Clinical trial NCT02425644: Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: relapsing multiple sclerosis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 1133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Annualized Confirmed Relapse Rate
timeFrame: From randomization to end of study (Week 108)
Secondary outcomes:
measure: 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
timeFrame: Baseline to Week 108
measure: Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108
timeFrame: Baseline to Week 108
measure: 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
timeFrame: Baseline to Week 60 and 108 Weeks
measure: 24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
timeFrame: Baseline to 60 Weeks and 108 Weeks
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Investigator Site 8045
state: California
city: Pomona
country: United States
facility: Investigator Site 8311
state: California
city: Denver
country: United States
facility: Investigator Site 8036
state: Colorado
city: Ormond Beach
country: United States
facility: Investigator Site 8065
state: Florida
city: Tampa
country: United States
facility: Investigator Site 8018
state: Florida
city: Indianapolis
country: United States
facility: Investigator Site 8013
state: Indiana
city: Raleigh
country: United States
facility: Investigator Site 8040
state: North Carolina
city: Columbus
country: United States
facility: Investigator Site 8006
state: Ohio
city: Franklin
country: United States
facility: Investigator Site 8015
state: Tennessee
city: Orem
country: United States
facility: Investigator Site 8042
state: Utah
city: Grodno
country: Belarus
facility: Investigator Site 3605
city: Minsk
country: Belarus
facility: Investigator Site 3603
city: Minsk
country: Belarus
facility: Investigator Site 3602
city: Vitebsk
country: Belarus
facility: Investigator Site 3606
city: Vitebsk
country: Belarus
facility: Investigator Site 3604
city: Sarajevo
country: Bosnia and Herzegovina
facility: Investigator Site 9104
city: Plovdiv
country: Bulgaria
facility: Investigator Site 2709
city: Sofia
country: Bulgaria
facility: Investigator Site 2711
city: Sofia
country: Bulgaria
facility: Investigator Site 2702
city: Sofia
country: Bulgaria
facility: Investigator Site 2707
city: Sofia
country: Bulgaria
facility: Investigator Site 2701
city: Sofia
country: Bulgaria
facility: Investigator Site 2708
city: Sofia
country: Bulgaria
facility: Investigator Site 2703
city: Edmonton
country: Canada
facility: Investigator Site 8102
state: Alberta
city: Victoria
country: Canada
facility: Investigator Site 8120
state: British Columbia
city: Ottawa
country: Canada
facility: Investigator Site 8101
state: Ontario
city: Greenfield Park
country: Canada
facility: Investigator Site 8113
state: Quebec
city: Osijek
country: Croatia
facility: Investigator Site 2506
city: Zagreb
country: Croatia
facility: Investigator Site 2502
city: Zagreb
country: Croatia
facility: Investigator Site 2508
city: Zagreb
country: Croatia
facility: Investigator Site 2509
city: Brno
country: Czechia
facility: Investigator Site 3009
city: Brno
country: Czechia
facility: Investigator Site 3003
city: Hradec Králové
country: Czechia
facility: Investigator Site 3010
city: Jihlava
country: Czechia
facility: Investigator Site 3006
city: Ostrava-Poruba
country: Czechia
facility: Investigator Site 3002
city: Pardubice
country: Czechia
facility: Investigator Site 3007
city: Praha 2
country: Czechia
facility: Investigator Site 3001
city: Praha 5
country: Czechia
facility: Investigator Site 3008
city: Teplice
country: Czechia
facility: Investigator Site 3004
city: Tampere
country: Finland
facility: Investigator Site 2212
city: Turku
country: Finland
facility: Investigator Site 2202
city: Bordeaux Cedex
country: France
facility: Investigator Site 1713
city: Clermont Ferrand Cedex 1
country: France
facility: Investigator Site 1703
city: Nantes Cedex 1
country: France
facility: Investigator Site 1715
city: Nice Cedex 1
