eligibility_summary
Eligible: ages 55–80, consented, RMS per 2017 McDonald, about to start or started ublituximab within 6 months per label. Exclude: active participation in an interventional MS trial, initial ublituximab dose >6 months before entry, prior life‑threatening infusion reaction to any anti‑CD20, significant ongoing infections needing long‑term systemic therapy or recurrent infections within 6–12 months before starting ublituximab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ublituximab (BRIUMVI), a glycoengineered chimeric IgG1 anti-CD20 monoclonal antibody (B-cell–depleting immunotherapy). Mechanism of action: binds CD20 on B lymphocytes and induces enhanced antibody-dependent cellular cytotoxicity (and complement-dependent cytotoxicity), resulting in rapid, sustained depletion of CD20+ B cells, this reduces antigen presentation, costimulation, and proinflammatory cytokine production that drive MS relapses. Target cells/pathways: CD20-expressing B-cell subsets (naïve and memory B cells), sparing stem cells and plasma cells, modulates B-cell–T-cell interaction pathways and downstream autoreactive immune responses in MS. Study is observational, safety endpoints focus on infections and TEAEs/SAEs.