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

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.

Completed

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Withdrawn from study 0881A3-312-EU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

Treatment and study plan

Enbrel (Etanercept)

Drug

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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Study completion: 2007
First posted: Mar 7, 2007
Registry last updated: Dec 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed