Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306592
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2006-01-31
Brief Title:
Natalizumab Re-Initiation of Dosing
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
An Open-Label Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 C-1802 or C-1803 and a Dosing Suspension Safety Evaluation
Status:
COMPLETED
Status Verified Date:
2017-02
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 objectives of this study are to further evaluate the safety of natalizumab Tysabri monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab and to confirm the safety of switching to natalizumab from interferon beta IFN-β glatiramer acetate GA or other multiple sclerosis MS therapies
Detailed Description:
Study 101-MS-322 NCT00306592 is conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial participants in Studies C-1801 NCT00027300 C-1802 NCT00030966 and C-1803 NCT00097760 This study includes participants in North America In parallel with the conduct of this study a similar study 101-MS-321 NCT00297232 is initiated for participants in Europe and the rest of the world The primary purpose and primary outcome for both studies are identical therefore the combined Week 48 data from both studies are presented In addition after 48 weeks participants from 101-MS-322 NCT00306592 can enter study 101-MS-321 NCT 00297232 which is considered the Long-Term Treatment Period of 101-MS-322 NCT00306592
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