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

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT06433765
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention — OTHER
    No intervention

Study Details

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®.

Key Dates

Start date
Jun 1, 2024
Status verified
May 2026
Primary completion
Mar 31, 2035
Completion
Mar 31, 2035

Study Design

Enrollment
728 participants (estimated)

Arms

  • Arm: 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 \[DOC\]).
  • Arm: 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.

Primary Outcome Measure

Percentage of Participants with Major Congenital Malformations (MCMs) [ Time Frame: Up to 52 weeks post-delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BRIUMVI® Pregnancy Registry Virtual Research Coordination CenterWilmingtonNorth Carolina28401-3331-

Find similar trials in Wilmington, NC

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center· Wilmington, NC

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