eligibility_summary
Adults 18–70 with relapsing MS per 2017 McDonald criteria, either starting ofatumumab within 60 days of baseline OCT/VA/phlebotomy or already on ofatumumab and completing study procedures. Must provide informed consent and agree to phlebotomy. Excludes uncontrolled diabetes or hypertension, glaucoma, refractive error >±6 diopters, and other neurologic or ophthalmologic disorders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06167642 (observational) follows RMS patients starting or already on ofatumumab. Drug/intervention: Ofatumumab (Kesimpta) is a fully human anti‑CD20 monoclonal antibody (immunotherapy) given subcutaneously in routine care. Mechanism: binds a membrane‑proximal CD20 epitope on B lymphocytes and depletes circulating naïve and memory B cells via complement‑dependent cytotoxicity and Fc‑mediated ADCC/ADCP (sparing plasma cells and stem cells), reducing B‑cell antigen presentation, costimulation, and pro‑inflammatory cytokines. Cells/pathways targeted: CD20+ B cells and B‑cell–driven adaptive immune pathways implicated in MS. Outcomes monitor neurodegeneration via OCT retinal atrophy and serum neurofilament light chain (axonal injury biomarker).