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A 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

NCT05170126

RecruitingN/A

Sponsor: Bristol-Myers Squibb

Conditions: Multiple Sclerosis

Countries: United States, Germany

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 overview

Sex: FEMALE

Study type: OBSERVATIONAL

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
Locations (3)
  • Bethesda, Maryland, United States
  • Bethesda, Maryland, United States
  • Herne, Germany