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NCT Number: NCT06433752

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

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

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Key information

Conditions

Relapsing Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

TG Therapeutics Investigational Trial Site, Guaynabo, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

No Intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-575-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)

Acronym: ENABLE

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
May 30, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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