Study Investigating Enbrel Treatment for Ankylosing Spondylitis

Completed

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT00195416
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-15
• Last Update Posted: 2009-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 526

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified