | 2009/07/01 | 2 April 2019 | Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL | Crohn's disease | Rosuvastatin (Crestor) 0mg/day: Control group Rosuvastatin (Crestor) 5mg/day: Low-dose group Rosuvastatin (Crestor) 20mg/day: High-dose group | Department of lower gastroenterology, Hyogo College of Medicine | Not Recruiting | 20years-old | 65years-old | Male and Female | 45 | Phase 2 | Japan | ||
624 | NCT00944736 | July 2009 | 19 February 2015 | Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease | Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission | Crohn's Disease | Dietary Supplement: VSL#3;Dietary Supplement: Placebo | Children's Mercy Hospital Kansas City | VSL Pharmaceuticals | Not recruiting | 11 Years | 17 Years | Both | 12 | Phase 3 | United States |
625 | NCT00950105 | July 2009 | 19 February 2015 | Single Ascending Dose Study of Oral CPSI-2364 (Semapimod) | A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Oral CPSI-2364 in Healthy Subjects | Crohn's Disease | Drug: CPSI-2364 or placebo | Ferring Pharmaceuticals | Not recruiting | 18 Years | 55 Years | Both | 30 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
626 | NCT00972218 | July 2009 | 26 September 2016 | Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease | Efficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's Disease | Spondyloarthritis;Crohn's Disease | Biological: Adalimumab | University of Alberta | Abbott | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | Canada |
627 | NCT00851565 | June 2009 | 19 February 2015 | Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy | Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy | Crohn's Disease | Procedure: Measurement of serum infliximab and anti-infliximab antibodies;Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status | Copenhagen University Hospital at Herlev | Aase and Ejnar Danielsens Foundation;Beckett Foundation;the Danish Biotechnology Program;Danish Colitis-Crohn Society;Danish Medical Association Research Fund;Frode V. Nyegaard and wife’s Foundation;Health Science Research Foundation of Region of Copenhagen;Herlev Hospital Research Council;Lundbeck Foundation;P. Carl Petersens Fund;Biomonitor A/S;Prometheus Inc.;The Danish Institute for Health Services Research | Not recruiting | 18 Years | N/A | Both | 120 | Phase 4 | Denmark |
628 | NCT01372969 | June 2009 | 23 April 2019 | Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease. | Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease. | Crohn's Disease;Anal Fistula | Drug: Cx601 | Tigenix S.A.U. | Not recruiting | 18 Years | N/A | All | 24 | Phase 1/Phase 2 | Spain | |
629 | NCT00790933 | May 22, 2009 | 26 February 2018 | 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 | Not recruiting | 18 Years | N/A | All | 2243 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic | |
630 | EUCTR2008-008359-40-AT | 07/05/2009 | 19 March 2012 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 Pharmaceutical Form: Powder for solution for infusion Pharmaceutical form of the placebo: Powder for solution for infusion Route of administration of the placebo: Intravenous use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 72 | Germany;Poland;Austria | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
631 | JPRN-UMIN000002604 | 2009/05/01 | 2 April 2019 | Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease | Crohn's disease | Patients are randomly divided into two groups, groups treated with or without infliximab by staffs of Keio Clinical Research Center at 2 to 4 weeks after surgery. Patients receive infliximab 5 mg/kg at 0, 2, 6 weeks, followed by every 8 weeks for 2 years. Alternatively, patients continue to receive infliximab with intervals of 8 weeks if they received infliximab within 8 weeks from the time point 0. Patients without infliximab receive maintenance therapy without immunomodulators. | Clinical Research Group of inflammatory bowel disease in Japan | Not Recruiting | 18years-old | Not applicable | Male and Female | 100 | Phase 4 | Japan | ||
632 | NCT00742781 | May 2009 | 19 October 2017 | Vitamin D Supplementation in Crohn's Patients | Vitamin D and Crohn's Disease From the Bench to the Clinic | Inflammatory Bowel Disease | Dietary Supplement: Vitamin D | Penn State University | Not recruiting | 18 Years | 70 Years | All | 21 | Phase 1 | United States | |
633 | NCT00889161 | May 2009 | 19 February 2015 | 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 | Not recruiting | 8 Years | 18 Years | Both | 11 | Phase 1 | United States | |
634 | NCT01510431 | May 2009 | 24 October 2016 | Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease | An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease | Crohn's Disease | Drug: PROCHYMAL (remestemcel-L) | Mesoblast International Sàrl | Not recruiting | 18 Years | 70 Years | Both | 11 | N/A | United States | |
635 | EUCTR2008-001137-99-GB | 28/04/2009 | 20 March 2012 | CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease | CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease | Crohn's Disease MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Ciprofloxacin Product Code: PL 20532/0012 Pharmaceutical Form: Tablet INN or Proposed INN: Ciprofloxacin hydrochloride CAS Number: 86393-32-0 Current Sponsor code: 3591 Concentration unit: mg milligram(s) Concentration type: not less then Product Name: Budesonide Product Code: PL 17901/0122 Pharmaceutical Form: Capsule INN or Proposed INN: Budesonide Current Sponsor code: 3591 Other descriptive name: Entocort CR Concentration unit: mg milligram(s) Concentration type: range Concentration number: 9-3 Trade Name: DOXYCYCLINE Product Name: DOXYCYCLINE Pharmaceutical Form: Tablet INN or Proposed INN: DOXYCYCLINE HYCLATE CAS Number: 564-25-0 Current Sponsor code: 3591 Other descriptive name: DOXYCYCLINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-200 Trade Name: HYDROXYCHLOROQUINE Product Name: HYDROXYCHLOROQUINE SULPHATE Pharmaceutical Form: Coated tablet INN or Proposed INN: HYDROXYCHLOROQUINE SULPHATE CAS Number: 747-36-4 Current Sponsor code: PL17907/0017 Other descriptive name: PLAQUENIL Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 200-600 | Royal Liverpool & Broadgreen University Hospitals Trust | University of Liverpool | Authorised | Female: yes Male: yes | 100 | United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
636 | EUCTR2008-002784-14-EE | 28/04/2009 | 5 February 2018 | 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 Level: LLT 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Millennium Pharmaceuticals, Inc. | 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 | |||
637 | EUCTR2008-007519-34-SE | 17/04/2009 | 19 March 2012 | 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 Pharmaceutical Form: Powder and solvent for solution for infusion | University of Leuven Hospitals, Division of Gastroenterology | Authorised | Female: yes Male: yes | 200 | Sweden | ||||
638 | EUCTR2008-006484-36-IT | 16/04/2009 | 23 May 2012 | MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE AND ANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION IN PEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE | MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE AND ANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION IN PEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE | Moderate-to-severe active Crohn`s disease. MedDRA version: 9.1 Level: LLT Classification code 10011398 Term: Crohn's | Trade Name: REMICADE Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: INFLIXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | Not Recruiting | Female: yes Male: yes | Italy | |||||
639 | NCT00899678 | April 2009 | 19 October 2017 | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents | A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) | Crohn's Disease | Drug: Certolizumab Pegol | UCB Celltech | Not recruiting | 6 Years | 17 Years | All | 99 | Phase 2 | United States;Australia;Canada;New Zealand | |
640 | EUCTR2009-009926-94-DK | 26/03/2009 | 8 August 2016 | Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy | Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy | Patients with Crohns diseases failing treatment with infliximab MedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Humira Pharmaceutical Form: Solution for injection | Department of medical gastroenterology, Herlev Hospital | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
641 | EUCTR2008-002783-33-ES | 02/03/2009 | 11 September 2012 | 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 Crohn?s Disease Estudio 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 enfermedad de Crohn 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 Crohn?s Disease Estudio 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 enfermedad de Crohn moderada o grave. | Moderate to Severe Crohn's Disease Enfermedad de Crohn moderada o grave MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns ;Moderate to Severe Crohn's Disease Enfermedad de Crohn moderada o grave MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Code: MLN0002 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Millennium Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 1060 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Denmark;Estonia;Spain;Greece | |||
642 | EUCTR2007-005455-42-NL | 26/02/2009 | 23 December 2013 | ENDO ACE TRIAL Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk; a randomized controlled trial - ENDO ACE TRIAL | ENDO ACE TRIAL Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk; a randomized controlled trial - ENDO ACE TRIAL | Crohn's disease. Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction. MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Budenofalk Product Name: Budenofalk Pharmaceutical Form: Capsule, soft INN or Proposed INN: BUDESONIDE CAS Number: 51333223 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3 -mg Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Kenacort Product Name: Kenacort Pharmaceutical Form: Solution for injection INN or Proposed INN: TRIAMCINOLONE CAS Number: 124947 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40-mg/ml Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraileal use (Noncurrent) | University Medical Center Utrecht | Not Recruiting | Female: yes Male: yes | 42 | Netherlands | ||||
643 | EUCTR2008-000649-77-NL | 06/02/2009 | 19 March 2012 | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ustekinumab Current Sponsor code: CNTO 1275 Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Ustekinumab Product Code: CNTO 1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab Current Sponsor code: CNTO 1275 Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90 - Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Centocor BV | Not Recruiting | Female: yes Male: yes | 500 | Phase 2b | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria | |||
644 | EUCTR2008-007329-38-IT | 06/02/2009 | 19 March 2012 | Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease | Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease | Patients with steroid-dependent Crohn?s Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml Product Code: ERY-DEX Pharmaceutical Form: Solution for infusion INN or Proposed INN: dexamethasone sodium phosphate CAS Number: 2392-39-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Route of administration not applicable | ERYDEL S.P.A. | Not Recruiting | Female: yes Male: yes | 184 | Spain;Italy | ||||
645 | NCT00245505 | February 2009 | 19 February 2015 | The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's Disease | The Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot Study | Crohn's Disease | Drug: Mesalazine (Mesalamine) | Ferring Pharmaceuticals | Not recruiting | 18 Years | 70 Years | Both | 3 | Phase 3 | Sweden | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
646 | EUCTR2008-002100-26-BE | 28/01/2009 | 27 January 2014 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: PENTASA Sachet Pharmaceutical Form: Prolonged-release granules INN or Proposed INN: MESALAZINE CAS Number: 89576 Current Sponsor code: FE999907 Other descriptive name: Mesalamine, 5-aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2000- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use | Ferring Pharmaceuticals A/S | Not Recruiting | Female: yes Male: yes | 510 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | ||||
647 | EUCTR2008-005903-25-DE | 08/01/2009 | 4 March 2013 | 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 Pharmaceutical Form: Film-coated tablet Current Sponsor code: SC12267 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35- Trade Name: Prednisolon Jenapharm Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prednisolon CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Prednisolon Jenapharm Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prednisolon CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Prednisolon Jenapharm Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prednisolon CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | 4SC AG | Not Recruiting | Female: yes Male: yes | 35 | Bulgaria;Germany | ||||
648 | NCT00844285 | January 2009 | 4 November 2019 | SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry | A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease | Crohn's Disease | Drug: Cimzia | UCB Pharma | Not recruiting | 18 Years | N/A | All | 3045 | Phase 1 | United States | |
649 | NCT01429922 | January 2009 | 19 February 2015 | Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose | Double Blind Placebo-controlled,Safety and Tolerability of ZP1848 Administered as Ascending Single Dose SUBCUTANEOUS Bolus Injections in Healthy Subjects Followed by Multiple Dose Cohort of Patients With Stable Crohn's Disease in Remission | Crohns Disease | Drug: ZP1848 | MDS Pharma Services | Not recruiting | 18 Years | 50 Years | Both | 60 | Phase 1/Phase 2 | United States | |
650 | NCT00771667 | December 2008 | 19 October 2017 | A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy | Crohn's Disease | Drug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP) | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 526 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
651 | NCT00774982 | December 2008 | 19 February 2015 | Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients | Pilot, Randomized, Open-Label, Two-Way Crossover Comparative Bioavailability Study of 40 mg Delayed Release Oral 6Mercaptopurine Versus 100 mg Purinethol in Patients With Crohns Disease | Crohns Disease | Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine | Teva GTC | Not recruiting | 18 Years | 50 Years | Both | 12 | Phase 1 | Israel | |
652 | NCT00783692 | December 2008 | 19 October 2017 | 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 Crohn's Disease | Crohn's Disease | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | 80 Years | All | 1116 | Phase 3 | United States;Canada;Puerto Rico | |
653 | NCT00801125 | December 2008 | 27 June 2016 | Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy | A Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | |
654 | NCT00805766 | December 2008 | 8 January 2018 | Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD) | Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD) | Crohn's Disease | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 16 Years | 75 Years | All | 39 | Phase 3 | Japan | |
655 | NCT01378390 | December 2008 | 23 April 2019 | Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease | Randomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease | Complex Perianal Fistula;Crohn Disease | Drug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: Placebo | Tigenix S.A.U. | Not recruiting | 18 Years | N/A | All | 56 | Phase 3 | Austria;Netherlands;Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
656 | EUCTR2008-003571-45-BE | 05/11/2008 | 19 March 2012 | 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 CROHN’S DISEASE | 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 CROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540-737-29-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | ||||
657 | NCT00603616 | November 2008 | 18 December 2018 | Induction of Clinical Response Using Rifaximin in Crohn's Disease | A Randomized, Prospective, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of Rifaximin for the Treatment of Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: Placebo Comparator;Drug: Rifaximin | Scott Lee | Valeant Pharmaceuticals International, Inc. | Not recruiting | 18 Years | 80 Years | All | 36 | Phase 2 | United States |
658 | NCT00752622 | November 2008 | 16 December 2017 | Treatment With Infliximab in a Medical Setting (Study P05587) | Optimization of Treatment With Infliximab in a Medical Setting | Crohn's Disease | Biological: Infliximab 5 mg/kg;Biological: Infliximab 5 mg/kg every 6 weeks;Biological: Infliximab 7 mg/kg every 8 weeks | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 100 | Phase 4 | Canada | |
659 | NCT01559142 | November 2008 | 19 February 2015 | Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease | Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study | Crohn Disease | Drug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone) | Children's Memorial Health Institute, Poland | Not recruiting | 7 Years | 17 Years | Both | 100 | Phase 3 | Poland | |
660 | EUCTR2008-004926-18-DE | 30/10/2008 | 19 March 2012 | Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP | Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP | Moderate to severe Crohn’s disease | Trade Name: Humira Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Remicade Pharmaceutical Form: Powder for infusion* | IBD Center LMU Munich | Authorised | Female: yes Male: yes | Germany | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
661 | NCT00764699 | October 2008 | 5 March 2018 | Effect of Increlex® on Children With Crohn Disease | Effect of Increlex® on Children With Crohn Disease | Crohn Disease | Drug: rhIGF (Increlex) | Nationwide Children's Hospital | Tercica | Not recruiting | 5 Years | 15 Years | All | 3 | Phase 2/Phase 3 | United States |
662 | NCT00791557 | October 2008 | 19 October 2017 | Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease | An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum | Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Infliximab | University Hospitals Cleveland Medical Center | Centocor, Inc. | Not recruiting | 18 Years | 75 Years | All | 2 | N/A | United States |
663 | NCT00808262 | October 2008 | 19 February 2015 | Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease | A Phase I/II, Open-label, Escalating Dose, Optimal Two-stage, Study of TNFa-Kinoid (TNF- K) Immunization in Crohn's Disease Patients | Crohn's Disease | Biological: TNFa Kinoid | Neovacs | Not recruiting | 18 Years | 65 Years | Both | 21 | Phase 1/Phase 2 | South Africa;Switzerland | |
664 | NCT00810030 | October 2008 | 19 February 2015 | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR | Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative Colitis | Drug: Ferric carboxymaltose;Drug: Iron Sucrose | Vifor Inc. | Parexel;ClinStar | Not recruiting | 18 Years | N/A | Both | 484 | Phase 3 | Austria;Russian Federation |
665 | EUCTR2008-003167-39-BE | 17/09/2008 | 7 October 2014 | Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn. | Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn. | Crohn' disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: diflucan Pharmaceutical Form: Capsule* INN or Proposed INN: FLUCONAZOLE CAS Number: 86386734 Concentration unit: mg milligram(s) Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Cliniques Universitaires Saint Luc | Authorised | Female: yes Male: yes | 60 | Belgium | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
666 | EUCTR2008-004276-49-ES | 16/09/2008 | 19 March 2012 | Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave. | Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave. | Enfermedad de Crohn activa de moderada a grave MedDRA version: 9.1 Level: PT Classification code 10011401 Term: Crohn's disease | Product Name: Laquinimod Cápsulas 0.5 mg Product Code: TV-5600 Pharmaceutical Form: Capsule* INN or Proposed INN: laquinimod CAS Number: 248282-07-7 Current Sponsor code: TV-5600 Other descriptive name: ABR-215062 sodium salt Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Teva Pharmaceutical Industries Ltd. | Authorised | Female: yes Male: yes | 199 | United Kingdom;Netherlands;Belgium;France;Spain;Italy | ||||
667 | NCT00731172 | September 2008 | 19 February 2015 | A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease | A Pilot Single Center,Randomized,Double Blind Placebo Controlled Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Inducing Remission in Patients With Moderately Active Crohn's Disease. | Crohns Disease | Drug: glatiramer acetate;Drug: placebo | Tel-Aviv Sourasky Medical Center | Teva Pharmaceutical Industries;Given Imaging Ltd. | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 2 | Israel |
668 | NCT00736983 | September 2008 | 19 February 2015 | Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's | Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin | Crohn's Disease With Perianal Fistulas | Drug: adalimumab;Drug: ciprofloxacin | Foundation for Liver Research | Not recruiting | 18 Years | 70 Years | Both | 76 | Phase 3 | Netherlands | |
669 | NCT00584740 | August 2008 | 19 October 2017 | Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease | Crohn's Disease | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 59 | Phase 2 | Germany;Canada;United States | |
670 | NCT00720538 | August 2008 | 19 February 2015 | Thalidomide in Pediatric Inflammatory Bowel Diseases. | 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. | Inflammatory Bowel Diseases;Crohn's Disease;Ulcerative Colitis | Drug: Thalidomide;Drug: placebo | IRCCS Burlo Garofolo | Ospedale Meyer;Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.;Vittore Buzzi Children's Hospital;University of Pisa;Pediatric Gastroenterology Unit, University of Messina.;Università degli Studi di Brescia;University of Trieste | Not recruiting | 2 Years | 18 Years | Both | 84 | Phase 3 | Italy |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
671 | NCT00715117 | July 2008 | 17 September 2018 | The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease | The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease | Crohn's Disease | Drug: Naltrexone;Other: Placebo, sugar pill | Milton S. Hershey Medical Center | Not recruiting | 6 Years | 17 Years | All | 14 | Phase 2 | United States | |
672 | NCT01235325 | July 2008 | 19 February 2015 | The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients | The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease | Supplementation;Bone Health;Crohn's Disease | Dietary Supplement: phylloquinone (vitamin K1);Dietary Supplement: placebo | University College Cork | Health Research Board, Ireland | Not recruiting | 18 Years | 70 Years | Both | 70 | Phase 4 | Ireland |
673 | NCT02997059 | July 2008 | 9 January 2017 | Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease. | Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo | Crohn's Disease Aggravated | Drug: Fluconazole;Other: Placebo | University Hospital, Lille | Ministry of Health, France | Not recruiting | 18 Years | N/A | Both | 35 | Phase 2 | France |
674 | EUCTR2007-001377-28-FR | 11/06/2008 | 19 March 2012 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome MedDRA version: 9.1 Level: LLT Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Merck Serono International S.A. | Authorised | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | |||
675 | NCT00707512 | June 2008 | 3 August 2015 | CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring | INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring | Crohn's Disease | Drug: natalizumab | Biogen | Not recruiting | 18 Years | N/A | Both | 87 | N/A | United States;Puerto Rico | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
676 | EUCTR2008-001131-35-NL | 14/05/2008 | 19 March 2012 | Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial | Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial | this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months | Trade Name: Remicade Product Name: Infliximab Product Code: EU/1/99/116/003 Pharmaceutical Form: Intravenous infusion Trade Name: Imuran Product Name: Azathioprine Product Code: RVG 05565 Pharmaceutical Form: Oral drops* | Academic Medical Center, department of Gastroenterology and hepatology | Authorised | Female: yes Male: yes | Netherlands | |||||
677 | NCT00686374 | May 1, 2008 | 11 June 2018 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's Disease | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | Not recruiting | 7 Years | 18 Years | All | 100 | Phase 3 | Belgium;Canada;Czech Republic;Czechia;France;Netherlands;Poland;United Kingdom;United States | |
678 | NCT00609973 | May 2008 | 19 October 2017 | Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease | Double-blind, Placebo Controlled, Randomized, Multicentre, Pilot Study on the Safety and Efficacy of Ciprofloxacin for Prophylactic Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease Patients | Crohn's Disease | Drug: Ciprofloxacin;Drug: Placebo | University of North Carolina, Chapel Hill | Crohn's and Colitis Foundation;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | 70 Years | All | 33 | Phase 2 | United States |
679 | NCT01297907 | May 2008 | 19 February 2015 | Bronchial Hyperreactivity in Children With Crohn Disease | Crohn's Disease | Other: Methacholine Challenge Test;Other: Fractional Exhaled NO (FENO);Other: Blood Test;Other: PCDAI | Rambam Health Care Campus | Not recruiting | 6 Years | 25 Years | Both | 47 | N/A | Israel | ||
680 | EUCTR2008-001466-93-GB | 30/04/2008 | 24 July 2012 | Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2 | Active Crohn's Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use | Imperial College London | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
681 | EUCTR2008-001467-10-GB | 30/04/2008 | 24 July 2012 | Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3 | Ulcerative colitis - in remission Crohn's Disease - in remission MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use | Imperial College London | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom | |||||
682 | EUCTR2007-006692-37-GB | 10/04/2008 | 19 March 2012 | 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 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use | Imperial College London | Authorised | Female: yes Male: yes | 210 | United Kingdom | ||||
683 | NCT01487759 | March 2008 | 19 February 2015 | Prebiotic Effect on Metabolites in Crohn's Disease | Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients | Crohn Disease | Dietary Supplement: Oligofructose enriched inulin;Dietary Supplement: Maltodextrin | Katholieke Universiteit Leuven | Not recruiting | 18 Years | N/A | Both | 67 | N/A | Belgium | |
684 | EUCTR2007-004269-16-GB | 28/02/2008 | 19 March 2012 | Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children | Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children | Growth failure in children with Crohn's disease | Trade Name: Increlex Product Name: Increlex 10mg/ml solution for injection Pharmaceutical Form: Solution for injection | Queen Mary, University of London | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
685 | EUCTR2007-003239-21-FR | 05/02/2008 | 19 March 2012 | A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT | A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT | Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: Certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Certolizumab pegol (rINN) CAS Number: 428863-50-7 Current Sponsor code: CDP870 Other descriptive name: Anti TNF humanized antibody Fab fragment-PEG conjugate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 150-+/- 15 | UCB PHARMA S.A. | Authorised | Female: yes Male: yes | Phase 3b | France | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
686 | NCT00609752 | February 2008 | 19 February 2015 | Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease | Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease | Crohn Disease | Drug: prednisolone;Dietary Supplement: Alicalm (polymeric liquid formula) | University Hospital Birmingham | SHS International;Children's Memorial Research Foundation;St George's University Hospital Research Foundation | Recruiting | 7 Years | 17 Years | Both | 80 | Phase 4 | United Kingdom |
687 | NCT00517296 | January 2008 | 16 December 2017 | Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas | EUS Guided Treatment With Humira for Crohn's Perianal Fistulas | Crohn Disease;Rectal Fistula | Procedure: EUA with seton placement if necessary;Drug: adalimumab;Procedure: EUS | Vanderbilt University Medical Center | Not recruiting | 18 Years | N/A | All | 21 | Phase 4 | United States | |
688 | NCT00615199 | January 2008 | 19 October 2017 | A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease | 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 Crohn's Disease. | Crohn's Disease | Drug: CP-690,550;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 139 | Phase 2 | United States;Belgium;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom | |
689 | NCT00621257 | January 2008 | 16 December 2017 | Vitamin D Levels in Children With IBD | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Dietary Supplement: ergocalciferol;Dietary Supplement: Cholecalciferol | Boston Children’s Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Crohn's and Colitis Foundation;NASPGHAN Foundation | Not recruiting | 5 Years | 21 Years | All | 134 | N/A | United States |
690 | NCT02185183 | January 2008 | 19 October 2017 | Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD) | Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD | Crohn's Disease | Drug: Alequel | Hadassah Medical Organization | Not recruiting | 18 Years | 70 Years | All | 22 | Phase 1/Phase 2 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
691 | EUCTR2007-001913-41-FI | 12/12/2007 | 19 March 2012 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: certolizumab pegol CAS Number: 428863-50-7 Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 150-+/-15 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB Celltech | Not Recruiting | Female: yes Male: yes | 550 | Phase 3b | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | |||
692 | EUCTR2007-002716-26-FI | 12/12/2007 | 26 June 2012 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: certolizumab pegol CAS Number: 428863-50-7 Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 150-+/- 15 | UCB Celltech | Not Recruiting | Female: yes Male: yes | 200 | Phase 3b | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | |||
693 | NCT00619489 | December 2007 | 19 October 2017 | 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. | Not recruiting | 18 Years | 75 Years | All | 72 | Phase 2 | Canada | |
694 | NCT00358683 | November 2007 | 19 February 2015 | A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease | Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study. | Crohn's Disease | Drug: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 0 | Phase 3 | ||
695 | NCT00562887 | November 2007 | 19 February 2015 | Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease | A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease. | Crohn's Disease | Biological: Placebo;Biological: ABT-874 | Abbott | Not recruiting | 18 Years | 74 Years | Both | 246 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Denmark;Puerto Rico;Germany | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
696 | NCT00543374 | October 2007 | 24 October 2016 | Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease | A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: PROCHYMAL adult human mesenchymal stem cells | Mesoblast International Sàrl | Not recruiting | 18 Years | 70 Years | Both | 98 | Phase 3 | United States;Canada | |
697 | NCT00774969 | October 2007 | 19 February 2015 | Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease | Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease | Perianal Crohns' | Drug: Metronidazole | S.L.A. Pharma AG | Not recruiting | 18 Years | 65 Years | Both | 19 | Phase 1 | United Kingdom | |
698 | NCT00792740 | October 2007 | 19 February 2015 | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | Crohn's Disease | Drug: ITF2357;Drug: Placebo capsules | Italfarmaco | Not recruiting | 18 Years | 88 Years | Both | 51 | Phase 1/Phase 2 | Belgium | |
699 | NCT00521950 | September 2007 | 19 February 2015 | Cost-effectiveness of TPMT Pharmacogenetics | Pharmacogenetic Testing in the Clinical Setting: is Screening for TPMT Genotype a Cost-effective Treatment Strategy? - The First Prospective Randomized Controlled Trial Within the Dutch Health Care System. | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Genetic: TPMT genotyping; Drug: azathioprine or 6-mercaptopurine;Drug: azathioprine (AZA) or 6-mercaptopurine (6-MP) | ZonMw: The Netherlands Organisation for Health Research and Development | Radboud University | Not recruiting | 18 Years | N/A | Both | 853 | N/A | Netherlands |
700 | EUCTR2007-000189-19-NL | 06/08/2007 | 19 March 2012 | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Italfarmaco S.p.A. | Not Recruiting | Female: yes Male: yes | 80 | Netherlands;Belgium;Italy | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
701 | NCT00511329 | August 2007 | 11 June 2018 | Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease | Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease | Arthritis, Juvenile Rheumatoid;Crohn Disease | Drug: somatropin [rDNA origin] for injection | Nationwide Children's Hospital | Pfizer | Not recruiting | 5 Years | 17 Years | All | 10 | Phase 2/Phase 3 | United States |
702 | EUCTR2007-001014-17-FR | 26/07/2007 | 19 March 2012 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Product Name: Rifaximin-EIR Pharmaceutical Form: Gastro-resistant tablet CAS Number: 80621-81-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Alfa Wassermann S.p.A. | Authorised | Female: yes Male: yes | 424 | Phase 2 | Hungary;Germany;France;Italy | |||
703 | EUCTR2006-003371-13-DE | 17/07/2007 | 19 March 2012 | 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 Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | 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 Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | |||
704 | NCT01144156 | July 2007 | 19 February 2015 | Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy | Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy | Crohn's Disease | Drug: Treatment with Adalimumab | Rabin Medical Center | Abbott | Not recruiting | 18 Years | N/A | Both | 30 | N/A | Israel |
705 | EUCTR2006-004784-58-BE | 22/06/2007 | 19 March 2012 | Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF | Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF | Crohn's disease MedDRA version: 8.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: remicade Product Name: remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- | University of Leuven | Authorised | Female: yes Male: yes | 25 | United Kingdom;Germany;Belgium;France | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
706 | JPRN-UMIN000004427 | 2007/06/01 | 2 April 2019 | A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection | Crohn's disease | Non-infliximab arm: Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum). Infliximab arm: Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial. | Lower GI disease, Hyogo College of Medicine | Not Recruiting | 16years-old | 65years-old | Male and Female | 30 | Phase 2,3 | Japan | ||
707 | NCT00495521 | June 2007 | 16 December 2017 | High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children | A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease | Crohn's Disease | Drug: 4-Aminosalicylic acid extended release granules | Jacobus Pharmaceutical | Not recruiting | 2 Years | 18 Years | All | 2 | Phase 2 | United States;Israel | |
708 | NCT00724529 | June 2007 | 19 February 2015 | Post Marketing Surveillance of Remicade | Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ankylosing Spondylitis | Biological: Infliximab | Janssen Korea, Ltd., Korea | Not recruiting | N/A | N/A | Both | 938 | Phase 4 | Korea, Republic of | |
709 | NCT00606346 | May 31, 2007 | 11 November 2019 | 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. | Not recruiting | 1 Month | 17 Years | All | 4970 | N/A | United States;Canada | |
710 | NCT00467922 | May 2007 | 19 February 2015 | An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy | A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid | Crohn's Disease;Ulcerative Colitis;Rectal Cancer;Colon Cancer;Colon Polyps;Rectal Polyps;Diverticulitis | Drug: Hextend;Drug: Lactated Ringers | Spectrum Health Hospitals | Deltex Medical, Inc. | Not recruiting | 18 Years | 80 Years | Both | 69 | Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
711 | NCT00482092 | May 2007 | 16 December 2017 | Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease | A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease | Crohn's Disease | Drug: adult human mesenchymal stem cells;Drug: Placebo | Mesoblast International Sàrl | Not recruiting | 18 Years | 70 Years | All | 330 | Phase 3 | United States;Australia;Canada;New Zealand | |
712 | NCT00307931 | April 2007 | 19 October 2017 | Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab | Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 16 | Phase 3 | Greece | |
713 | NCT00409682 | April 2007 | 19 October 2017 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease | A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Adalimumab | Abbott | Not recruiting | 6 Years | 17 Years | All | 192 | Phase 3 | United States;Belgium;Canada;Czech Republic;France;Netherlands;Poland;United Kingdom;Italy | |
714 | JPRN-JapicCTI-070367 | 01/3/2007 | 2 April 2019 | A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease | A Multi-Center, Randomized, Double-Blind, Placebo-controlled study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease | Crohn's disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : Subcutaneous Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneous | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 15 | 75 | BOTH | 80 | Phase 2-3 | ||
715 | NCT00445432 | March 2007 | 19 October 2017 | A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: adalimumab;Other: Placebo | Abbott | Eisai Co., Ltd. | Not recruiting | 15 Years | 75 Years | All | 82 | Phase 2/Phase 3 | Japan |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
716 | NCT00462072 | March 2007 | 19 October 2017 | Centocor Microarray Study of Patients | Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases | Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease | Drug: Infliximab | University of Rochester | Centocor, Inc. | Not recruiting | 12 Years | N/A | All | 31 | Phase 4 | United States |
717 | JPRN-JapicCTI-070366 | 01/2/2007 | 2 April 2019 | A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease | Crohn's disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : Subcutaneous Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneous | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 15 | 75 | BOTH | 80 | Phase 2-3 | ||
