Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477113
Status:
COMPLETED
Last Update Posted:
2015-06-22
First Post:
2007-05-21
Brief Title:
TYSABRI Global Observational Program in Safety
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
TYGRIS TYSABRI Global Observational Program in Safety
Status:
COMPLETED
Status Verified Date:
2015-06
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:
TYGRIS
Brief Summary:
The Primary objective of this study is to determine the incidence and pattern of serious infections malignancies and other serious adverse events SAE in participants with multiple sclerosis MS treated with Tysabri natalizumab
Detailed Description:
The TYSABRI Global Observational Program in Safety TYGRIS is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis MS participants treated with natalizumab in a clinical practice setting in the United States or Canada
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