Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-04 @ 1:15 AM
Study NCT ID:
NCT03344094
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2017-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanism of Action of Ocrelizumab in Multiple Sclerosis
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
Mechanism of Action of Ocrelizumab in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.
Detailed Description:
The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.
Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.
Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: