96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-004346-42-SK (EUCTR) | 23/11/2021 | 09/06/2021 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, 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 (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 2 | EUCTR2020-001811-26-BE (EUCTR) | 18/11/2021 | 22/07/2021 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Belgium;Netherlands | ||
| 3 | EUCTR2018-004346-42-HU (EUCTR) | 15/10/2021 | 31/01/2020 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, 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 (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 4 | EUCTR2019-002942-19-DK (EUCTR) | 12/03/2021 | 05/11/2020 | Nordic study of treatment strategy in inflammatory bowel disease | NORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile | Crohn's disease and Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Imurel INN or Proposed INN: Azathioprine Trade Name: Puri-nethol INN or Proposed INN: MERCAPTOPURINE | Region Örebro län | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 5 | EUCTR2020-001811-26-NL (EUCTR) | 30/09/2020 | 08/07/2020 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Netherlands | ||
| 6 | EUCTR2018-004346-42-IT (EUCTR) | 03/09/2020 | 24/05/2021 | 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 - 52-Week Phase 2b/3 Crohn's Disease Study | 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;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® Product Name: NA Product Code: [NA] INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anticorpo monoclonale umano anti-Interleuchina-23 Immunoglobulina G2 (IgG2); precedentemente denominato MEDI2070 e AMG 139 | ALLERGAN LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | ||
| 7 | EUCTR2018-004346-42-AT (EUCTR) | 18/06/2020 | 21/01/2020 | A study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severly 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 (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Astrazeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 8 | EUCTR2018-004346-42-BG (EUCTR) | 28/05/2020 | 08/01/2020 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany | ||
| 9 | EUCTR2018-004346-42-RO (EUCTR) | 19/05/2020 | 18/03/2022 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;South Africa;Germany | ||
| 10 | EUCTR2018-004346-42-BE (EUCTR) | 15/04/2020 | 03/03/2020 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | ||
| 11 | EUCTR2018-004346-42-CZ (EUCTR) | 24/03/2020 | 22/01/2020 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, 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 (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 221 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 12 | EUCTR2018-004346-42-ES (EUCTR) | 26/12/2019 | 11/11/2019 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 13 | EUCTR2018-004346-42-DE (EUCTR) | 10/12/2019 | 17/06/2019 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, 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 (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 14 | EUCTR2018-004346-42-FR (EUCTR) | 05/11/2019 | 10/07/2019 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 15 | NCT04131322 (ClinicalTrials.gov) | October 10, 2019 | 10/10/2019 | Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. | Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study | Crohn Disease;Ulcerative Colitis | Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | NULL | Terminated | 18 Years | N/A | All | 24 | Phase 4 | Spain |
| 16 | EUCTR2017-004588-11-NL (EUCTR) | 10/09/2019 | 10/09/2019 | Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment. | Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial | The chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira | University Maastricht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 4 | Netherlands | ||
| 17 | EUCTR2018-004346-42-GB (EUCTR) | 10/09/2019 | 30/05/2019 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 18 | EUCTR2019-000717-37-ES (EUCTR) | 27/06/2019 | 28/06/2019 | Loss of response of the Adalimumba biosimilar compared with the original drug | LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study | Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: Humira (adalimumab original) | Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI) | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 4 | Spain | ||
| 19 | EUCTR2018-004967-30-GB (EUCTR) | 30/04/2019 | 14/01/2019 | Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over Study | IBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS | Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imraldi Product Name: Imraldi INN or Proposed INN: adalimumab Trade Name: Humira Product Name: Humira INN or Proposed INN: adalimumab | University Hospital Southampton NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United Kingdom | ||
| 20 | EUCTR2018-002064-15-NL (EUCTR) | 15/04/2019 | 15/04/2019 | Patient preference model: treatment of perianal fistulas in Crohn's disease | Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial | Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 4 | Netherlands | ||
| 21 | NCT03759288 (ClinicalTrials.gov) | December 7, 2018 | 20/11/2018 | 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, 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 (INTREPID Lead-In) | Crohn's Disease;IBD | Drug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira®;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 80 Years | All | 928 | Phase 2/Phase 3 | United States;Australia;Austria;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Romania |
| 22 | EUCTR2017-004209-41-BE (EUCTR) | 25/10/2018 | 21/08/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 23 | EUCTR2017-004209-41-DE (EUCTR) | 16/10/2018 | 21/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 24 | EUCTR2017-004209-41-NL (EUCTR) | 01/10/2018 | 27/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 25 | EUCTR2017-004209-41-BG (EUCTR) | 26/09/2018 | 19/07/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one year | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 26 | EUCTR2017-004209-41-IT (EUCTR) | 31/08/2018 | 17/06/2021 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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] INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Humira® Product Name: Adalimumab Product Code: [Adalimumab] INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 27 | EUCTR2017-004209-41-CZ (EUCTR) | 27/08/2018 | 13/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 28 | EUCTR2017-004209-41-GB (EUCTR) | 24/08/2018 | 22/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 29 | EUCTR2017-004209-41-PL (EUCTR) | 03/08/2018 | 20/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 30 | EUCTR2017-004209-41-FR (EUCTR) | 30/07/2018 | 14/06/2018 | 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 - SEAVUE: 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 31 | EUCTR2017-004209-41-ES (EUCTR) | 21/06/2018 | 21/05/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | 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 - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | 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 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 32 | EUCTR2016-000522-18-BE (EUCTR) | 02/05/2018 | 08/01/2018 | 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 | Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: humira INN or Proposed INN: ADALIMUMAB Product Name: Imurel INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Methotrexate Product Name: methotrexate | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 33 | EUCTR2016-000522-18-CZ (EUCTR) | 24/04/2018 | 25/04/2018 | 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-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Azathioprin INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2016-000522-18-GB (EUCTR) | 28/03/2018 | 05/12/2017 | Risk-stratified randomised 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 randomised 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 | Paediatric 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;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40mg/0.4ml pre-filled syringe Product Name: Humira 40mg/0.4ml pre-filled syringe INN or Proposed INN: ADALIMUMAB Other descriptive name: SUB20016 Product Name: Azathioprine INN or Proposed INN: Azathioprine Other descriptive name: Azathioprine INN or Proposed INN: Azathioprine Product Name: Methotrexate INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate Product Name: Mercaptopurine INN or Proposed INN: Mercaptopurine Other descriptive name: 6-Mercaptopurine | PIBD net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 35 | EUCTR2016-000522-18-NL (EUCTR) | 28/12/2017 | 03/07/2017 | 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] | Trade Name: Humira Product Name: humira INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine Product Name: imuran INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: methotrexate Product Name: methotrexate Product Code: L01BA INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Not Recruiting | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 36 | EUCTR2016-000612-14-HR (EUCTR) | 10/05/2017 | 07/06/2017 | 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 | 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 | 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: Cyltezo Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Belarus;Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 37 | NCT03108326 (ClinicalTrials.gov) | April 15, 2017 | 30/3/2017 | 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 | NULL | Recruiting | 18 Years | 80 Years | All | 900 | Germany | |
| 38 | EUCTR2016-000612-14-GR (EUCTR) | 31/03/2017 | 02/02/2017 | 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, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | Moderately to severely active Crohn’s disease MedDRA version: 19.1;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: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 286 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 39 | EUCTR2016-000522-18-IT (EUCTR) | 24/02/2017 | 08/06/2021 | Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease. | Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL | Crohn Disease MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML Product Name: Methotrexate Product Code: N.A Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: N.A Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE Product Name: Azatioprina Product Code: N.A Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE Product Name: Purinethol | UMBERTO I - POLICLINICO DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 40 | EUCTR2016-000612-14-GB (EUCTR) | 25/01/2017 | 29/09/2016 | 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. | 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 Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 41 | EUCTR2016-003321-42-NL (EUCTR) | 18/01/2017 | 08/12/2016 | 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 INN or Proposed INN: ADALIMUMAB | Radboud University Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 42 | EUCTR2016-000612-14-DE (EUCTR) | 18/01/2017 | 05/09/2016 | 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. | 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: Cyltezo Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina;Belarus;Serbia;United States;Greece;Ukraine;Turkey | ||
| 43 | EUCTR2016-000522-18-DE (EUCTR) | 05/01/2017 | 01/08/2016 | 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-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Product Name: Methotrexat INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBD-Net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 3 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 44 | EUCTR2016-000612-14-CZ (EUCTR) | 14/12/2016 | 24/10/2016 | 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 | 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: Cyltezo Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 45 | NCT02871635 (ClinicalTrials.gov) | September 28, 2016 | 15/8/2016 | 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 | NULL | Completed | 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 |
| 46 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 47 | EUCTR2013-003199-11-BE (EUCTR) | 25/09/2015 | 27/07/2015 | 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 | GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | France;Belgium | ||
| 48 | EUCTR2014-001050-41-DE (EUCTR) | 12/06/2015 | 15/12/2014 | 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 | Robarts Clinical Trials | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 4 | United States;Canada;Germany;United Kingdom | ||
| 49 | EUCTR2013-004034-15-BE (EUCTR) | 04/06/2015 | 05/01/2015 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with 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] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 50 | EUCTR2010-020137-10-LT (EUCTR) | 13/05/2015 | 12/03/2015 | 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: 17.1;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 INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | 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 | ||
| 51 | EUCTR2013-004034-15-FR (EUCTR) | 07/05/2015 | 22/06/2015 | 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 | 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 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 52 | EUCTR2013-004034-15-IT (EUCTR) | 31/03/2015 | 03/10/2014 | 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 | 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 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 53 | EUCTR2013-004034-15-DK (EUCTR) | 06/03/2015 | 27/10/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | 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] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 54 | EUCTR2013-004034-15-DE (EUCTR) | 09/02/2015 | 29/08/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with 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] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 55 | EUCTR2013-004034-15-GB (EUCTR) | 27/01/2015 | 29/08/2014 | 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 | 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 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 56 | EUCTR2013-001746-33-FR (EUCTR) | 14/01/2015 | 22/06/2015 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Hungary;United States;Switzerland;Spain;Canada;Netherlands;Czech Republic;Austria;Belgium;European Union;Denmark;Italy;Israel;Slovakia;France;Germany | ||
| 57 | EUCTR2013-001746-33-BE (EUCTR) | 12/01/2015 | 03/04/2014 | 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Hungary;United States;Switzerland;Spain;Canada;Netherlands;Czech Republic;Austria;Belgium;European Union;Denmark;Italy;Israel;Slovakia;France;Germany | ||
| 58 | EUCTR2013-004034-15-AT (EUCTR) | 11/12/2014 | 12/11/2014 | 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 | 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 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] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 59 | EUCTR2013-004034-15-SK (EUCTR) | 10/12/2014 | 13/10/2014 | 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 | 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 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] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 60 | EUCTR2013-001746-33-NL (EUCTR) | 28/11/2014 | 22/04/2014 | 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands;Germany | ||
| 61 | EUCTR2013-004034-15-ES (EUCTR) | 25/11/2014 | 22/09/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Denmark | ||
| 62 | EUCTR2013-001746-33-DK (EUCTR) | 23/10/2014 | 15/05/2014 | 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | 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 | ||
| 63 | EUCTR2013-001746-33-DE (EUCTR) | 08/10/2014 | 01/04/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses forInduction and Maintenance Therapy in Subjects with Moderately toSeverely 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | 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 | ||
| 64 | EUCTR2013-004034-15-HU (EUCTR) | 07/10/2014 | 25/08/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 65 | EUCTR2013-001746-33-IT (EUCTR) | 09/09/2014 | 10/04/2014 | 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 INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 66 | EUCTR2013-003199-11-FR (EUCTR) | 12/08/2014 | 26/03/2018 | CURE | Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY - CURE | Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: ADALIMUMAB Product Name: HUMIRA | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | France;Belgium | ||
| 67 | EUCTR2013-001746-33-CZ (EUCTR) | 10/07/2014 | 15/05/2014 | 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: 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] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Netherlands | ||
| 68 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 69 | EUCTR2013-001746-33-ES (EUCTR) | 23/06/2014 | 25/04/2014 | 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 INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 70 | EUCTR2013-001746-33-HU (EUCTR) | 18/06/2014 | 23/04/2014 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands | |||
| 71 | EUCTR2013-001746-33-SK (EUCTR) | 10/06/2014 | 15/04/2014 | 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | 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 | ||
| 72 | EUCTR2013-001746-33-AT (EUCTR) | 05/06/2014 | 15/05/2014 | 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 Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | 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 | ||
| 73 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 74 | EUCTR2013-004781-34-ES (EUCTR) | 16/04/2014 | 25/02/2014 | 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 INN or Proposed INN: ADALIMUMAB | AbbVie Farmacéutica S.L.U. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 4 | Spain | ||
| 75 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 76 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 77 | EUCTR2012-001723-12-ES (EUCTR) | 07/10/2013 | 14/08/2013 | 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 INN or Proposed INN: ADALIMUMAB | Fundació Clínic per a la Recerca Biomèdica | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | Spain | ||
