Trial · NCT02425644
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
NCT02425644, Phase 3, Completed, Actelion; results first posted 2021-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis. Trials, record NCT02425644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02425644
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
- NCT number
- NCT02425644
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,133 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Multiple Sclerosis
- Interventions
- ponesimod, teriflunomide
- First posted
- 2015-04-24
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2012-000540-10
- Results first posted
- 2021-06-11
- Limitations and caveats
Low probability of this study to provide robust evaluation of ponesimod effect on disability accumulation compared to active comparator; study was not powered for this secondary endpoint. Impact of accelerated elimination procedure during safety follow-up: Accelerated elimination procedure for teriflunomide with cholestyramine/activated charcoal was frequently associated with benign, transient elevation in liver enzymes. Confounding effect of this procedure on assessing liver test was included.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Confirmed Relapse Rate | 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). |
| Secondary | 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 | 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. |
| Secondary | Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 | 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. |
| Secondary | 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | 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). |
| Secondary | 24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Confirmed Relapse Rate | From randomization to end of study (Week 108) | Full analysis set (FAS) included all participants randomized in the study. | relapses per year | MEAN |
| SECONDARY | 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 | Baseline to Week 108 | FAS included all participants randomized in the study. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure with available baseline and at least one post-baseline assessment. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 | Baseline to Week 108 | FAS included all participants randomized in the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | lesions per year | MEAN |
| SECONDARY | 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | Baseline to Week 60 and 108 Weeks | FAS included all participants randomized in this study. | Percentage of Participants | NUMBER |
| SECONDARY | 24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | Baseline to 60 Weeks and 108 Weeks | FAS included all participants randomized in this study. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Confirmed Relapse Rate | Ponesimod 20 mg | 0.202 | 99% Confidence Interval 0.165 to 0.246 | relapses per year | |
| Annualized Confirmed Relapse Rate | Teriflunomide 14 mg | 0.290 | 99% Confidence Interval 0.244 to 0.345 | relapses per year | |
| 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 | Ponesimod 20 mg | -0.01 | 95% Confidence Interval -1.60 to 1.58 | score on scale | |
| 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 | Teriflunomide 14 mg | 3.56 | 95% Confidence Interval 1.96 to 5.16 | score on scale | |
| Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 | Ponesimod 20 mg | 1.405 | 95% Confidence Interval 1.215 to 1.624 | lesions per year | |
| Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 | Teriflunomide 14 mg | 3.164 | 95% Confidence Interval 2.757 to 3.631 | lesions per year | |
| 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | Ponesimod 20 mg | 60 Weeks- from Kaplan Meier estimates | 7.6 | 95% Confidence Interval 5.7 to 10.2 | Percentage of Participants |
| 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | Teriflunomide 14 mg | 60 Weeks- from Kaplan Meier estimates | 8.3 | 95% Confidence Interval 6.3 to 11.0 | Percentage of Participants |
| 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | Ponesimod 20 mg | 108 Weeks- from Kaplan Meier estimates | 10.8 | 95% Confidence Interval 8.4 to 13.7 | Percentage of Participants |
| 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS | Teriflunomide 14 mg | 108 Weeks- from Kaplan Meier estimates | 13.2 | 95% Confidence Interval 10.6 to 16.3 | Percentage of Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ponesimod 20 mg | 567 | |
| Overall Study | STARTED | Teriflunomide 14 mg | 566 | |
| Overall Study | Treated | Ponesimod 20 mg | 565 | |
| Overall Study | Treated | Teriflunomide 14 mg | 566 | |
| Overall Study | COMPLETED | Ponesimod 20 mg | 490 | |
| Overall Study | COMPLETED | Teriflunomide 14 mg | 495 | |
| Overall Study | NOT COMPLETED | Ponesimod 20 mg | 77 | |
| Overall Study | NOT COMPLETED | Teriflunomide 14 mg | 71 |
Source ClinicalTrials.gov
Adverse events298
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Ponesimod 20 mg | 6 | 565 | |
| other | Neutropenia | Blood and lymphatic system disorders | Teriflunomide 14 mg | 13 | 566 | |
| other | Vertigo | Ear and labyrinth disorders | Ponesimod 20 mg | 13 | 565 | |
| other | Vertigo | Ear and labyrinth disorders | Teriflunomide 14 mg | 7 | 566 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ponesimod 20 mg | 9 | 565 | |
| other | Abdominal Pain | Gastrointestinal disorders | Teriflunomide 14 mg | 18 | 566 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Ponesimod 20 mg | 19 | 565 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Teriflunomide 14 mg | 24 | 566 | |
| other | Constipation | Gastrointestinal disorders | Ponesimod 20 mg | 16 | 565 | |
| other | Constipation | Gastrointestinal disorders | Teriflunomide 14 mg | 21 | 566 |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ponesimod 20 mg | 0 | 565 |
| Total, all-cause mortality | Teriflunomide 14 mg | 2 | 566 |
| Total, other adverse events | Ponesimod 20 mg | 434 | 565 |
| Total, other adverse events | Teriflunomide 14 mg | 422 | 566 |
| Total, serious adverse events | Ponesimod 20 mg | 49 | 565 |
| Total, serious adverse events | Teriflunomide 14 mg | 46 | 566 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ponesimod 20 mg vs Teriflunomide 14 mg: deaths from any cause | Trial comparisons |
| Ponesimod 20 mg vs Teriflunomide 14 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02425644
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