Skip to main content
OpenTrials
Completed

NCT Number: NCT03381170

An Extension of the TG1101-RMS201 Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TG Therapeutics Investigational Trial Site, Pasadena, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ublituximab

Biological

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

Other names: TG1101

Primary outcomes

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

    Time frame: 96 weeks on therapy

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

Secondary outcomes

  1. Evaluate the % of participants with relapses

    Time frame: up to 96 Weeks

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2017
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.