718 | NCT00445939 | February 2007 | 19 October 2017 | A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: adalimumab;Biological: placebo | Abbott | Abbott Japan Co.,Ltd;Eisai Co., Ltd. | Not recruiting | 15 Years | 75 Years | All | 90 | Phase 2/Phase 3 | Japan |
719 | EUCTR2006-006632-22-BE | 26/01/2007 | 19 March 2012 | Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial | Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial | Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy MedDRA version: 8.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: HUMIRA Pharmaceutical Form: Injection* Trade Name: REMICADE Pharmaceutical Form: Intravenous infusion | University of Leuven, Division of Gastroenterology | Authorised | Female: yes Male: yes | Belgium | |||||
720 | NCT00354367 | January 2007 | 19 February 2015 | Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas | A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas. | Crohn Disease | Drug: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 0 | Phase 3 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
721 | NCT00356408 | January 2007 | 19 October 2017 | Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease | An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752). | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 106 | Phase 3 | United States;Canada;Germany | |
722 | NCT00417690 | January 2007 | 19 February 2015 | High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease | A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease | Crohn's Disease | Drug: 4-Aminosalicylic acid;Drug: PASER placebo granules | Jacobus Pharmaceutical | Not recruiting | 18 Years | 65 Years | Both | 54 | Phase 2 | United States;Israel | |
723 | NCT00427804 | January 2007 | 19 October 2017 | Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption | Tumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium Absorption | Rheumatoid Arthritis;Crohn's Disease | Drug: calcitriol | Atlanta VA Medical Center | Emory University | Not recruiting | 18 Years | 50 Years | Male | 9 | N/A | United States |
724 | NCT00427921 | January 2007 | 19 October 2017 | Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) | A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) | Crohn's Disease | Biological: adalimumab | Abbott | Not recruiting | 18 Years | N/A | All | 304 | Phase 3 | United States | |
725 | NCT00513552 | January 2007 | 19 February 2015 | Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis | Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis | Crohn's Disease | Drug: Rifabutin, Clarithromycin, and Clofazimine | Medstar Research Institute | Recruiting | 18 Years | 90 Years | Both | 20 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
726 | NCT00406653 | December 2006 | 19 October 2017 | A Study of Abatacept in Patients With Active Crohn's Disease | 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 Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy | Crohn's Disease | Drug: abatacept;Drug: placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 451 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;Argentina;Ireland;Korea, Republic of;Spain;United Kingdom | |
727 | NCT00417391 | December 2006 | 19 February 2015 | Phase II Study of RR110 in Patients With Active Crohn's Disease | Phase II Study of RR110 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: RR110 (Tamibarotene) | R&R Inc. | Not recruiting | 20 Years | N/A | Both | 24 | Phase 2 | Japan | |
728 | NCT00349752 | November 2006 | 19 October 2017 | Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease | A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease. | Crohn's Disease | Biological: certolizumab pegol 400 mg;Other: Placebo | UCB Pharma | Not recruiting | 18 Years | N/A | All | 174 | Phase 3 | United States;Canada;Germany;Belgium | |
729 | EUCTR2006-002078-23-NL | 12/10/2006 | 5 August 2013 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1 Level: LLT Classification code 10013099 Term: Disease Crohns | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: adalimumab Concentration unit: mg milligram(s) Concentration type: range Concentration number: 40-160 Product Name: Humira pre-filled PEN Pharmaceutical Form: Injection* INN or Proposed INN: adalimumab Concentration unit: mg milligram(s) Concentration type: range Concentration number: 40-160 | Abbott GmbH & Co. KG (Abbott) | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||||
730 | EUCTR2005-000496-17-SE | 06/10/2006 | 19 March 2012 | Atorvastatin in moderat active Crohns disease | Atorvastatin in moderat active Crohns disease | Crohn's disease is an idiopathic chronic inflammatory bowel disease thought to result from inappropriate and ongoing activation of the mucosal immune system driven by the presence of normal luminal flora. It may affect the hole gastrointestinal tract, from mouth to rectum, with symptoms such as diarrhea, weight lose, malabsorption, abdominal pain and fever. | Product Name: atorvastatin Pharmaceutical Form: Tablet | Region Skåne | Not Recruiting | Female: yes Male: yes | 12 | Sweden | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
731 | NCT00333788 | October 2006 | 19 October 2017 | Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease | Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study. | Crohn's Disease | Biological: Certolizumab pegol (CDP870) | UCB Pharma | Not recruiting | 18 Years | N/A | All | 233 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom | |
732 | NCT00454545 | October 2006 | 19 February 2015 | Atorvastatin in Moderate Active Crohns Disease | Crohns Disease | Drug: Atorvastatin | Skane University Hospital | Not recruiting | 18 Years | 65 Years | Both | 12 | Phase 2 | Sweden | ||
733 | NCT00573469 | October 2006 | 19 October 2017 | Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | Crohn's Disease | Drug: D9421-C, 9mg;Drug: D9421-C, 15mg;Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | 65 Years | All | 75 | Phase 2 | Japan | |
734 | NCT00897312 | October 2006 | 2 May 2016 | Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease | Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics | Melanoma | Biological: infliximab;Biological: pegylated interferon alfa;Biological: ticilimumab;Drug: ribavirin;Other: high performance liquid chromatography;Other: laboratory biomarker analysis | Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) | Not recruiting | N/A | N/A | Both | 7 | N/A | |
735 | EUCTR2006-002494-48-GB | 27/09/2006 | 19 March 2012 | Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease | Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease | Active colonic Crohn's disease MedDRA version: 8.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) | Trade Name: Viagra Pharmaceutical Form: Film-coated tablet | University College London / University College London Hospitals NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | 15 | United Kingdom | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
736 | NCT00343642 | September 2006 | 19 February 2015 | Dietary Treatment of Crohn's Disease | Dietary Treatment of Crohn's Disease | Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: Time and attention + fructo-oligosaccharide placebo;Dietary Supplement: dietary therapy + fructo-oligosaccharide placebo;Drug: Time and attention + active fructooligosaccharide supplementation | Rush University Medical Center | National Center for Complementary and Integrative Health (NCCIH) | Not recruiting | 18 Years | 80 Years | Both | 73 | Phase 1/Phase 2 | United States |
737 | NCT00353756 | September 2006 | 19 February 2015 | Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn’s Disease | A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn’s Disease | Crohn's Disease | Drug: C326, IL-6 Inhibitory Avimer protein | Avidia | Recruiting | 18 Years | 65 Years | Both | 52 | Phase 1 | Australia | |
738 | NCT00588393 | September 2006 | 19 February 2015 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Not recruiting | 18 Years | N/A | Both | 75 | Phase 2 | United States |
739 | NCT00663117 | September 2006 | 19 October 2017 | The Effects of Naltrexone on Active Crohn's Disease | The Effects of Naltrexone in Active Crohn's Disease | Inflammation;Crohn's Disease | Drug: Naltrexone-HCl;Drug: Placebo | Penn State University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);The Broad Foundation | Not recruiting | 18 Years | 75 Years | All | 40 | Phase 2 | United States |
740 | NCT00348283 | August 2006 | 19 October 2017 | Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | Crohn's Disease | Biological: adalimumab;Biological: placebo | Abbott | Not recruiting | 18 Years | 75 Years | All | 135 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Sweden | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
741 | EUCTR2005-005291-32-BE | 20/07/2006 | 19 March 2012 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1 Level: LLT Classification code 10057035 | Product Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: Adalimumab Concentration unit: mg milligram(s) Concentration type: range Concentration number: 40-160 Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Subcutaneous use | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | ||||
742 | EUCTR2005-005363-28-GB | 11/07/2006 | 19 March 2012 | 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 Pharmaceutical Form: Granules INN or Proposed INN: AST-120 Current Sponsor code: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use | Ocera Therapeutics, Inc. | Authorised | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | ||||
743 | NCT00287170 | July 2006 | 19 February 2015 | Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease | Pilot, Open-Label, Randomized, Parallel Group Study to Evaluate Clinical/ and Immunological Efficacy/Safety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CD | Crohn's Disease | Drug: Delayed Release 6MP or Calcitriol vs. Purinethol | Teva GTC | Not recruiting | 18 Years | 75 Years | Both | 15 | Phase 1/Phase 2 | Israel | |
744 | NCT00305409 | June 2006 | 19 February 2015 | Synbiotic Treatment in Crohn's Disease Patients | Synbiotic Treatment in Crohn's Disease Patients | Crohn's Disease | Drug: Synbiotic (Synergy I / B.longum) | University of Dundee | Not recruiting | 18 Years | 79 Years | Both | 50 | N/A | United Kingdom | |
745 | NCT00329537 | June 2006 | 19 February 2015 | Study of Sargramostim in Moderately to Severely Active Crohn's Disease | Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study) | Crohn's Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | Not recruiting | 18 Years | N/A | Both | 11 | Phase 2 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
746 | NCT00338650 | June 2006 | 19 February 2015 | Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE) | A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab | Crohn's Disease | Drug: adalimumab | Abbott | Not recruiting | 18 Years | 75 Years | Both | 1000 | Phase 3 | United States | |
747 | EUCTR2005-003827-38-GB | 02/05/2006 | 18 April 2012 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B Pharmaceutical Form: Capsule* Current Sponsor code: CCX282-B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | ChemoCentryx, Inc | Authorised | Female: yes Male: yes | 598 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | ||||
748 | NCT00257699 | May 2006 | 19 February 2015 | Study of Antibiotics in the Treatment of Colonic Crohn's Disease | Metronidazole and Ciprofloxacin in the Treatment of Colonic Crohn's Disease: The MACINTOCC Trial. | Crohn's Disease | Drug: Metronidazole placebo;Drug: ciprofloxacin placebo;Drug: ciprofloxacin;Drug: metronidazole | Mount Sinai Hospital, Canada | Crohn's and Colitis Foundation | Not recruiting | 16 Years | N/A | Both | 12 | Phase 2 | Canada |
749 | NCT00317369 | May 2006 | 19 February 2015 | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease | Crohn Disease | Drug: OPC-6535(Tetomilast) | Otsuka Pharmaceutical Co., Ltd. | Not recruiting | 16 Years | 65 Years | Both | 60 | Phase 2 | Japan | |
750 | NCT00329420 | May 2006 | 19 October 2017 | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668) | A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | Not recruiting | 16 Years | 64 Years | All | 46 | Phase 2 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
751 | NCT00329550 | May 2006 | 19 October 2017 | Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease | A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol (CZP) | UCB Japan Co. Ltd. | Not recruiting | 16 Years | 64 Years | All | 40 | Phase 2 | Japan | |
752 | NCT00655733 | April 2006 | 19 October 2017 | Phase II Study of HMPL-004 in Subjects With Crohn's Disease | Crohn's Disease | Drug: HMPL004;Drug: Placebo | Hutchison Medipharma Limited | Not recruiting | 18 Years | N/A | All | 101 | Phase 2 | United States | ||
753 | EUCTR2005-004104-37-BE | 23/03/2006 | 3 April 2012 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: certolizumab pegol Current Sponsor code: CDP870 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 150-+/- 15 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | UCB S.A. | Not Recruiting | Female: yes Male: yes | 600 | Phase 3b | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | |||
754 | EUCTR2005-005414-20-IT | 06/03/2006 | 19 March 2012 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Thalidomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | ISTITUTO PER L INFANZIA BURLO GAROFOLO | Authorised | Female: yes Male: yes | 124 | Italy | ||||
755 | NCT00291668 | March 2006 | 16 March 2015 | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease | Crohn's Disease | Biological: Certolizumab Pegol;Other: Placebo | UCB Japan Co. Ltd. | Not recruiting | 16 Years | 65 Years | Both | 94 | Phase 2 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
756 | NCT00306215 | March 2006 | 19 February 2015 | A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease | A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: CCX282-B | ChemoCentryx | Not recruiting | 18 Years | N/A | Both | 436 | Phase 2 | Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;Netherlands;Poland;South Africa;Sweden;United Kingdom | |
757 | EUCTR2005-003337-40-GB | 13/02/2006 | 19 March 2012 | Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC | Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC | Patients with Crohn's disease who have not responded to immunosupressant medication | Product Name: Cyclophosphamide Product Code: N/A Pharmaceutical Form: Intravenous infusion INN or Proposed INN: cyclophosphamide CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 4000- INN or Proposed INN: cyclophosphamide CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 200- Product Name: Filgrastim Product Code: N/A Pharmaceutical Form: Injection* INN or Proposed INN: Filgrastim CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: µg/kg microgram(s)/kilogram Concentration type: range Concentration number: 50-100 Product Name: rabbit antithymocyte globulin Product Code: rbATG Pharmaceutical Form: Intravenous infusion INN or Proposed INN: rabbit antithymocyte globulin CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 7.5- Product Name: Mesna Product Code: N/A Pharmaceutical Form: Intravenous infusion INN or Proposed INN: mensa CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg/m2 milligram(s)/square meter Concentration type: range Concentration number: 3200-4800 Product Name: methyl prednisolone Product Code: N/A Pharmaceutical Form: Intravenous infusion INN or Proposed INN: methyl prednisolone CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 3- Product Name: ciprofloxacin Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed INN: ciprofloxacin CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: g gram(s) Concentration type: range Concentration number: 1-90 | European Group for Blood and Marrow Transplantation (EMBT) | Authorised | Female: yes Male: yes | 48 | United Kingdom | ||||
758 | NCT00286689 | February 3, 2006 | 18 December 2018 | Effects of Growth Hormone in Chronically Ill Children | Hurler Syndrome;Cerebral Palsy;Juvenile Rheumatoid Arthritis;Crohn Disease;HIV Infections | Drug: Growth Hormone;Procedure: Whole body Protein turnover;Procedure: DEXA scan | University of Texas Southwestern Medical Center | Not recruiting | 3 Years | 17 Years | All | 0 | N/A | United States | ||
759 | NCT00294112 | February 2006 | 19 February 2015 | Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease | A Phase II, Open-label, Randomized Study to Evaluate the Safety and Efficacy of PROCHYMAL™ IBD (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects Experiencing Moderate-to-severe Crohn's Disease That is Refractory to Steroids and Immune Suppressants | Crohn's Disease | Drug: Prochymal™ adult human mesenchymal stem cells;Drug: adult human mesenchymal stem cells | Mesoblast International Sàrl | Not recruiting | 18 Years | 70 Years | Both | 10 | Phase 2 | United States | |
760 | NCT00297648 | February 2006 | 19 October 2017 | Mucosal Healing Study in Crohn's Disease (CD) | A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease. | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | Not recruiting | 18 Years | N/A | All | 89 | Phase 3 | Belgium;France;Germany | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
761 | NCT00583232 | February 2006 | 16 December 2017 | Protein and Energy Metabolism in Pediatric Crohn's Disease | Protein and Energy Metabolism in Pediatric Crohn's Disease | Crohn's Disease;Protein Metabolism;Energy Metabolism | Drug: Stable isotope infusions | Indiana University | GlaxoSmithKline;Crohn's and Colitis Foundation;National Center for Research Resources (NCRR) | Not recruiting | 6 Years | 18 Years | All | 15 | Phase 1 | United States |
762 | NCT00587041 | February 2006 | 19 October 2017 | Use of Oral Probiotics to Reduce Urinary Oxalate Excretion | Use of Oral Probiotics to Reduce Urinary Oxalate Excretion | Nephrolithiasis;Hyperoxaluria;Crohn's Disease | Dietary Supplement: Oxadrop;Dietary Supplement: Agri-King Synbiotic (AKSB);Other: Placebo | Mayo Clinic | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institutes of Health (NIH);National Center for Complementary and Integrative Health (NCCIH);National Center for Research Resources (NCRR) | Not recruiting | 18 Years | N/A | All | 40 | Phase 1/Phase 2 | United States |
763 | NCT00727298 | February 2006 | 19 October 2017 | Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840) | Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases | Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Psoriasis;Crohn's Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 4485 | N/A | Germany |
764 | EUCTR2005-002857-29-HU | 04/01/2006 | 19 March 2012 | A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s Disease | Moderate to severe, active Crohn’s disease MedDRA version: 3.2 Level: LLT Classification code 10011401 | Product Name: STA-5326 mesylate Product Code: S38 Pharmaceutical Form: Coated tablet Current Sponsor code: STA-5326 mesylate Other descriptive name: STA-6838, STA-5326 m, S38 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | Synta Pharmaceutical Corporation | Not Recruiting | Female: yes Male: yes | 282 | Hungary | ||||
765 | NCT00295165 | January 2006 | 19 February 2015 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | Not recruiting | 18 Years | N/A | Both | 33 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
766 | NCT00630643 | January 2006 | 19 February 2015 | NI-0401 in Active Crohn's Disease | A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease | Moderate to Severe Crohn's Disease | Biological: NI-0401 (anti-CD3 mAB);Drug: Placebo | NovImmune SA | Not recruiting | 18 Years | 70 Years | Both | 40 | Phase 1/Phase 2 | ||
767 | EUCTR2005-002319-26-DE | 20/12/2005 | 19 March 2012 | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study | Crohn's disease | Product Code: AZD9056 Pharmaceutical Form: Tablet Current Sponsor code: AZD9056 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Hungary;Germany;Belgium;Austria | |||
768 | JPRN-C000000300 | 2005/12/01 | 2 April 2019 | Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with Crohn's disease in active phase - | Patients with Crohn's disease in active phase | Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. | Zeria Pharmaceutical Co.,LTD | Not Recruiting | 16years-old | 64years-old | Male and Female | 60 | Phase 3 | Japan | ||
769 | JPRN-C000000301 | 2005/12/01 | 2 April 2019 | Z-206 Phase III Clinical Trial -Investigation on the remission–maintaining effect in patients with Crohn's disease in remission phase- | Patients with Crohn's disease in remission phase | Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. | Zeria Pharmaceutical Co.,LTD. | Not Recruiting | 16years-old | 64years-old | Male and Female | 40 | Phase 2,3 | Japan | ||
770 | NCT00132899 | December 2005 | 19 February 2015 | COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial) | A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD) | Crohn's Disease | Drug: Methotrexate;Drug: Placebo | University of Western Ontario, Canada | Schering-Plough | Not recruiting | 18 Years | N/A | Both | 128 | Phase 3 | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
771 | NCT00571337 | December 2005 | 19 February 2015 | Stop Infliximab in Patients With Crohn's Disease | Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab | Crohn Disease | Drug: Infliximab | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Not recruiting | 18 Years | N/A | Both | 126 | Phase 3 | Belgium;France | |
772 | NCT00250198 | November 3, 2005 | 16 December 2017 | The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease | A Randomized, Double-blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease | Crohn's Disease | Drug: STA-5326 | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | 75 Years | All | 12 | Phase 2 | United States | |
773 | NCT00234741 | November 2005 | 19 February 2015 | Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease | Crohn's Disease | Drug: STA-5326 mesylate | Synta Pharmaceuticals Corp. | National Institute of Allergy and Infectious Diseases (NIAID);National Institutes of Health (NIH) | Not recruiting | 18 Years | 75 Years | Both | 12 | Phase 2 | United States |
774 | NCT00265772 | November 2005 | 19 February 2015 | Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis | Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis | Crohn's Disease;Pediatric | Drug: MODULEN IBD (R) (specific Enteral Nutrition);Drug: prednisolon | Hôpital Necker-Enfants Malades | Institut National de la Santé Et de la Recherche Médicale, France;Nestlé | Recruiting | 6 Years | 18 Years | Both | 24 | Phase 4 | France |
775 | NCT00838149 | November 2005 | 19 February 2015 | Effect of Glutamine on Intestinal Permeability in Crohn's Disease | Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial | Crohn's Disease | Dietary Supplement: Glutamine;Dietary Supplement: Whey protein | All India Institute of Medical Sciences, New Delhi | Not recruiting | 15 Years | 60 Years | Both | 30 | Phase 1 | India | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
776 | NCT00225810 | October 2005 | 19 February 2015 | A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease | Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s Disease | Crohn's Disease | Drug: Crohn's Disease | Ferring Pharmaceuticals | Not recruiting | 8 Years | 18 Years | Both | 50 | Phase 4 | Czech Republic | |
777 | NCT02247258 | October 2005 | 8 June 2015 | Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence. | Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study. | Crohn Disease;Recurrence;Azathioprine;Prevention | Drug: Azathioprine;Drug: Azathioprine in case of endoscopic recurrence;Procedure: Ileocolonoscopy;Procedure: Small bowel follow trough | Universitaire Ziekenhuizen Leuven | International organization for the study of inflammatory bowel disease (IOIBD) | Not recruiting | 16 Years | 75 Years | Both | 63 | Phase 2 | Belgium;Czech Republic;Greece |
778 | EUCTR2005-002472-15-SE | 22/09/2005 | 19 March 2012 | The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. | The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. | Mild to moderate active Crohn's disease MedDRA version: 7.1 Level: PT Classification code 10011401 | Trade Name: Pentasa Sachet 1 g prolonged release granules Product Name: Pentasa Sachet 1 g Pharmaceutical Form: Prolonged-release granules INN or Proposed INN: mesalazine Other descriptive name: 5-Aminosalicylic acid Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- | Ferring Laegemidler A/S | Not Recruiting | Female: yes Male: yes | 10 | Sweden | ||||
779 | NCT00132184 | September 2005 | 19 February 2015 | Vitamin D Treatment for Crohn´s Disease | Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation | Crohns Disease | Drug: Vitamin D | University of Aarhus | Not recruiting | 18 Years | 90 Years | Both | 110 | Phase 2/Phase 3 | Denmark | |
780 | NCT00252369 | September 2005 | 19 February 2015 | Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment. | Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease. | Crohn's Disease | Drug: Infliximab;Procedure: Instillation of fibrin glue | Sheba Medical Center | Not recruiting | 18 Years | 90 Years | Both | N/A | Israel | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
781 | NCT00130390 | August 2005 | 19 February 2015 | Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease | Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults | Crohn's Disease | Drug: Nitazoxanide;Other: Placebo | Romark Laboratories L.C. | Not recruiting | 18 Years | N/A | Both | 98 | Phase 2 | United States | |
782 | NCT00138840 | August 2005 | 19 February 2015 | Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's Disease | Crohn's Disease | Drug: STA-5326 mesylate | Synta Pharmaceuticals Corp. | Not recruiting | 18 Years | 75 Years | Both | 282 | Phase 2 | United States;Canada | |
783 | EUCTR2005-002048-25-SE | 20/07/2005 | 19 March 2012 | A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease. | A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease. | Inflammatory Bowel Disease (IBD) is the comprehensive term for disorders involving chronic inflammation in the gastrointestinal tract, often the small intestine and colon. It is believed to be a disorder mediated by T lymphocytes that arise in genetically susceptible persons as a result of a breakdown in the regulatory constraints on mucosal immune responses to enteric bacteria. Evidence suggests that Th1 T cells play an important pathogenetic role in Crohn´s disease. Level: PT Classification code 10011401 | Product Name: rCTB-401 Pharmaceutical Form: Oral solution Other descriptive name: rCTB-401 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- | SBL Vaccin AB | Not Recruiting | Female: yes Male: yes | 25 | Sweden | ||||
