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 Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis (NCT00475865), a randomized phase 2 study. The primary outcome is Overview of Adverse Events (AE].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00475865 |
| Phase | Phase 2 |
| Condition | Multiple Sclerosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 123 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sanofi |
| Results posted | Yes |
2. Clinical Question
Population
People with multiple sclerosis and relapses who were receiving a stable dose of glatiramer acetate. The primary-outcome population is described as all randomized and treated participants, classified according to the drug actually received. Further eligibility details, such as age criteria or disease-duration requirements, are not reported in the registry record.
Intervention
Teriflunomide taken once daily for 24 weeks alongside glatiramer acetate. The registry lists two teriflunomide dose groups: 7 mg and 14 mg. The study’s primary objective was to estimate tolerability and safety for these doses when used with glatiramer acetate.
Comparator
Placebo for teriflunomide, taken once daily alongside glatiramer acetate for 24 weeks. Glatiramer acetate was therefore part of each listed treatment group, while the teriflunomide component differed between active-dose and placebo groups.
Primary question
What safety and tolerability findings were observed during treatment and the specified follow-up period when either teriflunomide dose was added to stable glatiramer acetate, compared with placebo added to glatiramer acetate? The registry’s primary outcome is an overview of adverse events, reported as numbers of participants. The posted results do not reduce this multi-category outcome to a single primary comparison.
This is a safety-focused question rather than a single test of whether the treatment changes multiple sclerosis activity. The registry also describes secondary aims concerning MRI measures, relapse rate, fatigue, and teriflunomide pharmacokinetics. Those aims supply context for the study, but the posted primary-outcome figures are adverse-event counts. Results for the secondary aims are not reported in the registry record.
3. Trial Design
The registry identifies this as a Phase II, randomized, triple-masked, parallel-group study. Its official title describes a multinational, double-blind, placebo-controlled pilot study intended to estimate tolerability, safety, pharmacokinetics, and pharmacodynamic effects when teriflunomide was added to glatiramer acetate for 24 weeks. The record lists enrollment of 123 and a completed status.
There were three treatment groups: placebo plus glatiramer acetate, teriflunomide 7 mg plus glatiramer acetate, and teriflunomide 14 mg plus glatiramer acetate. Each treatment was described as once daily for 24 weeks. The primary-outcome population was all randomized and treated participants, with participants assigned to the group corresponding to the drug actually received. The adverse-event group counts are 41 for placebo plus glatiramer acetate, 42 for teriflunomide 7 mg plus glatiramer acetate, and 40 for teriflunomide 14 mg plus glatiramer acetate.
In general, random assignment is intended to make treatment groups comparable on average, while masking is intended to limit the influence of treatment knowledge on care or assessment. The registry labels masking as triple, but does not report which roles were masked or how masking was maintained. It describes the study as double-blind in the official title as well; the details needed to reconcile those labels are not reported in the registry record.
The primary safety observation window began with first study-drug intake and continued up to 112 days after last intake or until first intake in extension study LTS6047, whichever occurred first, with a maximum of 40 weeks. This adverse-event follow-up window is distinct from the 24-week treatment period. The record lists a start date of 2007-04 and primary completion in 2009-10. A more detailed account of randomization procedures, allocation concealment, study sites, treatment adherence, and participant flow is 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: Randomization was stratified by country. 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. 123 participants were randomized.
Overall Study
| Stage | Placebo + GA | Teriflunomide 7 mg + GA | Teriflunomide 14 mg + GA |
|---|---|---|---|
| STARTED | 41 | 42 | 40 |
| Treated | 41 | 42 | 40 |
| COMPLETED | 39 | 37 | 34 |
| NOT COMPLETED | 2 | 5 | 6 |
Reasons for not completing this period:
| Reason | Placebo + GA | Teriflunomide 7 mg + GA | Teriflunomide 14 mg + GA |
|---|---|---|---|
| Adverse Event | 0 | 3 | 4 |
| Lack of Efficacy | 1 | 0 | 0 |
| Progressive disease | 0 | 1 | 2 |
| Participant did not wish to continue | 1 | 0 | 0 |
| Other than above | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
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 + GA | Teriflunomide 7 mg + GA | Teriflunomide 14 mg + GA | Total |
|---|---|---|---|---|---|
| Participants analysed | 41 | 42 | 40 | 123 | |
| Age Continuous | years | 41.8 (SD 8.5) | 42.1 (SD 7.8) | 40.3 (SD 7.5) | 41.4 (SD 7.9) |
| Sex: Female, Male: Female | Participants | 32 | 33 | 32 | 97 |
| Sex: Female, Male: Male | Participants | 9 | 9 | 8 | 26 |
| Region of Enrollment: Europe | participants | 23 | 22 | 21 | 66 |
| Region of Enrollment: North America | participants | 18 | 20 | 19 | 57 |
| Time since first diagnosis of Multiple Sclerosis [MS] | years | 7.61 (SD 6.04) | 8.82 (SD 5.85) | 7.60 (SD 6.03) | 8.02 (SD 5.95) |
| Number of MS relapses: Within the past year | MS relapses | 1 (0 to 3) | 1 (0 to 3) | 1 (0 to 4) | 1 (0 to 4) |
| Number of MS relapses: Within the past 2 years | MS relapses | 1 (0 to 5) | 1 (0 to 7) | 1 (0 to 6) | 1 (0 to 7) |
| Time since most recent MS relapse onset | months | 24.90 (SD 34.84) | 21.52 (SD 30.48) | 23.88 (SD 31.53) | 23.41 (SD 32.09) |
| MS subtype: Relapsing Remitting | participants | 39 | 40 | 37 | 116 |
| MS subtype: Secondary Progressive | participants | 2 | 2 | 3 | 7 |
| MS subtype: Progressive Relapsing | participants | 0 | 0 | 0 | 0 |
| Baseline Expanded Disability Status Scale [EDSS] score | units on a scale | 2.54 (SD 1.11) | 2.43 (SD 1.23) | 2.60 (SD 1.28) | 2.52 (SD 1.20) |
6. Primary Endpoint
The registry lists the primary outcome as Overview of Adverse Events (AE], measured over from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled “Overview of Adverse Events” and is measured as the number of participants. The registry defines an adverse event as an unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. The outcome population includes all randomized and treated participants, classified according to the drug actually received.
Adverse events are used in clinical trials to describe safety observations during exposure and follow-up. Counting participants with events gives a direct summary of how many people experienced an event within each treatment group; it is not the same as counting every event occurrence. A participant can experience more than one event, so participant counts should not be interpreted as total event counts.
The registry reports serious adverse events separately from other adverse events in the posted results. The observation period extended beyond the 24-week treatment period for some participants, according to the stated follow-up rule. As a result, the counts concern the specified safety window, not only events during the 24 weeks of assigned treatment.
The primary outcome is presented across several categories rather than as one specified contrast. The registry record does not report a single effect estimate comparing a teriflunomide group with placebo, nor a confidence interval or hypothesis test for the primary outcome. The posted counts can therefore be read descriptively, but they do not by themselves establish the precision of a treatment-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary-outcome results give participant counts for serious and other adverse events in each treatment group. In the placebo plus glatiramer acetate group, 3 of 41 participants had a serious adverse event and 20 of 41 had another adverse event. In the teriflunomide 7 mg plus glatiramer acetate group, the corresponding counts were 3 of 42 and 20 of 42. In the teriflunomide 14 mg plus glatiramer acetate group, they were 1 of 40 and 25 of 40.
These are descriptive counts within the registry’s safety population and follow-up window. They allow readers to see how many participants in each group were recorded in each broad category. They do not report the timing, duration, recurrence, severity distribution, or clinical course of events beyond the categories and terms listed. The record also does not report a formal comparison of these group counts, an adjusted analysis, or uncertainty intervals for the differences.
The serious-event counts are close in the placebo and 7 mg groups as reported, while the 14 mg group has a lower recorded count. The other-event counts are 20 in each of the first two groups and 25 in the 14 mg group. These descriptions should remain at the level of the posted data: without a reported inferential analysis and its uncertainty, the counts cannot establish whether apparent differences reflect a treatment effect or chance variation. No conclusion about benefit or harm should be drawn from the counts alone.
The registry also lists serious-event terms with percentages: suicidal ideation at 2.5%, and abscess, cerebral ischaemia, hepatic enzyme increased, facial bones fracture, and epilepsy each at 2.4%. The record does not explain the denominator or the method used to derive these percentages in the information available for interpretation. They should therefore be read as registry-listed figures, not as percentages recalculated from the group-level participant counts.
The study’s stated secondary objectives include MRI measures, relapse rate, fatigue, and pharmacokinetic analyses. The registry record does not report their results in the posted outcome information. Thus, the available results address the primary safety summary but do not answer whether MRI findings, relapse rate, fatigue, or drug concentrations differed between groups.
The primary outcome has multiple categories and is not reduced to one comparison in the registry results. That limits direct statements about a single contrast between either teriflunomide dose and placebo. The record’s lack of confidence intervals and a reported statistical test also means that the precision of any group difference is not quantified. The most defensible reading is a descriptive account of adverse-event participants during the specified safety period, with uncertainty and comparative inference left unresolved.
9. Statistical Methods Explained
The registry identifies the study as randomized, triple-masked, and parallel-group. These design labels describe how the trial was organized, but the registry record does not report the detailed procedures used to generate the random sequence, conceal assignments, or maintain masking. The official title also calls the study double-blind; which participants or staff were masked, and how the two masking labels relate to one another, is not reported in the registry record.
What does a randomized parallel-group design contribute?
General explanation: random allocation is intended to reduce systematic differences between treatment groups at the start of a trial. In a parallel-group design, participants are assigned to one treatment group and followed in that group rather than crossing over between treatments. These features support a comparative interpretation when outcomes, follow-up, and analysis are handled appropriately. They do not guarantee that groups will be identical, and the registry record does not provide baseline characteristics or enough analysis detail to assess all aspects of comparability.
Here, the three groups combined glatiramer acetate with either placebo, teriflunomide 7 mg, or teriflunomide 14 mg. The primary-outcome description says participants were included according to the drug actually received. This is the population and classification approach stated for that outcome; a separate intention-to-treat analysis population is not reported in the registry record.
How should participant counts be understood?
The primary outcome is measured as numbers of participants, and the posted results distinguish serious adverse events from other adverse events. A participant count answers how many people in a group were recorded as having an event in the category. It is not an event-rate calculation over person-time, and the record does not describe a time-to-event analysis for the primary outcome. Because a participant may have more than one adverse event, counts of participants should not be confused with counts of event episodes.
General explanation: a confidence interval expresses uncertainty around an estimate under a specified statistical model. It helps distinguish a relatively precise estimate from one compatible with a broad range of values. No confidence interval for a primary-outcome treatment contrast is reported in the registry record. Similarly, no primary-outcome p-value or formal comparison is reported, so the descriptive counts cannot be converted into a claim of statistical significance.
Why can sparse event counts be difficult to compare?
General explanation: when event counts are small, estimates can be imprecise, and a small change in the observed count can substantially affect a comparison. Statistical methods for binary outcomes may account for this uncertainty, but the appropriate method depends on the analysis question and prespecified plan. The registry record does not report a statistical method for comparing the serious or other adverse-event participant counts. No method should be inferred from the fact that counts are presented.
