Danish Multicenter Study of Adalimumab in Spondyloarthritis

Study Overview
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Brief Summary
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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
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See brief summary

Official Title
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Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Drug: Adalimumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.<br>|
| Active Comparator: Adalimumab<br> | Drug: Adalimumab<br>* sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in BASDAI of 20 mm or 50% |  | 12-24 weeks of treatment |