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Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00503503
First received: July 16, 2007
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  Purpose

The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Enbrel (etanercept)
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan

Resource links provided by NLM:

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

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

Study Start Date: March 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   11 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503503

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 by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00503503     History of Changes
Other Study ID Numbers: 0881Y1-4460
Study First Received: July 16, 2007
Last Updated: December 20, 2007
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
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 June 18, 2013