Study Investigating Enbrel Treatment for Ankylosing Spondylitis

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

1. Unknown adverse reactions, especially serious adverse reactions 2. Change of the incidences of adverse reactions under the routine drug uses 3. Factors that may affect the safety of the drug 4. Factors that may affect the effectiveness of the drug

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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

Observational

Primary location

Gyunggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion criteria

Patients with known hypersensitivity to Enbrel or any component of the product
Patients with sepsis or risk of sepsis
Patients with active infections including chronic or localized infections such as tuberculosis.

Treatment and study plan

etanercept

Drug

Etanercept 25mg Injection, 2 times/week

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Sep 19, 2005
Registry last updated: Sep 16, 2009

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