A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
- Conditions
- Relapsing Multiple SclerosisMultiple 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:<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.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualized Relapse Rate (ARR)
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants with Infusion Related Reaction (IRR) at Each Infusion