An Extension of the TG1101-RMS201 Trial

NCT ID: NCT03381170

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-11-11

Brief Summary

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

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Keywords

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ublituximab

Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E

Group Type EXPERIMENTAL

Ublituximab

Intervention Type BIOLOGICAL

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

Interventions

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Ublituximab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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TG1101

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TG Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TG Therapeutics Investigational Trial Site

Pasadena, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Aurora, Colorado, United States

Site Status

TG Therapeutics Investigational Trial Site

Lexington, Kentucky, United States

Site Status

TG Therapeutics Investigational Trial Site

Columbus, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Westerville, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Knoxville, Tennessee, United States

Site Status

TG Therapeutics Investigational Trial Site

Round Rock, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TG1101-RMS201E

Identifier Type: -

Identifier Source: org_study_id