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Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ponesimod
teriflunomide
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring relapsing multiple sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site 8045
  • Investigator Site 8311
  • Investigator Site 8036
  • Investigator Site 8065
  • Investigator Site 8018
  • Investigator Site 8013
  • Investigator Site 8040
  • Investigator Site 8006
  • Investigator Site 8015
  • Investigator Site 8042
  • Investigator Site 3605
  • Investigator Site 3603
  • Investigator Site 3602
  • Investigator Site 3606
  • Investigator Site 3604
  • Investigator Site 9104
  • Investigator Site 2709
  • Investigator Site 2711
  • Investigator Site 2702
  • Investigator Site 2707
  • Investigator Site 2701
  • Investigator Site 2708
  • Investigator Site 2703
  • Investigator Site 8102
  • Investigator Site 8120
  • Investigator Site 8101
  • Investigator Site 8113
  • Investigator Site 2506
  • Investigator Site 2502
  • Investigator Site 2508
  • Investigator Site 2509
  • Investigator Site 3009
  • Investigator Site 3003
  • Investigator Site 3010
  • Investigator Site 3006
  • Investigator Site 3002
  • Investigator Site 3007
  • Investigator Site 3001
  • Investigator Site 3008
  • Investigator Site 3004
  • Investigator Site 2212
  • Investigator Site 2202
  • Investigator Site 1713
  • Investigator Site 1703
  • Investigator Site 1715
  • Investigator Site 1706
  • Investigator Site 1705
  • Investigator Site 3905
  • Investigator Site 3904
  • Investigator Site 3903
  • Investigator Site 3906
  • Investigator Site 3902
  • Investigator Site 1113
  • Investigator Site 1107
  • Investigator Site 1109
  • Investigator Site 1104
  • Investigator Site 1102
  • Investigator Site 1303
  • Investigator Site 1301
  • Investigator Site 1307
  • Investigator Site 2903
  • Investigator Site 2905
  • Investigator Site 2910
  • Investigator Site 2902
  • Investigator Site 2909
  • Investigator Site 4005
  • Investigator Site 4004
  • Investigator Site 4006
  • Investigator Site 4010
  • Investigator Site 1403
  • Investigator Site 1409
  • Investigator Site 1413
  • Investigator Site 1405
  • Investigator Site 3401
  • Investigator Site 3402
  • Investigator Site 3403
  • Investigator Site 3502
  • Investigator Site 3503
  • Investigator Site 3504
  • Investigator Site 7410
  • Investigator Site 7409
  • Investigator Site 3219
  • Investigator Site 3215
  • Investigator Site 3208
  • Investigator Site 3217
  • Investigator Site 3203
  • Investigator Site 3205
  • Investigator Site 3216
  • Investigator Site 3220
  • Investigator Site 3202
  • Investigator Site 3214
  • Investigator Site 3207
  • Investigator Site 3213
  • Investigator Site 1602
  • Investigator Site 1605
  • Investigator Site 1603
  • Investigator Site 1604
  • Investigator Site 2807
  • Investigator Site 2811
  • Investigator Site 2804
  • Investigator Site 2802
  • Investigator Site 3821
  • Investigator Site 3818
  • Investigator Site 3837
  • Investigator Site 3836
  • Investigator Site 3811
  • Investigator Site 3822
  • Investigator Site 3814
  • Investigator Site 3823
  • Investigator Site 3831
  • Investigator Site 3803
  • Investigator Site 3840
  • Investigator Site 3810
  • Investigator Site 3802
  • Investigator Site 3834
  • Investigator Site 3835
  • Investigator Site 3829
  • Investigator Site 3839
  • Investigator Site 3812
  • Investigator Site 3813
  • Investigator Site 3805
  • Investigator Site 3825
  • Investigator Site 3808
  • Investigator Site 3833
  • Investigator Site 3807
  • Investigator Site 3815
  • Investigator Site 3801
  • Investigator Site 3819
  • Investigator Site 3842
  • Investigator Site 2601
  • Investigator Site 2606
  • Investigator Site 2607
  • Investigator Site 2603
  • Investigator Site 2602
  • Investigator Site 1509
  • Investigator Site 1505
  • Investigator Site 1504
  • Investigator Site 1502
  • Investigator Site 1501
  • Investigator Site 1506
  • Investigator Site 2103
  • Investigator Site 2110
  • Investigator Site 2101
  • Investigator Site 9004
  • Investigator Site 3714
  • Investigator Site 3701
  • Investigator Site 3713
  • Investigator Site 3711
  • Investigator Site 3723
  • Investigator Site 3724
  • Investigator Site 3716
  • Investigator Site 3715
  • Investigator Site 3721
  • Investigator Site 3703
  • Investigator Site 3717
  • Investigator Site 3730
  • Investigator Site 3718
  • Investigator Site 3722
  • Investigator Site 3725
  • Investigator Site 2015
  • Investigator Site 2021
  • Investigator Site 2003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ponesimod

