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

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Ozanimod; Drug: Select DMTs other than ozanimod; Drug: No DMTs

• Registration Number: NCT06133049
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-16
• Study First Submitted: 2023-10-18
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15
• Primary Completion: 2031-03-31
• Study Completion: 2031-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2961

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ozanimod exposed	Ozanimod	-
Other DMT exposed	Select DMTs other than ozanimod	-
Not DMT exposed	No DMTs	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

OptumInsight Life Sciences Inc; 🇺🇸 Eden Prairie, Minnesota, United States