Status:
COMPLETED
An Extension of the TG1101-RMS201 Trial
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03381170
Start Date
June 1 2017
End Date
November 11 2022
Last Update
December 21 2022
Active Locations (8)
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1
TG Therapeutics Investigational Trial Site
Pasadena, California, United States, 91105
2
TG Therapeutics Investigational Trial Site
Aurora, Colorado, United States, 80045
3
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, United States, 40513
4
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States, 43210