This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (NCT02425644), a randomized phase 3 study. The primary outcome is Annualized Confirmed Relapse Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02425644 |
| Phase | Phase 3 |
| Condition | Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1133 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Actelion |
| Results posted | Yes |
2. Clinical Question
Population
Participants with relapsing multiple sclerosis were eligible for the trial. The primary analysis population was the full analysis set, defined in the registry as all participants randomized in the study.
Intervention
The intervention was ponesimod 20 mg. The study was designed to compare its efficacy and safety with an active treatment rather than with placebo.
Comparator
The comparator was teriflunomide 14 mg. The registry describes the study as active-controlled, randomized, double-blind, parallel-group, and designed to test superiority.
Primary question
The primary question concerned the annualized confirmed relapse rate from randomization to the end of the study at Week 108. The registry reports each group’s rate and a negative binomial regression comparison between groups.
In practical statistical terms, the comparison asks whether the fitted rate of confirmed relapses differed between the randomized groups over the specified follow-up. A confirmed relapse required an acute episode of new or worsened multiple sclerosis symptoms that was not associated with fever or infection and lasted at least 24 hours after a stable 30-day period. Confirmation also required a specified increase in the Expanded Disability Status Scale score or in qualifying Functional Systems scores from baseline.
The registry lists 567 participants in the ponesimod group and 566 in the teriflunomide group for the primary outcome. The registered result is an estimate of a group-level rate comparison; it does not describe the experience of every individual participant. The endpoint definition and the analysis population therefore matter when interpreting what the comparison represents.
3. Trial Design
This was a Phase 3, randomized, parallel-group, active-controlled superiority study of ponesimod and teriflunomide in relapsing multiple sclerosis. The official title describes a multicenter, double-blind design with quadruple masking. The registry classifies allocation as randomized and masking as quadruple, but the identities of the parties included in that masking classification are not reported in the registry record.
The trial enrolled 1133 participants. The primary-outcome groups included 567 participants assigned to ponesimod 20 mg and 566 assigned to teriflunomide 14 mg. The registry lists Actelion as the sponsor and describes the study as international. The recorded start date is 2015-06-04, the primary completion date is 2019-05-16, and the status is completed.
Each participant was assigned to one of the two active-treatment groups. A parallel-group design means that the randomized groups are followed alongside one another rather than participants switching between the treatments as part of the comparison. Random allocation is intended to support a fair comparison of groups, while masking is intended to limit influences on treatment delivery and outcome assessment. These are general purposes of the design features; the registry does not report further details about how masking was implemented or maintained.
The primary endpoint was annualized confirmed relapse rate from randomization through the end of the study at Week 108. The registry also lists secondary outcomes covering fatigue-related symptoms, cumulative combined unique active lesions, and 12-week and 24-week confirmed disability accumulation. These outcomes provide different measures of symptoms, disease activity, and disability accumulation, but their presence does not establish that all were analyzed under a common statistical procedure or multiplicity adjustment. Those details are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: As planned, Placebo was not a separate arm as this was included for double dummy design study part (up to Day 14).
