Study Evaluating the Safety of Enbrel (Etanercept)

This study is currently recruiting participants.

Verified by Wyeth, May 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00683384

Purpose

To collect post-marketing information on the safety of Enbrel in Filipino patients

Condition	Intervention
Arthritis, Psoriatic	Drug: Etanercept (Enbrel)

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection

Further study details as provided by Wyeth:

Primary Outcome Measures:

Spontaneous Adverse Events will be collected until 30 days after each injection [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	99
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Drug: Etanercept (Enbrel)

Eligibility

Genders Eligible for Study:	Male
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 and who have not previously discontinued therapy due to safety concerns.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683384

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Philippines
	Recruiting
Mandaluyong City, Philippines

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A-102300
Study First Received:	May 21, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683384
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Wyeth:

Arthritis
psoriatic

Study placed in the following topic categories:

Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
TNFR-Fc fusion protein
Bone Diseases
Antibodies

Musculoskeletal Diseases
Psoriasis
Arthritis
Immunoglobulin G
Spondylarthritis
Skin Diseases, Papulosquamous
Immunoglobulins
Spondylarthropathies

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009