An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
Phase 4
Completed
- Conditions
- Ankylosing Spondylitis
- Registration Number
- NCT00444340
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Completed study 0881A3-312-EU
- Agreeable to utilize medically acceptable form of contraception
- Able to reconstitute and self-inject or have a designee
Exclusion Criteria
- Withdrawn from study 0881A3-312-EU
- Abnormal hematology or chemistry profiles
- Clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
- Secondary Outcome Measures
Name Time Method To assess the long-term clinical efficacy of etanercept in these study subjects.