Clinical Trial: Adalimumab in the Treatment of Chronic Pouchitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Odense University Hospital

Current Primary Outcome: 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).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: Odense University Hospital

Dates:
Date Received: August 8, 2012
Date Started: August 2012
Date Completion:
Last Updated: January 27, 2016
Last Verified: January 2016