RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-07-22
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06433752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed Multiple Sclerosis (MS) diagnosis.
  2. 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. 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. 2. Any active infection (e.g., active Hepatitis B virus \[HBV\])
  3. 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.

Contacts and Locations

Study Contact

TG Therapeutics Clinical Support Team
CONTACT
1-877-555-8489
clinicalsupport@tgtxinc.com

Study Locations (Sites)

TG Therapeutics Investigational Trial Site
Birmingham, Alabama, 35209
United States
TG Therapeutics Investigational Trial Site
Gilbert, Arizona, 85297
United States
TG Therapeutics Investigational Trial Site
Phoenix, Arizona, 85032
United States
TG Therapeutics Investigational Trial Site
Newport Beach, California, 92663
United States
TG Therapeutics Investigational Trial Site
Denver, Colorado, 80222
United States
TG Therapeutics Investigational Trial Site
Fort Collins, Colorado, 80528
United States
TG Therapeutics Investigational Trial Site
Farmington, Connecticut, 06032
United States
TG Therapeutics Investigational Trial Site
Clearwater, Florida, 33761
United States
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30309
United States
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30327
United States
TG Therapeutics Investigational Trial Site
Chicago, Illinois, 60612
United States
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, 40504
United States
TG Therapeutics Investigational Trial Site
Louisville, Kentucky, 40202
United States
TG Therapeutics Investigational Trial Site
Glen Burnie, Maryland, 21061
United States
TG Therapeutics Investigational Trial Site
Norfolk, Massachusetts, 02481
United States
TG Therapeutics Investigational Trial Site
Farmington, Michigan, 48334
United States
TG Therapeutics Investigational Trial Site
Owosso, Michigan, 48867
United States
TG Therapeutics Investigational Trial Site
Livingston, New Jersey, 07039
United States
TG Therapeutics Investigational Trial Site
Amherst, New York, 14226
United States
TG Therapeutics Investigational Trial Site
Charlotte, North Carolina, 28210
United States
TG Therapeutics Investigational Trial Site
Raleigh, North Carolina, 27607
United States
TG Therapeutics Investigational Trial Site
Centerville, Ohio, 45429
United States
TG Therapeutics Investigational Trial Site
Portland, Oregon, 97225
United States
TG Therapeutics Investigational Trial Site
Austin, Texas, 78723
United States
TG Therapeutics Investigational Trial Site
Norfolk, Virginia, 23502
United States
TG Therapeutics Investigational Trial Site
Vienna, Virginia, 22182
United States
TG Therapeutics Investigational Trial Site
Kirkland, Washington, 98034
United States
TG Therapeutics Investigational Trial Site
Greenfield, Wisconsin, 53228
United States

Collaborators and Investigators

Sponsor: TG Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2024-07-22
Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsing Multiple Sclerosis
  • Multiple Sclerosis