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

Active Not RecruitingN/A

Sponsor: Bristol-Myers Squibb

Conditions: Multiple Sclerosis

Interventions: Ozanimod, Select DMTs other than ozanimod, No DMTs

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to 49 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Eden Prairie, Minnesota, United States