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 Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (NCT00134563), a randomized phase 3 study. The primary outcome is Annualized Relapse Rate [ARR]: Poisson Regression Estimates.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00134563 |
| Phase | Phase 3 |
| Condition | Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 1088 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Sanofi |
| Results posted | Yes |
2. Clinical Question
Population
Participants with multiple sclerosis with relapses were studied. The primary analysis population is described as all randomized and treated participants, analyzed in their originally assigned groups.
Intervention
Participants were assigned to teriflunomide 7 mg or teriflunomide 14 mg, each described as once daily for 108 weeks.
Comparator
The comparator was placebo, also described as once daily for 108 weeks.
Primary question
The trial asked whether teriflunomide changed the frequency of confirmed relapses during treatment, expressed as the annualized relapse rate. The registry also identifies disability progression, MRI burden of disease, fatigue, and safety and tolerability as secondary objectives. The primary question is about relapse frequency over the treatment period; it does not by itself answer every question about disability, imaging findings, fatigue, or adverse events.
The registry describes a randomized, placebo-controlled study with parallel groups and triple masking. Its official title describes a double-blind study, while the masking field records triple masking; the registry record does not specify which roles were masked. The question is therefore best read as a comparison of the recorded assigned regimens with placebo, rather than as a claim about outcomes beyond those measured and posted.
3. Trial Design
The registry identifies this as a phase 3, randomized, placebo-controlled, parallel-group trial sponsored by Sanofi. It lists enrollment as 1088 and status as completed. The recorded start is 2004-09 and primary completion is 2010-07. The condition is multiple sclerosis.
There were placebo and teriflunomide groups at 7 mg and 14 mg. Each regimen is described as once daily for 108 weeks. Allocation is listed as randomized, and masking as triple; the official title calls the study double-blind. The registry record does not explain this difference or identify the masked roles. Randomization supports comparisons based on assigned group, while a placebo comparator helps distinguish outcome patterns associated with the assigned regimens from patterns in the control group. Those design features do not remove uncertainty from the estimates or answer questions the reported outcomes did not measure.
The primary outcome was annualized relapse rate (ARR), assessed over 108 weeks. The primary analysis population is described as all randomized and treated participants, with participants retained in their originally assigned groups. This is an intent-to-treat description qualified by the requirement that participants were treated; further details about handling participants without outcome data are not reported in the registry record.
The registry lists secondary objectives concerning disability progression, MRI lesion burden, and fatigue, alongside safety and tolerability. Numerical findings are not present for every listed secondary outcome in the record summarized by these results. The study’s design and the registry’s listed objectives describe what was intended to be evaluated; they do not establish that every endpoint was fully observed or that every analysis was reported.
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: Randomization was stratified by country and baseline disability (Expanded Disability Status Scale \[EDSS\] score ≤3.5 or \>3.5). Assignment to groups was done centrally using an Interactive Voice Response System (IVRS\] in a 1:1:1 ratio after confirmation of the selection criteria. 1088 participants were randomized.
