Study Evaluating the Safety of Enbrel (Etanercept)

Completed

• Conditions: Arthritis, Psoriatic
• Interventions: Drug: Etanercept (Enbrel)

• Registration Number: NCT00683384
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-10
• Results First Submitted: 2010-10-15
• Results First Submitted QC: 2010-10-15
• Last Update Submitted: 2010-10-15
• Results First Posted: 2010-11-16
• Last Update Posted: 2010-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.

Exclusion Criteria

• Previously discontinued Enbrel therapy due to significant safety concern.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Etanercept (Enbrel)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection	30 days post injection up to 3 years