Over-dispersion is a general concern for count outcomes when observed variation exceeds what a chosen count model expects. It can make standard errors too small if the model does not allow for the extra variation. This is a general statistical issue, not a reported feature or diagnosis of the primary safety data in this trial. The registry record does not state that an over-dispersion adjustment was used for the primary outcome.
What does the observation window imply?
The adverse-event window starts at first study-drug intake and ends at the earlier of 112 days after last intake or first intake in extension study LTS6047, with a maximum of 40 weeks. This means the posted safety outcome is defined over a period that can extend beyond the 24-week assigned treatment period. General explanation: specifying follow-up time matters because participants with different observation durations may have different opportunities to experience and report events. The record does not provide participant-level follow-up durations or an exposure-adjusted analysis, so those cannot be assessed from the counts.
The registry describes the trial’s primary aim as estimating tolerability and safety, and the study as a pilot. The sample-size illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect specified as a fraction of the observed effect. For outcomes other than time-to-event outcomes, such illustrations are expressed as participants per arm; they are planning illustrations, not observed power. The registry record does not report that these assumptions were the trial’s original design rationale or that the illustrations reproduce the sponsor’s planning process.
The record does not report a prespecified primary-outcome statistical model, a formal testing hierarchy, adjustment for multiple comparisons, interim analyses, or a sample-size justification. It also does not report confidence intervals or sponsor analyses for the primary adverse-event categories. The registry’s lists of secondary outcomes include MRI lesion measures, annualized relapse rate estimates, and teriflunomide plasma concentration, but their analysis methods and results are not reported in the registry record. Poisson regression appears in the labels for certain secondary MRI and relapse outcomes; it should not be assumed to describe the primary safety analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry describes several secondary objectives in addition to the primary safety and tolerability objective. These include MRI parameters, relapse rate, patient-reported fatigue, and pharmacokinetic analyses. The listed secondary outcomes include change in total lesion volume, number and volume of gadolinium-enhancing T1 lesions, annualized relapse rate estimates, and teriflunomide plasma concentration. Considering multiple outcomes can create a multiplicity issue: in general, testing many hypotheses increases the chance of at least one apparently unusual result if no adjustment or prespecified hierarchy is used. The registry record does not report a multiplicity strategy, testing hierarchy, or which outcomes were treated as confirmatory.
The registry record does not report how missing outcome values were handled, whether any imputation was used, or how participants with incomplete follow-up were treated in analyses. It does not provide outcome-specific denominators beyond the adverse-event counts, nor does it describe reasons for missingness or withdrawals. These details matter because incomplete observation can affect both the amount of information and the interpretation of group comparisons.
For the primary outcome, the stated population is all randomized and treated participants, with participants assigned according to the drug actually received. This is the population definition reported for that outcome. A separate intention-to-treat population, per-protocol population, or analysis population for secondary outcomes is not reported in the registry record. The record does not report interim analyses or stopping rules. These absences limit assessment of how the study managed multiplicity, missing data, and analysis populations; they do not establish that a particular procedure was or was not used outside the registry information.
11. 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 + GA | 3 | 41 | 7.3% |
| Teriflunomide 7 mg + GA | 3 | 42 | 7.1% |
| Teriflunomide 14 mg + GA | 1 | 40 | 2.5% |
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 + GA | 20 of 41 |
| Teriflunomide 7 mg + GA | 20 of 42 |
| Teriflunomide 14 mg + GA | 25 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo + GA | Teriflunomide 7 mg + GA | Teriflunomide 14 mg + GA |
|---|---|---|---|---|
| Abscess | Infections and infestations | 1 of 41 | 0 of 42 | 0 of 40 |
| Suicidal ideation | Psychiatric disorders | 0 of 41 | 0 of 42 | 1 of 40 |
| Cerebral ischaemia | Nervous system disorders | 1 of 41 | 0 of 42 | 0 of 40 |
| Epilepsy | Nervous system disorders | 0 of 41 | 1 of 42 | 0 of 40 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 0 of 41 | 1 of 42 | 0 of 40 |
| Alanine aminotransferase increased | Investigations | 0 of 41 | 1 of 42 | 0 of 40 |
| Hepatic enzyme increased | Investigations | 1 of 41 | 0 of 42 | 0 of 40 |
| Facial bones fracture | Injury, poisoning and procedural complications | 1 of 41 | 0 of 42 | 0 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo + GA | Teriflunomide 7 mg + GA | Teriflunomide 14 mg + GA |
|---|---|---|---|---|
| Headache | Nervous system disorders | 5 of 41 | 6 of 42 | 6 of 40 |
| Fatigue | General disorders | 6 of 41 | 3 of 42 | 7 of 40 |
| Nasopharyngitis | Infections and infestations | 3 of 41 | 6 of 42 | 4 of 40 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 41 | 5 of 42 | 7 of 40 |
| Diarrhoea | Gastrointestinal disorders | 0 of 41 | 3 of 42 | 8 of 40 |
| Urinary tract infection | Infections and infestations | 3 of 41 | 4 of 42 | 2 of 40 |
| Nausea | Gastrointestinal disorders | 2 of 41 | 4 of 42 | 3 of 40 |
| Upper respiratory tract infection | Infections and infestations | 4 of 41 | 1 of 42 | 2 of 40 |
| Rash | Skin and subcutaneous tissue disorders | 0 of 41 | 1 of 42 | 5 of 40 |
| Dizziness | Nervous system disorders | 3 of 41 | 1 of 42 | 0 of 40 |
Serious events with the highest arm-level rate: suicidal ideation (2.5%), abscess (2.4%), cerebral ischaemia (2.4%), hepatic enzyme increased (2.4%), facial bones fracture (2.4%).
The serious adverse-event figures are participant counts in the registry’s specified safety population and follow-up period. Serious events were recorded for 3 of 41 participants in the placebo plus glatiramer acetate group, 3 of 42 in the teriflunomide 7 mg plus glatiramer acetate group, and 1 of 40 in the teriflunomide 14 mg plus glatiramer acetate group. The counts for other adverse events were 20 of 41, 20 of 42, and 25 of 40, respectively.
These broad-category counts do not describe the clinical details of each event, when it began, whether it recurred, or how long it lasted. The serious-event term list includes suicidal ideation at 2.5%, and abscess, cerebral ischaemia, hepatic enzyme increased, facial bones fracture, and epilepsy each at 2.4%. The registry record does not explain the denominator for those percentages, so they should not be treated as group-specific percentages or recalculated from the participant counts.
Deaths are not reported in the registry record. The posted counts are descriptive, and no formal comparison or uncertainty interval for the group differences is reported. They should not be interpreted as proof that one group had greater or lesser safety risk.
12. What the Result Does, and Does Not, Mean
The registry results describe adverse-event participants in three randomized treatment groups in a Phase II study of teriflunomide added to glatiramer acetate. They show the recorded counts for serious and other adverse events over a window beginning at first study-drug intake and ending according to the stated follow-up rule. This is useful descriptive information about the outcome categories the registry reports.
The results do not provide a single primary-outcome contrast between either teriflunomide dose and placebo. They also do not report confidence intervals, a formal statistical test for these categories, or a detailed account of event severity and timing. Without those elements, the counts do not quantify the precision of a treatment difference or establish that a difference is attributable to treatment rather than chance or other sources of variation.
The record’s secondary aims concern MRI findings, relapse rate, fatigue, and pharmacokinetics, but their results are not reported in the registry record. The adverse-event findings therefore cannot be used to answer those secondary questions. Nor do they establish how outcomes might look outside the studied population, treatment combinations, doses, and follow-up period.
General explanation: a randomized comparison can support causal interpretation when allocation, follow-up, outcome measurement, and analysis are sufficiently well conducted. A registry record is not a substitute for full analysis details. In this case, the stated randomized design is relevant context, but details about randomization procedures, missing data, and inferential analyses are not reported. The appropriate conclusion is limited to the recorded adverse-event counts and their stated observation window, without extending them to a broader claim about treatment benefit or harm.
The study was described as a pilot intended to estimate safety, tolerability, pharmacokinetics, and pharmacodynamic effects. Estimates from a pilot can help characterize what was observed and inform further study, but the registry record does not report the original sample-size justification or a prespecified precision target. Planning illustrations based on an observed effect are not observed power and do not replace uncertainty intervals around the trial’s actual estimates.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a study’s broad objectives and the result that can be interpreted from its posted primary outcome. The study aimed to estimate tolerability and safety for two teriflunomide doses when added to glatiramer acetate. The registry gives participant counts for serious and other adverse events, but it does not provide one prespecified-looking numerical contrast with an uncertainty interval or inferential test. That distinction matters when readers are tempted to treat a set of group counts as a definitive comparison.
The trial also illustrates why outcome definitions and follow-up windows need to be read together. Treatment was described for 24 weeks, while adverse-event observation could extend to 112 days after last intake or until the first intake in an extension study, whichever occurred first, with a maximum of 40 weeks. The resulting safety counts are not limited to events during active 24-week treatment. In general, the period during which outcomes are collected is part of what an estimate means.
Finally, the registry names multiple secondary outcomes, while reporting no results for them in the information. In general, multiple outcomes raise questions about which analyses were planned as primary, how multiplicity was handled, and how missing measurements were managed. Those details are not reported in the registry record. The statistical lesson is to separate the design labels and stated aims from the analyses actually documented, and to match the strength of interpretation to the level of detail in the posted results.
14. 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 available record does not report a single treatment-effect estimate for the primary outcome. It gives participant counts by serious and other adverse-event categories, but no confidence intervals, p-values, or formal between-group comparison for those categories. This prevents an assessment of statistical precision and leaves the observed count differences descriptive.
Details needed to evaluate the safety data are also limited. The record does not report the timing, duration, recurrence, severity distribution, or individual clinical descriptions of adverse events. It gives serious-event term percentages, but does not explain their denominator in the information. Deaths are not reported in the registry record.
The adverse-event follow-up period can extend beyond the 24-week treatment period, and participant-specific observation time is not reported. No exposure-adjusted analysis or account of incomplete follow-up is described. The registry record also does not report missing-data methods, withdrawals by group, baseline characteristics, randomization procedures, allocation concealment, or which roles were masked. The official title’s double-blind wording and the design label of triple masking are both recorded, but the masking details are not reported.
The record identifies MRI measures, relapse rate, fatigue, and pharmacokinetic assessments as secondary aims or outcomes, but does not report their results. It does not report a multiplicity plan, analysis hierarchy, interim analyses, or original sample-size justification. These limitations restrict both the interpretation of the primary safety counts and evaluation of the broader study objectives. They are limitations of the information reported in the registry record and should not be taken as proof that procedures were absent from the full study documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis — NCT00475865.
- Registry record last updated 2012-11-06; status last verified 2012-11.
- Results first posted 2012-11-02.
- 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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18. Record Summary
NCT00475865 is a completed Phase II randomized, triple-masked, parallel-group study sponsored by Sanofi. The registry lists enrollment of 123, a start date of 2007-04, and primary completion in 2009-10. The study compared placebo, teriflunomide 7 mg, or teriflunomide 14 mg, each alongside glatiramer acetate for 24 weeks.
The primary objective was to estimate tolerability and safety. The primary outcome is an overview of adverse events measured as participant counts, with observation from first study-drug intake through the stated follow-up window, up to a maximum of 40 weeks. The posted results report serious and other adverse-event counts for each group. A single primary comparison, uncertainty intervals, and a formal test are not reported in the registry record. Results for the listed secondary aims are not reported in the registry record.