Overall Study
| Stage | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg |
|---|---|---|---|
| STARTED | 363 | 366 | 359 |
| Treated | 363 | 365 | 358 |
| COMPLETED | 259 | 274 | 263 |
| NOT COMPLETED | 104 | 92 | 96 |
Reasons for not completing this period:
| Reason | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg |
|---|---|---|---|
| Not treated due to protocol violation | 0 | 1 | 1 |
| Adverse Event | 29 | 37 | 38 |
| Lack of Efficacy | 24 | 14 | 17 |
| Protocol Violation | 3 | 2 | 5 |
| Lost to Follow-up | 4 | 0 | 2 |
| progressive disease | 11 | 4 | 2 |
| did not wish to continue | 33 | 32 | 26 |
| Reason other than above | 0 | 2 | 5 |
Analysis population for the primary outcome, as defined in the registry: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
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 | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 363 | 365 | 358 | 1086 | |
| Age Continuous | years | 38.4 (SD 9.0) | 37.5 (SD 9.0) | 37.8 (SD 8.2) | 37.9 (SD 8.8) |
| Sex: Female, Male: Female | Participants | 275 | 254 | 254 | 783 |
| Sex: Female, Male: Male | Participants | 88 | 111 | 104 | 303 |
| Region of enrollment: America | participants | 82 | 83 | 80 | 245 |
| Region of enrollment: Eastern Europe | participants | 114 | 116 | 108 | 338 |
| Region of enrollment: Western Europe | participants | 167 | 166 | 170 | 503 |
| Time since first diagnosis of multiple sclerosis (MS) | Years | 5.13 (SD 5.59) | 5.29 (SD 5.36) | 5.59 (SD 5.44) | 5.33 (SD 5.48) |
| Number of MS relapses: Within the past year | MS relapses | 1 (0 to 6) | 1 (0 to 6) | 1 (0 to 4) | 1 (0 to 6) |
| Number of MS relapses: Within the past 2 years | MS relapses | 2 (1 to 7) | 2 (1 to 12) | 2 (1 to 9) | 2 (1 to 12) |
| Time since most recent MS relapse onset | months | 6.28 (SD 3.62) | 6.29 (SD 3.29) | 6.50 (SD 3.71) | 6.35 (SD 3.54) |
| MS subtype: Relapsing Remitting | participants | 329 | 332 | 332 | 993 |
| MS subtype: Secondary Progressive | participants | 22 | 17 | 12 | 51 |
| MS subtype: Progressive Relapsing | participants | 12 | 16 | 14 | 42 |
| MS medication in the past 2 years: Yes | participants | 90 | 102 | 102 | 294 |
| MS medication in the past 2 years: No | participants | 273 | 263 | 256 | 792 |
| Baseline EDSS total score: ≤ 3.5 | participants | 281 | 280 | 276 | 837 |
| Baseline EDSS total score: > 3.5 | participants | 82 | 85 | 82 | 249 |
6. Primary Endpoint
The registry lists the primary outcome as Annualized Relapse Rate [ARR]: Poisson Regression Estimates, measured over 108 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | relapses per year |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is annualized relapse rate, reported as relapses per year. It represents the number of confirmed relapses during treatment relative to the amount of treatment time observed. The registry defines a relapse as the appearance or worsening of a clinical symptom that had been stable for at least 30 days, persisted for at least 24 hours, and occurred without fever. Confirmation required an increase in EDSS score or Functional System scores.
Annualizing relapse frequency makes rates more comparable when participants have different treatment durations. The registry’s analysis accounts for those differences by using treatment duration as an offset in a Poisson regression model. In general, an offset adjusts a count model for differing exposure time, so the model estimates a rate rather than treating every participant’s observation period as identical.
Relapse frequency is used because it directly addresses the stated primary objective: the effect of teriflunomide on relapse frequency in participants with relapsing multiple sclerosis. It is not interchangeable with disability progression, MRI lesion burden, fatigue, or safety outcomes. Those outcomes address different aspects of the study objectives and require their own measures and analyses.
The reported ARR estimates are 0.539 for placebo, 0.37 for teriflunomide 7 mg, and 0.369 for teriflunomide 14 mg. Their posted confidence intervals describe uncertainty around the group rate estimates, not directly around the reported relative risk reductions. The registry gives no confidence interval for those relative risk reduction comparisons.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted ARR estimates are lower in both teriflunomide groups than in the placebo group: 0.37 for teriflunomide 7 mg and 0.369 for teriflunomide 14 mg, compared with 0.539 for placebo. The registry’s reported Poisson regression analyses describe relative risk reductions of 31.2% for teriflunomide 7 mg and 31.5% for teriflunomide 14 mg. The reported p-values are small, indicating that the sponsor’s analyses found evidence against equal relapse rates under their model.
