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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06133049
• Collaborator: (none)
• Enrollment: 2,961
• Location: 1
• Anticipated Duration (Months): 125.5
• Patients Per Site Per Month: 23.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Ozanimod; Drug: Select DMTs other than ozanimod; Drug: No DMTs

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2961 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
• Actual Study Start Date: Mar 16, 2021
• Anticipated Primary Completion Date: Mar 31, 2031
• Anticipated Study Completion Date: Aug 31, 2031

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of spontaneous abortions [Up to 11 years]

2. Number of preterm births [Up to 11 years]

3. Number of stillbirths [Up to 11 years]

4. Number of participants with pre-eclampsia [Up to 11 years]

5. Number of participants with eclampsia [Up to 11 years]

6. Number of infants small for gestational age [Up to 11 years]

7. Number of serious or opportunistic infections in liveborn infants up to one year of age [Up to 11 years]

8. Number of infant postnatal growth deficiencies [Up to 11 years]

9. Number of infant developmental deficiencies [Up to 11 years]

10. Number of neonatal hospitalizations [Up to 11 years]

11. Number of infant deaths [Up to 11 years]

12. Number of neonatal deaths [Up to 11 years]

13. Number of perinatal deaths [Up to 11 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OptumInsight Life Sciences Inc	Eden Prairie	Minnesota	United States	55344

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT06133049
• Other Study ID Numbers: IM047-002
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Ozanimod

Study Results

No Results Posted as of Nov 15, 2023