Comparing Continuing Anti-CD20 Therapy Versus Switching to Platform Treatments in Adults 40 and Older with Relapsing-Remitting Multiple Sclerosis

What this Trial Is About

Relapsing-Remitting Multiple Sclerosis RRMS is a central nervous system autoimmune disorder that often leads to disability in young adults. Over the past two decades, various disease-modifying therapies have been developed, ranging from moderately effective ones with good safety profiles to highly effective immunosuppressive therapies. Among these, anti-CD20 therapies have shown higher efficacy in reducing disease activity, especially when used early in the disease. This trial aims to compare continued anti-CD20 therapy versus switching to platform therapies after age 40 to see if the latter strategy maintains disease control without worsening disability. Participants in this phase 3 trial will be randomly assigned to one of two groups. The experimental group will receive platform therapies such as Dimethyl Fumarate, Diroximel Fumarate, Teriflunomide, Glatiramer Acetate, or Beta-interferons for 36 months. The control group will continue anti-CD20 therapies, including Ocrelizumab, Rituximab, or Ofatumumab, at their respective dosing intervals for the same duration. Treatment switches within the assigned therapy class are allowed if needed, but switching outside the assigned class is considered a major protocol deviation. During the 36-month study period, participants will undergo regular assessments including monitoring of relapses and brain MRI lesions, evaluation of disability using the Expanded Disability Status Scale EDSS, and safety checks such as adverse events and infection monitoring. Blood tests will measure B-cell counts and serum immunoglobulin levels. The study will track participants closely to evaluate disease activity, treatment effects, and safety over time, with the goal to determine if switching therapies after age 40 preserves disease stability.

A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis