An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Enbrel (Etanercept) (Drug)
Phase: Phase 4
Sponsored by: Wyeth
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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
Official title: An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary outcome: To assess the long-term clinical efficacy of etanercept in these study subjects.
Minimum age: 18 Years.
Maximum age: N/A.
- Completed study 0881A3-312-EU
- Agreeable to utilize medically acceptable form of contraception
- Able to reconstitute and self-inject or have a designee
- Withdrawn from study 0881A3-312-EU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
Locations and Contacts
Starting date: April 2004
Ending date: July 2007
Last updated: December 5, 2007