An Extension of the TG1101-RMS201 Trial

TG Therapeutics, Inc.48 enrolled

Overview

This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

UblituximabBIOLOGICAL

Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (8)

TG Therapeutics Investigational Trial Site

Pasadena, California, United States

TG Therapeutics Investigational Trial Site

Aurora, Colorado, United States

TG Therapeutics Investigational Trial Site

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Number of participants with treatment-related events as assessed by CTCAE V4.0

to determine the incidence of adverse events and any abnormal laboratory values

Time frame: 96 weeks on therapy

Secondary Outcomes

Evaluate the % of participants with relapses

Time frame: up to 96 Weeks

Data from ClinicalTrials.gov

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