Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-06 @ 10:46 AM
Study NCT ID:
NCT06495593
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Identifying Ocrelizumab-resistant Lymphocytes in Lymphoid Tissue in Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2025-02
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:
OCREFINA
Brief Summary:
B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph nodes, which are important sites of B cell activation. This study is being conducted to determine to what extent B cells are targeted in lymph nodes following ocrelizumab treatment, which may have important consequences for long-term MS outcomes.
Detailed Description:
This is a phase IV single-arm observational study to study the effects of early ocrelizumab treatment on B cells and T cells in patients with multiple sclerosis (MS). Eligible patients must be 18-65 years old, have a diagnosis of relapsing-remitting MS, and have not been previously treated with a disease modifying therapy for MS, but plan to begin ocrelizumab treatment. Enrolled patients will undergo blood and lymph node fine needle aspiration before beginning treatment and again three months after treatment. Patients will receive two courses of ocrelizumab as part of the study.
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?:
False
Is an FDA AA801 Violation?: