Adalimumab in the Treatment of Chronic Pouchitis (ADAP)

Odense University Hospital

Status and phase: Completed; Phase 3

Conditions: Pouchitis; Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01670240

2011-004268-31

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Adalimumab

Active Comparator group

Description:

Every second week, mg: 160-80-40-40-40-40 12 weeks in all

Treatment:

Drug: Adalimumab

Placebo

Placebo Comparator group

Description:

Given as the active comparator, every second week

Treatment:

Drug: Placebo