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Study Evaluating the Safety of Enbrel (Etanercept)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00683384
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : November 16, 2010
Last Update Posted : November 16, 2010
Information provided by:

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

Condition or disease Intervention/treatment
Arthritis, Psoriatic Drug: Etanercept (Enbrel)

Study Design

Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection
Study Start Date : January 2007
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection [ Time Frame: 30 days post injection up to 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683384

Metro Manila, Philippines
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00683384     History of Changes
Other Study ID Numbers: 0881A-102300
First Posted: May 23, 2008    Key Record Dates
Results First Posted: November 16, 2010
Last Update Posted: November 16, 2010
Last Verified: October 2010

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors