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Adalimumab in the Treatment of Chronic Pouchitis

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis; Pouchitis

Intervention: Adalimumab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Odense University Hospital

Official(s) and/or principal investigator(s):
Jens Kjeldsen, Phd, Principal Investigator, Affiliation: Odense University Hospital

Overall contact:
Mie D Kjaer, MD, Phone: + 45 29913103, Email: mie.kjaer@rsyd.dk

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical response on treatment with Adalimumab

Secondary outcome:

Clinical improvement after 12 weeks of treatment

Clinical remission after 12 weeks

Endoscopic and histologic response after treatment with Adalimumab

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Operated with proctocolectomy and construction of an IPAA

- Prior to surgery diagnosed with ulcerative colitis according to established

clinically, 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 microscopy

for parasites

- Serology negative for chronic hepatitis B

- Negative examination for tuberculosis (including x-ray of thorax and a interferon

gamma test)

- Signed informed consent

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 arising

from 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

as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks

Locations and Contacts

Mie D Kjaer, MD, Phone: + 45 29913103, Email: mie.kjaer@rsyd.dk

Odense University Hospital, Odense 5000, Denmark; Recruiting
Mie D Kjaer, MD, Phone: + 45 29913103, Email: mie.kjaer@rsyd.dk
Jens Kjeldsen, phd, Principal Investigator
Mie D Kjaer, MD, Sub-Investigator
Niels Qvist, Dr.med, prof, Sub-Investigator
Additional Information

Starting date: August 2012
Last updated: April 30, 2015

Page last updated: August 23, 2015

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