Multiple Sclerosis Clinical Trial
— ENABLEOfficial title:
REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
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
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | July 1, 2027 |
| Est. primary completion date | July 1, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) | Up to Week 96 | ||
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 96 | ||
| Secondary | Number of Participants with Infusion Related Reaction (IRR) at Each Infusion | Up to Week 96 |
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