eligibility_summary
RMS patients with disease activity, diagnosed per 2017 McDonald before starting ofatumumab, consented, able to complete assessments, on ofatumumab 3–12 months at inclusion. Cohort 1: treatment-naive or first-line BRACE/teriflunomide/fumarates, switched to ofatumumab within 3 years of first DMT. Cohort 2: on BRACE/teriflunomide/fumarates ≥3 years before switch. Exclude investigational drugs, prior high-efficacy DMTs, or any other DMTs before ofatumumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Non-interventional, real-world 24-month study in Austrian relapsing MS comparing early vs later initiation of ofatumumab. Intervention: Ofatumumab (Kesimpta) only, a fully human anti-CD20 monoclonal antibody (B-cell–depleting immunotherapy) administered subcutaneously. Mechanism: binds CD20 on B lymphocytes and induces complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis, resulting in sustained depletion of circulating CD20+ B cells. Targets/pathways: naive and memory B cells (sparing stem cells and plasma cells), reducing antigen presentation, proinflammatory cytokine signaling, and B cell–driven CNS inflammation. Cohorts: early use (treatment-naive or ≤3 years from first DMT) vs later use (≥3 years on BRACE/teriflunomide/fumarates before switch).