A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups; to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups; and to estimate the incidence of live birth and compare the incidence between the DRF and comparator groups.
Age
18–49
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
Continuous medical Optum Research Database (ORD) and pharmacy (ORD and Market Clarity) coverage for a minimum of 6 months prior to and including the estimated LMP.
Presence of MS.
You may not be if
\- Pregnancies will be excluded from this study if they are exposed to any known teratogens from 5 half-lives (rounded up to the nearest whole day) before the estimated date of conception through the end of the relevant exposure window.
Clareo Health | A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
