drugset / Trial / NCT01670240
Adalimumab in the Treatment of Chronic Pouchitis
Phase 3
Completed
13 enrolled
Odense University Hospital
Aarhus University Hospital · collabAbbVie · collabHvidovre University Hospital · collabUniversity of Southern Denmark · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis. The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis. Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. It is a double-blinded randomized placebo controlled study.
Timeline
- Start
- 2012-08
- Primary completion
- 2015-09
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | — |