eligibility_summary
Adults (≥18) with RMS per 2017 McDonald criteria and active disease, who consented and used ofatumumab per EU Kesimpta SmPC for ≥12 months, or discontinued after ≥1 dose with ≥12 months monitoring. Exclude those currently in another trial, unlikely to complete study activities, or with any SmPC contraindication to ofatumumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ofatumumab (Kesimpta) — a fully human IgG1 monoclonal antibody (B‑cell–depleting immunotherapy) administered subcutaneously. Mechanism: Binds CD20 on B lymphocytes with high affinity and depletes them via complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC), consequently reduces B‑cell antigen presentation, proinflammatory cytokine secretion, and autoantibody production, attenuating CNS neuroinflammation in relapsing MS. Targets: CD20+ pre‑B to mature B cells (sparing stem cells and plasma cells), engages complement cascade and Fcγ receptor–mediated effector pathways, downstream effects include reduced B/T cell interaction and adaptive immune activation. Study: non-interventional, cross-sectional, real-world Spanish practice assessing effectiveness, safety, and adherence.