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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ozanimod; Drug: Select DMTs other than ozanimod; Drug: No DMTs

• Study Type: Observational
• Enrollment (Estimated): 2961

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • OptumInsight Life Sciences Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant adult women with MS with an estimated date of conception between April 1, 2020 and July 31, 2030

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ozanimod exposed	Drug: Ozanimod; Women with MS who were exposed to ozanimod during pregnancy
Other DMT exposed	Drug: Select DMTs other than ozanimod; Women with MS exposed to select DMTs other than ozanimod during pregnancy
Not DMT exposed	Drug: No DMTs; Women with MS not exposed to any DMTs during pregnancy

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): August 31, 2031

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Ozanimod
• Other Study ID Numbers: IM047-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No