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Clinical Trial NCT06433752 (ENABLE) for Relapsing Multiple Sclerosis, Multiple Sclerosis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) (ENABLE)

Recruiting
Clinical Trial NCT06433752 (ENABLE) is an observational study for Relapsing Multiple Sclerosis, Multiple Sclerosis that is recruiting. It started on 22 July 2024 with plans to enroll 500 participants. Led by TG Therapeutics, Inc., it is expected to complete by 1 July 2027. The latest data from ClinicalTrials.gov was last updated on 3 November 2025.
Brief 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
Official Title

REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)

Conditions
Relapsing Multiple SclerosisMultiple Sclerosis
Other Study IDs
  • ENABLE
  • TG1101-RMS406
NCT ID Number
NCT06433752
Start Date (Actual)
2024-07-22
Last Update Posted
2025-11-03
Completion Date (Estimated)
2027-07-01
Enrollment (Estimated)
500
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
BRIUMVI® (Ublituximab-xiiy)
Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.
No Intervention
No Intervention
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Annualized Relapse Rate (ARR)
Up to Week 96
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to Week 96
Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
Up to Week 96
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
TG Therapeutics, Inc. logoTG Therapeutics, Inc.11 active trials to explore
Study Central Contact
Contact: TG Therapeutics Clinical Support Team, 1-877-575-8489, [email protected]
64 Study Locations in 2 Countries

Alabama

TG Therapeutics Investigational Trial Site, Birmingham, Alabama, 35209, United States
Recruiting

Arizona

TG Therapeutics Investigational Trial Site, Gilbert, Arizona, 85297, United States
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TG Therapeutics Investigational Trial Site, Phoenix, Arizona, 85032, United States
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California

TG Therapeutics Investigational Trial Site, Newport Beach, California, 92663, United States
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TG Therapeutics Investigational Trial Site, Orange, California, 68130, United States
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Colorado

TG Therapeutics Investigational Trial Site, Aurora, Colorado, 80045, United States
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TG Therapeutics Investigational Trial Site, Basalt, Colorado, 81621, United States
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TG Therapeutics Investigational Trial Site, Colorado Springs, Colorado, 80918, United States
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TG Therapeutics Investigational Trial Site, Denver, Colorado, 80222, United States
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TG Therapeutics Investigational Trial Site, Fort Collins, Colorado, 80528, United States
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Connecticut

TG Therapeutics Investigational Trial Site, Farmington, Connecticut, 06032, United States
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TG Therapeutics Investigational Trial Site, Hartford, Connecticut, 06112, United States
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District of Columbia

TG Therapeutics Investigational Trial Site, Washington D.C., District of Columbia, 20010, United States
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Florida

TG Therapeutics Investigational Trial Site, Altamonte Springs, Florida, 32714, United States
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TG Therapeutics Investigational Trial Site, Boca Raton, Florida, 33486, United States
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TG Therapeutics Investigational Trial Site, Clearwater, Florida, 33761, United States
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TG Therapeutics Investigational Trial Site, Maitland, Florida, 32751, United States
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TG Therapeutics Investigational Trial Site, Naples, Florida, 34105, United States
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Georgia

TG Therapeutics Investigational Trial Site, Atlanta, Georgia, 30309, United States
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TG Therapeutics Investigational Trial Site, Atlanta, Georgia, 30327, United States
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Idaho

TG Therapeutics Investigational Trial Site, Coeur d'Alene, Idaho, 83814, United States
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Illinois

TG Therapeutics Investigational Trial Site, Chicago, Illinois, 60612, United States
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TG Therapeutics Investigational Trial Site, Evanston, Illinois, 60201, United States
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TG Therapeutics Investigational Trial Site, Urbana, Illinois, 61801, United States
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Kentucky

TG Therapeutics Investigational Trial Site, Lexington, Kentucky, 40504, United States
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TG Therapeutics Investigational Trial Site, Louisville, Kentucky, 40202, United States
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Maryland

TG Therapeutics Investigational Trial Site, Baltimore, Maryland, 21237, United States
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TG Therapeutics Investigational Trial Site, Glen Burnie, Maryland, 21061, United States
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Massachusetts

TG Therapeutics Investigational Trial Site, Burlington, Massachusetts, 01805, United States
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TG Therapeutics Investigational Trial Site, Norfolk, Massachusetts, 02481, United States
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Michigan

TG Therapeutics Investigational Trial Site, Ann Arbor, Michigan, 48019, United States
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TG Therapeutics Investigational Trial Site, Farmington, Michigan, 48334, United States
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TG Therapeutics Investigational Trial Site, Owosso, Michigan, 48867, United States
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Nebraska

TG Therapeutics Investigational Trial Site, Omaha, Nebraska, 68154, United States
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Nevada

TG Therapeutics Investigational Trial Site, Las Vegas, Nevada, 89106, United States
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New Jersey

TG Therapeutics Investigational Trial Site, Livingston, New Jersey, 07039, United States
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TG Therapeutics Investigational Trial Site, Neptune City, New Jersey, 00753, United States
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TG Therapeutics Investigational Trial Site, Teaneck, New Jersey, 07666, United States
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New York

TG Therapeutics Investigational Trial Site, Amherst, New York, 14226, United States
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TG Therapeutics Investigational Trial Site, New York, New York, 11501, United States
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North Carolina

TG Therapeutics Investigational Trial Site, Charlotte, North Carolina, 28210, United States
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TG Therapeutics Investigational Trial Site, Raleigh, North Carolina, 27607, United States
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Ohio

TG Therapeutics Investigational Trial Site, Centerville, Ohio, 45429, United States
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TG Therapeutics Investigational Trial Site, Centerville, Ohio, 45459, United States
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TG Therapeutics Investigational Trial Site, Cincinnati, Ohio, 45212, United States
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TG Therapeutics Investigational Trial Site, Cleveland, Ohio, 44195, United States
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TG Therapeutics Investigational Trial Site, Columbus, Ohio, 43214, United States
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TG Therapeutics Investigational Trial Site, Toledo, Ohio, 43608, United States
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Oregon

TG Therapeutics Investigational Trial Site, Portland, Oregon, 97225, United States
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Tennessee

TG Therapeutics Investigational Trial Site, Knoxville, Tennessee, 37996, United States
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TG Therapeutics Investigational Trial Site, Nashville, Tennessee, 37215, United States
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Texas

TG Therapeutics Investigational Trial Site, Austin, Texas, 78712, United States
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TG Therapeutics Investigational Trial Site, Austin, Texas, 78723, United States
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TG Therapeutics Investigational Trial Site, Austin, Texas, 78758, United States
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TG Therapeutics Investigational Trial Site, Dallas, Texas, 75206, United States
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TG Therapeutics Investigational Trial Site, San Antonio, Texas, 78229, United States
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Virginia

TG Therapeutics Investigational Trial Site, Norfolk, Virginia, 23502, United States
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TG Therapeutics Investigational Trial Site, Vienna, Virginia, 22182, United States
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Washington

TG Therapeutics Investigational Trial Site, Kirkland, Washington, 98034, United States
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Wisconsin

TG Therapeutics Investigational Trial Site, Greenfield, Wisconsin, 53228, United States
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TG Therapeutics Investigational Trial Site, Milwaukee, Wisconsin, 53226, United States
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TG Therapeutics Investigational Trial Site, Neenah, Wisconsin, 54956, United States
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TG Therapeutics Investigational Trial Site, Waukesha, Wisconsin, 53188, United States
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TG Therapeutics Investigational Trial Site, Guaynabo, 00968, Puerto Rico
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