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Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)

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ClinicalTrials.gov Identifier: NCT02425644
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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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

Study Design
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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
Actual Study Completion Date : May 16, 2019

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Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Actelion
Investigators
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Study Director: Tatiana Scherz, MD, PhD Actelion
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02425644    
Other Study ID Numbers: AC-058B301
2012-000540-10 ( EudraCT Number )
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: April 2020

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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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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases