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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Etanercept

Criteria

Inclusion Criteria:

• Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria

• Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4

• 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:

• Evidence of current or recent episode of uveitis

• Evidence of IBD flare within 6 months

• Previous treatment with an anti Tumor necrosis factor(TNF)

• Active tuberculosis

• Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally