eligibility_summary
Eligible: adults ≥18 with RMS per 2017 McDonald, consented and able to complete assessments/PROs, on ofatumumab per Portuguese indication for active RMS, initiated ≤12 months before inclusion or initiating at inclusion. Exclude: any investigational drug in specified windows, or prior high-efficacy therapy (ocrelizumab, natalizumab, mitoxantrone, rituximab, alemtuzumab).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ofatumumab (Kesimpta) — a fully human anti-CD20 IgG1κ monoclonal antibody given subcutaneously. Mechanism: Binds a membrane-proximal epitope on CD20 on B lymphocytes, driving rapid, sustained depletion of circulating CD20+ B cells via complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and phagocytosis, spares stem cells and plasma cells. Targets/cellular pathways: CD20+ pre-B to mature B cells, reduces B-cell receptor–driven activity, antigen presentation to T cells, proinflammatory cytokine release, and autoantibody contribution, thereby dampening CNS inflammation in RMS. Study: Observational, real-world in Portugal comparing early (≤3 years post-diagnosis) vs late (>3 years) initiation of ofatumumab.