Study Evaluating the Safety of Enbrel (Etanercept)

October 15, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Drug: Etanercept (Enbrel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection
Time Frame: 30 days post injection up to 3 years
30 days post injection up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (ESTIMATE)

May 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2010

Last Update Submitted That Met QC Criteria

October 15, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A-102300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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