Adalimumab in the Treatment of Chronic Pouchitis (ADAP)

January 27, 2016 updated by: Mie Dilling Kjaer, Odense University Hospital

Adalimumab (Humira) in the Treatment of Chronic Pouchitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adalimumab
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
Drug: Adalimumab
Other Names:
  • Humira
Placebo Comparator: Placebo
Given as the active comparator, every second week
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response on treatment with Adalimumab
Time Frame: 12 weeks

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement after 12 weeks of treatment
Time Frame: 12 weeks
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
Clinical remission after 12 weeks
Time Frame: 12 weeks
The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)
12 weeks
Endoscopic and histologic response after treatment with Adalimumab
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

AbbVie
Aarhus University Hospital
Hvidovre University Hospital
University of Southern Denmark

Investigators

  • Principal Investigator: Jens Kjeldsen, Phd, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-004268-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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