Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Michael Sy (uci)

Description

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)

Keywords

Relapsing Multiple Sclerosis, Multiple Sclerosis, BRIUMVI® (Ublituximab-xiiy)

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • TG Therapeutics Investigational Trial Site accepting new patients
    West Hollywood California 90048 United States
  • TG Therapeutics Investigational Trial Site accepting new patients
    Newport Beach California 92663 United States
  • TG Therapeutics Investigational Trial Site accepting new patients
    Fresno California 93720 United States

Lead Scientist at University of California Health

  • Michael Sy (uci)
    Associate Clinical Professor, Neurology, School of Medicine. Authored (or co-authored) 11 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TG Therapeutics, Inc.
ID
NCT06433752
Study Type
Observational
Participants
Expecting 2000 study participants
Last Updated