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Monoclonal Antibodies

Ublituximab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by TG Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 336
Awards & highlights

Study Summary

This trial will test how safe and effective ublituximab is for treating relapsing multiple sclerosis over the long term.

Who is the study for?
This trial is for people with relapsing multiple sclerosis who completed prior ublituximab studies. They must be willing to use contraception and have no unstable disease activity, malignancies (except certain skin lesions), recent live vaccines, significant medical issues, or ongoing pregnancy. Those who started other MS treatments after previous studies are excluded.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of a medication called Ublituximab in individuals with relapsing multiple sclerosis. Participants will receive this drug to see how well it continues to work over time and what side effects may occur with extended use.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like Ublituximab can include infusion reactions such as fever or chills, potential infections due to immune system changes, fatigue, headache, nausea, and possibly others based on individual health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 336
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 336 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Relapse Rate (ARR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ublituximab InfusionsExperimental Treatment1 Intervention
RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
2017
Completed Phase 3
~2090

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
4,531 Total Patients Enrolled
6 Trials studying Multiple Sclerosis
1,507 Patients Enrolled for Multiple Sclerosis

Media Library

Ublituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04130997 — Phase 3
Multiple Sclerosis Research Study Groups: Ublituximab Infusions
Multiple Sclerosis Clinical Trial 2023: Ublituximab Highlights & Side Effects. Trial Name: NCT04130997 — Phase 3
Ublituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130997 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this type of clinical trial been conducted before?

"Since 2015, ublituximab has undergone extensive clinical research. The first trial was sponsored by TG Therapeutics, Inc. and completed in the same year. After this initial study involving 600 patients, ublituximab received Phase 3 drug approval. Today, there are 11 live trials for ublituximab being conducted across 133 cities in 13 countries."

Answered by AI

Are people with the required conditions able to enroll in this research right now?

"This study is not recruiting new patients at the moment, as reflected by its last update date of October 19th, 2020. However, there are 563 other studies seeking participants who have sclerosis and 11 studies involving Ublituximab that are currently open to candidates."

Answered by AI

What has been the outcome of prior research on Ublituximab?

"There are 11 Ublituximab trials ongoing, with 3 in Phase 3. Most of these New york-based studies will soon be completed, but there are still 290 locations running trials for Ublituximab across the country."

Answered by AI

At how many locations is this experiment being conducted?

"If you are interested in participating in this trial, please note that it is currently recruiting out of 18 sites. The locations closest to Dallas, Round Rock and Las Vegas are ideal to minimize travel requirements."

Answered by AI

What is the official governmental stance on Ublituximab?

"Ublituximab is believed to be safe as it has progressed to Phase 3 clinical trials. This means that not only does the medication have some data supporting its efficacy, but there are also multiple rounds of data affirming its safety."

Answered by AI

How many people fit the requirements to be in this clinical trial?

"Although this study is no longer recruiting, it was active from November 18th, 2019 to October 19th, 2020. If you are interested in finding other clinical trials, 563 studies involving sclerosis and 11 research projects involving Ublituximab are still searching for participants."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
2019. "An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04130997.
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