Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Public ClinicalTrials.gov record NCT03277261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03277261
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 549 participants
Conditions and interventions
Conditions
Interventions
- Ublituximab Biological
- Teriflunomide Drug
- Oral Placebo Drug
- IV Placebo Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 18, 2017
- Primary completion
- Jul 22, 2020
- Completion
- Nov 5, 2020
- Last update posted
- Dec 5, 2021
2017 – 2020
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TG Therapeutics RMS Investigational Trial Site | Carlsbad | California | 92001 | — |
| TG Therapeutics RMS Investigational Trial Site | Long Beach | California | 90808 | — |
| TG Therapeutics RMS Investigational Trial Site | Pasadena | California | 91105 | — |
| TG Therapeutics RMS Investigational Trial Site | Stanford | California | 94305 | — |
| TG Therapeutics RMS Investigational Trial Site | Miami | Florida | 33136 | — |
| TG Therapeutics RMS Investigational Trial Site | Northbrook | Illinois | 60062 | — |
| TG Therapeutics RMS Investigational Trial Site | Kansas City | Kansas | 66160 | — |
| TG Therapeutics RMS Investigational Trial Site | Detroit | Michigan | 48201 | — |
| TG Therapeutics RMS Investigational Trial Site | Amherst | New York | 14226 | — |
| TG Therapeutics RMS Investigational Trial Site | Westerville | Ohio | 43081 | — |
| TG Therapeutics RMS Investigational Trial Site | Franklin | Tennessee | 37064 | — |
| TG Therapeutics RMS Investigational Trial Site | Knoxville | Tennessee | 37922 | — |
| TG Therapeutics RMS Investigational Trial Site | Dallas | Texas | 75246 | — |
| TG Therapeutics RMS Investigational Site | Round Rock | Texas | 78681 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03277261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 5, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03277261 live on ClinicalTrials.gov.