Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493298
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2007-06-27
Brief Title:
Tysabri Observational Program
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
TOP TYSABRI Observational Program
Status:
COMPLETED
Status Verified Date:
2024-04
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:
TOP
Brief Summary:
The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis RRMS in a clinical practice setting
Detailed Description:
TOP is an epidemiological observational study of participants receiving natalizumab with each participant to be followed for up to 15 years This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases
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