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Adalimumab in the Treatment of Chronic Pouchitis — ADAP  

Ulcerative Colitis Clinical Trial

Official title:
Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01670240
Study type Interventional
Source Odense University Hospital
Contact
Status Completed
Phase Phase 3
Start date August 2012
Completion date January 2016
View Details
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