Ignite Creation Date:
2024-05-05 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00536120
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2007-09-25
Brief Title:
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2016-12
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 were to evaluate the effect of Tysabri natalizumab on antibody responses after immunization with a neoantigen keyhole limpet hemocyanin KLH and a recall antigen tetanus toxoid Td and to evaluate the effect of Tysabri on circulating lymphocyte subsets CD3 CD4 CD8 CD19 and CD56 over time in participants with relapsing forms of multiple sclerosis MS The secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time
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