An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis

INTERVENTION: Product Name: ponesimod Product Code: ACT‐128800 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: ACT‐128800 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Product Name: ponesimod Product Code: ACT‐128800 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: ACT‐128800 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ CONDITION: relapsing‐remitting multiple sclerosis ; MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: All objectives for this study are exploratory:; ; ‐To investigate the long‐term safety and tolerability of 10 and 20 mg/day ponesimod for up to 528 weeks.; ; ‐ To investigate the long‐term efficacy of 10 and 20 mg/day ponesimod for up to 528 weeks.; ; ‐ To investigate the long‐term safety and tolerability of 40 mg/day ponesimod for up to 96 weeks.; ; ‐ To investigate the long‐term efficacy of 40 mg/day ponesimod for up to 96 weeks.; ; ‐ To explore the dose response relationship of 10, 20 and 40 mg ponesimod on lymphocyte count, MRI endpoints and annualized relapse rate (ARR). Primary end point(s): Only exploratory efficacy endpoints will be investigated.; ; The following exploratory endpoints will be analyzed:; 1. Annualized confirmed relapse rate.; 2. Time to first confirmed relapse; 3. Time to 3‐/6‐month confirmed disability progression up to end of the study.; ; Additional endpoints/parameters based on MRI scans, relapses as well as endpoints related to safety and tolerability will be investigated.; Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: Not applicable SECONDARY OUTCOME: Secondary end point(s): Not applicable Timepoint(s) of evaluation of this end point: Not applicable INCLUSION CRITERIA: 1. Patients who completed study treatment at their regular Week 24 (EOT) visit within the core study (AC‐058B201). 2. Signed informed consent for participating in the extension study. 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 353 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range