| 78 | NCT01674413 (ClinicalTrials.gov) | October 2013 | 16/8/2012 | 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 | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United States |
| 79 | EUCTR2013-002932-25-NL (EUCTR) | 21/08/2013 | 25/07/2013 | 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 Trade Name: Humira Product Name: Adalimumab | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 80 | EUCTR2011-006084-22-GB (EUCTR) | 04/10/2012 | 15/08/2012 | Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment | Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab | Royal Liverpool University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 0 | United Kingdom | |||
| 81 | EUCTR2010-020137-10-HU (EUCTR) | 12/01/2012 | 22/11/2011 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden | ||
| 82 | EUCTR2011-003966-34-ES (EUCTR) | 10/01/2012 | 13/10/2011 | 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 INN or Proposed INN: ADALIMUMAB | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Spain | |||
| 83 | JPRN-UMIN000007514 | 2012/01/01 | 15/03/2012 | Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence | Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence - PAD study | 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 MedicineDepartment of Gastroenterology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan |
| 84 | EUCTR2011-000885-36-ES (EUCTR) | 26/12/2011 | 29/11/2011 | 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 INN or Proposed INN: Adalimumab Other descriptive name: Adalimumab Trade Name: Imurel Product Name: Imurel INN or Proposed INN: Azatioprina Other descriptive name: Imurel Trade Name: Flagyl Product Name: Flagyl INN or Proposed INN: Metronidazol Other descriptive name: Flagyl | GETECCU | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| 85 | EUCTR2011-003966-34-BE (EUCTR) | 06/12/2011 | 11/10/2011 | 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 INN or Proposed INN: ADALIMUMAB | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Spain;Belgium | ||
| 86 | EUCTR2010-020137-10-BE (EUCTR) | 23/03/2011 | 04/10/2010 | 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 Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | 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 | ||
| 87 | EUCTR2010-020137-10-NL (EUCTR) | 17/12/2010 | 23/12/2010 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden | ||
| 88 | EUCTR2010-020137-10-CZ (EUCTR) | 08/11/2010 | 04/08/2010 | 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: 17.1;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 INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | 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 | ||
| 89 | EUCTR2010-020137-10-IT (EUCTR) | 07/11/2010 | 08/11/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms 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: 9.1;Level: LLT;Classification code 10011401 | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab Trade Name: Azathioprin-ratiopharm 25 mg INN or Proposed INN: Azathioprine Trade Name: Azathioprine - ratiopharm 50 mg INN or Proposed INN: Azathioprine Trade Name: Decortin 5 mg INN or Proposed INN: Prednisone Trade Name: Decortin 20 mg INN or Proposed INN: Prednisone | Abbott GmBH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 90 | JPRN-UMIN000005762 | 2010/10/27 | 13/06/2011 | The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease | The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease - The Efficacy of Adalimumab | 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 | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 40 | Not selected | Japan |
| 91 | JPRN-UMIN000005761 | 2010/10/27 | 13/06/2011 | The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab | The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab - The Efficacy of Adalimumab | 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 | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 50 | Not selected | Japan |
| 92 | EUCTR2010-020137-10-ES (EUCTR) | 20/10/2010 | 20/08/2010 | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Enfermedad de Crohn.Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 93 | EUCTR2006-002078-23-IE (EUCTR) | 20/10/2010 | 25/09/2006 | 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 pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 94 | EUCTR2010-020137-10-FR (EUCTR) | 14/10/2010 | 23/08/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms 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: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 95 | EUCTR2010-020137-10-DE (EUCTR) | 05/10/2010 | 20/07/2010 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | 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 | ||
| 96 | EUCTR2010-020137-10-GB (EUCTR) | 20/09/2010 | 19/07/2010 | 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 Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 97 | EUCTR2010-020137-10-AT (EUCTR) | 16/09/2010 | 11/08/2010 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | 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 | ||
| 98 | EUCTR2010-020137-10-SE (EUCTR) | 15/09/2010 | 27/07/2010 | 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: 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: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | 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 | ||
| 99 | EUCTR2007-006494-90-GB (EUCTR) | 24/12/2009 | 18/06/2009 | 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 | 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 MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab | Abbott GmbH & Co. K.G. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;United Kingdom | ||
| 100 | NCT00972218 (ClinicalTrials.gov) | July 2009 | 31/8/2009 | 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 | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | Canada |
| 101 | EUCTR2009-009926-94-DK (EUCTR) | 26/03/2009 | 25/02/2009 | 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 Trade Name: Humira | Department of medical gastroenterology, Herlev Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 102 | EUCTR2007-006494-90-CZ (EUCTR) | 11/02/2009 | 07/11/2008 | 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 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: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Canada;Belgium;Poland;United Kingdom | ||
