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Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02425644
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ponesimod Drug: teriflunomide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2015
Actual Primary Completion Date : May 16, 2019
Estimated Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ponesimod
Subjects to receive 20 mg ponesimod
Drug: ponesimod
film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning
Other Name: ACT-128800

Active Comparator: Teriflunomide
Subjects to receive 14 mg teriflunomide
Drug: teriflunomide
film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning




Primary Outcome Measures :
  1. Annualized relapse rate (ARR) [ Time Frame: From baseline to End-of-Treatment (EOT, Week 108) ]
    ARR is defined as the number of confirmed relapses per subject-year


Secondary Outcome Measures :
  1. Change from baseline to Week 108 in fatigue-related symptoms as measured by the symptoms domain of the Fatigue Symptoms and Impact Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) [ Time Frame: From baseline to EOT (Week 108) ]
    The FSIQ-RMS is a 20-item patient-reported outcome (PRO) measure that was developed by Actelion to evaluate fatigue-related symptoms and the impacts of those symptoms on the lives of people with relapsing multiple sclerosis (RMS).

  2. Cumulative number of combined unique active lesions (CUAL) from baseline to Week 108 [ Time Frame: From baseline to EOT (Week 108) ]
    CUAL is defined as new gadolinium-enhancing (Gd+) T1 lesions puls new or enlarging T2 lesions (wihtout double-counting of lesions) measured by magnetic resonance imaging (MRI).

  3. Time to 12-week confirmed disability accumulation (CDA) from baseline to End-of-Study (EOS) [ Time Frame: From baseline to EOS (Week 108 + 30 days) ]
    The 12-week CDA is an increase in the Expanded Disability Status Scale (EDSS) score relative to the EDSS score at baseline as defined in the study protocol. The EDSS score is based on the examination by a neurologist and ranges from 0 (lowest) to 10 (highest) with 0.5 unit increments. EDSS quantifies disability and monitors changes in the level of disability over time.

  4. Time to 24-week CDA from baseline to EOS [ Time Frame: From baseline to EOS (Week 108 + 30 days) ]
    The 24-week CDA is an increase in the Expanded Disability Status Scale (EDSS) score relative to the EDSS score at baseline as defined in the study protocol. The EDSS score is based on the examination by a neurologist and ranges from 0 (lowest) to 10 (highest) with 0.5 unit increments. EDSS quantifies disability and monitors changes in the level of disability over time.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425644


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Locations
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United States, California
Investigator Site 8045
Carlsbad, California, United States, 92011
Investigator Site 8311
Pomona, California, United States, 91767
United States, Colorado
Investigator Site 8036
Denver, Colorado, United States, 80209
United States, Florida
Investigator Site 8065
Ormond Beach, Florida, United States, 32174
Investigator Site 8018
Tampa, Florida, United States, 33612
United States, Indiana
Investigator Site 8013
Indianapolis, Indiana, United States, 46256
United States, North Carolina
Investigator Site 8040
Raleigh, North Carolina, United States, 27607
United States, Ohio
Investigator Site 8006
Columbus, Ohio, United States, 43214
United States, Tennessee
Investigator Site 8015
Franklin, Tennessee, United States, 37064
United States, Utah
Investigator Site 8042
Orem, Utah, United States, 84058
Belarus
Investigator Site 3605
Grodno, Belarus, 230017
Investigator Site 3603
Minsk, Belarus, 220026
Investigator Site 3602
Minsk, Belarus, 220114
Investigator Site 3606
Vitebsk, Belarus, 210023
Investigator Site 3604
Vitebsk, Belarus, 210037
Bosnia and Herzegovina
Investigator Site 9104
Sarajevo, Bosnia and Herzegovina, 71000
Bulgaria
Investigator Site 2709
Plovdiv, Bulgaria, 4002
Investigator Site 2711
Sofia, Bulgaria, 1113
Investigator Site 2702
Sofia, Bulgaria, 1309
Investigator Site 2707
Sofia, Bulgaria, 1407
Investigator Site 2701
Sofia, Bulgaria, 1431
Investigator Site 2708
Sofia, Bulgaria, 1431
Investigator Site 2703
Sofia, Bulgaria, 1606
Canada, Alberta
Investigator Site 8102
Edmonton, Alberta, Canada, T6G 1Z1
Canada, British Columbia
Investigator Site 8120
Victoria, British Columbia, Canada, V8R 1J8
Canada, Ontario
Investigator Site 8101
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Investigator Site 8113
Greenfield Park, Quebec, Canada, J4V 2J2
Croatia
Investigator Site 2506
Osijek, Croatia, 31000
Investigator Site 2502
Zagreb, Croatia, 10000
Investigator Site 2508
Zagreb, Croatia, 10000
Investigator Site 2509
Zagreb, Croatia, 10000
Czechia
Investigator Site 3009
Brno, Czechia, 625 00
Investigator Site 3003
Brno, Czechia, 656 91
Investigator Site 3010
Hradec Králové, Czechia, 500 05
Investigator Site 3006
Jihlava, Czechia, 586 33
Investigator Site 3002
Ostrava-Poruba, Czechia, 708 52
Investigator Site 3007
Pardubice, Czechia, 532 03
Investigator Site 3001
Praha 2, Czechia, 128 08
Investigator Site 3008
Praha 5, Czechia, 150 06
Investigator Site 3004
Teplice, Czechia, 415 29
Finland
Investigator Site 2212
Tampere, Finland, 33100
Investigator Site 2202
Turku, Finland, 20520
France
Investigator Site 1713
Bordeaux Cedex, France, 33076
Investigator Site 1703
Clermont Ferrand Cedex 1, France, 63003
Investigator Site 1715
Nantes Cedex 1, France, 44093
Investigator Site 1706
Nice Cedex 1, France, 06002
Investigator Site 1705
Strasbourg Cedex, France, 67091
Georgia
Investigator Site 3905
Tbilisi, Georgia, 0112
Investigator Site 3904
Tbilisi, Georgia, 0160
Investigator Site 3903
Tbilisi, Georgia, 0179
Investigator Site 3906
Tbilisi, Georgia, 0179
Investigator Site 3902
Tbilisi, Georgia, 0194
Germany
Investigator Site 1113
Dresden, Germany, 01307
Investigator Site 1107
Erfurt, Germany, 99089
Investigator Site 1109
Leipzig, Germany, 04107
Investigator Site 1104
Mainz, Germany, 55131
Investigator Site 1102
Ulm, Germany, 89081
Greece
Investigator Site 1303
Athens, Greece, 11521
Investigator Site 1301
Athens, Greece, 11525
Investigator Site 1307
Athens, Greece, 15125
Hungary
Investigator Site 2903
Budapest, Hungary, 1145
Investigator Site 2905
Budapest, Hungary, 1204
Investigator Site 2910
Esztergom, Hungary, 2500
Investigator Site 2902
Gyor, Hungary, 9023
Investigator Site 2909
Kistarcsa, Hungary, 2143
Israel
Investigator Site 4005
Ashkelon, Israel, 7830604
Investigator Site 4004
Haifa, Israel, 3109601
Investigator Site 4006
Jerusalem, Israel, 9112001
Investigator Site 4010
Zfat, Israel, 13100
Italy
Investigator Site 1403
Cefalu, Italy, 90015
Investigator Site 1409
Genova, Italy, 16132
Investigator Site 1413
L'Aquila, Italy, 67100
Investigator Site 1405
Roma, Italy, 00189
Latvia
Investigator Site 3401
Riga, Latvia, 1015
Investigator Site 3402
Riga, Latvia, LV-1002
Investigator Site 3403
Riga, Latvia, LV-1038
Lithuania
Investigator Site 3502
Kaunas, Lithuania, 50161
Investigator Site 3503
Klaipeda, Lithuania, 92288
Investigator Site 3504
Siauliai, Lithuania, 76231
Mexico
Investigator Site 7410
Chihuahua, Mexico, 31203
Investigator Site 7409
Monterrey, Mexico, 64710
Poland
Investigator Site 3219
Bialystok, Poland, 15-270
Investigator Site 3215
