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Trial ID IM047-003  |   NCT05170126

A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Summary

  • Female Gender icon
  • N/A
    Age Range
  • 2
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria: - Diagnosis of Multiple sclerosis (MS) - Currently or recently pregnant - Reside in a country where ozanimod is prescribed for treatment of MS Exclusion Criteria: - Diagnostic prenatal test results known prior to first contact with the Registry Coordination Center (RCC) - Exposure to known teratogens and/or investigational medications during pregnancy Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Ozanimod-exposed

ASSIGNED INTERVENTION

Study Arms

Unexposed comparator cohort with MS

ASSIGNED INTERVENTION

Study Arms

Unexposed comparator cohort without MS

ASSIGNED INTERVENTION
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