Status:
COMPLETED
Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will represent the sponsor's first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and efficacy of etanercep...
Detailed Description
Multicenter, double-blind, randomized, parallel and placebo-controlled outpatient study. The study consists of 2 parts: part A is a 6-week double-blind treatment period and part B is a 6-week open-lab...
Eligibility Criteria
Inclusion
- Must be of Chinese ancestry and living in China.
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness 30 and two of the following: VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30; BASFI greater than or equal to 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 a (TNFa), or other TNFa 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00434044
Start Date
February 1 2007
End Date
June 1 2007
Last Update
December 13 2007
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