Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
This study tests a medication called Ublituximab (Briumvi) given twice per year to people with early-stage relapsing multiple sclerosis. Researchers will monitor how safe the medication is and how well patients tolerate it over about 12 months of treatment.
Key Objective: The trial aims to determine if Ublituximab is safe and well-tolerated as a treatment option for people with early relapsing multiple sclerosis.
Who to Consider: People with early forms of relapsing multiple sclerosis who are interested in trying a newer B-cell therapy and can commit to receiving infusions twice per year should consider enrolling.
Trial Parameters
Brief Summary
In this prospective, open-label, single-arm, single-institution trial, the investigators will accomplish the following two aims: 1. study the safety and tolerability of Ublituximab (Briumvi) twice annually in participants with early MS over a treatment observation period of \~12 months. 2. study the pre- and post-treatment change in plasma neurofilament light chain, tested at baseline pre-Ublituximab treatment, and q24 weeks for 96 weeks post Ublituximab treatment initiation.
Eligibility Criteria
Inclusion Criteria: * Meet 2024 Criteria for Multiple Sclerosis (Montalban et al.) as confirmed by a neurologist; Includes dissemination in space in two of five topographies (with optic nerve included) and/or biomarker evidence such as positive cerebrospinal fluid oligoclonal bands, elevated kappa free light chains, at least six central vein lesions, or at least one paramagnetic rim lesion; * Adult age 18-70 years, * EDSS \<2.5, * Able to provide individual informed consent, * MRI brain available to confirm the diagnosis of MS with fewer than 10 demyelinating lesions, * Diagnosis of MS within the past \<5 years, * Planning to start Ublituximab for the treatment of relapsing MS, Exclusion Criteria: * Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment, * Prior exposure to other B-cell depleting agent including Ocrelizumab, Rituximab, Ofatumumab, and Inebilizumab. * Current clinical trial participant, * Unable to spea