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

Description

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.

Conditions

Multiple Sclerosis

Study Overview

Study Details

Study 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.

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

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

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Bethesda

Evidera, Bethesda, Maryland, United States, 20814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of Multiple sclerosis (MS)
  • * Currently or recently pregnant
  • * Reside in a country where ozanimod is prescribed for treatment of MS
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-06-30