Multiple Sclerosis
Conditions
Brief summary
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.
Interventions
DRUGOzanimod
Women with MS who were exposed to ozanimod during pregnancy
DRUGSelect DMTs other than ozanimod
Women with MS exposed to select DMTs other than ozanimod during pregnancy
DRUGNo DMTs
Women with MS not exposed to any DMTs during pregnancy
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18 to 49 years at date of conception * Date of conception between April 1, 2020 and July 31, 2030
Exclusion criteria
* Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes) * Exposure to the DMTs fingolimod, siponimod, mitoxantrone, and teriflunomide within a period of 5 half-lives prior to the estimated date of conception through the end of the first trimester
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of major congenital malformations among infants | Up to 11 years | Prevalence of major congenital malformations among infants born to women with MS exposed to ozanimod during the first trimester, and to compare this to the prevalence among each of the two comparator groups of pregnant women (other DMT exposed or NO DMT exposed) |
Secondary
| Measure | Time frame |
|---|---|
| Number of preterm births | Up to 11 years |
| Number of stillbirths | Up to 11 years |
| Number of participants with pre-eclampsia | Up to 11 years |
| Number of participants with eclampsia | Up to 11 years |
| Number of infants small for gestational age | Up to 11 years |
| Number of serious or opportunistic infections in liveborn infants up to one year of age | Up to 11 years |
| Number of spontaneous abortions | Up to 11 years |
| Number of infant developmental deficiencies | Up to 11 years |
| Number of neonatal hospitalizations | Up to 11 years |
| Number of infant deaths | Up to 11 years |
| Number of neonatal deaths | Up to 11 years |
| Number of perinatal deaths | Up to 11 years |
| Number of infant postnatal growth deficiencies | Up to 11 years |
Countries
United States
Outcome results
None listed