Bydgoszcz, Poland, 85-795
Investigator Site 3208
Gdansk, Poland, 80-803
Investigator Site 3217
Katowice, Poland, 40-595
Investigator Site 3203
Katowice, Poland, 40-752
Investigator Site 3205
Konstancin-Jeziorna, Poland, 05-510
Investigator Site 3216
Ksawerow, Poland, 95-054
Investigator Site 3220
Lublin, Poland, 20-015
Investigator Site 3202
Poznan, Poland, 60-355
Investigator Site 3214
Poznan, Poland, 60-848
Investigator Site 3207
Poznan, Poland, 61-853
Investigator Site 3213
Wroclaw, Poland, 51-685
Portugal
Investigator Site 1602
Amadora, Portugal, 2720 276
Investigator Site 1605
Braga, Portugal, 4710-243
Investigator Site 1603
Coimbra, Portugal, 3000-075
Investigator Site 1604
Porto, Portugal, 4099-001
Romania
Investigator Site 2807
Bucuresti, Romania, 010825
Investigator Site 2811
Bucuresti, Romania, 022903
Investigator Site 2804
Bucuresti, Romania, 050098
Investigator Site 2802
Timisoara, Romania, 300723
Russian Federation
Investigator Site 3821
Barnaul, Altai Krai, Russian Federation, 656024
Investigator Site 3818
Belgorod, Russian Federation, 308007
Investigator Site 3837
Bryansk, Russian Federation, 241033
Investigator Site 3836
Ekaterinburg, Russian Federation, 620102
Investigator Site 3811
Kazan, Russian Federation, 420029
Investigator Site 3822
Kemerovo, Russian Federation, 650066
Investigator Site 3814
Krasnoyarsk, Russian Federation, 660037
Investigator Site 3823
Kursk, Russian Federation, 305007
Investigator Site 3831
Moscow, Russian Federation, 119049
Investigator Site 3803
Moscow, Russian Federation, 127015
Investigator Site 3840
Moscow, Russian Federation, 127015
Investigator Site 3810
Moscow, Russian Federation, 129128
Investigator Site 3802
Nizhniy Novgorod, Russian Federation, 603155
Investigator Site 3834
Nizhny Novgorod, Russian Federation, 603076
Investigator Site 3835
Novgorod, Russian Federation, 173008
Investigator Site 3829
Novosibirsk, Russian Federation, 630007
Investigator Site 3839
Perm, Russian Federation, 614990
Investigator Site 3812
Pyatigorsk, Russian Federation, 357538
Investigator Site 3813
Saint Petersburg, Russian Federation, 197110
Investigator Site 3805
Samara, Russian Federation, 443095
Investigator Site 3825
Smolensk, Russian Federation, 214019
Investigator Site 3808
St. Petersburg, Russian Federation, 194354
Investigator Site 3833
St. Petersburg, Russian Federation, 197022
Investigator Site 3807
St. Petersburg, Russian Federation, 197376
Investigator Site 3815
St. Petersburg, Russian Federation, 197706
Investigator Site 3801
Tomsk, Russian Federation, 634050
Investigator Site 3819
Tver, Russian Federation, 170026
Investigator Site 3842
Yaroslavl, Russian Federation, 150030
Serbia
Investigator Site 2601
Belgrade, Serbia, 11000
Investigator Site 2606
Belgrade, Serbia, 11000
Investigator Site 2607
Belgrade, Serbia, 11080
Investigator Site 2603
Kragujevac, Serbia, 34000
Investigator Site 2602
Nis, Serbia, 18000
Spain
Investigator Site 1509
Barcelona, Spain, 08003
Investigator Site 1505
Barcelona, Spain, 08035
Investigator Site 1504
Barcelona, Spain, 08036
Investigator Site 1502
Madrid, Spain, 28006
Investigator Site 1501
Malaga, Spain, 29010
Investigator Site 1506
Sevilla, Spain, 41009
Sweden
Investigator Site 2103
Goteborg, Sweden, 413 45
Investigator Site 2110
Stockholm, Sweden, 141 86
Investigator Site 2101
Stockholm, Sweden, 171 76
Turkey
Investigator Site 9004
Trabzon, Turkey, 61080
Ukraine
Investigator Site 3714
Chernihiv, Ukraine, 14001
Investigator Site 3701
Chernihiv, Ukraine, 14029
Investigator Site 3713
Ivano-Frankivsk, Ukraine, 76008
Investigator Site 3711
Ivano-Frankivsk, Ukraine, 76018
Investigator Site 3723
Kharkiv, Ukraine, 61103
Investigator Site 3724
Kharkiv, Ukraine, 61176
Investigator Site 3716
Kyiv, Ukraine, 03115
Investigator Site 3715
Lviv, Ukraine, 79000
Investigator Site 3721
Lviv, Ukraine, 79010
Investigator Site 3703
Odessa, Ukraine, 65009
Investigator Site 3717
Poltava, Ukraine, 36011
Investigator Site 3730
Ternopil, Ukraine, 46027
Investigator Site 3718
Vinnytsia, Ukraine, 21005
Investigator Site 3722
Zaporizhia, Ukraine, 69000
Investigator Site 3725
Zhytomyr, Ukraine, 10008
United Kingdom
Investigator Site 2015
Glasgow, United Kingdom, G51 4TF
Investigator Site 2021
Lancashire, United Kingdom, PR2 9HT
Investigator Site 2003
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Tatiana Scherz, MD, PhD Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02425644     History of Changes
Other Study ID Numbers: AC-058B301
2012-000540-10 ( EudraCT Number )
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Actelion:
relapsing multiple sclerosis

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases