Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Spondyloarthritis
- Sponsor
- Glostrup University Hospital, Copenhagen
- Enrollment
- 52
- Locations
- 13
- Primary Endpoint
- Reduction in BASDAI of 20 mm or 50%
- Last Updated
- 14 years ago
Overview
Brief Summary
Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
Detailed Description
See brief summary
Investigators
MOstergaard
Professor
Glostrup University Hospital, Copenhagen
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria
- •Clinical active disease, defined as a BASDAI score \> 4 despite concurrent NSAID therapy
- •Presence of sacroiliitis on conventional radiography or MRI.
- •Among other issues: Age \>18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists
Exclusion Criteria
- •Previous TNFα inhibitor therapy
- •Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- •Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- •Pregnancy or lactation
- •HIV, hepatitis B or C, tuberculosis, other infections
- •Malignancies
- •Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
- •Contraindications to anti-TNFa-therapy
- •Contraindications to MRI
Arms & Interventions
Placebo
Intervention: Placebo
Adalimumab
Intervention: Adalimumab
Outcomes
Primary Outcomes
Reduction in BASDAI of 20 mm or 50%
Time Frame: 12-24 weeks of treatment