About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).
Trial design
Case-only
Prospective
Treatments tested in this trial
No Intervention
Other interventionNo Intervention
Treatment groups
Trial outcomes
Primary outcomes
Annualized Relapse Rate (ARR)
Secondary outcomes
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
Sponsors and contacts
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