An Extension of the TG1101-RMS201 Trial
Phase 2
Completed
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Registration Number
- NCT03381170
- Lead Sponsor
- TG Therapeutics, Inc.
- Brief Summary
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Subjects currently enrolled in TG1101-RMS201 trial
- Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit
Exclusion Criteria
- Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
- Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
- Pregnant or nursing mothers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related events as assessed by CTCAE V4.0 96 weeks on therapy to determine the incidence of adverse events and any abnormal laboratory values
- Secondary Outcome Measures
Name Time Method Evaluate the % of participants with relapses up to 96 Weeks
Trial Locations
- Locations (1)
TG Therapeutics Investigational Trial Site
🇺🇸San Antonio, Texas, United States
TG Therapeutics Investigational Trial Site🇺🇸San Antonio, Texas, United States