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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Immunoglobulin G
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014