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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | |||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 |