NCT00477893

Danish Multicenter Study of Adalimumab in Spondyloarthritis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Adalimumab	sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
DRUG	Placebo	sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-01-01
• Completion: 2013-01-01
• First posted: 2007-05-24
• Last updated: 2012-03-28

Locations

13 sites across 1 country: Denmark