Study Evaluating the Safety of Enbrel (Etanercept)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00683384
First received: May 21, 2008
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention
Arthritis, Psoriatic
Drug: Etanercept (Enbrel)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection [ Time Frame: 30 days post injection up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: Etanercept (Enbrel)

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00683384     History of Changes
Other Study ID Numbers: 0881A-102300
Study First Received: May 21, 2008
Results First Received: October 15, 2010
Last Updated: October 15, 2010
Health Authority: Philippines: Bureau of Food and Drugs

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
TNFR-Fc fusion protein
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014