| 103 | EUCTR2006-004814-41-GB (EUCTR) | 16/01/2009 | 07/03/2008 | A Multicenter, 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 | A Multicenter, 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 | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Trade Name: Humira 40 mg solution for injection in pre-filled pen INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom | |||
| 104 | EUCTR2004-002163-24-GB (EUCTR) | 08/12/2008 | 17/02/2005 | 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 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 105 | EUCTR2007-006494-90-BE (EUCTR) | 24/11/2008 | 18/08/2008 | 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 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 INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | Abbvie Deutschland GmbH & Co. K.G. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Belgium;United States;Czech Republic;Canada;Poland | ||
| 106 | EUCTR2008-004926-18-DE (EUCTR) | 30/10/2008 | 30/10/2008 | 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 Trade Name: Remicade | IBD Center LMU Munich | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 107 | EUCTR2006-004814-41-NL (EUCTR) | 24/07/2008 | 22/01/2008 | A Multicenter, 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 | A Multicenter, 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 | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 108 | EUCTR2006-004814-41-IT (EUCTR) | 19/05/2008 | 13/03/2008 | 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 - ND | 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 - ND | Moderate to severe Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA INN or Proposed INN: Adalimumab Trade Name: HUMIRA INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 109 | EUCTR2006-004814-41-CZ (EUCTR) | 12/03/2008 | 01/06/2007 | A Multicenter, 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 | A Multicenter, 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 | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 110 | EUCTR2006-004814-41-BE (EUCTR) | 21/01/2008 | 01/06/2007 | A Multicenter, 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 | A Multicenter, 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 | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 111 | NCT00517296 (ClinicalTrials.gov) | January 2008 | 15/8/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 112 | EUCTR2006-004814-41-FR (EUCTR) | 07/08/2007 | 21/05/2007 | A Multicenter, 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 | A Multicenter, 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 | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 3 | France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom | ||
| 113 | EUCTR2006-002078-23-GR (EUCTR) | 27/02/2007 | 10/10/2006 | 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 to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | 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 | |||
| 114 | EUCTR2006-002078-23-GB (EUCTR) | 22/02/2007 | 09/10/2006 | 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 pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 115 | EUCTR2006-002078-23-PT (EUCTR) | 06/02/2007 | 01/09/2006 | 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 to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 116 | EUCTR2006-006632-22-BE (EUCTR) | 26/01/2007 | 19/12/2006 | 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 Trade Name: REMICADE | University of Leuven, Division of Gastroenterology | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Belgium | ||
| 117 | EUCTR2006-002078-23-FI (EUCTR) | 10/01/2007 | 31/08/2006 | 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 to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 118 | EUCTR2006-002078-23-SE (EUCTR) | 10/01/2007 | 09/10/2006 | 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 to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira Product Code: ABT Humira Product Name: Humira pre-filled PEN Product Code: ABT Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 119 | EUCTR2006-002078-23-DE (EUCTR) | 07/12/2006 | 22/09/2006 | 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 | Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 120 | EUCTR2006-002078-23-DK (EUCTR) | 24/11/2006 | 26/09/2006 | 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 to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 121 | EUCTR2006-002078-23-FR (EUCTR) | 24/11/2006 | 29/09/2006 | 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 INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB Product Name: Humira pre-filled PEN INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 122 | EUCTR2006-002078-23-ES (EUCTR) | 23/11/2006 | 19/06/2013 | 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.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. | 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.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).Enfermedad de Crohn moderada a grave. MedDRA version: 16.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 | Trade Name: Humira Product Name: Humira pre-filled PEN Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 123 | EUCTR2006-002078-23-CZ (EUCTR) | 21/11/2006 | 21/11/2006 | 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 Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Greece | |||
| 124 | EUCTR2005-005291-32-DE (EUCTR) | 24/10/2006 | 06/06/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 125 | EUCTR2006-002078-23-NO (EUCTR) | 23/10/2006 | 22/08/2006 | 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. - CARE | 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. - CARE | 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 pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 126 | EUCTR2006-002078-23-BE (EUCTR) | 16/10/2006 | 16/08/2006 | 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 pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | 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 | |||
