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NCT03277248 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
A Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 545
- Enrollment target
- 13
- Study locations
NCT03277248: Completed Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics.
NCT03277248 is a Phase 3 study of Relapsing Multiple Sclerosis (RMS) that has completed, run by TG Therapeutics. The registered enrollment target is 545 participants, below the 615-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (11% lower). The trial reports 13 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03277248, a Phase 3 study of Relapsing Multiple Sclerosis (RMS), has completed, sponsored by TG Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 545 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.
Primary Outcome
ARR is defined as the number of Independent Relapse Adjudication Committee (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.
Conditions Studied
Interventions
- BIOLOGICAL Ublituximab
- DRUG Oral Placebo
- DRUG Teriflunomide
- DRUG IV Placebo
Study Locations (13)
Arizona
- TG Therapeutics RMS Investigational Trial site - Phoenix
Colorado
- TG Therapeutics RMS Investigational Trial Site - Aurora
Florida
- TG Therapeutics RMS Investigational Trial Site - Tampa
Kentucky
- TG Therapeutics RMS Investigational Trial Site - Lexington
Missouri
- TG Therapeutics RMS Investigational Trial Site - Chesterfield
Nevada
- TG Therapeutics RMS Investigational Trial Site - Las Vegas
New Jersey
- TG Therapeutics RMS Investigational Trial Site - Teaneck
New Mexico
- TG Therapeutics RMS Investigational Trial Site - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2017-08-25 |
| Est. Completion | 2020-11-12 |
| Phase | Phase 3 |
What the finished NCT03277248 record still lists
NCT03277248 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, below the 615-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis (RMS) appearing as the primary indexed condition, and to 4 interventions - of which Ublituximab is the first listed.
NCT03277248 lists 13 locations in 13 states (Arizona, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT03277248 about?
NCT03277248 is a clinical study titled "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)". This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.
What is the current status of trial NCT03277248?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 545 participants. The study started on 2017-08-25. Estimated completion is 2020-11-12.
What conditions does trial NCT03277248 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis (RMS).
What interventions are being tested in trial NCT03277248?
The interventions under investigation include: Ublituximab (BIOLOGICAL), Oral Placebo (DRUG), Teriflunomide (DRUG), IV Placebo (DRUG).
Who is sponsoring clinical trial NCT03277248?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03277248 being conducted?
This trial has 13 study locations across Arizona, Colorado, Florida, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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