Overall Study
| Stage | Ponesimod 20 mg | Teriflunomide 14 mg |
|---|---|---|
| STARTED | 567 | 566 |
| Treated | 565 | 566 |
| COMPLETED | 490 | 495 |
| NOT COMPLETED | 77 | 71 |
Reasons for not completing this period:
| Reason | Ponesimod 20 mg | Teriflunomide 14 mg |
|---|---|---|
| Lost to Follow-up | 2 | 3 |
| Withdrawal by Subject | 41 | 36 |
| Lack of Efficacy | 3 | 10 |
| Adverse Event | 13 | 3 |
| Death | 0 | 2 |
| Other | 18 | 17 |
Analysis population for the primary outcome, as defined in the registry: Full analysis set (FAS) included all participants randomized in the study.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Ponesimod 20 mg | Teriflunomide 14 mg | Total |
|---|---|---|---|---|
| Participants analysed | 567 | 566 | 1133 | |
| Age, Continuous | years | 36.7 (SD 8.74) | 36.8 (SD 8.74) | 36.7 (SD 8.74) |
| Sex: Female, Male: Female | Participants | 363 | 372 | 735 |
| Sex: Female, Male: Male | Participants | 204 | 194 | 398 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): White | Participants | 551 | 553 | 1104 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 13 | 10 | 23 |
| Region of Enrollment: BELARUS | Participants | 21 | 24 | 45 |
| Region of Enrollment: BULGARIA | Participants | 18 | 27 | 45 |
| Region of Enrollment: CANADA | Participants | 10 | 7 | 17 |
| Region of Enrollment: CROATIA | Participants | 14 | 20 | 34 |
| Region of Enrollment: CZECH REPUBLIC | Participants | 55 | 46 | 101 |
| Region of Enrollment: FINLAND | Participants | 4 | 3 | 7 |
| Region of Enrollment: FRANCE | Participants | 8 | 8 | 16 |
| Region of Enrollment: GEORGIA | Participants | 24 | 17 | 41 |
| Region of Enrollment: GERMANY | Participants | 9 | 7 | 16 |
| Region of Enrollment: GREECE | Participants | 9 | 6 | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Annualized Confirmed Relapse Rate, measured over From randomization to end of study (Week 108).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 99% Confidence Interval |
| Unit | relapses per year |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was annualized confirmed relapse rate, expressed as relapses per year, from randomization to the end of the study at Week 108. A relapse was defined as an acute episode of one or more new symptoms or worsened symptoms of multiple sclerosis, not associated with fever or infection, and lasting 24 hours after a stable 30-day period.
To count as confirmed, a relapse also had to meet a neurological examination criterion: an increase from baseline of at least 0.5 point on the Expanded Disability Status Scale, or an increase of one point in one, two, or three qualifying Functional Systems. Bowel/bladder and cerebral/mental Functional Systems were excluded from that confirmation rule. The registry describes the Expanded Disability Status Scale as an ordinal scale from 0, normal neurological examination, to 10, death due to multiple sclerosis. Functional Systems scores assess specified areas of neurological function, with higher scores indicating greater functional impairment.
A confirmed relapse rate is used to summarize the frequency of qualifying events over follow-up in a way that is expressed on an annual basis. It focuses on events meeting the registry’s clinical and examination criteria rather than on every reported symptom. As a rate endpoint, it also differs from an endpoint that records only whether a participant had any event. The registry identifies the full analysis set as the population for the primary outcome: all participants randomized in the study.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The ponesimod group’s annualized confirmed relapse rate was 0.202 relapses per year, with a 99% confidence interval from 0.165 to 0.246. The teriflunomide group’s rate was 0.29 relapses per year, with a 99% confidence interval from 0.244 to 0.345. These are the posted group-level estimates for the primary endpoint in the full analysis set.
The registry reports a negative binomial regression comparison with a rate ratio of 0.695 and a 99% confidence interval from 0.536 to 0.902. The reported p-value is < 0.001, and the analysis is labelled as a superiority analysis. In the listed group order, the comparison is between ponesimod and teriflunomide. A rate ratio below 1 indicates that the fitted rate for the first group in that comparison is lower relative to the second group under the reported model. The confidence interval does not include 1, the value corresponding to equal rates in a ratio comparison.
A confidence interval describes the uncertainty around an estimate under the assumptions of the analysis. The 99% interval gives a range of values compatible with the model and data at that confidence level; it does not mean that individual outcomes fall within that range. The interval is for the estimated rate ratio, while the separate intervals for each group describe uncertainty around their rates. Their overlap or non-overlap should not replace the direct regression comparison.
