Relapsing Multiple SclerosisENABLENCT06433752
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
An observational study of Relapsing Multiple Sclerosis and Multiple Sclerosis, run by TG Therapeutics, Inc. at 113 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 113 sitesin 3 countries
- Study dates
- 22 Jul 2024to 1 Apr 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).
Who may be able to join
- Confirmed Multiple Sclerosis (MS) diagnosis.
- 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.
Who cannot join
- Have received any live or live-attenuated vaccines (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.
- Any active infection (e.g., active Hepatitis B virus [HBV])
- Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.
Trial locations and contacts
113 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
113 sites in 3 countries
United States111 sites, 111 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Altamonte Springs, Florida, 32714
- Recruiting
TG Therapeutics Investigational Trial Site
Amherst, New York, 14226
- Recruiting
TG Therapeutics Investigational Trial Site
Ann Arbor, Michigan, 48019
- Recruiting
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30309
- Recruiting
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30327
- Recruiting
TG Therapeutics Investigational Trial Site
Aurora, Colorado, 80045
- Recruiting
TG Therapeutics Investigational Trial Site
Austin, Texas, 78712
- Recruiting
TG Therapeutics Investigational Trial Site
Austin, Texas, 78723
- Recruiting
TG Therapeutics Investigational Trial Site
Austin, Texas, 78758
- Recruiting
TG Therapeutics Investigational Trial Site
Avon, Indiana, 46123
- Recruiting
TG Therapeutics Investigational Trial Site
Baltimore, Maryland, 21237
- Recruiting
TG Therapeutics Investigational Trial Site
Basalt, Colorado, 81621
- Recruiting
TG Therapeutics Investigational Trial Site
Bethlehem, Pennsylvania, 18017
- Recruiting
TG Therapeutics Investigational Trial Site
Billings, Montana, 59101
- Recruiting
TG Therapeutics Investigational Trial Site
Birmingham, Alabama, 35209
- Recruiting
TG Therapeutics Investigational Trial Site
Boca Raton, Florida, 33486
- Recruiting
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, 02215
- Recruiting
TG Therapeutics Investigational Trial Site
Bridgewater, New Jersey, 08807
- Recruiting
TG Therapeutics Investigational Trial Site
Burlington, Massachusetts, 01805
- Recruiting
TG Therapeutics Investigational Trial Site
Centerville, Ohio, 45429
- Recruiting
TG Therapeutics Investigational Trial Site
Centerville, Ohio, 45459
- Recruiting
TG Therapeutics Investigational Trial Site
Charlotte, North Carolina, 28210
- Recruiting
TG Therapeutics Investigational Trial Site
Charlottesville, Virginia, 22908
- Recruiting
TG Therapeutics Investigational Trial Site
Cherry Hill, New Jersey, 08002
- Recruiting
TG Therapeutics Investigational Trial Site
Chicago, Illinois, 60611
- Recruiting
TG Therapeutics Investigational Trial Site
Chicago, Illinois, 60612
- Recruiting
TG Therapeutics Investigational Trial Site
Cincinnati, Ohio, 45212
- Recruiting
TG Therapeutics Investigational Trial Site
Clearwater, Florida, 33761
- Recruiting
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, 44195
- Recruiting
TG Therapeutics Investigational Trial Site
Coeur d'Alene, Idaho, 83814
- Recruiting
TG Therapeutics Investigational Trial Site
Colorado Springs, Colorado, 80918
- Recruiting
TG Therapeutics Investigational Trial Site
Colorado Springs, Colorado, 80920
- Recruiting
TG Therapeutics Investigational Trial Site
Columbus, Ohio, 43214
- Recruiting
TG Therapeutics Investigational Trial Site
Columbus, Ohio, 43235
- Recruiting
TG Therapeutics Investigational Trial Site
Cullman, Alabama, 35058
- Recruiting
TG Therapeutics Investigational Trial Site
Dallas, Texas, 75206
- Recruiting
TG Therapeutics Investigational Trial Site
Dallas, Texas, 75243
- Recruiting
TG Therapeutics Investigational Trial Site
Denver, Colorado, 80222
- Recruiting
TG Therapeutics Investigational Trial Site
Detroit, Michigan, 48202
- Recruiting
TG Therapeutics Investigational Trial Site
Edinburg, Texas, 78572
- Recruiting
TG Therapeutics Investigational Trial Site
Evanston, Illinois, 60201
- Recruiting
TG Therapeutics Investigational Trial Site
Farmington, Connecticut, 06032
- Recruiting
TG Therapeutics Investigational Trial Site
