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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503503
First Posted: July 18, 2007
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

  Contacts and Locations
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): 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

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
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System 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