eligibility_summary
Eligibility: Pregnant women. C1: MS plus Kesimpta exposure from 166 days pre-LMP to delivery. C2: MS with or without other MS meds (no Kesimpta/prohibited agents near conception). C3 (OTIS): healthy controls (no MS/autoimmune disease, no Kesimpta/Mayzent). All consent to study procedures. Exclude prior enrollment, non-MS use, prohibited MS drugs, known major fetal defects pre-enrollment, retrospective entry, and known human teratogen exposure (C3).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05634967 is an observational pregnancy registry assessing outcomes after exposure to Kesimpta (ofatumumab) in women with MS. Drug/intervention: Ofatumumab (Kesimpta), a fully human IgG1 monoclonal antibody immunotherapy, administered subcutaneously. Mechanism of action: Binds a membrane-proximal epitope on CD20, depleting CD20+ B lymphocytes via complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and apoptosis, reduces naive and memory B cells while sparing stem cells and plasma cells (CD20−). Cells/pathways targeted: CD20+ B cells, complement and Fc effector pathways, downstream suppression of B-cell antigen presentation and humoral immune activity relevant to MS. Comparators include MS pregnancy controls unexposed to Kesimpta and (in OTIS) healthy pregnant controls.