ClinicalTrials.gg
RecruitingNCT06433752ENABLEUpdated Oct 30, 2026

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

An observational study in Relapsing Multiple Sclerosis and Multiple Sclerosis, sponsored by TG Therapeutics, Inc.. Recruiting at 113 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by TG Therapeutics, Inc. · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Updated Oct 30, 20263 sites added1 site removedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

02

Conditions studied

  • Relapsing Multiple Sclerosis
  • Multiple Sclerosis

Browse trials for

03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Confirmed Multiple Sclerosis (MS) diagnosis.
  2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.

Exclusion criteria

Exclusion Criteria:

  1. Have received any live or (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.
  2. Any active infection (e.g., active virus [HBV])
  3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • BRIUMVI® (Ublituximab-xiiy)

    Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. Annualized Relapse Rate (ARR)

    Time frame: Up to Week 96

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Week 96

  2. Number of Participants with Infusion Related Reaction (IRR) at Each Infusion

    Time frame: Up to Week 96

07

Study locations

113 of 113 sites recruiting
  • TG Therapeutics Investigational Trial Site
    Birmingham, Alabama 35209, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Cullman, Alabama 35058, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Huntsville, Alabama 35802, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Mobile, Alabama 36604, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Gilbert, Arizona 85297, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Phoenix, Arizona 85032, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Scottsdale, Arizona 85253, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Fresno, California 93720, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Newport Beach, California 92663, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Orange, California 68130, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    West Hollywood, California 90048, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Aurora, Colorado 80045, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Basalt, Colorado 81621, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Colorado Springs, Colorado 80918, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Colorado Springs, Colorado 80920, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Denver, Colorado 80222, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Fort Collins, Colorado 80528, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Grand Junction, Colorado 81501, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Farmington, Connecticut 06032, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Hartford, Connecticut 06112, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Altamonte Springs, Florida 32714, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Boca Raton, Florida 33486, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Clearwater, Florida 33761, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Gainesville, Florida 32611, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Maitland, Florida 32751, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Miami, Florida 33176, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Naples, Florida 34105, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Orlando, Florida 32806, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Pensacola, Florida 32504, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Weston, Florida 33331, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Atlanta, Georgia 30309, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Atlanta, Georgia 30327, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Savannah, Georgia 31406, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Smyrna, Georgia 30080, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Honolulu, Hawaii 96817, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Coeur d'Alene, Idaho 83814, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Chicago, Illinois 60611, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Chicago, Illinois 60612, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Evanston, Illinois 60201, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Urbana, Illinois 61801, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Avon, Indiana 46123, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Roeland Park, Kansas 66205, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Lexington, Kentucky 40504, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Louisville, Kentucky 40202, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Baltimore, Maryland 21237, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Glen Burnie, Maryland 21061, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Boston, Massachusetts 02215, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Burlington, Massachusetts 01805, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Norfolk, Massachusetts 02481, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Ann Arbor, Michigan 48019, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Detroit, Michigan 48202, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Farmington, Michigan 48334, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Owosso, Michigan 48867, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Rochester Hills, Michigan 48307, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Golden Valley, Minnesota 55422, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Plymouth, Minnesota 55446, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Billings, Montana 59101, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Lincoln, Nebraska 68502, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Omaha, Nebraska 68154, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Las Vegas, Nevada 89106, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Bridgewater, New Jersey 08807, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Cherry Hill, New Jersey 08002, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Freehold, New Jersey 07728, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Livingston, New Jersey 07039, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Neptune City, New Jersey 00753, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Paramus, New Jersey 07652, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Teaneck, New Jersey 07666, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Amherst, New York 14226, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Lake Success, New York 11042, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    New York, New York 11501, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    The Bronx, New York 10467, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Charlotte, North Carolina 28210, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    New Bern, North Carolina 28562, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Raleigh, North Carolina 27607, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Centerville, Ohio 45429, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Centerville, Ohio 45459, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Cincinnati, Ohio 45212, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Cleveland, Ohio 44195, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Columbus, Ohio 43214, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Columbus, Ohio 43235, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Toledo, Ohio 43608, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Norman, Oklahoma 73019, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Portland, Oregon 97225, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Bethlehem, Pennsylvania 18017, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Franklin, Tennessee 37067, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Knoxville, Tennessee 37996, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Mount Juliet, Tennessee 37122, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Nashville, Tennessee 37215, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Spring Hill, Tennessee 37174, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Austin, Texas 78712, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Austin, Texas 78723, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Austin, Texas 78758, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Dallas, Texas 75206, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Dallas, Texas 75243, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Edinburg, Texas 78572, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Frisco, Texas 75035, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Lubbock, Texas 79414, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    San Antonio, Texas 78229, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Ogden, Utah 84403, United States
    Recruiting

Showing the first 100 of 113 sites across 3 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Apr 2032, 92 months after the start.

Of 91 industry-sponsored observational studies under Multiple Sclerosis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 81. This study's planned 92 months is above that.

Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
May 30, 2024
StartActual
Jul 22, 2024
Primary completionEst.
Apr 1, 2032
CompletionEst.
Apr 1, 2032
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added, 1 site removed
Show 3 added (3 United States)
  • TG Therapeutics Investigational Trial Site · Paramus, United States
  • TG Therapeutics Investigational Trial Site · Lake Success, United States
  • TG Therapeutics Investigational Trial Site · The Bronx, United States
Show 1 removed
  • TG Therapeutics Investigational Trial Site · Smith, United States
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    3 sites added, 1 site removed
    Show 3 added (3 United States)
    • TG Therapeutics Investigational Trial Site · Paramus, United States
    • TG Therapeutics Investigational Trial Site · Lake Success, United States
    • TG Therapeutics Investigational Trial Site · The Bronx, United States
    Show 1 removed
    • TG Therapeutics Investigational Trial Site · Smith, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06433752
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Jul 22, 2024
Primary completion
Apr 1, 2032 (estimated)
Completion
Apr 1, 2032 (estimated)
Last update
Oct 30, 2026

Study contacts

TG Therapeutics Clinical Support Team
Contact
clinicalsupport@tgtxinc.com
1-877-575-8489

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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