Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503503
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2007-07-16
Brief Title:
Study Evaluating the Efficacy of Enbrel Etanercept in Subjects in Japan
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
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 surveillanceInfection 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None