The primary objectives of the study are to estimate the risk of major congenital malformations (MCM) in infants born to women with MS who were exposed to diroximel furmarate (DRF) at any time from 2 weeks after the first day of their last menstrual period up through the first trimester of pregnancy and to compare these pregnancy outcomes of MCM with those in the following: i) women with MS who were unexposed to DMTs, and ii) women with MS who were exposed to other DMTs
The purpose of this study is to characterize how DRF may affect pregnancy and infant outcomes.
1. MS diagnosis 2. Exposed to DRF any time from 2 weeks after the first day of their last menstrual period up through any time through pregnancy 3. Unexposed to any DMT during pregnancy
Protocol Number: 24-1345
More information available at ClinicalTrials.gov: NCT05658497
Principal Investigator