A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants

Study Overview
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Brief Summary
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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.

Official Title
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Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Ozanimod
* Drug: Select DMTs other than ozanimod
* Drug: No DMTs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ozanimod exposed<br> | Drug: Ozanimod<br>* Women with MS who were exposed to ozanimod during pregnancy<br>|
| Other DMT exposed<br> | Drug: Select DMTs other than ozanimod<br>* Women with MS exposed to select DMTs other than ozanimod during pregnancy<br>|
| Not DMT exposed<br> | Drug: No DMTs<br>* Women with MS not exposed to any DMTs during pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of major congenital malformations among infants | 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) | Up to 11 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of spontaneous abortions |  | Up to 11 years | 
| 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 infant postnatal growth deficiencies |  | 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 |