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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTG Therapeutics, Inc.

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    No Intervention

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: BRIUMVI® (Ublituximab-xiiy)1 intervention

Trial outcomes

Primary outcomes

1

Annualized Relapse Rate (ARR)

Time frame
Up to Week 96

Secondary outcomes

1

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Up to Week 96
2

Number of Participants with Infusion Related Reaction (IRR) at Each Infusion

Time frame
Up to Week 96

Other outcomes

Sponsors and contacts

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