Adalimumab in the Treatment of Chronic Pouchitis

Last updated: January 27, 2016
Sponsor: Odense University Hospital
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Ulcers

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT01670240
2011-004268-31
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Operated with proctocolectomy and construction of an IPAA

  • Prior to surgery diagnosed with ulcerative colitis according to establishedclinically, radiologic, endoscopic and histological criteria.

  • Diagnosed with chronic pouchitis as defined above

  • PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3

  • Age >18 years

  • Negative stool cultures for bacterial bowel pathogens and negative stool microscopyfor parasites

  • Serology negative for chronic hepatitis B

  • Negative examination for tuberculosis (including x-ray of thorax and a interferongamma test)

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Treatment with glucocorticoids within the last 4 weeks

  • Diagnosed with Crohn's disease

  • Need of an interpreter or if patients do not understand oral or written information.

  • Surgical complications as anal stenosis, leak of the anastomosis, or fistula arisingfrom the pouch

  • Abuse of medicine, alcohol or drugs

  • Ongoing treatment with NSAID (non steroid anti inflammatory drug)

  • Pregnancy or nursing

  • A diverting stoma

  • Malignancy or other severe chronic disease or expected longevity less than one year

  • Patients diagnosed with immune deficiency

  • Ongoing infectious disease

  • Contraindications against treatment with tumor necrosis factor-alpha antibody, such asheart disease, former cancer disease, in vivo vaccination within the last 4 weeks

Study Design

Total Participants: 13
Study Start date:
August 01, 2012
Estimated Completion Date:
January 31, 2016

Connect with a study center

  • Odense University Hospital

    Odense, 5000
    Denmark

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.