Farmington, Michigan, 48334
- Recruiting
TG Therapeutics Investigational Trial Site
Fort Collins, Colorado, 80528
- Recruiting
TG Therapeutics Investigational Trial Site
Franklin, Tennessee, 37067
- Recruiting
TG Therapeutics Investigational Trial Site
Freehold, New Jersey, 07728
- Recruiting
TG Therapeutics Investigational Trial Site
Fresno, California, 93720
- Recruiting
TG Therapeutics Investigational Trial Site
Frisco, Texas, 75035
- Recruiting
TG Therapeutics Investigational Trial Site
Gainesville, Florida, 32611
- Recruiting
TG Therapeutics Investigational Trial Site
Gilbert, Arizona, 85297
- Recruiting
TG Therapeutics Investigational Trial Site
Glen Burnie, Maryland, 21061
- Recruiting
TG Therapeutics Investigational Trial Site
Golden Valley, Minnesota, 55422
- Recruiting
TG Therapeutics Investigational Trial Site
Grand Junction, Colorado, 81501
- Recruiting
TG Therapeutics Investigational Trial Site
Greenfield, Wisconsin, 53228
- Recruiting
TG Therapeutics Investigational Trial Site
Hartford, Connecticut, 06112
- Recruiting
TG Therapeutics Investigational Trial Site
Honolulu, Hawaii, 96817
- Recruiting
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, 35802
- Recruiting
TG Therapeutics Investigational Trial Site
Kirkland, Washington, 98034
- Recruiting
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, 37996
- Recruiting
TG Therapeutics Investigational Trial Site
Lake Success, New York, 11042
- Recruiting
TG Therapeutics Investigational Trial Site
Las Vegas, Nevada, 89106
- Recruiting
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, 40504
- Recruiting
TG Therapeutics Investigational Trial Site
Lincoln, Nebraska, 68502
- Recruiting
TG Therapeutics Investigational Trial Site
Livingston, New Jersey, 07039
- Recruiting
TG Therapeutics Investigational Trial Site
Louisville, Kentucky, 40202
- Recruiting
TG Therapeutics Investigational Trial Site
Lubbock, Texas, 79414
- Recruiting
TG Therapeutics Investigational Trial Site
Maitland, Florida, 32751
- Recruiting
TG Therapeutics Investigational Trial Site
Miami, Florida, 33176
- Recruiting
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, 53226
- Recruiting
TG Therapeutics Investigational Trial Site
Mobile, Alabama, 36604
- Recruiting
TG Therapeutics Investigational Trial Site
Morgantown, West Virginia, 26506
- Recruiting
TG Therapeutics Investigational Trial Site
Mount Juliet, Tennessee, 37122
- Recruiting
TG Therapeutics Investigational Trial Site
Naples, Florida, 34105
- Recruiting
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, 37215
- Recruiting
TG Therapeutics Investigational Trial Site
Neenah, Wisconsin, 54956
- Recruiting
TG Therapeutics Investigational Trial Site
Neptune City, New Jersey, 00753
- Recruiting
TG Therapeutics Investigational Trial Site
New Bern, North Carolina, 28562
- Recruiting
TG Therapeutics Investigational Trial Site
New York, New York, 11501
- Recruiting
TG Therapeutics Investigational Trial Site
Newport Beach, California, 92663
- Recruiting
TG Therapeutics Investigational Trial Site
Norfolk, Massachusetts, 02481
- Recruiting
TG Therapeutics Investigational Trial Site
Norman, Oklahoma, 73019
- Recruiting
TG Therapeutics Investigational Trial Site
Ogden, Utah, 84403
- Recruiting
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, 68154
- Recruiting
TG Therapeutics Investigational Trial Site
Orange, California, 68130
- Recruiting
TG Therapeutics Investigational Trial Site
Orlando, Florida, 32806
- Recruiting
TG Therapeutics Investigational Trial Site
Owosso, Michigan, 48867
- Recruiting
TG Therapeutics Investigational Trial Site
Paramus, New Jersey, 07652
- Recruiting
TG Therapeutics Investigational Trial Site
Pensacola, Florida, 32504
- Recruiting
TG Therapeutics Investigational Trial Site
Phoenix, Arizona, 85032
- Recruiting
TG Therapeutics Investigational Trial Site
Plymouth, Minnesota, 55446
- Recruiting
TG Therapeutics Investigational Trial Site
Portland, Oregon, 97225
- Recruiting
TG Therapeutics Investigational Trial Site
Raleigh, North Carolina, 27607
- Recruiting
TG Therapeutics Investigational Trial Site
Rochester Hills, Michigan, 48307
- Recruiting
TG Therapeutics Investigational Trial Site
Roeland Park, Kansas, 66205
- Recruiting
TG Therapeutics Investigational Trial Site
Salem, Virginia, 24153
- Recruiting
TG Therapeutics Investigational Trial Site
