Adalimumab in the Treatment of Chronic Pouchitis

Sponsor
Odense University Hospital
Study ID
NCT01670240
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 31, 2012
Status verified
Jan 2016
Primary completion
Sep 30, 2015
Completion
Jan 31, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab
    Every second week, mg: 160-80-40-40-40-40 12 weeks in all
  • Placebo Comparator: Placebo
    Given as the active comparator, every second week

Primary Outcome Measure

Clinical response on treatment with Adalimumab [ Time Frame: 12 weeks ]

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