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Study Evaluating the Safety of Enbrel (Etanercept)

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ClinicalTrials.gov Identifier: NCT00683384
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : November 16, 2010
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:
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.

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

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
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

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



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 ]


Information from the National Library of Medicine

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

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.

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


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

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:
Arthritis
psoriatic

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