Evaluating real-world experiences of patients treated with BRIUMVI® for relapsing multiple sclerosis
Official title: REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
Run by TG Therapeutics, Inc. · NCT06433752 · Data updated 2026-11-12
This study is looking to see how well BRIUMVI® works and what side effects it has for people with relapsing multiple sclerosis in everyday settings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | TG Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | ublituximab |
| Locations | 113 sites (Birmingham, Alabama and 112 other locations) |
| Status | Recruiting |
| Started | July 22, 2024 |
| Main results expected | April 1, 2032 |
| Study ends | April 1, 2032 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT06433752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with a confirmed diagnosis of relapsing multiple sclerosis who have not yet received BRIUMVI® treatment.
✕Probably not a fit
Patients who have received live vaccines recently or are currently participating in other interventional MS trials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety and effectiveness of BRIUMVI® (ublituximab-xiiy) in patients diagnosed with relapsing multiple sclerosis (RMS). It focuses on gathering insights into the treatment experiences of participants who have been prescribed this medication in a real-world setting. Participants will be monitored for their health outcomes and any side effects following their first infusion of BRIUMVI®. The study does not involve any experimental interventions, as it is designed to observe the existing treatment protocol.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of BRIUMVI® for patients with relapsing multiple sclerosis.
How similar studies have gone: While this study is observational and focuses on real-world data, similar studies evaluating treatment experiences with other MS therapies have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: 1. 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. 2. Any active infection (e.g., active Hepatitis B 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.
Where it's running
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TG Therapeutics Investigational Trial Site
Birmingham, Alabama, United States Recruiting -
TG Therapeutics Investigational Trial Site
Cullman, Alabama, United States Recruiting -
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States Recruiting -
TG Therapeutics Investigational Trial Site
Mobile, Alabama, United States Recruiting -
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Gilbert, Arizona, United States Recruiting -
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Phoenix, Arizona, United States Recruiting
Show 44 more locations
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Scottsdale, Arizona, United States Recruiting -
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Fresno, California, United States Recruiting -
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Newport Beach, California, United States Recruiting -
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Orange, California, United States Recruiting -
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West Hollywood, California, United States Recruiting -
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Aurora, Colorado, United States Recruiting -
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Basalt, Colorado, United States Recruiting -
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Colorado Springs, Colorado, United States Recruiting -
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Colorado Springs, Colorado, United States Recruiting -
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Denver, Colorado, United States Recruiting -
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Fort Collins, Colorado, United States Recruiting -
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Grand Junction, Colorado, United States Recruiting -
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Farmington, Connecticut, United States Recruiting -
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Hartford, Connecticut, United States Recruiting -
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Washington D.C., District of Columbia, United States Recruiting -
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Altamonte Springs, Florida, United States Recruiting -
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Boca Raton, Florida, United States Recruiting -
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Clearwater, Florida, United States Recruiting -
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Gainesville, Florida, United States Recruiting -
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Maitland, Florida, United States Recruiting -
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Miami, Florida, United States Recruiting -
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Naples, Florida, United States Recruiting -
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Orlando, Florida, United States Recruiting -
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Pensacola, Florida, United States Recruiting -
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Weston, Florida, United States Recruiting -
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Atlanta, Georgia, United States Recruiting -
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Atlanta, Georgia, United States Recruiting -
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Savannah, Georgia, United States Recruiting -
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Smyrna, Georgia, United States Recruiting -
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Honolulu, Hawaii, United States Recruiting -
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Coeur d'Alene, Idaho, United States Recruiting -
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Chicago, Illinois, United States Recruiting -
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Chicago, Illinois, United States Recruiting -
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Evanston, Illinois, United States Recruiting -
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Urbana, Illinois, United States Recruiting -
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Avon, Indiana, United States Recruiting -
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Roeland Park, Kansas, United States Recruiting -
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Lexington, Kentucky, United States Recruiting -
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Louisville, Kentucky, United States Recruiting -
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Baltimore, Maryland, United States Recruiting -
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Glen Burnie, Maryland, United States Recruiting -
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Boston, Massachusetts, United States Recruiting -
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Burlington, Massachusetts, United States Recruiting -
TG Therapeutics Investigational Trial Site
Norfolk, Massachusetts, United States Recruiting
+63 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: TG Therapeutics Clinical Support Team
- Email: clinicalsupport@tgtxinc.com
- Phone: 1-877-575-8489
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ublituximab in MS: how injection site and delivery method affect absorption
This study tests how different SC injection sites and a prefilled pen delivery compare in how ublituximab behaves in the body for people with relapsing MS.
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Switching to ublituximab for ocrelizumab wearing-off in multiple sclerosis
This pilot will try switching people with relapsing MS who experience symptom 'wearing off' on ocrelizumab to ublituximab to see if their symptoms improve or return later.
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Ublituximab (Briumvi) for early relapsing MS
This study will test whether giving Ublituximab (Briumvi) about twice a year is safe and changes a blood marker (neurofilament light) in adults with early relapsing MS.
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Ublituximab in Pediatric Relapsing MS: See if a B-cell therapy works in kids
This study tests whether ublituximab can work in children and teens with relapsing MS and compares it to fingolimod in eligible participants.
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Evaluating a modified treatment regimen of ublituximab for relapsing multiple sclerosis
This study is testing a new way to use ublituximab to see if it can help people with relapsing multiple sclerosis feel better and stay safe.
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Treadmill-based virtual reality walking training for MS patients
This study tests whether a treadmill with virtual reality and smart socks can help people with multiple sclerosis walk better and feel safer in daily life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.