Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297232
Status:
TERMINATED
Last Update Posted:
2016-07-15
First Post:
2006-02-27
Brief Title:
Natalizumab Tysabri 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 C-1803 or C-1808 and a Dosing Suspension Safety Evaluation
Status:
TERMINATED
Status Verified Date:
2015-05
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:
STRATA
Brief Summary:
The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon IFN glatiramer acetate or other multiple sclerosis MS therapies to natalizumab The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale EDSS changes over time
Detailed Description:
Study 101-MS-322 NCT00306592 was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 NCT00027300 C-1802 NCT00030966 and C-1803 NCT00097760 and included subjects in North America In parallel with the conduct of that study this study 101-MS-321 NCT00297232 was initiated for participants in Europe and the rest of the world In addition after 48 weeks participants from 101-MS-322 NCT00306592 could enter study 101-MS-321 NCT 00297232 which was considered the Long-Term Treatment Period of 101-MS-322 NCT00306592
The primary purpose and primary outcome for both studies are identical therefore the combined long-term data from both studies are presented Combined Week 48 data from both studies are presented in the 101-MS-322 NCT00306592 record
The primary purpose and primary outcome for both studies are identical therefore the combined long-term data from both studies are presented Combined Week 48 data from both studies are presented in the 101-MS-322 NCT00306592 record
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