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

N/AActive Not RecruitingNCT06133049

Bristol-Myers Squibb2,961 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,961

Conditions

Multiple Sclerosis

Interventions

OzanimodDRUG

Women with MS who were exposed to ozanimod during pregnancy

Select DMTs other than ozanimodDRUG

Women with MS exposed to select DMTs other than ozanimod during pregnancy

No DMTsDRUG

Women with MS not exposed to any DMTs during pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

OptumInsight Life Sciences Inc

Eden Prairie, Minnesota, United States

Outcomes

Primary Outcomes

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)

Time frame: Up to 11 years

Secondary Outcomes

Number of spontaneous abortions

Time frame: Up to 11 years

Number of preterm births

Time frame: Up to 11 years

Number of stillbirths

Time frame: Up to 11 years

Number of participants with pre-eclampsia

Time frame: Up to 11 years

Number of participants with eclampsia

Time frame: Up to 11 years

Number of infants small for gestational age

Time frame: Up to 11 years

Number of serious or opportunistic infections in liveborn infants up to one year of age

Time frame: Up to 11 years

Number of infant postnatal growth deficiencies

Time frame: Up to 11 years

Number of infant developmental deficiencies

Time frame: Up to 11 years

Number of neonatal hospitalizations

Data from ClinicalTrials.gov

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