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Lay Description

Evaluate effectiveness and safety in BRIUMVI® (ublituximab-xiiy) treated patients in real-world clinical practice. Observe patient demographics, baseline disease activity, and rationale for selecting BRIUMVI® (ublituximab-xiiy). 

Category

  • Nervous System
IRB Number
STUDY00000612
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

Eligible Ages
-
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  • ≥18 yr old patients with relapsing forms of MS 
  • Confirmed MS diagnosis
  • Patients who have not recieved BRIUMVI® infusion prior to enrollment
  • Patients prescribed BRIUMVI®, but have not yet recieved their first infusion on Day 1 of 150mg.

Exclusion Criteria

  • patients who have recieved any live or live-attenuated vaccines (including varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® administration
  • Any non-live vaccines within 2 weeks prior to first BRIUMVI® administration
  • Any active infection (e.g., Hepatitis B Virus [HBV]) 
  • Concurrent interventional MS trials or planned concurrent treatment with others MS DMT during study period.

Study Design

Participants who have been diagnosed with Multiple Sclerosis (MS),managed per routine standard care. 6 BRIUMVI® infusions corresponding to 96 weeks of therapy, 6th infusion to be considered the end of the study. At each treatment 2 questionnaires will be given, one will give insight on how the patient feels, and the other will provide insight on the impact in the patients day to day life. 

Study Contact

Regulatory Point of Contact
Jannel Gamboa
gamboaj1@uthscsa.edu

Regulatory Point of Contact
Charlotte Rhodes
210-450-8454
rhodesc1@uthscsa.edu

Regulatory Point of Contact
Luis Garcia
210-450-8451
garcial38@uthscsa.edu

Local Recruitment Point of Contact
Luis Garcia
210-450-8451
garcial38@uthscsa.edu

Principal Investigator
Tania Reyna