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NCT03277261 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
A Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 549
- Enrollment target
- 14
- Study locations
NCT03277261: Completed Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics.
NCT03277261 is a Phase 3 study of Relapsing Multiple Sclerosis (RMS) that has completed, run by TG Therapeutics. The registered enrollment target is 549 participants, below the 614-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (11% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03277261, a Phase 3 study of Relapsing Multiple Sclerosis (RMS), has completed, sponsored by TG Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 549 participants
- Enrollment target
- 14
- 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 Panel (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 (14)
California
- TG Therapeutics RMS Investigational Trial Site - Carlsbad
- TG Therapeutics RMS Investigational Trial Site - Long Beach
- TG Therapeutics RMS Investigational Trial Site - Pasadena
- TG Therapeutics RMS Investigational Trial Site - Stanford
Tennessee
- TG Therapeutics RMS Investigational Trial Site - Franklin
- TG Therapeutics RMS Investigational Trial Site - Knoxville
Texas
- TG Therapeutics RMS Investigational Trial Site - Dallas
- TG Therapeutics RMS Investigational Site - Round Rock
Florida
- TG Therapeutics RMS Investigational Trial Site - Miami
Illinois
- TG Therapeutics RMS Investigational Trial Site - Northbrook
Kansas
- TG Therapeutics RMS Investigational Trial Site - Kansas City
Michigan
- TG Therapeutics RMS Investigational Trial Site - Detroit
New York
- TG Therapeutics RMS Investigational Trial Site - Amherst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2017-09-19 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 3 |
What the finished NCT03277261 record still lists
NCT03277261 is an interventional study that assigns participants to a tested intervention. The registered 549 participants enrollment target is mid-sized for trials with a published cap, below the 614-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.
NCT03277261 lists 14 locations in 9 states (California, Tennessee, Texas).
Frequently Asked Questions
What is clinical trial NCT03277261 about?
NCT03277261 is a clinical study titled "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )". 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 NCT03277261?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2017-09-19. Estimated completion is 2020-11-06.
What conditions does trial NCT03277261 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis (RMS).
What interventions are being tested in trial NCT03277261?
The interventions under investigation include: Ublituximab (BIOLOGICAL), Oral Placebo (DRUG), Teriflunomide (DRUG), IV Placebo (DRUG).
Who is sponsoring clinical trial NCT03277261?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03277261 being conducted?
This trial has 14 study locations across California, Florida, Illinois, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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