NCT06495593

Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis

Identifying Ocrelizumab-resistant Lymphocytes in Lymphoid Tissue in Multiple Sclerosis

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Standard ocrelizumab dosing

Timeline

• Start date: 2025-02-04
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-07-10
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study