Examining the safety of ozanimod in pregnant women with multiple sclerosis
ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
This study is trying to see how safe the medication ozanimod is for pregnant women with multiple sclerosis and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1182 (estimated) |
| Sex | Female |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 3 sites (Bethesda, Maryland and 2 other locations) |
| Trial ID | NCT05170126 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the safety and outcomes for mothers and their infants who have been exposed to ozanimod during pregnancy. It focuses on understanding the maternal, fetal, and infant health implications of ozanimod exposure, allowing healthcare providers and patients to make informed decisions regarding treatment options during pregnancy. Participants must have a diagnosis of multiple sclerosis and be currently or recently pregnant, residing in the United States, Canada, or Germany.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with multiple sclerosis who have been exposed to ozanimod.
Not a fit: Patients who are not pregnant or who have been exposed to other S1P therapies during the first trimester may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of ozanimod for pregnant women with multiple sclerosis, guiding treatment decisions.
How similar studies have performed: While this study focuses on a specific medication during pregnancy, similar observational studies have provided valuable safety data for other treatments in pregnant populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland and 2 other locations
- Evidera INC. — Bethesda, Maryland, United States (Recruiting)
- Evidera — Bethesda, Maryland, United States (Recruiting)
- Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum — Herne, Germany (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.