The confidence intervals attached to each ARR estimate show uncertainty in the group-specific rates. They are 0.466 to 0.623 for placebo, 0.318 to 0.432 for teriflunomide 7 mg, and 0.308 to 0.441 for teriflunomide 14 mg. These intervals are not confidence intervals for the relative risk reduction contrasts. Since the registry record does not give confidence intervals for those contrasts, it does not show their precision directly in that form. A p-value alone does not communicate the full range of effect sizes compatible with the analysis.
The primary model adjusted for region of enrollment and baseline EDSS stratum and used robust error variance. Its outcome was the total number of confirmed relapses, with log-transformed treatment duration used as an offset. The registry identifies the analysis population as randomized and treated participants retained in their originally assigned groups. Interpretation of the result should therefore remain tied to this population, endpoint definition, and model.
The estimates for the two doses are close to each other in the posted results. That descriptive similarity is not, by itself, a formal comparison between doses: the reported analyses compare each dose with placebo. The registry record does not report a direct dose-versus-dose test. Nor do the primary results establish effects on disability, MRI findings, fatigue, or safety. Those questions depend on separate outcomes and their analyses.
The posted primary results support a distinction between statistical evidence and precision. The reported analyses indicate evidence of differences in relapse rates relative to placebo, while the absence of contrast confidence intervals limits direct assessment of the uncertainty around the relative risk reduction estimates. The results describe this trial and its analysis; they do not establish what would occur in other populations or under other treatment conditions.
9. Statistical Methods Explained
The primary analysis uses Poisson regression for a count outcome. In general, a Poisson model relates an event count to explanatory variables and estimates how event frequency varies across groups. Relapses are counts, but participants can contribute different amounts of observed treatment time. The registry says that log-transformed treatment duration was included as an offset. In general, an offset allows a count model to account for differing exposure time when estimating rates.
Why use robust error variance?
The registry specifies robust error variance. In general, robust variance estimation adjusts the uncertainty calculation when the data may not meet the model’s ideal variance assumptions. Over-dispersion occurs when counts vary more than a standard Poisson model expects. If present and ignored, that extra variation can make standard errors too small and confidence intervals too narrow. Robust variance can reduce reliance on the strict Poisson variance assumption, although it does not correct every source of bias or make the model’s mean structure automatically appropriate.
The model included treatment group, region of enrollment, and baseline EDSS stratum as covariates. In general, covariate adjustment estimates treatment-group differences while accounting for the listed variables in the model. The registry does not report the detailed model specification beyond these features, nor does it state whether additional sensitivity analyses were performed.
What do the confidence intervals describe?
The posted 95% confidence intervals accompany the ARR estimate for each group. In general, a confidence interval expresses the uncertainty of an estimate under the analysis model and sampling assumptions. It is not a guarantee that a particular range contains the true value, and it is not a probability statement about the observed participants. Here, the intervals are for group-specific rates. They should not be read as intervals for the relative risk reduction comparisons because no such contrast intervals are reported in the registry record.
The sponsor’s reported primary comparisons use Poisson regression and give relative risk reduction estimates with p-values. A p-value describes how compatible the observed data are with a specified null hypothesis under the model; it is not the probability that the null hypothesis is true, nor does it measure clinical importance. The registry does not provide confidence limits for these comparison estimates, so the reported p-values and effect estimates do not supply the same information as an interval estimate.
How should the continuous-outcome recalculations be read?
The posted recalculations for fatigue are unadjusted comparisons based on summary statistics, not replacements for the sponsor’s analysis. They estimate differences in least-squares means and use an approximate pooled standard deviation derived from reported standard errors. The approximation is explicitly indicated in the calculations. In general, summary-statistic recalculations can help describe scale and uncertainty, but they cannot reproduce an adjusted model without participant-level data and full model details.
The recalculated fatigue intervals include values on either side of no mean difference, and the unadjusted p-values do not indicate a clear difference under those simple comparisons. This does not establish equivalence or absence of an effect. The registry’s own reported two-sided t-test p-values are close but not identical to the recalculated p-values. Differences can arise because the recalculations use approximate standard deviations and simple unadjusted methods, whereas the record does not provide enough detail to reproduce every aspect of the sponsor’s analysis.
What do the planning illustrations mean?
The sample-size illustrations use the observed fatigue effects as planning inputs, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They show participants per arm for 80% or 90% power when planning for 100%, 75%, or 50% of the observed effect. For example, planning for 100% of the observed effect gives 4,089 participants per arm for 80% power in the teriflunomide 7 mg comparison, and 64,156 participants per arm for 80% power in the teriflunomide 14 mg comparison. These are planning illustrations, not observed power, and they are not the trial’s own design justification. The registry record does not report the trial’s sample-size justification. The large planning requirements reflect the small observed mean differences used as inputs and should not be mistaken for a retrospective evaluation of the trial’s power.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Regression, Poisson | Relative risk reduction (%) 31.5 | not reported | < 0.001 |
| Regression, Poisson | Relative Risk Reduction (%) 31.2 | not reported | < 0.001 |
The registry’s primary results report Poisson regression estimates of relative risk reduction for each teriflunomide group versus placebo: 31.2% for teriflunomide 7 mg and 31.5% for teriflunomide 14 mg. The record also reports small p-values for those comparisons. There is no recalculated primary contrast in the posted summary statistics to set alongside the sponsor’s estimates, and no confidence interval for either relative risk reduction is reported. The sponsor’s primary analysis therefore supplies the comparison result available in the registry record.
For fatigue, the posted unadjusted recalculations are distinct from the registry’s reported two-sided t-test analyses. The recalculated estimates use summary statistics and an approximate pooled standard deviation; they are not a reconstruction of the sponsor’s full analysis. The resulting p-values differ slightly from the reported p-values, while the overall interpretation is similar: the available comparisons do not provide a clear signal of a mean difference. The registry record does not supply sufficient detail to explain the small numerical differences. The discrepancy indicator is false, but that does not make a summary-statistic recalculation equivalent to the sponsor’s analysis.
11. Multiplicity, Missing Data and Analysis Populations
The registry record does not report how multiplicity was handled across the primary and secondary analyses, across the two dose-versus-placebo comparisons, or across any additional analyses. When researchers test several outcomes or contrasts, the chance of a nominally unusual result can rise. In general, a prespecified hierarchy or multiplicity adjustment can address that concern. Without a reported plan, the p-values should be interpreted as results of the listed analyses rather than as a complete account of family-wise error control.
Missing-data methods are not reported in the registry record. The primary analysis population is described as all randomized and treated participants, analyzed according to original assignment, but that description does not specify how participants with incomplete treatment time or missing relapse information were handled. The offset accounts for differing treatment durations in the model; it does not, by itself, explain how missing outcomes were addressed or whether missingness could bias results.
The record does not report imputation methods, sensitivity analyses for missing data, or assumptions about why observations might be missing. These details matter because an analysis can be affected if participants with missing outcomes differ systematically from those whose outcomes are observed. No particular missing-data mechanism or remedy should be inferred from the stated model alone.
The listed primary population is also described as randomized and treated, rather than simply all randomized participants. The registry does not explain how this qualification was applied in practice. The number of participants included in each posted outcome group is stated, but the record does not provide a full participant-flow account in the information. These reporting limits make it harder to assess the reach of the analysis population and the potential influence of incomplete follow-up.
