NCT00195416

Study Investigating Enbrel Treatment for Ankylosing Spondylitis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 526 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Etanercept	Etanercept 25mg Injection, 2 times/week

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2005-09-19
• Last updated: 2009-09-16

Locations

3 sites across 1 country: South Korea