Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)
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|ClinicalTrials.gov Identifier: NCT02425644|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: ponesimod Drug: teriflunomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Subjects to receive 20 mg 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
film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning
- 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
- 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).
- 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).
- 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.
- 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.
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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|Study Director:||Tatiana Scherz, MD, PhD||Actelion|