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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06133049
Other study ID # IM047-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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