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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites526 target enrollmentJune 2005

ConditionsAnkylosing Spondylitis

DrugsEtanercept

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ankylosing Spondylitis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 526
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

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

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

August 2008

Last Updated

16 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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.