Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Source: ClinicalTrials.gov NCT02425644 ↗Summary
Linked Publications (5)
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Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial.
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Matching-Adjusted Indirect Comparisons of Diroximel Fumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis.
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An exposure-response analysis of ponesimod clinical efficacy in a randomized phase III study in patients with relapsing multiple sclerosis.
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The relevance of fatigue to relapse rate in multiple sclerosis: Applying patient preference data to the OPTIMUM trial.
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Efficacy and Safety of Ponesimod Compared with Teriflunomide in Female Patients with Relapsing Multiple Sclerosis: Findings from the Pivotal OPTIMUM Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Confirmed Relapse Rate |
0.202; 0.290 | 0.0003 sig |
| SECONDARY Change From Baseline in Fatigue-related Symptoms as Measured by the Symptoms Domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) Score to Week 108 |
-0.01; 3.56 | 0.0019 sig |
| SECONDARY Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 |
1.405; 3.164 | <.0001 sig |
| SECONDARY 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS |
7.6; 8.3; 10.8; 13.2 | 0.2939 |
| SECONDARY 24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS |
6.3; 6.9; 8.7; 10.5 | 0.3720 |
Eligibility Criteria
Inclusion Criteria
Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).
Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.
Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy.
Exclusion Criteria
Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study.
Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.
Data sourced from ClinicalTrials.gov (NCT02425644) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.