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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |