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Clinical Trials in the USA / NCT06133049
Active, not recruiting Observational

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

NCT06133049 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2021-03-16
Last updated
2023-11-15

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ozanimod →Select DMTs other than ozanimodNo DMTs

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)

Trial sites (1)

FacilityCityRegionStatus
OptumInsight Life Sciences Inc Eden Prairie Minnesota

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Official registry record

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.

View NCT06133049 on ClinicalTrials.gov ↗ ← All trials in the USA