Clinical trial NCT06433752: A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Official title: REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsing Multiple Sclerosis
Multiple Sclerosis
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).

Brief 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 criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Up to Week 96
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 96
measure: Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Gilbert
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Phoenix
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Newport Beach
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Aurora
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Basalt
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Colorado Springs
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Denver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Fort Collins
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Farmington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
city: Hartford
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
city: Washington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: District of Columbia
city: Boca Raton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Clearwater
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Naples
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Atlanta
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Atlanta
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Chicago
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Evanston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Urbana
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Lexington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Louisville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Baltimore
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Glen Burnie
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Burlington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Massachusetts
city: Norfolk
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Farmington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Owosso
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Omaha
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
city: Las Vegas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nevada
city: Livingston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Neptune
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Teaneck
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Amherst
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Charlotte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Raleigh
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Centerville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Cincinnati
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Cleveland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Columbus
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Toledo
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Portland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Knoxville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Nashville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Austin
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Austin
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Austin
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Dallas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Norfolk
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Vienna
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Kirkland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Greenfield
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Milwaukee
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Waukesha
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: TG Therapeutics Investigational Trial Site
Study officials:
References: