Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2012-08-31
2016-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adalimumab
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
Adalimumab
Placebo
Given as the active comparator, every second week
Placebo
Interventions
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Adalimumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Hvidovre University Hospital
OTHER
Aarhus University Hospital
OTHER
AbbVie
INDUSTRY
Odense University Hospital
OTHER
Responsible Party
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Mie Dilling Kjaer
Principal investigator
Principal Investigators
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Jens Kjeldsen, Phd
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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2011-004268-31
Identifier Type: -
Identifier Source: org_study_id
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