Overview

Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

Status:
Unknown status
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.
Phase:
Phase 2
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Etanercept
Sulfasalazine