Adalimumab in the Treatment of Chronic Pouchitis (ADAP)
|ClinicalTrials.gov Identifier: NCT01670240|
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : January 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Pouchitis||Drug: Adalimumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adalimumab (Humira) in the Treatment of Chronic Pouchitis|
|Study Start Date :||August 2012|
|Primary Completion Date :||September 2015|
|Study Completion Date :||January 2016|
Active Comparator: Adalimumab
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
Other Name: Humira
Placebo Comparator: Placebo
Given as the active comparator, every second week
- Clinical response on treatment with Adalimumab [ Time Frame: 12 weeks ]
The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira).
Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points).
- Clinical improvement after 12 weeks of treatment [ Time Frame: 12 weeks ]The number of patients with a clinical improvement (PDAI reduction ≥ 2)at week 12 See the description of clinical improvement and PDAI under primary endpoint
- Clinical remission after 12 weeks [ Time Frame: 12 weeks ]The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)
- Endoscopic and histologic response after treatment with Adalimumab [ Time Frame: 12 weeks ]Effect (reduction in PDAI)of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis Endoscopical and histological activity is defined from PDAI (pouchitis disease activity index). Endoscopically the presence of Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates or Ulceration, gives 1 point each (max 6 points). Histological the presence of polymorphic nuclear leukocyte infiltration and ulceration each gives 1-3 points regarding severity (max 6 points)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670240
|Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Jens Kjeldsen, Phd||Odense University Hospital|