Ignite Creation Date:
2024-05-06 @ 7:19 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02519413
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2015-07-16
Brief Title:
Tecfidera Lymphocyte Chart Review
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Retrospective Multi-Center Observational Study to Assess the Effect of Tecfidera Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis REALIZE
Status:
COMPLETED
Status Verified Date:
2016-08
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:
REALIZE
Brief Summary:
The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes with a focus on CD4 and CD8 T cells in participants on Tecfidera therapy for at least 6 months The secondary objective is to investigate changes in lymphocyte subtypes other than CD4 and CD8 T cells
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