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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 May 2021 |
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Main ID: |
NCT03277248 |
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Date of registration:
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07/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2)
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Scientific title:
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ubLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) |
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Date of first enrolment:
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August 1, 2017 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03277248 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 - 55 age
- Diagnosis of RMS (McDonald Criteria 2010)
- Active disease
- Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening
Exclusion Criteria:
- Treatment with prior Anti-CD20 or other B cell directed treatment
- Treatment with the following therapies at any time prior to randomization:
Alemtuzumab, Natalizumab, teriflunomide, Leflunomide and Stem cell transplantation
- Diagnosed with Primary Progressive MS (PPMS)
- Pregnant or nursing
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing Multiple Sclerosis (RMS)
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Intervention(s)
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Biological: Ublituximab
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Drug: Teriflunomide
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Primary Outcome(s)
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Annualized Relapse Rate (ARR)
[Time Frame: 96 weeks on therapy]
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Secondary Outcome(s)
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
[Time Frame: 96 weeks on therapy]
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Secondary ID(s)
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TG1101-RMS302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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