Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
Participant gender:
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.