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Etanercept in Chinese subjects with Ankylosing Spondylitis
NCT00434044Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2007
- Sponsor
- Pfizer
- Modality
- Fc-Fusion Proteins
- Drugs
- etanercept
- Conditions
- ankylosing spondylitis (AS)
01
Overview
Phase 3, randomised, double-blind trial in ankylosing spondylitis (AS) comparing Etanercept with Placebo (2 arms). Primary endpoint: Assessment in Ankylosing Spondylitis Response Criteria 20% at 6 weeks. Started Feb 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Etanercept
Etanercept 25 mg (2 injections) SC once weekly
Placebo
Placebo SC once weekly
03
Who it enrols
Chinese subjects with active Ankylosing Spondylitis defined by Modified New York Criteria, with inadequate response or intolerance to NSAIDs/DMARDs (implied by active disease and allowed background meds).
04
Endpoints
Primary
Assessment in Ankylosing Spondylitis Response Criteria 20%
Secondary
Assessment in Ankylosing Spondylitis Response Criteria 20%
Assessment in Ankylosing Spondylitis Response Criteria 50%
Assessment in Ankylosing Spondylitis Response Criteria 70%
Assessment in Ankylosing Spondylitis Response Criteria 40%
Assessment in Ankylosing Spondylitis Response Criteria 5/6
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