Trials / Completed
CompletedNCT01670240
Adalimumab in the Treatment of Chronic Pouchitis
Adalimumab (Humira) in the Treatment of Chronic Pouchitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Odense University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adalimumab | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2015-09-01
- Completion
- 2016-01-01
- First posted
- 2012-08-22
- Last updated
- 2016-01-28
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01670240. Inclusion in this directory is not an endorsement.