Teriflunomide

Arm Description

Subjects to receive 20 mg ponesimod

Subjects to receive 14 mg teriflunomide

Outcomes

Primary Outcome Measures

Annualized Confirmed Relapse Rate
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

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
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
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
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
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).

Full Information

First Posted
April 21, 2015
Last Updated
January 3, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT02425644
Brief Title
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Acronym
OPTIMUM
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2015 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
May 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
relapsing multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ponesimod
Arm Type
Experimental
Arm Description
Subjects to receive 20 mg ponesimod
Arm Title
Teriflunomide
Arm Type
Active Comparator
Arm Description
Subjects to receive 14 mg teriflunomide
Intervention Type
Drug
Intervention Name(s)
ponesimod
Other Intervention Name(s)
ACT-128800
Intervention Description
film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning
Intervention Type
Drug
Intervention Name(s)
teriflunomide
Intervention Description
film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning
Primary Outcome Measure Information:
Title
Annualized Confirmed Relapse Rate
Description
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).
Time Frame
From randomization to end of study (Week 108)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 108
Title
Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108
Description
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.
Time Frame
Baseline to Week 108
Title
12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
Description
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).
Time Frame
Baseline to Week 60 and 108 Weeks
Title
24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
Description
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).
Time Frame
Baseline to 60 Weeks and 108 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Scherz, MD, PhD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 8045
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Investigator Site 8311
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Investigator Site 8036
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Investigator Site 8065
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Investigator Site 8018
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Investigator Site 8013
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Investigator Site 8040
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Investigator Site 8006
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Investigator Site 8015
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Investigator Site 8042
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Investigator Site 3605
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
Investigator Site 3603
City
Minsk
ZIP/Postal Code
220026
Country
Belarus
Facility Name
Investigator Site 3602
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
Facility Name
Investigator Site 3606
City
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Investigator Site 3604
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Investigator Site 9104
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Investigator Site 2709
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Investigator Site 2711
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Investigator Site 2702
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Investigator Site 2707
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Investigator Site 2701
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigator Site 2708
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigator Site 2703
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Investigator Site 8102
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Investigator Site 8120
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Investigator Site 8101
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Investigator Site 8113
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Investigator Site 2506
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Investigator Site 2502
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigator Site 2508
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigator Site 2509
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigator Site 3009
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Investigator Site 3003
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Investigator Site 3010
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Investigator Site 3006
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Investigator Site 3002
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Investigator Site 3007
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Investigator Site 3001
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Investigator Site 3008
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Investigator Site 3004
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Investigator Site 2212
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Investigator Site 2202
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Investigator Site 1713
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Investigator Site 1703
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Investigator Site 1715
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Investigator Site 1706
City
Nice Cedex 1
ZIP/Postal Code
06002
Country
France
Facility Name
Investigator Site 1705
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Investigator Site 3905
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Investigator Site 3904
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Investigator Site 3903
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Investigator Site 3906
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Investigator Site 3902
City
Tbilisi
ZIP/Postal Code
0194
Country
Georgia
Facility Name
Investigator Site 1113
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigator Site 1107
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Investigator Site 1109
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Investigator Site 1104
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Investigator Site 1102
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Investigator Site 1303
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Investigator Site 1301
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Investigator Site 1307
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
Investigator Site 2903
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Investigator Site 2905
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Investigator Site 2910
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Investigator Site 2902
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Investigator Site 2909
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Investigator Site 4005
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Investigator Site 4004
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Investigator Site 4006
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Investigator Site 4010
City
Zfat
ZIP/Postal Code
13100
Country
Israel
Facility Name
Investigator Site 1403
City
Cefalu
ZIP/Postal Code
