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

NCT06133049 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: IM047-002
• Study Type: observational
• Target: 2,961
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (3)

Ozanimod exposed

Drug: Ozanimod

Other DMT exposed

Drug: Select DMTs other than ozanimod

Not DMT exposed

Drug: No DMTs

Interventions

Ozanimod DRUG

Women with MS who were exposed to ozanimod during pregnancy

Ozanimod exposed

Select DMTs other than ozanimod DRUG

Women with MS exposed to select DMTs other than ozanimod during pregnancy

Other DMT exposed

No DMTs DRUG

Women with MS not exposed to any DMTs during pregnancy

Not DMT exposed

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Women aged 18 to 49 years at date of conception
• Date of conception between April 1, 2020 and July 31, 2030

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

OptumInsight Life Sciences Inc

Eden Prairie, Minnesota, 55344, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 15, 2023
• Study Start: March 16, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

US (1)