NCT00444340
Completed
Phase 4
An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Wyeth is now a wholly owned subsidiary of Pfizer0 sites70 target enrollmentApril 2004
ConditionsAnkylosing Spondylitis
DrugsEnbrel (Etanercept)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 70
- Primary Endpoint
- To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
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- •Withdrawn from study 0881A3-312-EU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
Outcomes
Primary Outcomes
To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary Outcomes
- To assess the long-term clinical efficacy of etanercept in these study subjects.
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