Multiple SclerosisNCT06433765
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by TG Therapeutics, Inc. at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 728 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 31 Mar 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.
Who may be able to join
- For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
- For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
- Diagnosis of MS.
- Currently or recently (within 1 year of pregnancy outcome) pregnant.
- Authorization from healthcare provider to provide data to registry.
Who cannot join
- Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
- Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
- Exposure to known teratogens and/or investigational medications during pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center contact
United States1 site, 1 recruiting
- Recruiting
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina, 28401-3331
CRGBriumviPregnancyRegistry@thermofisher.com
About this study
Official title: BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
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
- Being tested
- No intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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]). Receives: Other: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Major Congenital Malformations (MCMs)
Measured: Up to 52 weeks post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024
- Primary completion31 Mar 2035 (estimated)
- Study completion31 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433765
- Sponsor's protocol ID
- TG1101-RMS403
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
- ClinicalTrials.gov ID
- NCT06433765
- Acronym / sponsor ID
- TG1101-RMS403
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2035 (estimated)
- Study completion
- 31 Mar 2035 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRIUMVI® Exposed Cohort | – | Other: No interventionPregnant 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 | – | Other: No interventionPregnant 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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.
Key inclusion criteria (5 listed)
- For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
- For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
- Diagnosis of MS.
- Currently or recently (within 1 year of pregnancy outcome) pregnant.
- Authorization from healthcare provider to provide data to registry.
Key exclusion criteria (3 listed)
- Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
- Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
- Exposure to known teratogens and/or investigational medications during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | BRIUMVI® Exposed Cohort, BRIUMVI® Unexposed Cohort |
Primary outcome
Percentage of Participants with Major Congenital Malformations (MCMs)
Time frame: Up to 52 weeks post-delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by TG Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BRIUMVI® Pregnancy Registry Virtual Research Coordination Center (1-877-411-4605, CRGBriumviPregnancyRegistry@thermofisher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Major Congenital Malformations (MCMs) (time frame: Up to 52 weeks post-delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.