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Adalimumab in the Treatment of Chronic Pouchitis (ADAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670240
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : January 28, 2016
University of Southern Denmark
Hvidovre University Hospital
Aarhus University Hospital
Information provided by (Responsible Party):
Mie Dilling Kjaer, Odense University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Pouchitis Drug: Adalimumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adalimumab (Humira) in the Treatment of Chronic Pouchitis
Study Start Date : August 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: Adalimumab
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
Drug: Adalimumab
Other Name: Humira

Placebo Comparator: Placebo
Given as the active comparator, every second week
Drug: Placebo

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

  2. Clinical remission after 12 weeks [ Time Frame: 12 weeks ]
    The number of patients with pouchitis in remission at week 12 (total PDAI ≤4)

  3. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670240

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Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Hvidovre University Hospital
Aarhus University Hospital
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Principal Investigator: Jens Kjeldsen, Phd Odense University Hospital

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Responsible Party: Mie Dilling Kjaer, Principal investigator, Odense University Hospital Identifier: NCT01670240     History of Changes
Other Study ID Numbers: 2011-004268-31
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Mie Dilling Kjaer, Odense University Hospital:
Ulcerative colitis

Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Ileal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents