Multiple Sclerosis, Relapsing Multiple Sclerosis
Conditions
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
Interventions
OTHERNo Intervention
No Intervention
Sponsors
TG Therapeutics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized Relapse Rate (ARR) | Up to Week 96 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 96 |
| Number of Participants with Infusion Related Reaction (IRR) at Each Infusion | Up to Week 96 |
Countries
Puerto Rico, United States
Contacts
CONTACTTG Therapeutics Clinical Support Team
Outcome results
None listed