Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03381170
  4. Details
NCT03381170 Clinical Trial

An Extension of the TG1101-RMS201 Trial

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03381170
Other study ID # TG1101-RMS201E
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 1, 2017
Est. completion date November 11, 2022

Study information
Verified date December 2022
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date November 11, 2022
Est. primary completion date November 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Aurora Colorado
United States TG Therapeutics Investigational Trial Site Columbus Ohio
United States TG Therapeutics Investigational Trial Site Knoxville Tennessee
United States TG Therapeutics Investigational Trial Site Lexington Kentucky
United States TG Therapeutics Investigational Trial Site Pasadena California
United States TG Therapeutics Investigational Trial Site Round Rock Texas
United States TG Therapeutics Investigational Trial Site San Antonio Texas
United States TG Therapeutics Investigational Trial Site Westerville Ohio

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 96 weeks on therapy
Secondary Evaluate the % of participants with relapses up to 96 Weeks
See also
  Status Clinical Trial Phase
Completed NCT01945359 - Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design N/A
Completed NCT01456416 - Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities Phase 4
Completed NCT01450124 - Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) Phase 2
Recruiting NCT05277740 - Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
Completed NCT03718247 - Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
Active, not recruiting NCT03471338 - Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme N/A
Recruiting NCT03004079 - Clinical Importance of Glucose Regulation in Relapsing MS
Terminated NCT02266121 - Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis N/A
Completed NCT01963611 - Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) Phase 2
Active, not recruiting NCT01464905 - Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Phase 3
Completed NCT01225289 - Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients Phase 4
Recruiting NCT00242268 - A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis Phase 3
Completed NCT00203086 - A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis Phase 4
Completed NCT00616187 - Atorvastatin in Relapsing-Remitting Multiple Sclerosis Phase 2
Recruiting NCT06083753 - Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis Phase 2
Active, not recruiting NCT04602390 - Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis Phase 1
Recruiting NCT06159712 - Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis N/A
Recruiting NCT04604041 - Investigation of Subclinical Markers of Multiple Sclerosis
Terminated NCT03536559 - Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis Phase 2
Completed NCT02490982 - Teriflunomide Observational Effectiveness Study