A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Recruiting · NCT05170126 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
- ther protocol-defined inclusion/exclusion criteria apply
Where it is running
3 locations listed across 1 US state.
- Evidera INC. - Bethesda, Maryland, United States
- Evidera - Bethesda, Maryland, United States
- Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum - Herne, Germany