Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195416
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2005-09-12
Brief Title:
Study Investigating Enbrel Treatment for Ankylosing Spondylitis
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Drug Use Investigation of Enbrel for Post-marketing Surveillance PMS for Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2009-09
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:
To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration KFDAs regulations
1 Unknown adverse reactions especially serious adverse reactions
2 Change of the incidences of adverse reactions under the routine drug uses
3 Factors that may affect the safety of the drug
4 Factors that may affect the effectiveness of the drug
1 Unknown adverse reactions especially serious adverse reactions
2 Change of the incidences of adverse reactions under the routine drug uses
3 Factors that may affect the safety of the drug
4 Factors that may affect the effectiveness of the drug
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