An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Phase 3

Completed

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT00421980
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.

Detailed Description

This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.

Study Timeline

• Study Start: 2002-06
• Study Completion: 2004-07
• Status Verified: 2007-01
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-12
• Last Update Submitted: 2007-01-12
• Study First Posted: 2007-01-15
• Last Update Posted: 2007-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL