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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

14mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach

2 countries

80 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress61%

Jul 2024Jul 2027

First Submitted

Initial submission to the registry

May 23, 2024

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

May 23, 2024

Last Update Submit

February 25, 2026

Conditions

Relapsing Multiple Sclerosis Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

Annualized Relapse Rate (ARR)
Up to Week 96

Secondary Outcomes (2)

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

Study Arms (1)

BRIUMVI® (Ublituximab-xiiy)

Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

BRIUMVI® (Ublituximab-xiiy)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.