A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
NCT ID: NCT06433765
Last Updated: 2026-01-02
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
728 participants
OBSERVATIONAL
2024-06-01
2035-03-31
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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BRIUMVI® Exposed Cohort
Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception \[DOC\]).
No intervention
No intervention
BRIUMVI® Unexposed Cohort
Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
3. Diagnosis of MS.
4. Currently or recently (within 1 year of pregnancy outcome) pregnant.
5. Authorization from healthcare provider to provide data to registry.
Exclusion Criteria
2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
3. Exposure to known teratogens and/or investigational medications during pregnancy.
15 Years
50 Years
FEMALE
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina, United States
Countries
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Central Contacts
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BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Role: CONTACT
Other Identifiers
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TG1101-RMS403
Identifier Type: -
Identifier Source: org_study_id
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