Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM
- Conditions
- relapsing multiple sclerosisMedDRA version: 20.0Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-000540-10-HR
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1133
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 baseline EDSS assessment, or by two or more MS attacks with onset within the 24 to 1 months prior to baseline EDSS assessment, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to baseline EDSS assessment.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, ocular) 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To determine whether ponesimod is more efficacious than teriflunomide in terms of reducing relapses in subjects with RMS.;Secondary Objective: - To assess the effect of ponesimod on disability accumulation and on other aspects of multiple sclerosis (MS) disease control<br>- To assess the safety and tolerability of ponesimod in subjects with RMS.;Primary end point(s): Annualized relapse rate defined as the number of confirmed relapses per subject-year.;Timepoint(s) of evaluation of this end point: All relapses up to EOS will be included in the analysis, irrespective of any treatment discontinuations prior to study completion.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Change from baseline to Week 108 in fatigue-related symptoms as measured by the symptoms domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ–RMS)<br>2) Cumulative number of Combined Unique Active lesions (CUAL) from baseline to Week 108<br>3) Time to 12-week Confirmed disability accumulation (CDA) from baseline to End of Study (EOS)<br>4) Time to 24-week CDA from baseline to EOS;Timepoint(s) of evaluation of this end point: 1: end of study<br>2, 4, 5: week 108<br>3: time to first confirmed relapse<br>