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Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing

NCT01174186 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-12-02

Study results available
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Summary

Studies with intestinally asymptomatic patients with spondyloarthritis showed that approximately 1/3 had visible ulcers in the colon by scopic examinations and 2/3 had changes detectable by microscopy. Only those patients who improved in arthritis symptoms showed improvement in colonic changes. In these studies only colon and the terminal ileum was examined. Inflammation of the small intestine was not examined. Newer studies have shown an immunological link between Crohns disease and spondyloarthritis but not ulcerative colitis. The investigators wish to examine the small intestine in these patients before and after treatment, since they expect to find ulcers there linking spondyloarthritis to Crohns disease and healing after treatment.

Conditions

  • Spondyloarthritis
  • Enterocolitis

Interventions

DRUG

Adalimumab

Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Medtronic - MITG

    collaborator INDUSTRY

  • Central Denmark Region

    collaborator OTHER

  • Regionshospitalet Silkeborg

    lead OTHER

Principal Investigators

  • Henning Glerup, M.D. · Regional Hospital Silkeborg, medical department

  • René D Oestgaard, M.D. · Regional Hospital Silkeborg, medical department

  • Bent Deleuran, M.D. · Department of Medical Microbiology and Immunology Aarhus University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-06-30
Completion
2014-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
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 NCT01174186 on ClinicalTrials.gov