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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

Page last updated: June 20, 2008

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