The reported p-value is evidence against the model’s null comparison of equal rates, under the assumptions used in the analysis. It does not measure the probability that the null hypothesis is true, nor does it quantify the size or practical importance of the difference. The rate ratio and its confidence interval convey the estimated relative contrast and its precision more directly. The registry labels the test as superiority, but statistical evidence from this endpoint alone does not establish conclusions about every secondary outcome or every aspect of treatment benefit and harm.
The registry lists 567 participants in the ponesimod group and 566 in the teriflunomide group for this endpoint. The primary analysis population includes all randomized participants by definition, but the registry’s endpoint results do not explain how missing outcome information, discontinuation, or varying follow-up was handled. Those details affect how fully the posted estimate can be assessed. The result should therefore be read as the reported model-based comparison for the defined endpoint and analysis population, not as a complete description of participant-level outcomes.
9. Statistical Methods Explained
The reported primary comparison uses negative binomial regression and presents the result as a rate ratio. The registry reports group-specific annualized confirmed relapse rates as means, together with 99% confidence intervals. The regression result is the direct modeled comparison between the randomized groups; it is distinct from simply comparing the two displayed group estimates by subtraction or by visual inspection.
What does a rate ratio express?
A rate ratio compares event rates between groups. A value of 1 corresponds to equal rates under the comparison, while a value below 1 indicates a lower fitted rate in the first group relative to the second when the groups are entered in that order. Here the reported rate ratio is 0.695, with a 99% confidence interval from 0.536 to 0.902. The registry presents the comparison as ponesimod versus teriflunomide. The ratio describes a relative contrast; it is not the number of relapses avoided by an individual, and it does not state the absolute difference between the groups.
Why use a negative binomial model?
General statistical context: count outcomes often have a distribution in which the variability is not well represented by a simple Poisson model. Over-dispersion means that observed variation exceeds what that simpler model would expect. A negative binomial model can accommodate such extra variation and is commonly used for event counts or rates. This is a general explanation of the model class, not a claim that the registry reports a particular diagnostic finding about these data. The registry names negative binomial regression but does not report its covariates, dispersion estimate, or model diagnostics.
For a count-rate analysis, the duration over which participants contribute observations can matter. Annualizing expresses the endpoint as events per year, but the registry record does not describe the specific exposure-time calculations or any handling of differing observation periods. It also does not give enough information to reconstruct the regression specification. The result should therefore be understood as the sponsor-reported model estimate, not as a fully reproducible model from the details in the registry record alone.
How should the confidence intervals be read?
General statistical context: a confidence interval represents uncertainty in an estimate under the model and its assumptions. A narrower interval indicates greater precision than a wider interval on the same scale, while an interval’s endpoints indicate a range of estimates compatible with the data and method at the stated confidence level. For a rate ratio, the value 1 is the equality reference. The reported 99% confidence interval, from 0.536 to 0.902, lies below that reference. The registry’s reported p-value is < 0.001, alongside its superiority classification.
The interval does not mean that the true rate has a 99% probability of lying inside this particular calculated range in the strict frequentist interpretation. Nor does it account for uncertainties not represented by the model, such as potential biases in measurement or unreported analytic choices. It is conditional on the analysis and data definitions used.
What does the p-value contribute?
General statistical context: a p-value measures how incompatible the observed data, or more extreme data, are with a specified null model, assuming that model and the analysis assumptions hold. It is not a measure of effect size, a probability that the null is true, or a measure of the chance that the finding occurred “by chance.” The reported value of < 0.001 is consistent with the registry’s superiority label for the primary comparison. The rate ratio and confidence interval remain important because they describe the estimated contrast and its precision.
The registry does not report whether this p-value was adjusted for testing multiple outcomes or analyses. It also does not report interim analyses or a detailed statistical analysis plan. No conclusion about those procedures can be inferred from the model name or the posted result.
What can planning illustrations establish?
General statistical context: sample-size planning calculations describe how many participants might be needed under stated assumptions to detect a specified effect with a chosen power and significance level. They are planning illustrations, not observed power and not evidence about the probability that a completed trial has produced a true result. The registry record does not report the trial’s sample-size justification. The planning assumptions described for illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. No planning sample-size values are reported in the registry record.
