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
Results First Posted : June 11, 2021
Last Update Posted : January 26, 2022
|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|
|Actual Study Completion Date :||May 16, 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 Confirmed Relapse Rate [ Time Frame: From randomization to end of study (Week 108) ]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).
- 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 [ Time Frame: Baseline 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 [ Time Frame: 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 [ Time Frame: Baseline to Week 60 and 108 Weeks ]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 [ Time Frame: Baseline to 60 Weeks and 108 Weeks ]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).
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
|Study Director:||Tatiana Scherz, MD, PhD||Actelion|