University of California, San Francisco
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.
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.
Inclusion Criteria: * Ability to provide written informed consent and be compliant with the study protocol * The treating neurologist's independent medical assessment and decision to initiate the patient on ocrelizumab treatment as most appropriate standard of care for the patient * Diagnosis of RR-MS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment * Treatment-naïve (i.e. no prior disease modifying therapy) * Disease duration from the onset of MS symptoms: less than 15 years in patients with an EDSS greater than 5.0 at screening * For women of childbearing potential: agreemen…
Standard ocrelizumab dosing
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