Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease

Sponsor
University of Alberta
Study ID
NCT00972218
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab subcutaneous injections 40 mg dose every other week for 24 weeks

Study Details

Adalimumab is an antibody treatment that targets and neutralizes a molecule produced in the body that is associated with inflammation, tumor necrosis factor (TNF). This molecule is an important factor in causing the inflammation seen in people with a form of inflammatory spinal arthritis called spondylitis as well as inflammation in the bowel called Crohn's disease. Spondylitis and Crohn's disease tend to go together and this study will assess to what degree this treatment is effective for those patients that have both disorders at the same time.

Key Dates

Start date
Jul 31, 2009
Status verified
Sep 2016
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enteropathic spondyloarthritis
    Patients have concomitant inflammatory spinal symptoms and inflammatory bowel disease.

Primary Outcome Measure

The primary efficacy outcome measure will be the Ankylosing Spondylitis Assessment Study group 20 (ASAS 20) response at 24 weeks. [ Time Frame: 24 weeks ]

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