country: France
facility: Investigator Site 1706
city: Strasbourg Cedex
country: France
facility: Investigator Site 1705
city: Tbilisi
country: Georgia
facility: Investigator Site 3905
city: Tbilisi
country: Georgia
facility: Investigator Site 3904
city: Tbilisi
country: Georgia
facility: Investigator Site 3903
city: Tbilisi
country: Georgia
facility: Investigator Site 3906
city: Tbilisi
country: Georgia
facility: Investigator Site 3902
city: Dresden
country: Germany
facility: Investigator Site 1113
city: Erfurt
country: Germany
facility: Investigator Site 1107
city: Leipzig
country: Germany
facility: Investigator Site 1109
city: Mainz
country: Germany
facility: Investigator Site 1104
city: Ulm
country: Germany
facility: Investigator Site 1102
city: Athens
country: Greece
facility: Investigator Site 1303
city: Athens
country: Greece
facility: Investigator Site 1301
city: Athens
country: Greece
facility: Investigator Site 1307
city: Budapest
country: Hungary
facility: Investigator Site 2903
city: Budapest
country: Hungary
facility: Investigator Site 2905
city: Esztergom
country: Hungary
facility: Investigator Site 2910
city: Gyor
country: Hungary
facility: Investigator Site 2902
city: Kistarcsa
country: Hungary
facility: Investigator Site 2909
city: Ashkelon
country: Israel
facility: Investigator Site 4005
city: Haifa
country: Israel
facility: Investigator Site 4004
city: Jerusalem
country: Israel
facility: Investigator Site 4006
city: Zfat
country: Israel
facility: Investigator Site 4010
city: Cefalu
country: Italy
facility: Investigator Site 1403
city: Genova
country: Italy
facility: Investigator Site 1409
city: L'Aquila
country: Italy
facility: Investigator Site 1413
city: Roma
country: Italy
facility: Investigator Site 1405
city: Riga
country: Latvia
facility: Investigator Site 3401
city: Riga
country: Latvia
facility: Investigator Site 3402
city: Riga
country: Latvia
facility: Investigator Site 3403
city: Kaunas
country: Lithuania
facility: Investigator Site 3502
city: Klaipeda
country: Lithuania
facility: Investigator Site 3503
city: Siauliai
country: Lithuania
facility: Investigator Site 3504
city: Chihuahua
country: Mexico
facility: Investigator Site 7410
city: Monterrey
country: Mexico
facility: Investigator Site 7409
city: Bialystok
country: Poland
facility: Investigator Site 3219
city: Bydgoszcz
country: Poland
facility: Investigator Site 3215
city: Gdansk
country: Poland
facility: Investigator Site 3208
city: Katowice
country: Poland
facility: Investigator Site 3217
city: Katowice
country: Poland
facility: Investigator Site 3203
city: Konstancin-Jeziorna
country: Poland
facility: Investigator Site 3205
city: Ksawerow
country: Poland
facility: Investigator Site 3216
city: Lublin
country: Poland
facility: Investigator Site 3220
city: Poznan
country: Poland
facility: Investigator Site 3202
city: Poznan
country: Poland
facility: Investigator Site 3214
city: Poznan
country: Poland
facility: Investigator Site 3207
city: Wroclaw
country: Poland
facility: Investigator Site 3213
city: Amadora
country: Portugal
facility: Investigator Site 1602
city: Braga
country: Portugal
facility: Investigator Site 1605
city: Coimbra
country: Portugal
facility: Investigator Site 1603
city: Porto
country: Portugal
facility: Investigator Site 1604
city: Bucuresti
country: Romania
facility: Investigator Site 2807
city: Bucuresti
country: Romania
facility: Investigator Site 2811
city: Bucuresti
country: Romania
facility: Investigator Site 2804
city: Timisoara
country: Romania
facility: Investigator Site 2802
city: Barnaul
country: Russian Federation
facility: Investigator Site 3821
state: Altai Krai
city: Belgorod
country: Russian Federation
facility: Investigator Site 3818
city: Bryansk
country: Russian Federation
facility: Investigator Site 3837
city: Ekaterinburg
country: Russian Federation
facility: Investigator Site 3836
city: Kazan
country: Russian Federation
facility: Investigator Site 3811
city: Kemerovo
