Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503503
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|