Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195403
Status:
COMPLETED
Last Update Posted:
2013-08-15
First Post:
2005-09-12
Brief Title:
A Drug Use Investigation of ENBREL for Post-marketing Surveillance PMS for RA and PsA
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Drug Use Investigation of Enbrel for Post-Marketing Surveillance
Status:
COMPLETED
Status Verified Date:
2013-06
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 investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration KFDAs regulation
1 Unknown adverse reactions especially serious adverse reactions
2 Incidences of adverse reactions under routine drug uses
3 Factors that may affect the safety of the drug
4 Factors that may affect the efficacy of the drug
This investigation spanned 3 different studies 0881A-101575 alias B1801105 NCT00195403 0881A-102018 alias B1801112 NCT00195416 and 0881A-102212 alias B1801113 All studies have been combined into this record
1 Unknown adverse reactions especially serious adverse reactions
2 Incidences of adverse reactions under routine drug uses
3 Factors that may affect the safety of the drug
4 Factors that may affect the efficacy of the drug
This investigation spanned 3 different studies 0881A-101575 alias B1801105 NCT00195403 0881A-102018 alias B1801112 NCT00195416 and 0881A-102212 alias B1801113 All studies have been combined into this record
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