Salt Lake City, Utah, 84103
- Recruiting
TG Therapeutics Investigational Trial Site
San Antonio, Texas, 78229
- Recruiting
TG Therapeutics Investigational Trial Site
Savannah, Georgia, 31406
- Recruiting
TG Therapeutics Investigational Trial Site
Scottsdale, Arizona, 85253
- Recruiting
TG Therapeutics Investigational Trial Site
Smyrna, Georgia, 30080
- Recruiting
TG Therapeutics Investigational Trial Site
Spring Hill, Tennessee, 37174
- Recruiting
TG Therapeutics Investigational Trial Site
Teaneck, New Jersey, 07666
- Recruiting
TG Therapeutics Investigational Trial Site
The Bronx, New York, 10467
- Recruiting
TG Therapeutics Investigational Trial Site
Toledo, Ohio, 43608
- Recruiting
TG Therapeutics Investigational Trial Site
Urbana, Illinois, 61801
- Recruiting
TG Therapeutics Investigational Trial Site
Vienna, Virginia, 22182
- Recruiting
TG Therapeutics Investigational Trial Site
Virginia Beach, Virginia, 23456
- Recruiting
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, 20010
- Recruiting
TG Therapeutics Investigational Trial Site
Waukesha, Wisconsin, 53188
- Recruiting
TG Therapeutics Investigational Trial Site
West Hollywood, California, 90048
- Recruiting
TG Therapeutics Investigational Trial Site
Weston, Florida, 33331
Puerto Rico1 site, 1 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Guaynabo, 00968
United Kingdom1 site, 1 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
London, SW170QT
About this study
Official title: REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
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
- Conditions
- Relapsing Multiple Sclerosis, 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® (Ublituximab-xiiy) | Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR)
Measured: Up to Week 96
Secondary outcomes (2)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 96
Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
Measured: Up to Week 96
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 start22 Jul 2024
- Primary completion1 Apr 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 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
- NCT06433752
- Sponsor's protocol ID
- TG1101-RMS406
- Acronym
- ENABLE
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 30 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
- ClinicalTrials.gov ID
- NCT06433752
- Acronym / sponsor ID
- ENABLE / TG1101-RMS406
- Conditions
- Relapsing Multiple Sclerosis, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 1 Apr 2032 (estimated)
- Study completion
- 1 Apr 2032 (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 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRIUMVI® (Ublituximab-xiiy) | – | Other: No InterventionParticipants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).
Key inclusion criteria (2 listed)
- Confirmed Multiple Sclerosis (MS) diagnosis.
- 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.
Key exclusion criteria (3 listed)
- Have received any live or live-attenuated vaccines (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.
- Any active infection (e.g., active Hepatitis B virus [HBV])
- Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.
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® (Ublituximab-xiiy) |
Primary outcome
Annualized Relapse Rate (ARR)
Time frame: Up to Week 96
2 secondary outcomes
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 96
Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
Time frame: Up to Week 96
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
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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.
113 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis and Multiple Sclerosis, run by TG Therapeutics, Inc. at 113 sites in 3 countries.
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 2 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 30 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 113 sites in United States, Puerto Rico, United Kingdom. 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 TG Therapeutics Clinical Support Team (1-877-575-8489, clinicalsupport@tgtxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized Relapse Rate (ARR) (time frame: Up to Week 96). 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 30 Oct 2026.