RecruitingNCT06433752
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
Sponsor
TG Therapeutics, Inc.
Enrollment
500 participants
Start Date
Jul 22, 2024
Study Type
OBSERVATIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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.
Exclusion Criteria3
- 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.
Interventions
OTHERNo Intervention
No Intervention
Locations(80)
View Full Details on ClinicalTrials.gov
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NCT06433752
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