NCT05170126 A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
| NCT ID | NCT05170126 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,182 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2032-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,182 participants in total. It began in 2022-07-15 with a primary completion date of 2032-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT05170126 clinical trial?
This trial is open to female participants only, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05170126 currently recruiting?
Yes, NCT05170126 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT05170126 trial being conducted?
This trial is being conducted at Bethesda, United States, Bethesda, United States, Herne, Germany.
Who is sponsoring the NCT05170126 clinical trial?
NCT05170126 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 1,182 participants.
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