Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)
- Conditions
- Relapsing multiple sclerosisMedDRA version: 20.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-000541-12-FR
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
- Signed informed consent prior to initiation of any study-mandated procedure.
- Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
- Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
- Ongoing treatment with DMF for at least 6 months prior to screening;
- Active disease in the 12 months prior to screening and after at least 3 months of DMF treatment
- Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).
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 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Lactating or pregnant women and women intending to become pregnant during the study.
- Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
- Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to determine whether add-on therapy with ponesimod reduces relapse frequency as compared to placebo in subjects with active RMS who are treated with DMF (Tecfidera®).;Secondary Objective: - To assess the effect of add-on therapy with ponesimod vs placebo on disability accumulation and on other aspects of MS disease control in subjects with RMS who are treated with DMF (Tecfidera®);<br>- To assess the safety and tolerability of add-on therapy with ponesimod vs placebo in subjects with RMS who are treated with DMF (Tecfidera®).;Primary end point(s): Annualized relapse rate (ARR); defined as the number of confirmed relapses per subject-year.;Timepoint(s) of evaluation of this end point: From randomization up to end of study (EOS)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Time to 12-week confirmed disability accumulation (CDA)<br>2. Time to first confirmed relapse; up to EOS.<br>3. Mean number of combined unique active lesions (CUALs) per subject per post-baseline MRI scan; up to EOS.<br>4. Longitudinal change over time in fatigue-related symptoms as measured by the symptoms domain of the FSIQ–RMS from baseline; up to EOS.<br>5. Longitudinal percent change over time in brain volume from baseline; up to EOS.;Timepoint(s) of evaluation of this end point: 1. From baseline up to EOS<br>2. From baseline up to EOS<br>3. From baseline up to EOS<br>4. From baseline up to EOS<br>5. From baseline up to EOS<br>