Study Evaluating the Safety of Enbrel (Etanercept)

Arthritis, Psoriatic Clinical Trial

Official title:

A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683384
• Other study ID #: 0881A-102300
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: October 15, 2010
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Psoriatic

Intervention

Drug:
• Etanercept (Enbrel)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection		30 days post injection up to 3 years	Yes