Adalimumab in the Treatment of Chronic Pouchitis

Ulcerative Colitis Clinical Trial

— ADAP  

Official title:

Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670240
• Other study ID #: 2011-004268-31
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2012
• Last updated: January 27, 2016
• Start date: August 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines AuthorityDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Pouchitis
• Ulcerative Colitis

Intervention

Drug:
• Adalimumab

• Placebo

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, AbbVie, Hvidovre University Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response on treatment with Adalimumab	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).	12 weeks	No
Secondary	Clinical improvement after 12 weeks of treatment	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	12 weeks	No
Secondary	Clinical remission after 12 weeks	The number of patients with pouchitis in remission at week 12 (total PDAI =4)	12 weeks	No
Secondary	Endoscopic and histologic response after treatment with Adalimumab	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)	12 weeks	No