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 | EUCTR2011-002981-19-PL (EUCTR) | 21/03/2012 | 12/01/2012 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease.Revised Protocol 043 incorporating Protocol Amendment 05Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.1;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Hungary;Belgium;Poland;South Africa | ||
| 2 | EUCTR2011-002981-19-HU (EUCTR) | 06/03/2012 | 27/12/2011 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | France;United States;Hungary;Belgium;Poland;South Africa | ||
| 3 | EUCTR2011-002981-19-BE (EUCTR) | 14/02/2012 | 14/12/2011 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | France;United States;Hungary;Poland;Belgium;South Africa | ||
| 4 | NCT01466374 (ClinicalTrials.gov) | December 2011 | 3/11/2011 | Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: BMS-936557 (Anti-IP-10 Antibody) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 121 | Phase 2 | United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa |