Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Enbrel (etanercept) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
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.
Clinical Details
Official title: Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan
Study design: Prospective
Eligibility
Minimum age: 11 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
ยท Patients with rheumatoid arthritis [only those refractory to the previous treatment]
Locations and Contacts
Additional Information
Starting date: March 2005
Ending date: October 2007
Last updated: December 20, 2007
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