Status:
COMPLETED
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).
Eligibility Criteria
Inclusion
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
- BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
- Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.
Exclusion
- Complete ankylosis (fusion) of spine.
- Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00458185
Start Date
August 1 2006
End Date
April 1 2007
Last Update
March 13 2008
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