Adalimumab in the Treatment of Chronic Pouchitis (ADAP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Adalimumab (Humira) in the Treatment of Chronic Pouchitis|
- Clinical response on treatment with Adalimumab [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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)
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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
|Contact: Mie Dilling Kjaer, MD||+ 45 email@example.com|
|Contact: Jens Kjeldsen, Ph.d||+45 firstname.lastname@example.org|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Mie Dilling Kjaer, MD + 45 29913103 email@example.com|
|Principal Investigator: Jens Kjeldsen, phd|
|Sub-Investigator: Mie Dilling Kjaer, MD|
|Sub-Investigator: Niels Qvist, Dr.med, professor|
|Principal Investigator:||Jens Kjeldsen, Phd||Odense University Hospital|