eligibility_summary
Eligible: adults (≥18) with relapsing MS, on-label EU-approved category 1 DMT per Hemmer 2023 for ≥3 months, with a commercially available sNfL test result within 3 months, and providing informed consent. Exclude: off-label DMT use, or concurrent participation in an interventional trial or another Novartis-sponsored non-interventional study with ofatumumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Design: Prospective non-interventional RMS study in Germany assessing clinical utility of serum neurofilament light chain (sNfL) to guide management, patients either continue category 1 DMTs or switch to ofatumumab. Interventions and mechanisms: Ofatumumab—fully human anti-CD20 monoclonal antibody, depletes CD20+ B cells to reduce antigen presentation, cytokines, and autoantibody activity. Dimethyl fumarate/diroximel fumarate—oral fumarates activating Nrf2, exerting antioxidant/anti-inflammatory effects, modulate T/B cells and microglia. Glatiramer acetate—peptide immunomodulator shifting Th1→Th2 and expanding Tregs, modulates APCs and MHC II presentation of myelin antigens. Interferon beta—cytokine therapy reducing T-cell activation, proinflammatory cytokines, and leukocyte BBB trafficking. Teriflunomide—oral DHODH inhibitor limiting proliferation of activated T and B cells. Targets/pathways: CD20+ B cells, Nrf2, Th1/Th2/Tregs, APC/MHC II, IFN signaling/trafficking, DHODH-dependent lymphocyte proliferation. Biomarker: sNfL reflects axonal injury.