NCT05170126Recruiting

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

Bristol-Myers Squibb

Start Date

7/15/2022

Completion Date

6/30/2032

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

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Conditions

Multiple Sclerosis

Locations

Evidera INC.

Bethesda, Maryland 20814

United States

Evidera

Bethesda, Maryland 20814

United States

Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum

Herne, 44625

Germany

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