Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
Relapsing Multiple Sclerosis
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
Interventions
BIOLOGICALUblituximab
Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Evaluate the % of participants with relapses | up to 96 Weeks |
Countries
United States
Outcome results
None listed