RecruitingNCT05170126

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

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

Sponsor

Bristol-Myers Squibb

Enrollment

1,182 participants

Start Date

Jul 15, 2022

Study Type

OBSERVATIONAL

Conditions

Multiple Sclerosis

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This safety study is following women with multiple sclerosis (MS) who were exposed to ozanimod (a medication used to treat MS that affects the immune system) during pregnancy — to understand whether this exposure poses any risk to the mother or baby. **You may be eligible if...** - You have a diagnosis of multiple sclerosis - You are currently pregnant or were recently pregnant - You live in the United States, Canada, or Germany **You may NOT be eligible if...** - You took other similar immune-modifying medications (S1P therapies like fingolimod, cladribine, or mitoxantrone) during the first trimester of pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Evidera INC.

Bethesda, Maryland, United States

Evidera

Bethesda, Maryland, United States

Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum

Herne, Germany

View Full Details on ClinicalTrials.gov

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NCT05170126

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