Planning results depend on the assumptions entered, including the effect used for planning. They cannot substitute for the reported trial analysis, nor can they establish whether the original enrollment target was chosen appropriately. For this trial, interpretation of the primary result should rest on the posted endpoint estimates and regression analysis, alongside the limits of the registry’s reporting.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Negative binomial regression model | Rate ratio 0.695 | 0.536 to 0.902 | < 0.001 |
The registry reports the sponsor’s primary comparison as a negative binomial regression rate ratio of 0.695, with a 99% confidence interval from 0.536 to 0.902 and p < 0.001. The analysis is labelled as superiority. These model-based results should be kept distinct from a simple unadjusted comparison of the displayed group rates, because the registry does not provide enough model details to reproduce the regression from the group summaries alone.
The record does not identify a discrepancy between the posted primary result and a recalculated result. No separate recalculated rate ratio or recalculated confidence interval is reported in the registry record, so a numerical comparison between sponsor and recalculated estimates is not available. The group rates—0.202 for ponesimod and 0.29 for teriflunomide—are descriptive endpoint estimates; they do not, by themselves, reproduce the regression analysis.
For interpretation, the sponsor-reported analysis is the available direct inferential comparison. It should be read with its stated model, confidence interval, and p-value, while recognizing that model covariates, missing-data procedures, and other details needed for independent reproduction are not reported in the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The primary outcome population is the full analysis set, which the registry defines as all participants randomized in the study. This definition establishes which randomized participants belong to the stated primary analysis population. The record does not explain how missing primary-outcome observations, treatment discontinuation, or incomplete follow-up were handled, and no imputation or sensitivity-analysis method is reported.
The registry lists four secondary outcomes: change from baseline in fatigue-related symptoms measured by the Symptoms Domain of the FSIQ-RMS score to Week 108; cumulative number of combined unique active lesions per year from baseline to Week 108; and 12-week and 24-week confirmed disability accumulation assessed from baseline to end of study. It lists five outcome measures and five analyses overall. The record does not provide a multiplicity procedure describing how inference across these endpoints or analyses was controlled. The presence of multiple outcomes alone does not show whether any adjustment was used.
The posted primary analysis has a stated 99% confidence interval and p-value. Those features do not, by themselves, establish how the analysis fits into a broader testing strategy. The registry does not report interim analyses, a detailed statistical analysis plan, or the rationale for selecting the reported confidence level. Those aspects are therefore not reported in the registry record.
The record also indicates that values were missing or not estimable for a two-arm comparison for another endpoint. It does not identify a usable two-arm result for that endpoint in the information available for this analysis. This is separate from the primary endpoint result and does not establish why the other result could not be estimated. In general, incomplete outcome data can affect precision and can introduce bias if the missingness is related to outcomes or group assignment. The registry does not provide the details needed to assess those possibilities.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ponesimod 20 mg | 49 | 565 | 8.7% |
| Teriflunomide 14 mg | 46 | 566 | 8.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ponesimod 20 mg | 0 of 565 |
| Teriflunomide 14 mg | 2 of 566 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ponesimod 20 mg | 434 of 565 |
| Teriflunomide 14 mg | 422 of 566 |
Most frequent serious adverse event terms
| Event term | Organ system | Ponesimod 20 mg | Teriflunomide 14 mg |
|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | 1 of 565 | 3 of 566 |
| Abdominal Pain | Gastrointestinal disorders | 3 of 565 | 0 of 566 |
| Appendicitis | Infections and infestations | 3 of 565 | 0 of 566 |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 565 | 2 of 566 |
| Lumbar Radiculopathy | Nervous system disorders | 2 of 565 | 1 of 566 |
| Concussion | Injury, poisoning and procedural complications | 0 of 565 | 2 of 566 |
| Alanine Aminotransferase Increased | Investigations | 0 of 565 | 2 of 566 |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | 1 of 565 | 1 of 566 |
| Multiple Sclerosis Relapse | Nervous system disorders | 1 of 565 | 1 of 566 |
| Endometrial Hyperplasia | Reproductive system and breast disorders | 1 of 565 | 1 of 566 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ponesimod 20 mg | Teriflunomide 14 mg |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 109 of 565 | 95 of 566 |
| Alanine Aminotransferase Increased | Investigations | 110 of 565 | 51 of 566 |
| Headache | Nervous system disorders | 64 of 565 | 72 of 566 |
| Upper Respiratory Tract Infection | Infections and infestations | 60 of 565 | 59 of 566 |
| Nausea | Gastrointestinal disorders | 43 of 565 | 47 of 566 |
| Alopecia | Skin and subcutaneous tissue disorders | 18 of 565 | 72 of 566 |
| Hypertension | Vascular disorders | 45 of 565 | 44 of 566 |
| Fatigue | General disorders | 34 of 565 | 37 of 566 |
| Back Pain | Musculoskeletal and connective tissue disorders | 33 of 565 | 38 of 566 |
| Diarrhoea | Gastrointestinal disorders | 20 of 565 | 44 of 566 |
Serious events with the highest arm-level rate: abdominal pain (0.5%), appendicitis (0.5%), cholelithiasis (0.5%), lumbar radiculopathy (0.4%), abortion induced (0.4%).
The registry reports serious adverse events for 49 of 565 participants at risk in the ponesimod group and 46 of 566 participants at risk in the teriflunomide group. It reports zero deaths in the ponesimod group and 2 in the teriflunomide group. These are descriptive counts and denominators; they do not establish that an event was caused by the assigned treatment.
For other adverse events, the registry reports 434 of 565 participants at risk in the ponesimod group and 422 of 566 at risk in the teriflunomide group. These figures count participants affected, not the total number of event episodes. They should not be interpreted as serious-event counts.
The listed serious-event terms and percentages are Abdominal Pain, 0.5%; Appendicitis, 0.5%; Cholelithiasis, 0.5%; Lumbar Radiculopathy, 0.4%; Abortion Induced, 0.4%; and Concussion, 0.4%. The registry listing does not assign these terms to a treatment group in the information, so they should not be attributed to either arm. Counts and percentages alone also do not show the timing, duration, severity beyond the serious classification, or causal relationship of individual events. The safety figures are best read as registry-reported summaries, not as a complete safety assessment.
13. What the Result Does, and Does Not, Mean
The primary result describes a model-based comparison of annualized confirmed relapse rates in the randomized groups. The ponesimod group estimate was 0.202 relapses per year and the teriflunomide group estimate was 0.29 relapses per year. The reported rate ratio was 0.695, with a 99% confidence interval from 0.536 to 0.902 and p < 0.001. The registry labels this analysis as superiority.
These statistics support a statement about the estimated relative rate for the defined endpoint in the reported analysis. They do not show that every participant in one group had a better outcome than every participant in the other group. Group-level rates cannot describe individual outcomes, and a relative rate comparison is not the same as an absolute difference in events or a measure of how a particular person will fare.
The result also does not resolve all questions about the study. The registry lists secondary outcomes, but a primary-endpoint result cannot establish findings for fatigue, active lesions, or disability accumulation. Details about multiplicity, missing observations, model covariates, and interim analyses are not reported in the registry record. Those omissions limit what can be concluded about the broader analysis strategy and the robustness of the posted estimate.
Statistical significance is not equivalent to clinical importance. The p-value describes evidence relative to a statistical null under assumptions; it does not assess the value of the estimated difference to patients or clinicians. The confidence interval communicates uncertainty in the rate ratio but does not account for unreported design and analysis details. Likewise, the serious adverse event counts are descriptive and do not establish causation or provide a complete accounting of safety.
Accordingly, the posted result should be understood narrowly: it is the registry-reported primary comparison for confirmed relapse rate, in the full analysis set, over the specified follow-up. It is not a guarantee of an individual outcome, a conclusion about every endpoint, or a comprehensive judgment of treatment benefit and harm.
14. Why This Trial Matters Statistically
This trial illustrates why the endpoint definition and statistical model are central to interpreting a clinical comparison. “Confirmed relapse” is not simply any report of a new or worsening symptom: the registry specifies duration, absence of fever or infection, a stable period, and neurological examination criteria. Those rules determine which events contribute to the outcome and make the estimate interpretable only in relation to that definition.
The outcome is a rate rather than a simple event/no-event measure. The reported analysis therefore compares annualized event rates, with negative binomial regression used for the primary comparison. The rate ratio and its confidence interval convey a relative group contrast, while the group estimates provide the corresponding rate summaries. Keeping these quantities distinct helps prevent a model-based comparison from being mistaken for a direct difference calculated from the displayed group rates.
The registry also illustrates the importance of matching inference to the stated population. The primary analysis is defined as the full analysis set, including all randomized participants, while the safety summaries use their own at-risk denominators. Reading a result requires attention to those denominators and to what each outcome counts.
Finally, the record shows the boundary between a reported result and a fully documented analysis. It identifies the model and primary estimate, but does not report the model specification, missing-data methods, multiplicity procedures, or detailed analysis plan. Recognizing these gaps is part of sound statistical interpretation: the available evidence can be described precisely without inferring analytic choices that the registry does not document.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record gives the primary endpoint definition, group estimates, and regression result, but does not report the negative binomial model’s covariates, diagnostics, or full specification. That limits independent reproduction of the reported rate ratio and assessment of the model assumptions. The record also does not describe how annualized exposure time was calculated or how differing follow-up was handled.
Missing-data procedures for the primary outcome are not reported. The record does not explain how outcomes after discontinuation were treated, whether all randomized participants contributed complete endpoint data, or whether sensitivity analyses addressed incomplete observations. These details matter because missingness can affect both precision and the interpretation of a treatment-group comparison.
The registry lists multiple secondary outcomes but does not report a multiplicity strategy. It also does not report interim analyses or the trial’s detailed statistical analysis plan. The record does not provide the trial’s sample-size justification; planning assumptions for illustrations are not a substitute for the original design rationale or for the primary analysis.
Safety summaries are limited to counts, at-risk denominators, deaths, and a list of serious-event terms with percentages. The record does not provide enough context to assess event timing, duration, relatedness, or all details of collection and coding. The serious-event terms are not linked to a specific group in the listed information. These limitations restrict interpretation of safety counts but do not alter what the registry reports about their numerical values.
Finally, the primary endpoint captures a defined class of confirmed relapses through Week 108. It does not by itself characterize every dimension of multiple sclerosis, all secondary endpoints, or each participant’s course. Conclusions should remain specific to the reported endpoint, population, and analysis.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis — NCT02425644.
- Registry record last updated 2025-03-30; status last verified 2025-03.
- Results first posted 2021-06-11.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT02425644 is a completed Phase 3 randomized, double-blind, parallel-group, active-controlled superiority study of ponesimod and teriflunomide in relapsing multiple sclerosis. The registry reports enrollment of 1133 participants and lists Actelion as sponsor. The recorded start date is 2015-06-04, and the primary completion date is 2019-05-16.
The primary endpoint was annualized confirmed relapse rate from randomization to the end of the study at Week 108. The full analysis set included all randomized participants. The posted group estimates were 0.202 relapses per year for ponesimod and 0.29 for teriflunomide. The registry reports a negative binomial regression rate ratio of 0.695, with a 99% confidence interval from 0.536 to 0.902 and p < 0.001, classified as a superiority analysis.
The record also lists secondary outcomes and descriptive adverse-event summaries. Details about missing-data handling, multiplicity, interim analyses, and the full model specification are not reported in the registry record.