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Adalimumab in the Treatment of Chronic Pouchitis

NCT01670240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-01-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Adalimumab

DRUG

Placebo

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • AbbVie

    collaborator INDUSTRY

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jens Kjeldsen, Phd · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-09-30
Completion
2016-01-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670240 on ClinicalTrials.gov