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 | 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 | ||
| 2 | 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 | ||
| 3 | EUCTR2019-003662-40-DE (EUCTR) | 18/12/2019 | 22/10/2019 | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED | MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 82 | Phase 4 | Germany | ||
| 4 | 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 |
| 5 | 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 |