| 127 | EUCTR2006-002078-23-NL (EUCTR) | 12/10/2006 | 10/08/2006 | 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 INN or Proposed INN: adalimumab Product Name: Humira pre-filled PEN INN or Proposed INN: adalimumab | Abbott GmbH & Co. KG (Abbott) | NULL | 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 | |||
| 128 | EUCTR2006-002078-23-AT (EUCTR) | 25/09/2006 | 04/10/2006 | 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 pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 129 | EUCTR2005-005291-32-IT (EUCTR) | 14/09/2006 | 13/12/2006 | A multi-center, randomized, double-blind, placebo-controlled study on 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 - ND | A multi-center, randomized, double-blind, placebo-controlled study on 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 - ND | Crohn s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab | Abbott GmbH Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 130 | EUCTR2005-005291-32-NL (EUCTR) | 23/08/2006 | 28/06/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 131 | EUCTR2005-005291-32-SE (EUCTR) | 25/07/2006 | 12/06/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 132 | EUCTR2005-005291-32-BE (EUCTR) | 20/07/2006 | 03/05/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 133 | EUCTR2005-005291-32-AT (EUCTR) | 28/06/2006 | 28/06/2006 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 134 | EUCTR2004-002163-24-IT (EUCTR) | 28/02/2005 | 15/06/2005 | 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 | 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 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: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab | Abbott GmBH Co KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;United Kingdom;Italy | |||
| 135 | EUCTR2004-002934-20-BE (EUCTR) | 22/02/2005 | 08/07/2005 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 136 | EUCTR2004-002163-24-DE (EUCTR) | 09/02/2005 | 25/10/2004 | 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 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;United Kingdom;Germany;Denmark;Spain;Italy | |||
| 137 | EUCTR2004-002163-24-SE (EUCTR) | 30/12/2004 | 12/11/2004 | 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 INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 138 | EUCTR2004-002163-24-ES (EUCTR) | 17/12/2004 | 07/06/2005 | 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.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. | 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.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 139 | EUCTR2004-002163-24-BE (EUCTR) | 25/11/2004 | 19/08/2005 | 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 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 140 | EUCTR2004-002163-24-HU (EUCTR) | 23/11/2004 | 13/10/2004 | 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 INN or Proposed INN: Adalimumab | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 141 | EUCTR2004-002163-24-DK (EUCTR) | 16/11/2004 | 09/07/2008 | 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 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;United Kingdom;Germany;Denmark;Spain;Italy | |||
| 142 | EUCTR2014-004560-38-Outside-EU/EEA (EUCTR) | 12/11/2014 | The purpose of this study is to demonstrate the efficacy and safety 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 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: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbott Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 80 | Japan | ||||
| 143 | EUCTR2016-000522-18-FR (EUCTR) | 21/06/2016 | 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 INN or Proposed INN: ADALIMUMAB Product Name: Imurel INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Methotrexate Product Name: methotrexate | PIBDNet | NULL | NA | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 144 | EUCTR2007-006494-90-Outside-EU/EEA (EUCTR) | 07/02/2012 | 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 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: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | Abbott GmbH & Co. K.G. | NULL | NA | Female: yes Male: yes | 100 | Belgium;Canada;Czech Republic;Poland;United Kingdom;United States | ||||
| 145 | EUCTR2015-004121-13-Outside-EU/EEA (EUCTR) | 17/11/2015 | 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 | 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 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: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie GK | NULL | NA | Female: yes Male: yes | 28 | Japan | ||||
| 146 | EUCTR2006-002078-23-SK (EUCTR) | 11/09/2006 | 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 to 7) | Trade Name: HUMIRA | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 147 | EUCTR2006-004814-41-Outside-EU/EEA (EUCTR) | 07/02/2012 | A Multicenter, 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 | A Multicenter, 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 | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 184 | NULL | ||||
| 148 | EUCTR2014-004531-39-Outside-EU/EEA (EUCTR) | 12/11/2014 | 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 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: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbott Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 80 | Japan | ||||
| 149 | EUCTR2016-000522-18-PL (EUCTR) | 04/04/2018 | 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 | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: HUMIRA INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine INN or Proposed INN: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | PIBDnet (Pediatric Inflammatory Bowel Disease Network) | NULL | NA | Female: no Male: no | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Czech Republic;Canada;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 150 | EUCTR2018-004346-42-PL (EUCTR) | 01/08/2019 | 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 - 52-Week Phase 2b/3 Crohn’s Disease Study | 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: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | NA | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Russian Federation;Romania;Hungary;United States;Ukraine;United Kingdom;Spain;Canada;Austria;Czech Republic;Belgium;Poland;Italy;South Africa;Israel;Slovakia;Bulgaria;France;Germany |