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Recruiting NCT06433752

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

— Observational Relapsing Multiple Sclerosis Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention.
Who it may be relevant to
Registry conditions: Relapsing Multiple Sclerosis, Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Other No Intervention
    No Intervention

Primary outcome measures

  • Annualized Relapse Rate (ARR) [Time frame: Up to Week 96]
Secondary outcome measures (2)
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to Week 96]
  • Number of Participants with Infusion Related Reaction (IRR) at Each Infusion [Time frame: Up to Week 96]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 90 centers
  • TG Therapeutics Investigational Trial Site — Birmingham
  • TG Therapeutics Investigational Trial Site — Huntsville
  • TG Therapeutics Investigational Trial Site — Mobile
  • TG Therapeutics Investigational Trial Site — Gilbert
  • TG Therapeutics Investigational Trial Site — Phoenix
  • TG Therapeutics Investigational Trial Site — Scottsdale
  • TG Therapeutics Investigational Trial Site — Fresno
  • TG Therapeutics Investigational Trial Site — Newport Beach
  • … and 82 more centers
Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06433752 · TG1101-RMS406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