Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)

Glostrup University Hospital, Copenhagen

Status and phase: Unknown; Phase 4

Conditions: Spondyloarthritis

Treatments: Drug: Placebo; Drug: Adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00477893

HUM 04-078

Details and patient eligibility

About

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.

Full description

See brief summary

Enrollment: 52 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Adalimumab

Active Comparator group

Treatment:

Drug: Adalimumab