Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
- Registration Number
- NCT02425644
- Lead Sponsor
- Actelion
- Brief Summary
International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- 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 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ponesimod ponesimod Subjects to receive 20 mg ponesimod Teriflunomide teriflunomide Subjects to receive 14 mg teriflunomide
- Primary Outcome Measures
Name Time Method Annualized Confirmed Relapse Rate From randomization to end of study (Week 108) Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).
- Secondary Outcome Measures
Name Time Method 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 The FSIQ-RMS is a 20-item Patient Reported Outcomes (PRO) measure to evaluate fatigue-related symptoms and the impacts of those symptoms on the lives of people. The FSIQ-RMS symptom domain (FSIQ-RMS-S) consists of seven items assessing fatigue-related symptoms daily with a recall period of 24 hours measured on an 11-point numeric rating scale; the (normalized) symptom domain score ranges from 0 to 100 with a higher score indicating greater fatigue. This domain was completed on 7 consecutive days. A negative change from baseline indicates an improvement in fatigue symptoms.
Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 Baseline to Week 108 CUALs was calculated as sum of new Gadolinium-enhanced (Gd+) T1 lesions plus new or enlarging T2 lesions (without double-counting of lesions) from baseline based on the Magnetic resonance imaging (MRI) scans up to Week 108. Average number of lesions per year were reported.
12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS Baseline to Week 60 and 108 Weeks A 12-week CDA was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (\>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS).
24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS Baseline to 60 Weeks and 108 Weeks A 24-week CDA was defined as an increase of at least 1.5 in EDSS for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score \>= 5.5, which was confirmed after 24 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. The EDSS is an ordinal scale ranging from 0 (normal neurological exam) to 10 (death to MS).
Trial Locations
- Locations (162)
Investigator Site 4006
🇮🇱Jerusalem, Israel
Investigator Site 1604
🇵🇹Porto, Portugal
Investigator Site 7410
🇲🇽Chihuahua, Mexico
Investigator Site 2807
🇷🇴Bucuresti, Romania
Investigator Site 3818
🇷🇺Belgorod, Russian Federation
Investigator Site 2703
🇧🇬Sofia, Bulgaria
Investigator Site 1703
🇫🇷Clermont Ferrand Cedex 1, France
Investigator Site 1715
🇫🇷Nantes Cedex 1, France
Investigator Site 8042
🇺🇸Orem, Utah, United States
Investigator Site 8065
🇺🇸Ormond Beach, Florida, United States
Investigator Site 2711
🇧🇬Sofia, Bulgaria
Investigator Site 3602
🇧🇾Minsk, Belarus
Investigator Site 1413
🇮🇹L'Aquila, Italy
Investigator Site 3215
🇵🇱Bydgoszcz, Poland
Investigator Site 1605
🇵🇹Braga, Portugal
Investigator Site 2212
🇫🇮Tampere, Finland
Investigator Site 3906
🇬🇪Tbilisi, Georgia
Investigator Site 2702
🇧🇬Sofia, Bulgaria
Investigator Site 8113
🇨🇦Greenfield Park, Quebec, Canada
Investigator Site 3905
🇬🇪Tbilisi, Georgia
Investigator Site 1113
🇩🇪Dresden, Germany
Investigator Site 8101
🇨🇦Ottawa, Ontario, Canada
Investigator Site 2910
🇭🇺Esztergom, Hungary
Investigator Site 4004
🇮🇱Haifa, Israel
Investigator Site 2701
🇧🇬Sofia, Bulgaria
Investigator Site 2708
🇧🇬Sofia, Bulgaria
Investigator Site 1713
🇫🇷Bordeaux Cedex, France
Investigator Site 1307
🇬🇷Athens, Greece
Investigator Site 1706
🇫🇷Nice Cedex 1, France
Investigator Site 3902
🇬🇪Tbilisi, Georgia
Investigator Site 1409
🇮🇹Genova, Italy
Investigator Site 3219
🇵🇱Bialystok, Poland
Investigator Site 3203
🇵🇱Katowice, Poland
Investigator Site 1109
🇩🇪Leipzig, Germany
Investigator Site 2902
🇭🇺Gyor, Hungary
Investigator Site 3403
🇱🇻Riga, Latvia
Investigator Site 3217
🇵🇱Katowice, Poland
Investigator Site 7409
🇲🇽Monterrey, Mexico
Investigator Site 3207
🇵🇱Poznan, Poland
Investigator Site 3213
🇵🇱Wroclaw, Poland
Investigator Site 2811
🇷🇴Bucuresti, Romania
Investigator Site 3220
🇵🇱Lublin, Poland
Investigator Site 1603
🇵🇹Coimbra, Portugal
Investigator Site 3836
🇷🇺Ekaterinburg, Russian Federation
Investigator Site 3823
🇷🇺Kursk, Russian Federation
Investigator Site 3803
🇷🇺Moscow, Russian Federation
Investigator Site 3812
🇷🇺Pyatigorsk, Russian Federation
Investigator Site 3802
🇷🇺Nizhniy Novgorod, Russian Federation
Investigator Site 3810
🇷🇺Moscow, Russian Federation
Investigator Site 3834
🇷🇺Nizhny Novgorod, Russian Federation
Investigator Site 3825
🇷🇺Smolensk, Russian Federation
Investigator Site 3815
🇷🇺St. Petersburg, Russian Federation
Investigator Site 3801
🇷🇺Tomsk, Russian Federation
Investigator Site 2601
🇷🇸Belgrade, Serbia
Investigator Site 2607
🇷🇸Belgrade, Serbia
Investigator Site 2603
🇷🇸Kragujevac, Serbia
Investigator Site 3714
🇺🇦Chernihiv, Ukraine
Investigator Site 3718
🇺🇦Vinnytsia, Ukraine
Investigator Site 3701
🇺🇦Chernihiv, Ukraine
Investigator Site 3713
🇺🇦Ivano-Frankivsk, Ukraine
Investigator Site 3724
🇺🇦Kharkiv, Ukraine
Investigator Site 8006
🇺🇸Columbus, Ohio, United States
Investigator Site 8013
🇺🇸Indianapolis, Indiana, United States
Investigator Site 3001
🇨🇿Praha 2, Czechia
Investigator Site 2709
🇧🇬Plovdiv, Bulgaria
Investigator Site 9104
🇧🇦Sarajevo, Bosnia and Herzegovina
Investigator Site 3903
🇬🇪Tbilisi, Georgia
Investigator Site 1301
🇬🇷Athens, Greece
Investigator Site 2909
🇭🇺Kistarcsa, Hungary
Investigator Site 4010
🇮🇱Zfat, Israel
Investigator Site 8045
🇺🇸Carlsbad, California, United States
Investigator Site 3606
🇧🇾Vitebsk, Belarus
Investigator Site 3604
🇧🇾Vitebsk, Belarus
Investigator Site 3605
🇧🇾Grodno, Belarus
Investigator Site 2502
🇭🇷Zagreb, Croatia
Investigator Site 3008
🇨🇿Praha 5, Czechia
Investigator Site 3009
🇨🇿Brno, Czechia
Investigator Site 3003
🇨🇿Brno, Czechia
Investigator Site 3010
🇨🇿Hradec Králové, Czechia
Investigator Site 3006
🇨🇿Jihlava, Czechia
Investigator Site 2509
🇭🇷Zagreb, Croatia
Investigator Site 2707
🇧🇬Sofia, Bulgaria
Investigator Site 8102
🇨🇦Edmonton, Alberta, Canada
Investigator Site 8120
🇨🇦Victoria, British Columbia, Canada
Investigator Site 2506
🇭🇷Osijek, Croatia
Investigator Site 3004
🇨🇿Teplice, Czechia
Investigator Site 2202
🇫🇮Turku, Finland
Investigator Site 3904
🇬🇪Tbilisi, Georgia
Investigator Site 1107
🇩🇪Erfurt, Germany
Investigator Site 1102
🇩🇪Ulm, Germany
Investigator Site 1104
🇩🇪Mainz, Germany
Investigator Site 3502
🇱🇹Kaunas, Lithuania
Investigator Site 3216
