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

Sponsor
Regionshospitalet Silkeborg
Study ID
NCT01174186
Phase
PHASE4
Status
Completed

Conditions

  • Enterocolitis
  • Spondyloarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2010
Status verified
Nov 2014
Primary completion
Jun 30, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Spondyloarthritis and calprotectin elevated
    Spondylitis patients with elevated levels of fecal calprotectin. Patients are treated with adalimumab
  • Active Comparator: Spondyloarthritis and calprotectin normal
    Spondylitis patients with normal levels of fecal calprotectin. Patients are treated with adalimumab.

Primary Outcome Measure

Change Lewis Score Index [ Time Frame: 20 weeks ]

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