eligibility_summary
Eligibility: Female ≥18 with relapsing MS, postpartum after term birth, plans exclusive breastfeeding with milk sampling, starting/restarting ofatumumab 2–24 weeks postpartum, consent given. Exclude: recent investigational/prohibited meds, pregnant or lacking required contraception, substance abuse, confounding medical/psychiatric issues, breast surgery, anti‑CD20 in late pregnancy, active infection/mastitis, immunodeficiency, active HBV, malignancy <5y, label contraindications, infant issues affecting breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase IV, open-label study in lactating women with relapsing MS to quantify ofatumumab levels in breast milk and monitor maternal/infant safety. Intervention: Ofatumumab (Kesimpta), a fully human anti-CD20 monoclonal antibody (IgG1) administered subcutaneously per label (weeks 0, 1, 2, then monthly). Mechanism: Binds the CD20 antigen on B lymphocytes, leading to B-cell depletion primarily via complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity/phagocytosis, may also induce apoptosis, spares stem cells and plasma cells. Targets: CD20+ mature B cells central to MS pathogenesis. Pathways affected include B-cell receptor signaling, antigen presentation to T cells, and proinflammatory cytokine production.