Ozanimod: Women with MS who were exposed to ozanimod during pregnancy
Select DMTs other than ozanimod: Women with MS exposed to select DMTs other than ozanimod during pregnancy
No DMTs: Women with MS not exposed to any DMTs during pregnancy
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
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
Primary outcome measure(s)
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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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