784 | NCT00113503 | July 2005 | 16 December 2017 | Imuran Dosing in Crohn's Disease Study | A Multi-site Trial of Azathioprine Dosing in Crohn's Disease | Crohn's Disease | Drug: Azathioprine weight-based dose;Drug: Azathioprine individualised dose | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Prometheus Laboratories | Not recruiting | 10 Years | 70 Years | All | 50 | Phase 2 | United States;Canada |
785 | NCT00167882 | July 2005 | 19 February 2015 | 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 | Not recruiting | 18 Years | 70 Years | Both | 24 | Phase 4 | Netherlands | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
786 | NCT00546546 | July 2005 | 4 May 2015 | Early Immunosuppressants in Crohn's Disease | Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease | Crohn's Disease | Drug: early immunosuppressants (azathioprine, methotrexate) | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Société Nationale Française de Gastroentérologie;Société Nationale Française de Gastroentérologie | Not recruiting | 18 Years | N/A | Both | 120 | Phase 4 | France |
787 | EUCTR2005-001148-22-SK | 27/06/2005 | 27 February 2017 | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | Crohn's disease MedDRA version: 7.1 Level: Low Classification code 10011401 | Trade Name: Certican Product Name: Certican Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Imuran Product Name: Imuran Pharmaceutical Form: Capsule* INN or Proposed INN: Azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Slovakia | |||
788 | EUCTR2004-004387-72-DE | 03/06/2005 | 19 March 2012 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1 Level: LLT Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Visilizumab Current Sponsor code: HuM291 Other descriptive name: Anti-CD3 Monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- | PDL BioPharma, Inc. | Not Recruiting | Female: yes Male: yes | 18 | Phase 2a | Germany | |||
789 | EUCTR2004-004388-31-DE | 03/06/2005 | 19 March 2012 | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD). MedDRA version: 7.1 Level: LLT Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Visilizumab Current Sponsor code: HuM291 Other descriptive name: Anti-CD3 Monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- | PDL BioPharma, Inc | Not Recruiting | Female: yes Male: yes | 18 | Phase 2a | Germany | |||
790 | NCT00114465 | June 2005 | 19 February 2015 | VSL#3 Versus Placebo in Maintenance of Remission in Crohn's Disease | Randomized, Double-Blind, Placebo-Controlled Study of VSL#3 Versus Placebo in the Maintenance of Remission in Crohn's Disease | Crohn's Disease | Drug: VSL#3;Other: Placebo | Orphan Australia | Not recruiting | 18 Years | 75 Years | Both | 38 | Phase 4 | Australia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
791 | EUCTR2004-002815-10-AT | 04/05/2005 | 22 April 2013 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 7.1 Classification code 10011401 | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Powder for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Imuran Product Name: Imuran Pharmaceutical Form: Tablet INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Centocor B.V. | Not Recruiting | Female: yes Male: yes | 500 | Spain;Denmark;Austria;Germany;United Kingdom;Sweden | ||||
792 | NCT00126373 | May 2005 | 19 February 2015 | A Trial of Wellbutrin for Crohn's Disease | A Randomized Controlled Trial of Wellbutrin for Crohn's Disease | Crohn Disease | Drug: Wellbutrin (bupropion) | Altschuler, Eric, M.D. | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 1 | Phase 2/Phase 3 | United States |
793 | NCT00509639 | May 2005 | 19 February 2015 | Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease | Phase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease Activity | Crohn's Disease | Drug: 10% Metronidazole Ointment | S.L.A. Pharma AG | Not recruiting | 18 Years | N/A | Both | 74 | Phase 3 | United States;United Kingdom | |
794 | NCT00829595 | May 2005 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 69 | N/A | United States | |
795 | EUCTR2004-004854-19-SK | 25/04/2005 | 20 February 2017 | A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease | A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease | Crohn's disease | Product Name: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-100 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Italfarmaco S.p.A. | Authorised | Female: yes Male: yes | 50 | Phase 2 | Slovakia | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
796 | NCT00098111 | April 2005 | 19 February 2015 | Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease | A Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS) | Crohn's Disease | Drug: azathioprine | Massachusetts General Hospital | Not recruiting | 14 Years | N/A | Both | 31 | Phase 3 | United States | |
797 | NCT00109473 | April 2005 | 16 December 2017 | Trial of Growth Hormone Therapy in Pediatric Crohn's Disease | A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease | Crohn's Disease | Drug: growth hormone;Drug: cortecosteroid | Children's Hospital Medical Center, Cincinnati | Genentech, Inc. | Not recruiting | 5 Years | N/A | All | 22 | Phase 2 | United States |
798 | NCT00271947 | April 2005 | 19 October 2017 | Crohn's Disease Stem Cell Transplantation | Crohn's Disease Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard Therapy | Crohn's Disease | Biological: Autologous Stem Cell Transplantation | Northwestern University | Not recruiting | 18 Years | 55 Years | All | 1 | Phase 2 | United States | |
799 | NCT00705471 | April 2005 | 20 April 2015 | Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED) | Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources | Crohn Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | 18 Years | N/A | Both | 42 | N/A | |
800 | EUCTR2004-002693-37-DE | 14/03/2005 | 19 March 2012 | A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2 | A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2 | Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents MedDRA version: 7.1 Level: LLT Classification code 10011401 | Trade Name: UVADEX Pharmaceutical Form: Solution for blood fraction modification INN or Proposed INN: methoxsalen CAS Number: 298-81-7 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20- | Therakos | Not Recruiting | Female: yes Male: yes | 25 | Germany | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
801 | NCT00094458 | March 2005 | 19 October 2017 | Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na?ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC | Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE? (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy | Crohn Disease | Biological: infliximab infusion; AZA placebo caps;Other: infliximab (IFX) infusion; azathioprine (AZA) caps;Drug: infliximab (IFX) placebo infusion | Centocor Ortho Biotech Services, L.L.C. | Schering-Plough | Not recruiting | 21 Years | 99 Years | All | 508 | Phase 3 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom |
802 | EUCTR2004-002934-20-BE | 22/02/2005 | 15 July 2013 | A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab | A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab | Crohn's Disease | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: Adalimumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40/0.8- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Abbott GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | Belgium | |||||
803 | EUCTR2004-003839-31-DK | 05/02/2005 | 19 March 2012 | A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 | A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 | Crohn's Disease (CD) | Product Name: natalizumab Product Code: AN100226 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: natalizumab Current Sponsor code: AN100226 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | Elan Pharma Ltd. | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Denmark | |||
804 | NCT00267709 | February 2005 | 19 February 2015 | Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease | A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease | Crohn's Disease | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Not recruiting | 18 Years | 70 Years | Both | 18 | Phase 2 | United States |
805 | NCT00267722 | February 2005 | 19 February 2015 | Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease | A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease | Crohn's Disease | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Not recruiting | 18 Years | 70 Years | Both | 18 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
806 | NCT00106314 | January 2005 | 19 February 2015 | An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease | A Randomized, Double-Blind, Multi-Center, Dose Response, Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Moderately Active Crohn's Disease | Crohn's Disease | Drug: Dehydroepiandrosterone [DHEA] | Inflabloc Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 75 | Phase 2 | United States;Canada | |
807 | NCT00688636 | January 2005 | 19 October 2017 | Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery | Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery | Crohn's Disease | Drug: infliximab;Drug: placebo | University of Pittsburgh | Centocor, Inc. | Not recruiting | 18 Years | 72 Years | All | 24 | Phase 4 | United States |
808 | EUCTR2004-004083-77-CZ | 13/12/2004 | 19 March 2012 | A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease | A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease | Moderate active Crohn disease | Product Name: Mesalazine EC 500 mg Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: mesalazine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Product Name: Salofalk 500 mg Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: mesalazine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | Disphar International B.V. | Not Recruiting | Female: yes Male: yes | 436 | Czech Republic | ||||
809 | EUCTR2004-002693-37-AT | 10/12/2004 | 22 April 2013 | A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - N/A | A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - N/A | Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents MedDRA version: 7.1 Level: LLT Classification code 10011401 | Trade Name: UVADEX Pharmaceutical Form: Solution for blood fraction modification INN or Proposed INN: methoxsalen CAS Number: 298-81-7 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20- | Therakos | Not Recruiting | Female: yes Male: yes | 25 | Austria;Germany | ||||
810 | NCT00206661 | December 2004 | 19 February 2015 | Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease | Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment Extension | Crohn Disease | Drug: Sargramostim (Leukine) | Genzyme, a Sanofi Company | Not recruiting | 6 Years | 16 Years | Both | 22 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
811 | NCT00221026 | December 2004 | 31 October 2016 | Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease | A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents | Crohn's Disease | Drug: Methoxsalen +ECP;Procedure: Extracorporeal Photopheresis | Mallinckrodt | ICON plc | Not recruiting | 18 Years | N/A | Both | 25 | Phase 2 | United States;Austria;Belgium;Germany |
812 | NCT00724958 | December 2004 | 19 October 2017 | Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED) | Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension | Crohn's Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | N/A | N/A | All | 348 | N/A | Austria |
813 | EUCTR2004-002163-24-HU | 23/11/2004 | 28 August 2014 | A Multi-Centre 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 Crohn's Disease. | A Multi-Centre 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 Crohn's Disease. | Crohn's Disease | Trade Name: Humira Product Name: Humira Pharmaceutical Form: Injection* INN or Proposed INN: Adalimumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Abbott Laboratories | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | ||||
814 | EUCTR2004-001213-34-CZ | 02/11/2004 | 19 March 2012 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0 Level: PT Classification code 10011401 | Pharmaceutical Form: Tablet INN or Proposed INN: mesalazine CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical Form: Capsule, hard INN or Proposed INN: budesonide CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 370 | United Kingdom;Czech Republic | ||||
815 | NCT00101946 | October 2004 | 20 April 2015 | Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: 683699 | GlaxoSmithKline | Not recruiting | 18 Years | 65 Years | Both | 17 | Phase 2 | United States;Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