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 |
|---|---|---|---|
| Placebo | 46 | 360 | 12.8% |
| Teriflunomide 7 mg | 52 | 368 | 14.1% |
| Teriflunomide 14 mg | 57 | 358 | 15.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 259 of 360 |
| Teriflunomide 7 mg | 271 of 368 |
| Teriflunomide 14 mg | 265 of 358 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg |
|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | 5 of 360 | 5 of 368 | 5 of 358 |
| Cholelithiasis | Hepatobiliary disorders | 1 of 360 | 6 of 368 | 0 of 358 |
| Multiple sclerosis | Nervous system disorders | 3 of 360 | 0 of 368 | 3 of 358 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 3 of 360 | 2 of 368 | 1 of 358 |
| Inguinal hernia | Gastrointestinal disorders | 0 of 360 | 0 of 368 | 4 of 358 |
| Transaminases increased | Investigations | 2 of 360 | 1 of 368 | 1 of 358 |
| Gastroenteritis | Infections and infestations | 2 of 360 | 0 of 368 | 1 of 358 |
| Pyelonephritis | Infections and infestations | 0 of 360 | 0 of 368 | 3 of 358 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 1 of 360 | 0 of 368 | 2 of 358 |
| Foot fracture | Injury, poisoning and procedural complications | 1 of 360 | 1 of 368 | 1 of 358 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 98 of 360 | 94 of 368 | 93 of 358 |
| Headache | Nervous system disorders | 64 of 360 | 81 of 368 | 67 of 358 |
| Diarrhoea | Gastrointestinal disorders | 32 of 360 | 54 of 368 | 64 of 358 |
| Fatigue | General disorders | 51 of 360 | 47 of 368 | 52 of 358 |
| Back pain | Musculoskeletal and connective tissue disorders | 46 of 360 | 39 of 368 | 40 of 358 |
| Influenza | Infections and infestations | 35 of 360 | 34 of 368 | 43 of 358 |
| Alanine aminotransferase increased | Investigations | 21 of 360 | 41 of 368 | 47 of 358 |
| Nausea | Gastrointestinal disorders | 26 of 360 | 32 of 368 | 49 of 358 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 47 of 360 | 26 of 368 | 33 of 358 |
| Paraesthesia | Nervous system disorders | 30 of 360 | 34 of 368 | 35 of 358 |
Serious events with the highest arm-level rate: cholelithiasis (1.6%), alanine aminotransferase increased (1.4%), inguinal hernia (1.1%), pyelonephritis (0.8%), multiple sclerosis (0.8%).
The registry reports serious adverse event counts among the groups at risk: 46 of 360 for placebo, 52 of 368 for teriflunomide 7 mg, and 57 of 358 for teriflunomide 14 mg. It also reports other adverse event counts of 259 of 360, 271 of 368, and 265 of 358, respectively. These are counts and denominators as posted; they should not be converted into comparative rates without a specified analysis and an appropriate interpretation of follow-up and event definitions.
Listed serious adverse event terms include cholelithiasis at 1.6%, alanine aminotransferase increased at 1.4%, inguinal hernia at 1.1%, and pyelonephritis, multiple sclerosis, and intervertebral disc protrusion at 0.8% each. The registry record does not provide context for comparing these terms across groups. Death counts are not reported in the registry record.
These safety figures describe observed reports in the trial groups. They do not establish that an event was caused by an assigned regimen, and the record does not give enough information to assess duration-adjusted risks, event timing, or a formal between-group safety comparison. They should be read as descriptive registry results, not as a complete safety evaluation.
13. What the Result Does, and Does Not, Mean
The primary result describes lower posted annualized relapse-rate estimates in both teriflunomide groups than in the placebo group, alongside sponsor-reported relative risk reductions and p-values. It is evidence from this randomized trial under its stated endpoint definition and Poisson regression analysis. The finding does not, by itself, determine the size or precision of the relative reduction as fully as an estimate accompanied by a confidence interval would.
The result is limited to relapse frequency over the treatment period and to the analysis population described in the registry. It does not establish what would happen in other populations, under different treatment conditions, or beyond the recorded treatment timeframe. It also does not answer whether disability progression, MRI burden, or fatigue changed in a way that agrees with the primary result. Numerical results for some of those outcomes are not reported in the registry record.
