eligibility_summary
Eligibility: Pregnant women 18–49 with MS, recorded pregnancy start/end, ≥12 months pre-index data incl. MSDMD exposure. Per outcome: live birth or any pregnancy outcome as needed, neonatal infection requires live newborn, SII alive on day 29. Exclude: exposure to known teratogens (MSDMD or other), chromosomal/genetic syndromes for MCM analyses, multiples for preterm/preeclampsia/eclampsia/SGA, no exposure during risk window for Kesimpta/MSDMD cohorts.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study type: observational, retrospective real‑world cohort in pregnant women with MS, comparing exposure groups. Interventions: exposure to Kesimpta (ofatumumab) vs other MS disease‑modifying drugs (MSDMDs) vs no MSDMD, no treatment is assigned. Drug and mechanism: Kesimpta is ofatumumab, a fully human type I anti‑CD20 monoclonal antibody (subcutaneous) that depletes B cells via complement‑dependent cytotoxicity and antibody‑dependent cellular cytotoxicity, dampening B‑cell antigen presentation and autoantibody production. Targets/pathways: CD20+ B lymphocytes, complement and Fc‑effector pathways, downstream adaptive immune/inflammatory pathways implicated in MS. Other MSDMDs have diverse mechanisms (unspecified here).