country: Russian Federation
facility: Investigator Site 3822
city: Krasnoyarsk
country: Russian Federation
facility: Investigator Site 3814
city: Kursk
country: Russian Federation
facility: Investigator Site 3823
city: Moscow
country: Russian Federation
facility: Investigator Site 3831
city: Moscow
country: Russian Federation
facility: Investigator Site 3803
city: Moscow
country: Russian Federation
facility: Investigator Site 3840
city: Moscow
country: Russian Federation
facility: Investigator Site 3810
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigator Site 3802
city: Nizhny Novgorod
country: Russian Federation
facility: Investigator Site 3834
city: Novgorod
country: Russian Federation
facility: Investigator Site 3835
city: Novosibirsk
country: Russian Federation
facility: Investigator Site 3829
city: Perm
country: Russian Federation
facility: Investigator Site 3839
city: Pyatigorsk
country: Russian Federation
facility: Investigator Site 3812
city: Saint Petersburg
country: Russian Federation
facility: Investigator Site 3813
city: Samara
country: Russian Federation
facility: Investigator Site 3805
city: Smolensk
country: Russian Federation
facility: Investigator Site 3825
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 3808
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 3833
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 3807
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 3815
city: Tomsk
country: Russian Federation
facility: Investigator Site 3801
city: Tver
country: Russian Federation
facility: Investigator Site 3819
city: Yaroslavl
country: Russian Federation
facility: Investigator Site 3842
city: Belgrade
country: Serbia
facility: Investigator Site 2601
city: Belgrade
country: Serbia
facility: Investigator Site 2606
city: Belgrade
country: Serbia
facility: Investigator Site 2607
city: Kragujevac
country: Serbia
facility: Investigator Site 2603
city: Nis
country: Serbia
facility: Investigator Site 2602
city: Barcelona
country: Spain
facility: Investigator Site 1509
city: Barcelona
country: Spain
facility: Investigator Site 1505
city: Barcelona
country: Spain
facility: Investigator Site 1504
city: Madrid
country: Spain
facility: Investigator Site 1502
city: Malaga
country: Spain
facility: Investigator Site 1501
city: Sevilla
country: Spain
facility: Investigator Site 1506
city: Goteborg
country: Sweden
facility: Investigator Site 2103
city: Stockholm
country: Sweden
facility: Investigator Site 2110
city: Stockholm
country: Sweden
facility: Investigator Site 2101
city: Trabzon
country: Turkey
facility: Investigator Site 9004
city: Chernihiv
country: Ukraine
facility: Investigator Site 3714
city: Chernihiv
country: Ukraine
facility: Investigator Site 3701
city: Ivano-Frankivsk
country: Ukraine
facility: Investigator Site 3713
city: Ivano-Frankivsk
country: Ukraine
facility: Investigator Site 3711
city: Kharkiv
country: Ukraine
facility: Investigator Site 3723
city: Kharkiv
country: Ukraine
facility: Investigator Site 3724
city: Kyiv
country: Ukraine
facility: Investigator Site 3716
city: Lviv
country: Ukraine
facility: Investigator Site 3715
city: Lviv
country: Ukraine
facility: Investigator Site 3721
city: Odessa
country: Ukraine
facility: Investigator Site 3703
city: Poltava
country: Ukraine
facility: Investigator Site 3717
city: Ternopil
country: Ukraine
facility: Investigator Site 3730
city: Vinnytsia
country: Ukraine
facility: Investigator Site 3718
city: Zaporizhia
country: Ukraine
facility: Investigator Site 3722
city: Zhytomyr
country: Ukraine
facility: Investigator Site 3725
city: Glasgow
country: United Kingdom
facility: Investigator Site 2015
city: Lancashire
country: United Kingdom
facility: Investigator Site 2021
city: Salford
country: United Kingdom
facility: Investigator Site 2003
Study officials:
affiliation: Actelion
name: Tatiana Scherz, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdova EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405.