816 | NCT00105300 | October 2004 | 19 February 2015 | Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab | Crohn's Disease | Drug: Adalimumab | Abbott | Not recruiting | 18 Years | 75 Years | Both | 300 | Phase 3 | United States;Belgium;Canada;France | |
817 | NCT00599625 | October 2004 | 19 February 2015 | Pravastatin Therapy in Patients With Active Crohn's Disease: A Pilot Study | Pravastatin Therapy in Patients With Active Crohn's Disease: A Pilot Study | Crohn's Disease | Drug: Pravastatin | University of Virginia | American College of Gastroenterology | Recruiting | 18 Years | 65 Years | Both | 40 | N/A | United States |
818 | NCT00195715 | September 2004 | 19 October 2017 | Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease | A Multi Center, 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 Crohn's Disease | Crohn's Disease | Biological: Adalimumab | Abbott | Not recruiting | 18 Years | 75 Years | All | 777 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Hungary;Italy;Netherlands;Poland;South Africa;Spain;Sweden;United Kingdom | |
819 | NCT00206674 | September 2004 | 19 February 2015 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | Not recruiting | 18 Years | N/A | Both | 286 | Phase 3 | Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom | |
820 | NCT00798473 | September 2004 | 19 February 2015 | Zoledronate for Osteopenia in Pediatric Crohn's | A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease | Crohn's Disease;Osteopenia;Osteoporosis | Drug: zoledronic acid;Other: IV saline infusion | McGill University Health Center | Crohn's and Colitis Foundation | Not recruiting | 6 Years | 18 Years | Both | 13 | Phase 3 | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
821 | NCT00102921 | August 2004 | 19 February 2015 | Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn’s Disease | Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn’s Disease | Crohn Disease | Drug: CCX282-B | ChemoCentryx | Not recruiting | 18 Years | 65 Years | Both | 70 | Phase 2 | United States | |
822 | NCT00160524 | July 2004 | 19 October 2017 | A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] | A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032 | Crohn's Disease | Biological: Certolizumab Pegol (CDP870) | UCB Pharma SA | Not recruiting | 18 Years | N/A | All | 596 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czech Republic;Denmark;Estonia;Georgia;Germany;Hong Kong;Hungary;Israel;Italy;Latvia;Lithuania;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Ukraine;Tunisia | |
823 | NCT00206713 | July 2004 | 19 February 2015 | Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim | Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | Not recruiting | 18 Years | N/A | Both | 264 | Phase 3 | United States | |
824 | NCT00245947 | April 2004 | 19 February 2015 | Study Evaluating ERB-041 in Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease | Crohn's Disease | Drug: ERB-041 | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 22 | Phase 1 | ||
825 | NCT00265122 | April 2004 | 19 October 2017 | A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease | A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab 90 mg;Drug: Ustekinumab 4.5 mg/kg;Drug: Placebo SC;Drug: Placebo IV | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 131 | Phase 2 | United States;Belgium;Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
826 | NCT00308438 | March 1, 2004 | 8 January 2018 | Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008 | An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008 | Crohn's Disease | Drug: Teduglutide (ALX-0600) | Shire | Not recruiting | 18 Years | N/A | All | 67 | Phase 2 | United States;Canada | |
827 | NCT00078611 | March 2004 | 27 June 2016 | A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease | A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 462 | Phase 3 | United States;Canada |
828 | NCT00088062 | February 2004 | 19 February 2015 | STA-5326 in Crohn's Disease Patients | A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450 | Crohn's Disease | Drug: STA-5326 | Synta Pharmaceuticals Corp. | Not recruiting | 18 Years | 65 Years | Both | 48 | Phase 1/Phase 2 | United States | |
829 | NCT00152425 | February 2004 | 19 February 2015 | Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870). | A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870 | Crohn's Disease | Drug: Certolizumab Pegol (CDP870) | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 392 | Phase 3 | ||
830 | NCT00160706 | February 2004 | 19 October 2017 | A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease | A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease. | Crohn's Disease | Biological: Certolizumab Pegol (CDP870) | UCB Pharma SA | Not recruiting | 18 Years | N/A | All | 310 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czech Republic;Denmark;Estonia;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Ukraine | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
831 | NCT00224562 | February 2004 | 19 February 2015 | The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists | The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists | Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis | Drug: TNF-alpha antagonists | Assistance Publique - Hôpitaux de Paris | Recruiting | N/A | N/A | Both | N/A | France | ||
832 | NCT00114803 | January 2004 | 19 February 2015 | Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease | Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study | Ulcerative Colitis;Crohn's Disease | Drug: Calcitonin nasal spray (salmon) | Children's Hospital Boston | Crohn's and Colitis Foundation;National Institutes of Health (NIH) | Not recruiting | 8 Years | 22 Years | Both | 66 | N/A | United States |
833 | NCT00152490 | December 2003 | 19 February 2015 | A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo) | A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease | Crohn's Disease | Drug: Certolizumab Pegol (CDP870) | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 604 | Phase 3 | ||
834 | NCT00175292 | December 2003 | 19 February 2015 | A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease. | A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis. | Crohn's Disease;Inflammatory Bowel Disease | Drug: Probiotic - VSL#3 | University of Alberta | Canadian Institutes of Health Research (CIHR) | Not recruiting | 16 Years | N/A | Both | 120 | Phase 3 | Canada |
835 | NCT00177866 | December 2003 | 19 October 2017 | Safety of Celecoxib in Patients With Crohn's Disease | The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease | Crohn's Disease | Drug: Celebrex;Drug: placebo | University of Pittsburgh | Shadyside Hospital Foundation;Pfizer | Not recruiting | 18 Years | 70 Years | All | 28 | Phase 4 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
836 | NCT00796250 | November 1, 2003 | 16 December 2017 | Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732) | Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine | Crohn's Disease | Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | All | 9 | Phase 3 | ||
837 | NCT00072839 | October 2003 | 23 November 2015 | Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease | A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease | Crohn's Disease | Drug: ALX-0600;Drug: placebo;Drug: teduglutide 0.05;Drug: teduglutide 0.2 mg;Drug: Teduglutide 0.05 dose;Drug: teduglutide 0.1 mg dose | Shire | Not recruiting | 18 Years | N/A | Both | 100 | Phase 2 | United States;Canada | |
838 | NCT00077779 | July 2003 | 19 February 2015 | Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center 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 Crohn's Disease | Crohn's Disease | Drug: Adalimumab | Abbott | Not recruiting | 18 Years | 75 Years | Both | 854 | Phase 3 | United States | |
839 | NCT00206596 | July 2003 | 19 February 2015 | Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease | Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | Not recruiting | 18 Years | 80 Years | Both | 127 | Phase 2 | United States;Canada | |
840 | NCT00705614 | July 2003 | 16 December 2017 | Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035) | Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy | Crohn's Disease | Biological: Remicade | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 2662 | N/A | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
841 | NCT00741910 | July 2003 | 19 February 2015 | Extension Study of Semapimod 60 mg IV x 3 Days | Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: Semapimod | Ferring Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 15 | Phase 2 | United States;Germany;Israel;Netherlands | |
842 | NCT00056355 | March 2003 | 19 February 2015 | Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's Disease | A Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohn's Disease Who May Also Be Refractory or Intolerant to Immunosuppressants and/or Anti-Tumor Necrosis Factor Agen | Crohn Disease | Drug: UVADEX and UVAR XTS Photopheresis System | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | N/A | N/A | Both | 10 | Phase 1 | United States | |
843 | NCT00206700 | February 2003 | 19 February 2015 | Open-label Trial of Leukine in Active Crohn's Disease | Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine) | Genzyme, a Sanofi Company | Not recruiting | 18 Years | N/A | Both | 378 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom | |
844 | NCT00207675 | February 2003 | 19 February 2015 | A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease | A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease. | Crohn Disease | Drug: infliximab | Centocor, Inc. | Centocor BV | Not recruiting | 6 Years | 17 Years | Both | 112 | Phase 3 | |
845 | NCT00613197 | January 2003 | 19 February 2015 | EPANOVA in Crohn's Disease, Study 1 | A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease. | Crohn's Disease | Drug: Epanova | Tillotts Pharma AG | Not recruiting | 18 Years | 70 Years | Both | 384 | Phase 3 | Belgium | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
846 | NCT00740103 | December 2002 | 19 February 2015 | Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease | Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo | Crohn's Disease | Drug: Semapimod | Ferring Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 119 | Phase 2 | United States;Belgium;Germany;Israel;Netherlands | |
847 | NCT00818272 | December 2002 | 19 October 2017 | Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED) | Remicade Safety Line (Crohn's Disease) | Crohn's Disease | Biological: Remicade (infliximab) | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 148 | N/A | Germany |
848 | NCT00739986 | October 2002 | 19 February 2015 | Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo | A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. Placebo | Crohn's Disease | Drug: Semapimod;Drug: Placebo | Ferring Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 152 | Phase 2 | United States;Belgium;Germany;Israel;Netherlands | |
849 | NCT00976690 | October 2002 | 19 February 2015 | Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease | A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease | Crohn Disease | Drug: Azathioprine OR Mesalazine | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Not recruiting | 18 Years | N/A | Both | 83 | Phase 3 | France | |
850 | NCT00074542 | September 2002 | 19 February 2015 | An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease | A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Epanova™ (Omega-3 Free Fatty Acids) | Tillotts Pharma AG | Not recruiting | 16 Years | N/A | Both | 364 | Phase 3 | United States;Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
851 | NCT00055497 | August 2002 | 19 October 2017 | Remission in Subjects With Crohn's Disease, 1 Year Phase | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Biological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mg | Abbott | Not recruiting | 18 Years | 75 Years | All | 276 | Phase 3 | United States | |
852 | NCT01070303 | August 2002 | 19 October 2017 | Remission in Subjects With Crohn's Disease, Open Label Extension | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension | Crohn's Disease | Biological: Adalimumab 40 mg eow or ew | Abbott | Not recruiting | 18 Years | 75 Years | All | 177 | Phase 3 | United States | |
853 | NCT00042055 | July 2002 | 19 February 2015 | CP-461 for the Treatment of Crohn's Disease | A Phase II Pilot Study of CP-461 in the Treatment of Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: CP-461 | Astellas Pharma Inc | Cell Pathways;OSI Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 30 | Phase 2 | United States |
854 | NCT00275418 | July 2002 | 19 February 2015 | Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease | Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission | Crohn's Disease | Drug: beta carotene from Dunaliella algae | Bnai Zion Medical Center | Recruiting | 17 Years | 75 Years | Both | 300 | Phase 3 | Israel | |
855 | NCT00280956 | July 2002 | 27 June 2016 | Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease | A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 2000 | Phase 4 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
