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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06133049
• Other study ID #: IM047-002
• Status: Active, not recruiting
• Start date: March 16, 2021
• Est. completion date: August 31, 2031

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2961
• Est. completion date: August 31, 2031
• Est. primary completion date: March 31, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	OptumInsight Life Sciences Inc	Eden Prairie	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of spontaneous abortions		Up to 11 years
Secondary	Number of preterm births		Up to 11 years
Secondary	Number of stillbirths		Up to 11 years
Secondary	Number of participants with pre-eclampsia		Up to 11 years
Secondary	Number of participants with eclampsia		Up to 11 years
Secondary	Number of infants small for gestational age		Up to 11 years
Secondary	Number of serious or opportunistic infections in liveborn infants up to one year of age		Up to 11 years
Secondary	Number of infant postnatal growth deficiencies		Up to 11 years
Secondary	Number of infant developmental deficiencies		Up to 11 years
Secondary	Number of neonatal hospitalizations		Up to 11 years
Secondary	Number of infant deaths		Up to 11 years
Secondary	Number of neonatal deaths		Up to 11 years
Secondary	Number of perinatal deaths		Up to 11 years

External Links

•   BMS Clinical Trial Information