Adalimumab (Humira) in the treatment of chronic pouchitis

Phase 1

• Conditions: Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis; MedDRA version: 14.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-004268-31-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-21
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis. <br>;Secondary Objective: Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity. ;Primary end point(s): The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically Pouchitis Disease Activity Index (PDAI) = 2 at any time within the 12 weeks of treatment with adalimumab (Humira). ;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (1) The number of patients with a clinical improvement at week 12 <br>(2) The number of patients with pouchitis in remission at week 12 (total PDAI <=4)<br>(3) Effect of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis. <br>;Timepoint(s) of evaluation of this end point: 12 weeks