🇵🇱Ksawerow, Poland
Investigator Site 3202
🇵🇱Poznan, Poland
Investigator Site 1303
🇬🇷Athens, Greece
Investigator Site 4005
🇮🇱Ashkelon, Israel
Investigator Site 3504
🇱🇹Siauliai, Lithuania
Investigator Site 3402
🇱🇻Riga, Latvia
Investigator Site 3503
🇱🇹Klaipeda, Lithuania
Investigator Site 1403
🇮🇹Cefalu, Italy
Investigator Site 1405
🇮🇹Roma, Italy
Investigator Site 3401
🇱🇻Riga, Latvia
Investigator Site 3208
🇵🇱Gdansk, Poland
Investigator Site 3205
🇵🇱Konstancin-Jeziorna, Poland
Investigator Site 3214
🇵🇱Poznan, Poland
Investigator Site 1602
🇵🇹Amadora, Portugal
Investigator Site 3821
🇷🇺Barnaul, Altai Krai, Russian Federation
Investigator Site 3831
🇷🇺Moscow, Russian Federation
Investigator Site 2804
🇷🇴Bucuresti, Romania
Investigator Site 3835
🇷🇺Novgorod, Russian Federation
Investigator Site 3829
🇷🇺Novosibirsk, Russian Federation
Investigator Site 2110
🇸🇪Stockholm, Sweden
Investigator Site 1509
🇪🇸Barcelona, Spain
Investigator Site 2802
🇷🇴Timisoara, Romania
Investigator Site 3837
🇷🇺Bryansk, Russian Federation
Investigator Site 3822
🇷🇺Kemerovo, Russian Federation
Investigator Site 3839
🇷🇺Perm, Russian Federation
Investigator Site 3807
🇷🇺St. Petersburg, Russian Federation
Investigator Site 3711
🇺🇦Ivano-Frankivsk, Ukraine
Investigator Site 3717
🇺🇦Poltava, Ukraine
Investigator Site 2606
🇷🇸Belgrade, Serbia
Investigator Site 2602
🇷🇸Nis, Serbia
Investigator Site 9004
🇹🇷Trabzon, Turkey
Investigator Site 1504
🇪🇸Barcelona, Spain
Investigator Site 1505
🇪🇸Barcelona, Spain
Investigator Site 3842
🇷🇺Yaroslavl, Russian Federation
Investigator Site 2101
🇸🇪Stockholm, Sweden
Investigator Site 3715
🇺🇦Lviv, Ukraine
Investigator Site 3703
🇺🇦Odessa, Ukraine
Investigator Site 2003
🇬🇧Salford, United Kingdom
Investigator Site 1501
🇪🇸Malaga, Spain
Investigator Site 1506
🇪🇸Sevilla, Spain
Investigator Site 8040
🇺🇸Raleigh, North Carolina, United States
Investigator Site 8036
🇺🇸Denver, Colorado, United States
Investigator Site 8018
🇺🇸Tampa, Florida, United States
Investigator Site 3840
🇷🇺Moscow, Russian Federation
Investigator Site 3007
🇨🇿Pardubice, Czechia
Investigator Site 8311
🇺🇸Pomona, California, United States
Investigator Site 8015
🇺🇸Franklin, Tennessee, United States
Investigator Site 3603
🇧🇾Minsk, Belarus
Investigator Site 2508
🇭🇷Zagreb, Croatia
Investigator Site 3002
🇨🇿Ostrava-Poruba, Czechia
Investigator Site 1705
🇫🇷Strasbourg Cedex, France
Investigator Site 2905
🇭🇺Budapest, Hungary
Investigator Site 3814
🇷🇺Krasnoyarsk, Russian Federation
Investigator Site 3811
🇷🇺Kazan, Russian Federation
Investigator Site 3805
🇷🇺Samara, Russian Federation
Investigator Site 3833
🇷🇺St. Petersburg, Russian Federation
Investigator Site 3813
🇷🇺Saint Petersburg, Russian Federation
Investigator Site 3808
🇷🇺St. Petersburg, Russian Federation
Investigator Site 3819
🇷🇺Tver, Russian Federation
Investigator Site 2103
🇸🇪Goteborg, Sweden
Investigator Site 1502
🇪🇸Madrid, Spain
Investigator Site 3723
🇺🇦Kharkiv, Ukraine
Investigator Site 3725
🇺🇦Zhytomyr, Ukraine
Investigator Site 3721
🇺🇦Lviv, Ukraine
Investigator Site 3716
🇺🇦Kyiv, Ukraine
Investigator Site 3722
🇺🇦Zaporizhia, Ukraine
Investigator Site 3730
🇺🇦Ternopil, Ukraine
Investigator Site 2015
🇬🇧Glasgow, United Kingdom
Investigator Site 2021
🇬🇧Lancashire, United Kingdom
Investigator Site 2903
🇭🇺Budapest, Hungary