eligibility_summary
Eligible: Individuals with MS who are pregnant or within 1 year of pregnancy outcome. Exposed cohort received ≥1 BRIUMVI dose, unexposed had no BRIUMVI in pregnancy. Provider authorization required. Exclude if anti‑CD20 mAb exposure in pregnancy, pregnancy outcome occurred before first VRCC contact, or exposure to known teratogens/investigational drugs during pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06433765 is an observational pregnancy registry in multiple sclerosis assessing safety outcomes (e.g., major congenital malformations) in women exposed to BRIUMVI (ublituximab) during or shortly before pregnancy vs unexposed controls. Drug/mechanism: Ublituximab is a glycoengineered type I anti-CD20 monoclonal antibody (immunotherapy) that depletes B cells by high‑affinity Fc–mediated ADCC and complement-dependent cytotoxicity, with secondary induction of apoptosis. Targets/cellular pathways: CD20 on pre‑B and mature B lymphocytes, downstream effects include reduced B‑cell antigen presentation, cytokine production, and T–B cell costimulation relevant to MS pathogenesis. No treatments are assigned, the unexposed cohort excludes anti‑CD20 agents.