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Clinical Trials in the USA / NCT06433765
Recruiting Observational

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

NCT06433765 · tracked via the Priya Life Science USA tracker
Sponsor
TG Therapeutics, Inc
Phase
Observational
Started
2024-06-01
Last updated
2026-10-29

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study 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

Sex
FEMALE
Min age
15 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of Participants with Major Congenital Malformations (MCMs) — Up to 52 weeks post-delivery

Trial sites (1)

FacilityCityRegionStatus
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center Wilmington North Carolina Recruiting

More TG Therapeutics, Inc. trials in the USA

A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders Recruiting
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis Active, not recruiting
Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel Recruiting
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab Recruiting
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk Active, not recruiting

Other trials for the same condition

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis Recruiting
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent Recruiting
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring Recruiting
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis Recruiting
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06433765 on ClinicalTrials.gov ↗ ← All trials in the USA