90015
Country
Italy
Facility Name
Investigator Site 1409
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigator Site 1413
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Investigator Site 1405
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Investigator Site 3401
City
Riga
ZIP/Postal Code
1015
Country
Latvia
Facility Name
Investigator Site 3402
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigator Site 3403
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Investigator Site 3502
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Investigator Site 3503
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Investigator Site 3504
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Investigator Site 7410
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Investigator Site 7409
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Investigator Site 3219
City
Bialystok
ZIP/Postal Code
15-270
Country
Poland
Facility Name
Investigator Site 3215
City
Bydgoszcz
ZIP/Postal Code
85-795
Country
Poland
Facility Name
Investigator Site 3208
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Investigator Site 3217
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Investigator Site 3203
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Investigator Site 3205
City
Konstancin-Jeziorna
ZIP/Postal Code
05-510
Country
Poland
Facility Name
Investigator Site 3216
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Investigator Site 3220
City
Lublin
ZIP/Postal Code
20-015
Country
Poland
Facility Name
Investigator Site 3202
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Investigator Site 3214
City
Poznan
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Investigator Site 3207
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Investigator Site 3213
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Investigator Site 1602
City
Amadora
ZIP/Postal Code
2720 276
Country
Portugal
Facility Name
Investigator Site 1605
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Investigator Site 1603
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigator Site 1604
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Investigator Site 2807
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Investigator Site 2811
City
Bucuresti
ZIP/Postal Code
022903
Country
Romania
Facility Name
Investigator Site 2804
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Investigator Site 2802
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Investigator Site 3821
City
Barnaul
State/Province
Altai Krai
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Investigator Site 3818
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Investigator Site 3837
City
Bryansk
ZIP/Postal Code
241033
Country
Russian Federation
Facility Name
Investigator Site 3836
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Investigator Site 3811
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Investigator Site 3822
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Investigator Site 3814
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Investigator Site 3823
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Investigator Site 3831
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Investigator Site 3803
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Investigator Site 3840
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Investigator Site 3810
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Investigator Site 3802
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Investigator Site 3834
City
Nizhny Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
Investigator Site 3835
City
Novgorod
ZIP/Postal Code
173008
Country
Russian Federation
Facility Name
Investigator Site 3829
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Investigator Site 3839
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Investigator Site 3812
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
Investigator Site 3813
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigator Site 3805
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Investigator Site 3825
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Investigator Site 3808
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigator Site 3833
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigator Site 3807
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Investigator Site 3815
City
St. Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Investigator Site 3801
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Investigator Site 3819
City
Tver
ZIP/Postal Code
170026
Country
Russian Federation
Facility Name
Investigator Site 3842
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Investigator Site 2601
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigator Site 2606
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigator Site 2607
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Investigator Site 2603
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Investigator Site 2602
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Investigator Site 1509
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Investigator Site 1505
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigator Site 1504
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigator Site 1502
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Investigator Site 1501
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigator Site 1506
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigator Site 2103
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Investigator Site 2110
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Investigator Site 2101
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Investigator Site 9004
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Investigator Site 3714
City
Chernihiv
ZIP/Postal Code
14001
Country
Ukraine
Facility Name
Investigator Site 3701
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Investigator Site 3713
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Investigator Site 3711
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigator Site 3723
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigator Site 3724
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Investigator Site 3716
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Investigator Site 3715
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Investigator Site 3721
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Investigator Site 3703
City
Odessa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Investigator Site 3717
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Investigator Site 3730
City
Ternopil
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
Investigator Site 3718
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Investigator Site 3722
City
Zaporizhia
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
Investigator Site 3725
City
Zhytomyr
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
Investigator Site 2015
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Investigator Site 2021
City
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Investigator Site 2003
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33779698
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=AC-058B301&attachmentIdentifier=24f4f084-9a98-4430-a172-80d455f49865&fileName=AC-058B301_Additional_result_data_CH.pdf&versionIdentifier=
Description
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

Learn more about this trial

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

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