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A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

RECRUITINGSponsored by TG Therapeutics, Inc.
Actively Recruiting
SponsorTG Therapeutics, Inc.
Started2024-06-01
Est. completion2035-03-31
Eligibility
Age15 Years – 50 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06433765

Summary

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

Eligibility

Age: 15 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
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:

1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
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.

Conditions1

Multiple Sclerosis

Locations1 site

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina, 28401-3331

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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