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

Overview

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.

Full Title of Study: “Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: Enbrel (etanercept)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
  • Overall Official(s)
    • Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

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