96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2012-004222-25-GR (EUCTR) | 25/06/2015 | 26/06/2015 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Morocco;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Tunisia | ||
| 2 | EUCTR2012-004222-25-SK (EUCTR) | 28/04/2014 | 09/01/2014 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Morocco;Slovakia;Greece;Belgium;Spain;Tunisia;India | ||
| 3 | EUCTR2012-004222-25-BE (EUCTR) | 26/11/2013 | 14/01/2013 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease | Crohn's disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Central African Republic;Slovakia;Greece;Spain;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Netherlands;Tunisia;Germany |