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

Recruiting
Conditions
Relapsing Multiple Sclerosis
Multiple Sclerosis
Registration Number
NCT06433752
Lead Sponsor
TG Therapeutics, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
500
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Confirmed Multiple Sclerosis (MS) diagnosis.<br><br> 2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to<br> study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but<br> have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be<br> included.<br><br>Exclusion Criteria:<br><br> 1. Have received any live or live-attenuated vaccines (including for varicella-zoster<br> virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy)<br> administration or any non-live vaccines within 2 weeks prior to first BRIUMVI®<br> (ublituximab-xiiy) administration.<br><br> 2. Any active infection (e.g., active Hepatitis B virus [HBV])<br><br> 3. Concurrent participation in any interventional MS trials, or planned concurrent<br> treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during<br> the study period.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Annualized Relapse Rate (ARR)
Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
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