Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis
Abstract
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.
Conditions: Multiple Sclerosis.
Primary outcome: Annualized Confirmed Relapse Rate (ARR); Time From Core Study Randomization to First Confirmed Relapse; Time to First 12-week Confirmed Disability Accumulation (CDA); Time to First 24-week Confirmed Disability Accumulation (CDA); Percentage of Participants With Absence of Relapses; Change From Baseline in Expanded Disability Status Scale (EDSS); Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Three Components (NEDA-3) at Extension End of Study; Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Four Components (NEDA-4) at Extension End of Study; Percent Change From Baseline in Brain Volume (PCBV) Measured by Magnetic Resonance Imaging (MRI); Cumulative Number of Combined Unique Active Lesions (CUAL) Measured by MRI; Number of Gadolinium-enhancing (Gd+) T1 Lesions Measured by MRI; Cumulative Number of New or Enlarging T2 Lesions Measured by MRI; Change From Baseline in Volume of MRI…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 877 participants or records.
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