856 | NCT00038766 | June 2002 | 19 February 2015 | CNI-1493 for Treatment of Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease | Crohn Disease | Drug: semapimod;Drug: placebo | Ferring Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 33 | Phase 2 | United States | |
857 | NCT00152841 | June 2002 | 19 February 2015 | Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis | Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ulcerative Colitis;Mild or Moderate Anaemia | Drug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IU | University Health Network, Toronto | Crohn's and Colitis Foundation | Not recruiting | 18 Years | N/A | Both | 30 | Phase 2 | Canada |
858 | NCT00048295 | May 2002 | 19 February 2015 | Alicaforsen (ISIS 2302) in Patients With Active Crohn’s Disease | ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn’s Disease | Crohn's Disease | Drug: Alicaforsen | Isis Pharmaceuticals | Not recruiting | 12 Years | N/A | Both | 150 | Phase 3 | Belgium;Czech Republic;Germany;Italy;Poland;Spain | |
859 | NCT00040521 | April 2002 | 19 February 2015 | Study Evaluating rhIL-11 in Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease | Crohn Disease;Inflammatory Bowel Disease | Drug: Recombinant Human Interleukin-11 (rhIL-11) | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 16 Years | N/A | Both | Phase 2 | United States | ||
860 | NCT00055367 | April 2002 | 27 June 2016 | Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease | A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 12 Years | 17 Years | Both | 30 | Phase 2 | United States;United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
861 | NCT00055523 | April 2002 | 19 February 2015 | A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab (D2E7) | Abbott | Not recruiting | 18 Years | 75 Years | Both | 300 | Phase 2 | United States | |
862 | NCT00055536 | April 2002 | 27 June 2016 | Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease | A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 60 | Phase 2 | United States |
863 | NCT00032786 | March 2002 | 27 June 2016 | Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease | A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | Phase 3 | ||
864 | NCT00072943 | March 2002 | 19 February 2015 | A Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease | A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease | Crohn's Disease;Colitis;Intestinal Disease;Gastrointestinal Disease;Digestive System Disease | Drug: anti-Interferon-gamma monoclonal antibody | Facet Biotech | Not recruiting | 18 Years | 70 Years | Both | 175 | Phase 2 | United States;Canada | |
865 | NCT00446433 | March 2002 | 12 December 2016 | A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease | Crohn's Disease | Drug: CC-5013 | Celgene Corporation | Not recruiting | 12 Years | 75 Years | Both | 90 | Phase 2 | United States;France;Israel;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
866 | NCT00261976 | February 2002 | 19 February 2015 | A Long-term Safety Study of Infliximab (Remicade) | Long-term Safety Follow-up of REMICADE (RESULTS) | Arthritis, Rheumatoid;Crohn Disease;Psoriasis | Drug: Infliximab (Remicade) | Centocor, Inc. | Centocor BV | Not recruiting | N/A | N/A | Both | 2971 | Phase 4 | United States;Argentina;Austria;Belgium;Canada;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Netherlands;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom |
867 | NCT00946946 | February 2002 | 19 February 2015 | Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine | Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence | Crohn's Disease | Drug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placebo | Dr. Falk Pharma GmbH | Not recruiting | 18 Years | 70 Years | Both | 78 | Phase 3 | Austria;Germany | |
868 | NCT00035503 | January 2002 | 19 February 2015 | Multicenter Trial For Patients With Acute Crohn's Disease | Crohn's Disease | Drug: etiprednol dicloacetate | Teva Branded Pharmaceutical Products, R&D Inc. | Not recruiting | 18 Years | N/A | Both | Phase 2 | United States;Canada | |||
869 | NCT00510978 | January 2002 | 19 February 2015 | Probiotics in GastroIntestinal Disorders | One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis | Ulcerative Colitis;Crohn's Disease | Biological: Bifidobacterium infantis 35624;Biological: Lactobacillus salivarius UCC118;Biological: Placebo | University College Cork | European Commission | Not recruiting | N/A | 75 Years | Both | 360 | Phase 2/Phase 3 | Ireland |
870 | NCT00032799 | December 2001 | 27 June 2016 | Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease | A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 905 | Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
871 | NCT00304252 | November 2001 | 19 February 2015 | Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease | A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease | Crohn's Disease | Drug: Interferon beta-1a | EMD Serono | Not recruiting | 18 Years | N/A | Both | 192 | Phase 2 | Germany;Italy;Sweden;Switzerland;United Kingdom | |
872 | NCT00025805 | October 23, 2001 | 16 December 2017 | G-CSF to Treat Crohn's Disease | Granulocyte-Colony Stimulating Factor Treatment for Crohn's Disease: A Pilot Study Assessing Immune and Clinical Response | Crohn's Disease | Drug: G-CSF | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | N/A | All | 23 | Phase 1 | United States | |
873 | NCT02209792 | October 2001 | 19 February 2015 | Dose Finding Study of BIRB 796 BS in Patients With Moderate to Severe Crohn's Disease | A Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included. | Crohn Disease | Drug: Placebo;Drug: BIBR 796 BS, 5 mg;Drug: BIBR 796 BS, 20 mg | Boehringer Ingelheim | Not recruiting | 18 Years | 65 Years | Both | 284 | Phase 2 | ||
874 | NCT00048113 | September 2001 | 19 February 2015 | Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease | ISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease | Crohn's Disease | Drug: Alicaforsen | Isis Pharmaceuticals | Not recruiting | 12 Years | N/A | Both | 150 | Phase 3 | United States;Canada | |
875 | NCT00554710 | May 2001 | 19 February 2015 | Top Down Versus Step Up Strategies in Crohn's Disease | The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux | Crohn's Disease | Drug: infliximab+azathioprine;Drug: methylprednisolone or budesonide | Belgian IBD Research Group | Centocor BV;Schering-Plough | Not recruiting | 16 Years | 75 Years | Both | 129 | Phase 4 | Belgium |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
876 | NCT00278577 | April 2001 | 19 February 2015 | Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease | Immune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease | CROHN'S DISEASE | Biological: Immune Ablation and Hematopoietic Stem Cell Support | Richard Burt, MD | Not recruiting | N/A | 60 Years | Both | 25 | Phase 1 | United States | |
877 | NCT00007163 | December 2000 | 19 February 2015 | Monoclonal Antibody Treatment of Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Safety Study of Two Parallel Dose Levels of Subcutaneously Administered Human Monoclonal Antibody to Interleukin-12 (J695) in Patients With Active Crohn's Disease | Crohn's Disease | Drug: J695 | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | N/A | N/A | Both | 40 | Phase 1 | United States | |
878 | NCT00207662 | July 2000 | 19 February 2015 | A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease | ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: infliximab or placebo | Centocor, Inc. | Not recruiting | 18 Years | N/A | Both | 580 | Phase 3 | ||
879 | NCT00940576 | July 2000 | 19 October 2017 | Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases | Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study. | Ulcerative Colitis;Crohns Disease | Dietary Supplement: mare´s milk;Other: placebo drink | University of Jena | German Federal Ministry of Education and Research | Not recruiting | 10 Years | 50 Years | All | 17 | N/A | Germany |
880 | NCT00207766 | June 2000 | 19 February 2015 | A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease | ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease | Crohn Disease | Drug: infliximab or placebo | Centocor, Inc. | Not recruiting | 18 Years | N/A | Both | 306 | Phase 3 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
881 | NCT00269386 | April 2000 | 19 February 2015 | Clarithromycin in Active Crohn's Disease | Randomised Controlled Trial of Clarithromycin in Active Crohn's Disease | Crohn's Disease | Drug: Clarithromycin;Drug: Placebo | Royal Liverpool University Hospital | Abbott | Not recruiting | 18 Years | N/A | Both | 44 | Phase 3 | United Kingdom |
882 | NCT00655135 | February 2000 | 19 February 2015 | Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients | Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease | Crohn's Disease | Drug: LDP-02;Drug: Placebo | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | 80 Years | Both | 185 | Phase 2 | ||
883 | NCT00004941 | July 1996 | 7 April 2015 | Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease | Crohn's Disease | Drug: monoclonal antibody cA2 | FDA Office of Orphan Products Development | Centocor, Inc. | Not recruiting | 18 Years | 65 Years | Both | 94 | Phase 3 | ||
884 | NCT00269841 | May 1996 | 19 February 2015 | An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease | A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease | Crohn Disease | Drug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: Placebo | Centocor, Inc. | Not recruiting | 18 Years | 65 Years | Both | 94 | Phase 3 | ||
885 | NCT00004423 | December 1995 | 7 April 2015 | Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease | Crohn's Disease | Drug: -aminosalicylic acid | University of Vermont | Not recruiting | 18 Years | 80 Years | Both | 80 | N/A | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
886 | NCT00269854 | June 1995 | 19 February 2015 | An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease | A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease | Crohn Disease | Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: Placebo | Centocor, Inc. | Not recruiting | 18 Years | 65 Years | Both | 108 | Phase 2/Phase 3 | ||
887 | JPRN-JapicCTI-080566 | 23 April 2019 | A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | Crohn's Disease | Intervention name : Budesonide Dosage And administration of the intervention : Oral | AstraZeneca | 18 | 65 | BOTH | Phase 2 | |||||
888 | JPRN-JapicCTI-111460 | 23 April 2019 | Phase II Study of Z-206 in Patients with Active Crohn's Disease | Phase II Study of Z-206 in Patients with Active Crohn's Disease | Active Crohn's disease | 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. | 16 | 64 | BOTH | Phase 2 | ||||
889 | JPRN-JapicCTI-121765 | 2 April 2019 | A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan | A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan | Crohn's Disease | Intervention name : D9421-C Dosage And administration of the intervention : 9mg, Oral once daily Control intervention name : Mesalazine Dosage And administration of the control intervention : 1g, Oral three times a day | AstraZeneca | 15 | BOTH | Phase 3 | ||||||
890 | JPRN-JapicCTI-183983 | 16 July 2019 | Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease | A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Intervention name : JNJ-64304500 Dosage And administration of the intervention : JNJ-64304500 Participants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22. JNJ-64304500 High Dose JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2, 4, 8, 12, 16, and 20. JNJ-64304500 Middle Dose JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2, 4, 8, 12, 16, and 20. JNJ-64304500 Low Dose JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Control intervention name : Placebo Dosage And administration of the control intervention : Part I : Placebo Participants will receive placebo Subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. From Week 12 Placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) or CDAI <150) will continue to receive placebo SC injections every 2 weeks from Week 12 through Week 22. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 400 mg SC at Week 12 and then JNJ-64304500 200 mg every two weeks from Week 14 through Week 22. Control intervention name : Placebo Ustekinumab Dosage And administration of the control intervention : Part II : Placebo Placebo SC at Weeks 0, 2, 4, and 8. From Week 12, placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in CDAI or CDAI <150) will continue to receive placebo at Weeks 12, 14, 16, and 20. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ- 64304500 150 mg SC at Week 12 and then JNJ- 64304500 75 mg at Weeks 14, 16, and 20. Part II : Ustekinumab Participants will receive tiered doses of Ustekinumab 260 mg (weight <=55 kg), Ustekinumab 390 mg (weight >55 kg and <=85 kg), Ustekinumab 520 mg (weight >85 kg) intravenously at Week 0 followed by 90 mg subcutaneously at Weeks 8 and 16. | Janssen Pharmaceutical K.K. | Recruiting | 18 | BOTH | 40 | Phase 2 |