CompletedPhase 3Relapsing and progressiveNCT024256442012-000540-10

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Annualized Confirmed Relapse RateRate ratio 0.6950.536–0.9020.0003

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Ponesimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

Compared with

Results by group

Annualized Confirmed Relapse Rate

From randomization to end of study (Week 108)

GroupValueIntervalNumber analysed
Ponesimod 20 mg0.202 relapses per year0.165–0.246567
Teriflunomide 14 mg0.290 relapses per year0.244–0.345566

Ponesimod 20 mg

0.202

Teriflunomide 14 mg

0.29

p = 0.0003; Rate ratio 0.695 (95% CI 0.536–0.902)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Ponesimod 20 mg56549 (8.7%)0
Teriflunomide 14 mg56646 (8.1%)2

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Annualized Confirmed Relapse Rate

    From randomization to end of study (Week 108)

    Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual function
  • Annualized relapse rate defined as the number of confirmed relapses per subject-year.

    Relapses

Other measures (5)

  • 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

    Baseline to Week 108

    FatigueQuality of life (reported by participants)
  • Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108

    Baseline to Week 108

    MRI lesions
  • 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS

    Baseline to Week 60 and 108 Weeks

    Disability progression
  • 24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS

    Baseline to 60 Weeks and 108 Weeks

    Disability progression
  • 1. Change from baseline to Week 108 in fatigue-related symptoms as

    Fatigue

Who could take part

Relapsing and progressive · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Jun 2015

    2. Main results due

      May 2019

    3. Finished

      May 2019

    4. Results posted

      Jun 2021

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