Clinical trial NCT06133049: A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
Official title: Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-11-15
Enrollment: 2961
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of major congenital malformations among infants
timeFrame: Up to 11 years
Secondary outcomes:
measure: Number of spontaneous abortions
timeFrame: Up to 11 years
measure: Number of preterm births
timeFrame: Up to 11 years
measure: Number of stillbirths
timeFrame: Up to 11 years
measure: Number of participants with pre-eclampsia
timeFrame: Up to 11 years
measure: Number of participants with eclampsia
timeFrame: Up to 11 years
measure: Number of infants small for gestational age
timeFrame: Up to 11 years
measure: Number of serious or opportunistic infections in liveborn infants up to one year of age
timeFrame: Up to 11 years
measure: Number of infant postnatal growth deficiencies
timeFrame: Up to 11 years
measure: Number of infant developmental deficiencies
timeFrame: Up to 11 years
measure: Number of neonatal hospitalizations
timeFrame: Up to 11 years
measure: Number of infant deaths
timeFrame: Up to 11 years
measure: Number of neonatal deaths
timeFrame: Up to 11 years
measure: Number of perinatal deaths
timeFrame: Up to 11 years
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: OptumInsight Life Sciences Inc
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: