Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516893
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2007-08-14
Brief Title:
Natalizumab High Titer Immunogenicity and Safety
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Multicenter Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material BG00002-E in Subjects With Relapsing Forms of Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2014-05
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 primary objective of the study was to evaluate the immunogenicity of natalizumab Tysabri produced by a modified manufacturing process natalizumab high titer BG00002-E administered intravenously IV to participants with relapsing forms of multiple sclerosis MS The secondary objective of this study was to evaluate the safety of natalizumab high titer
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