eligibility_summary
Key eligibility: Adults with RMS (McDonald 2017), <5 years since first MS symptom, treated with ofatumumab 3–6 months per EU label, written consent, able to complete assessments. MRI ≥3 months after start (or planned within 31 days), if non‑Gd+, prior pre‑treatment Gd+ MRI needed, MRI not within 30 days post‑steroids. Exclude: recent/ongoing investigational drugs (per washouts) and pregnancy, intent to conceive, or breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ofatumumab (Kesimpta)—a subcutaneous, fully human anti-CD20 monoclonal antibody (B-cell–depleting biologic). Mechanism: binds a distinct CD20 epitope on B lymphocytes and triggers complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity, depleting CD20+ B cells and reducing antigen presentation and proinflammatory cytokines that drive MS activity. Primary targets: CD20+ B cells, downstream effects on T-cell activation pathways. External comparators (from STHENOS SoC) and mechanisms: interferon beta—type I interferon immunomodulator that downregulates antigen presentation and T-cell activation, glatiramer acetate—MBP-mimetic peptide that skews immunity toward Th2/Treg and inhibits myelin-reactive T cells, teriflunomide—oral DHODH inhibitor blocking de novo pyrimidine synthesis, limiting proliferation of activated T and B cells, dimethyl fumarate—oral fumarate activating Nrf2, with antioxidant/anti-inflammatory effects and lymphocyte reduction.