A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Male and female subjects aged 18 years and over at the time of consent to the study.

• Diagnosis of SpA, as defined by the ASAS criteria for axial SpA

• Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.

• Active axial involvement defined by mini BASDAI

Exclusion Criteria:

• Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

• Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.

• Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.