Overview

Danish Multicenter Study of Adalimumab in Spondyloarthritis

Status:
Unknown status
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Collaborator:
Abbott
Treatments:
Adalimumab
Criteria
Inclusion Criteria:

1. Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group
(ESSG) criteria

2. Clinical active disease, defined as a BASDAI score > 4 despite concurrent NSAID
therapy

3. Presence of sacroiliitis on conventional radiography or MRI.

4. Among other issues: Age >18 years; adequate birth control; no contraindications for
anti-TNFa-therapy, no previous TNFa-antagonists

Exclusion Criteria:

1. Previous TNFα inhibitor therapy

2. Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening

3. Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks
before screening

4. Pregnancy or lactation

5. HIV, hepatitis B or C, tuberculosis, other infections

6. Malignancies

7. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological,
gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral
disease (including demyelinating disease)

8. Contraindications to anti-TNFa-therapy

9. Contraindications to MRI