Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

VUMERITY

Medical condition to be studied

Multiple sclerosis
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Estimated number of subjects

908
Study design details

Main study objective

The purpose of this Pregnancy Registry is to better characterize how diroximel fumarate (DRF) may affect pregnancy and infant outcomes.

Outcomes

Number of Major Congenital Malformations (MCMs), Number of: Elective/Therapeutic Terminations, Spontaneous Abortions, Fetal Deaths Including Still Birth, Live Births, Ectopic Pregnancies, Molar Pregnancies, Maternal Deaths, Neonatal Deaths, Perinatal Deaths, Infant Deaths, Serious or Opportunistic Infections in Liveborn Children, Infants with Abnormal Postnatal Growth and Development, Subjects with Pregnancy Complications

Data analysis plan

All analyses will be conducted on an overall basis, as well as stratified by earliest trimester exposure. For MCMs, analyses will be conducted for participants who only have exposure in the first trimester in the exposed cohort. Participants who had earliest DRF exposure after the first trimester will be excluded from the analysis for MCMs. The prevalence and 95% confidence interval (CIs) of MCMs and spontaneous abortion will be calculated. Other negative pregnancy outcomes will be similarly examined as the sample size permits. Infants with minor malformations, chromosomal abnormalities, genetic syndromes, positional defects, and prematurity-related defects will be excluded from the primary outcome analyses related to MCM prevalence.