Danish Multicenter Study of Adalimumab in Spondyloarthritis

Phase 4

• Conditions: Spondyloarthritis
• Interventions: Drug: Placebo; Drug: Adalimumab

• Registration Number: NCT00477893
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2009-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Adalimumab	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
Reduction in BASDAI of 20 mm or 50%	12-24 weeks of treatment

Trial Locations

Locations (13)

Department of Radiology, Aabenraa Hospital; 🇩🇰 Aabenraa, Denmark

Department of Radiology, Herlev University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Rheumatology, Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Rheumatology, Gentofte University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Rheumatology, Glostrup University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Rheumatology, Herlev University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Rheumatology, Hvidovre University Hospital; 🇩🇰 Copenhagen, Denmark

King Christian X´s Hospital of Rheumatic Diseases; 🇩🇰 Graasten, Denmark

Department of Rheumatology, Hørsholm Hospital; 🇩🇰 Hørsholm, Denmark

Department of Rheumatology, Slagelse Hospital; 🇩🇰 Slagelse, Denmark

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