Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes
Phase 3
- Conditions
- Health Condition 1: null- Spondylitis, Ankylosing
- Registration Number
- CTRI/2012/11/003121
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria
2.Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) greater than or equal to 4
3.Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks
Exclusion Criteria
1.Evidence of current or recent episode of uveitis
2.Evidence of IBD flare within 6 months
3.Previous treatment with an anti Tumor necrosis factor(TNF)
4.Active tuberculosis
5.Radiographic sacroiliitis grade 3-4 unilaterally or greater than or equal to 2 bilaterally
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12Timepoint: The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12
- Secondary Outcome Measures
Name Time Method