Recruiting

BRIUMVI

Sponsor:

TG Therapeutics, Inc.

Code:

NCT06433765

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief 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®.

Conditions

Multiple Sclerosis

Study ID

NCT06433765

Start date

Jun 1, 2024

Status verified date

Aug, 2026

Completion date

Mar 31, 2035

Anticipated

Primary completion date

Mar 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not 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.

Study Design

Enrollment

728 participants

Anticipated

Interventions and Outcome Measures

Arms

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 \[DOC\]).

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.

Interventions

No intervention

No intervention

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

1-877-411-4605briumvipregnancyregistry@ppd.com

TG Therapeutics Clinical Support Team

1-877-555-8489clinicalsupport@tgtxinc.com

Locations

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

Recruiting

Wilmington, North Carolina, United States, 28401-3331

More Information

Sponsor

TG Therapeutics, Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TG Therapeutics, Inc. on 2026-08-21.