Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT00503503
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Study Overview
Official Title:
Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: