Trial · NCT00134563
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
NCT00134563, Phase 3, Completed, Sanofi; results first posted 2012-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis. Trials, record NCT00134563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00134563
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
- NCT number
- NCT00134563
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,088 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Multiple Sclerosis
- Interventions
- Teriflunomide, Placebo (for teriflunomide)
- First posted
- 2005-08-25
- Last updated
- 2013-01-04
- Other registries' IDs
- eudract:2004-000555-42
- Results first posted
- 2012-11-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate [ARR]: Poisson Regression Estimates | 108 weeks | ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and baseline EDSS stratum as covariates). |
| Secondary | Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | 108 weeks | 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score \>5.5) that persisted for at least 12 weeks. Probability of disability progression at 24, 48 and 108 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation. Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t. |
| Secondary | Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) | baseline (before randomization) and 108 weeks | Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis. |
| Secondary | Changes From Baseline in Fatigue Impact Scale [FIS] Total Score | baseline (before randomization) and 108 weeks | FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures \[MMRM\] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). |
| Other | Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) | 108 weeks | Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as "offset" variable; treatment group, region of enrollment, baseline EDSS stratum and baseline number of Gd-enhancing T1-lesions as covariates). |
| Other | Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan | 108 weeks | Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate [ARR]: Poisson Regression Estimates | 108 weeks | All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis). | relapses per year | NUMBER |
| SECONDARY | Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | 108 weeks | All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis). | percent probability | NUMBER |
| SECONDARY | Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) | baseline (before randomization) and 108 weeks | All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis). | mililiters (mL) | MEAN |
| OTHER_PRE_SPECIFIED | Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) | 108 weeks | All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis). | lesions per scan | NUMBER |
| OTHER_PRE_SPECIFIED | Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan | 108 weeks | All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis). | mililiters (mL) | MEAN |
| SECONDARY | Changes From Baseline in Fatigue Impact Scale [FIS] Total Score | baseline (before randomization) and 108 weeks | All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis). | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate [ARR]: Poisson Regression Estimates | Placebo | 0.539 | 95% Confidence Interval 0.466 to 0.623 | relapses per year | |
| Annualized Relapse Rate [ARR]: Poisson Regression Estimates | Teriflunomide 7 mg | 0.370 | 95% Confidence Interval 0.318 to 0.432 | relapses per year | |
| Annualized Relapse Rate [ARR]: Poisson Regression Estimates | Teriflunomide 14 mg | 0.369 | 95% Confidence Interval 0.308 to 0.441 | relapses per year | |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Placebo | Probability of disability progression at 24 weeks | 8.6 | 95% Confidence Interval 5.7 to 11.6 | percent probability |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Teriflunomide 7 mg | Probability of disability progression at 24 weeks | 5.8 | 95% Confidence Interval 3.3 to 8.3 | percent probability |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Teriflunomide 14 mg | Probability of disability progression at 24 weeks | 6.2 | 95% Confidence Interval 3.6 to 8.8 | percent probability |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Placebo | Probability of disability progression at 48 weeks | 16.0 | 95% Confidence Interval 12.1 to 20.0 | percent probability |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Teriflunomide 7 mg | Probability of disability progression at 48 weeks | 13.1 | 95% Confidence Interval 9.4 to 16.7 | percent probability |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Teriflunomide 14 mg | Probability of disability progression at 48 weeks | 11.3 | 95% Confidence Interval 7.9 to 14.8 | percent probability |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Placebo | Probability of disability progression at 108 weeks | 27.3 | 95% Confidence Interval 22.3 to 32.3 | percent probability |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 363 | |
| Overall Study | STARTED | Teriflunomide 7 mg | 366 | |
| Overall Study | STARTED | Teriflunomide 14 mg | 359 | |
| Overall Study | Treated | Placebo | 363 | |
| Overall Study | Treated | Teriflunomide 7 mg | 365 | |
| Overall Study | Treated | Teriflunomide 14 mg | 358 | |
| Overall Study | COMPLETED | Placebo | 259 | |
| Overall Study | COMPLETED | Teriflunomide 7 mg | 274 | |
| Overall Study | COMPLETED | Teriflunomide 14 mg | 263 | |
| Overall Study | NOT COMPLETED | Placebo | 104 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events462
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Placebo | 22 | 360 | |
| other | Bronchitis | Infections and infestations | Teriflunomide 7 mg | 18 | 368 | |
| other | Bronchitis | Infections and infestations | Teriflunomide 14 mg | 29 | 358 | |
| other | Gastroenteritis | Infections and infestations | Placebo | 15 | 360 | |
| other | Gastroenteritis | Infections and infestations | Teriflunomide 7 mg | 22 | 368 | |
| other | Gastroenteritis | Infections and infestations | Teriflunomide 14 mg | 20 | 358 | |
| other | Influenza | Infections and infestations | Placebo | 35 | 360 | |
| other | Influenza | Infections and infestations | Teriflunomide 7 mg | 34 | 368 | |
| other | Influenza | Infections and infestations | Teriflunomide 14 mg | 43 | 358 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 98 | 360 |
1 to 10 of 462Source ClinicalTrials.gov
See all 462 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Teriflunomide 7 mg | ||
| Total, all-cause mortality | Teriflunomide 14 mg | ||
| Total, other adverse events | Placebo | 259 | 360 |
| Total, other adverse events | Teriflunomide 7 mg | 271 | 368 |
| Total, other adverse events | Teriflunomide 14 mg | 265 | 358 |
| Total, serious adverse events | Placebo | 46 | 360 |
| Total, serious adverse events | Teriflunomide 7 mg | 52 | 368 |
| Total, serious adverse events | Teriflunomide 14 mg | 57 | 358 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00134563
GET https://conductscience.org/api/trials/v1/NCT00134563/results?page=2