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Clinical Trials/NCT05170126
NCT05170126
Recruiting
Not Applicable

ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Bristol-Myers Squibb3 sites in 2 countries1,182 target enrollmentJuly 15, 2022
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ConditionsMultiple Sclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Bristol-Myers Squibb
Enrollment
1182
Locations
3
Primary Endpoint
Major congenital malformations
Status
Recruiting
Last Updated
5 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
June 30, 2032
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of Multiple sclerosis (MS)
  • •Currently or recently pregnant
  • •Reside in the United States, Canada or Germany.

Exclusion Criteria

  • •Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
  • •Other protocol-defined inclusion/exclusion criteria apply

Outcomes

Primary Outcomes

Major congenital malformations

Time Frame: Up to first year of life

Secondary Outcomes

  • Postnatal growth deficiency(Up to first year of life)
  • Minor congenital malformations(Up to first year of life)
  • Neonatal death(Up to first year of life)
  • Serious or opportunistic infant infection (SOI)(Up to first year of life)
  • Spontaneous abortion(Through pregnancy)
  • Stillbirth(Through pregnancy)
  • Preterm birth(Through pregnancy)
  • Perinatal death(Up to first year of life)
  • Pre-eclampsia(Through pregnancy)
  • Eclampsia(Through pregnancy)
  • Elective termination(Through pregnancy)
  • Small for gestational age(Up to first year of life)
  • Infant developmental deficiency(Up to first year of life)
  • Infant death(Up to first year of life)

Study Sites (3)

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