eligibility_summary
Eligible: outpatients ≥18 with RRMS (McDonald 2017) newly starting ofatumumab per label/AIFA, already qualified via SmPC/RMP screening, and providing informed consent. Exclude: outside-label use, pregnant/lactating, conditions limiting compliance (per investigator), participation in an interventional trial, prior ofatumumab before enrollment or initiation >7 days after baseline.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ofatumumab (Kesimpta) — a fully human IgG1 monoclonal antibody immunotherapy targeting CD20. Mechanism of action: binds a distinct epitope on CD20 on mature B cells, inducing rapid and sustained B‑cell depletion predominantly via complement‑dependent cytotoxicity (CDC) and antibody‑dependent cellular cytotoxicity (ADCC), with possible direct apoptosis, it spares hematopoietic stem cells and plasma cells (CD20‑negative). Cells/pathways targeted: circulating CD20+ B cells and their functions—antigen presentation, costimulation, and pro‑inflammatory cytokine production—thereby indirectly reducing pathogenic T‑cell activation and CNS inflammation in RRMS. Study design: 12‑month, Italian, multicenter, observational, single‑arm real‑world cohort of RRMS patients newly starting ofatumumab, outcomes include relapses, disability progression, cognition, fatigue, quality of life, and safety.