A small p-value is not a measure of how important an effect is to participants, nor does it establish that the result is free from bias or model limitations. Conversely, an imprecise secondary estimate does not establish equivalence or prove there is no effect. The registry’s missing details on multiplicity, missing data, and some secondary results restrict broader interpretation.
The safety counts describe adverse events recorded in the groups, but they are not a causal comparison and do not substitute for a detailed safety analysis. Overall, the posted findings support a statistical description of the trial’s relapse-rate comparisons; they should not be translated into medical advice or a universal claim about treatment outcomes.
14. Why This Trial Matters Statistically
This trial illustrates why endpoint definition and exposure time matter for clinical count outcomes. A raw relapse count can be misleading if participants contribute different amounts of treatment time. The registry’s Poisson model uses an offset for treatment duration to estimate annualized rates, making the target of inference a rate rather than a simple count.
It also shows the difference between group estimates and treatment contrasts. The registry reports confidence intervals for each group’s ARR, but not confidence intervals for the relative risk reduction comparisons. Those are different quantities. Group-specific intervals help describe uncertainty around each rate, whereas a contrast interval would directly describe uncertainty around the estimated comparison.
Model choice is another statistical feature of interest. The stated use of robust error variance recognizes that count data may not follow the variance assumptions of a basic Poisson model. Adjustment for region and baseline EDSS stratum further defines how the primary comparison was estimated. These features make clear that a result is tied to an analysis model, not just to the observed group values.
Finally, the record highlights reporting limits that matter in evidence appraisal. Primary results are available, but contrast intervals, multiplicity procedures, missing-data handling, and numerical results for some secondary outcomes are not reported in the registry record. Distinguishing what the analysis directly estimates from what remains unreported is essential to interpreting clinical trial results with appropriate precision.
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 does not report confidence intervals for the primary relative risk reduction estimates. Although it provides confidence intervals for each group’s ARR, those do not directly quantify uncertainty in the between-group relative risk reductions. This limits assessment of the precision of the primary comparative effects.
Further limitations concern reporting of analysis decisions. The model covariates and robust variance approach are described, but the record does not provide a full statistical analysis plan, the trial’s sample-size justification, interim analysis details, or multiplicity procedures. Missing-data handling and sensitivity analyses are also not reported in the registry record. These omissions make it difficult to assess how robust the findings are to alternative analysis choices.
The record describes the primary population as randomized and treated participants analyzed in their assigned groups, but does not explain the treated-participant qualification or provide a full account of missing outcome information. Numerical results for some listed secondary outcomes are also not reported in the registry record. The fatigue recalculations are approximate, unadjusted analyses from summary statistics and should not be treated as a reproduction of the sponsor’s full analysis.
Finally, the listed safety counts are descriptive and do not establish causality or supply a formal comparative safety analysis. These trial-specific reporting limits do not negate the posted results, but they constrain how completely their precision, robustness, and broader relevance can be evaluated.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis — NCT00134563.
- Registry record last updated 2013-01-04; status last verified 2013-01.
- Results first posted 2012-11-06.
- 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
The registry record identifies NCT00134563 as a completed phase 3 randomized, placebo-controlled, parallel-group study sponsored by Sanofi. Enrollment is listed as 1088. The recorded start is 2004-09 and primary completion is 2010-07.
Participants were assigned to placebo, teriflunomide 7 mg, or teriflunomide 14 mg, with each regimen described as once daily for 108 weeks. The primary endpoint was annualized relapse rate, analyzed with Poisson regression, robust error variance, and treatment duration as an offset. The listed primary population was randomized and treated participants analyzed in their originally assigned groups.
The registry reports lower ARR estimates for both teriflunomide groups than placebo and relative risk reduction estimates from the sponsor’s Poisson analyses. It also lists secondary outcomes concerning disability progression, MRI burden, and fatigue, along with safety outcomes. The record does not report several details needed for a full appraisal, including primary contrast confidence intervals, multiplicity procedures, and missing-data methods.