A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
NCT ID: NCT05170126
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1182 participants
OBSERVATIONAL
2022-07-15
2032-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ozanimod-exposed participants
Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window.
No interventions assigned to this group
Comparator-exposed participants
Women with a diagnosis of MS who are not exposed to ozanimod or other sphingosine 1-phosphate (S1P) therapies during the exposure window but who are exposed to other products approved to treat MS during the exposure window.
No interventions assigned to this group
Unexposed participants
Women with a diagnosis of MS who are not exposed to ozanimod or other products approved to treat MS during the exposure window.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Currently or recently pregnant
* Reside in the United States, Canada or Germany.
Exclusion Criteria
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Evidera INC.
Bethesda, Maryland, United States
Evidera
Bethesda, Maryland, United States
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
Herne, , Germany
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Marielle Bassel, Site 0003
Role: primary
Marielle Bassel, Site 0001
Role: primary
Kerstin Hellwig, Site 0002
Role: primary
Related Links
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BMS Clinical Trial Information
Other Identifiers
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IM047-003
Identifier Type: -
Identifier Source: org_study_id
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