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L'essai clinique NCT06433752 (ENABLE) pour Sclérose en Plaques Récurrente, Sclérose en plaques est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) (ENABLE)

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06433752 (ENABLE) est un essai observationnel pour Sclérose en Plaques Récurrente, Sclérose en plaques. Son statut actuel est : en recrutement. L'étude a débuté le 22 juillet 2024 et vise à recruter 500 participants. Dirigé par TG Therapeutics, l'essai devrait être terminé d'ici le 1 juillet 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 3 novembre 2025.
Résumé succinct
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
Titre officiel

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

Conditions
Sclérose en Plaques RécurrenteSclérose en plaques
Autres identifiants de l'essai
  • ENABLE
  • TG1101-RMS406
Numéro NCT
NCT06433752
Date de début (réel)
2024-07-22
Dernière mise à jour publiée
2025-11-03
Date de fin (estimée)
2027-07-01
Inscription (estimée)
500
Type d'essai
Observationnel
Statut
En recrutement
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
BRIUMVI® (Ublituximab-xiiy)
Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.
AUCUNE INTERVENTION
No Intervention
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Annualized Relapse Rate (ARR)
Up to Week 96
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  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 Therapeutics11 essais cliniques actifs à explorer
Contact central de l'essai
Contact: TG Therapeutics Clinical Support Team, 1-877-575-8489, [email protected]
64 Centres de l'essai dans 2 pays

Alabama

TG Therapeutics Investigational Trial Site, Birmingham, Alabama, 35209, United States
En recrutement

Arizona

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

California

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

Colorado

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

Connecticut

TG Therapeutics Investigational Trial Site, Farmington, Connecticut, 06032, United States
En recrutement
TG Therapeutics Investigational Trial Site, Hartford, Connecticut, 06112, United States
En recrutement

District of Columbia

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

Florida

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

Georgia

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

Idaho

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

Illinois

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

Kentucky

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

Maryland

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

Massachusetts

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

Michigan

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

Nebraska

TG Therapeutics Investigational Trial Site, Omaha, Nebraska, 68154, United States
En recrutement

Nevada

TG Therapeutics Investigational Trial Site, Las Vegas, Nevada, 89106, United States
En recrutement

New Jersey

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

New York

TG Therapeutics Investigational Trial Site, Amherst, New York, 14226, United States
En recrutement
TG Therapeutics Investigational Trial Site, New York, New York, 11501, United States
En recrutement

North Carolina

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

Ohio

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

Oregon

TG Therapeutics Investigational Trial Site, Portland, Oregon, 97225, United States
En recrutement

Tennessee

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

Texas

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

Virginia

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

Washington

TG Therapeutics Investigational Trial Site, Kirkland, Washington, 98034, United States
En recrutement

Wisconsin

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