Status:
COMPLETED
Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly 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:
PHASE3
Brief Summary
The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in pa...
Eligibility Criteria
Inclusion
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
Exclusion
- Complete ankylosis (fusion) of spine.
- Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or other TNFα inhibitors or other biologic agents.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects 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.
- Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
- Dose of NSAID changed within 2 weeks of baseline evaluation.
- Dose of prednisone \>10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00418548
Start Date
June 1 2004
End Date
February 1 2005
Last Update
January 5 2007
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