Trial · NCT00751881
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
NCT00751881, Phase 3, Completed, Sanofi; results first posted 2013-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis. Trials, record NCT00751881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00751881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
- NCT number
- NCT00751881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,169 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Multiple Sclerosis
- Interventions
- Placebo, Teriflunomide
- First posted
- 2008-09-12
- Last updated
- 2016-07-07
- Other registries' IDs
- eudract:2007-004452-36
- Results first posted
- 2013-06-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate | Core treatment period between 48 - 152 weeks depending on time of enrollment | ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of 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 Expanded Disability Status Scale (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 | Core Treatment Period: Time to Disability Progression | Core treatment period between 48 - 152 weeks depending on time of enrollment | Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression \[i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score \>5.5) that persisted for at least 12 weeks\]. 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 | Core Treatment Period: Time Without Relapse | Core treatment period between 48 - 152 weeks depending on time of enrollment | Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. |
| Secondary | Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score | Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model. |
| Secondary | Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score | Baseline (before randomization), Week 12, Week 24 and Week 48 | FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Baseline adjusted least-squares means at week 48 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). All the timepoints from randomization up to Week 48 were included in the model. |
| Secondary | Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score | Baseline (before randomization) and up to Week 152 | Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors). |
| Secondary | Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores | Baseline (before randomization), Week 12, Week 24 and Week 48 | SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Two summary scores are obtained: * the physical health component summary score, * the mental health component summary score. Both scores range from 0 to 100 and a high score indicates a more favorable health state. Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures \[MMRM\] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model. |
| Secondary | Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores | Baseline (before randomization) and up to Week 152 | Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors). |
| Secondary | Core Treatment Period: Overview of Adverse Events | From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first | Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. |
| Secondary | Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE) | From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period | AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate | Core treatment period between 48 - 152 weeks depending on time of enrollment | Intent-to-treat population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received. | relapses per year | NUMBER |
| SECONDARY | Core Treatment Period: Time to Disability Progression | Core treatment period between 48 - 152 weeks depending on time of enrollment | Intent-to-treat population | percent probability | NUMBER |
| SECONDARY | Core Treatment Period: Time Without Relapse | Core treatment period between 48 - 152 weeks depending on time of enrollment | Intent-to-treat population | percent probability | NUMBER |
| SECONDARY | Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score | Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48 | Intent-to-treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score | Baseline (before randomization), Week 12, Week 24 and Week 48 | Intent-to-treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score | Baseline (before randomization) and up to Week 152 | Intent-to-treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores | Baseline (before randomization), Week 12, Week 24 and Week 48 | Intent-to-treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores | Baseline (before randomization) and up to Week 152 | Intent-to-treat population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Core Treatment Period: Overview of Adverse Events | From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first | All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group. | participants | NUMBER |
| SECONDARY | Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE) | From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period | Safety population: all randomized participants who received at least 1 dose of investigational product.~Two participants in placebo of core study received teriflunomide and were analyzed according to teriflunomide dose.~One participant in teriflunomide 14 mg in core study group who received 7 mg was analyzed in teriflunomide 7 mg group. | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate | Placebo | 0.501 | 95% Confidence Interval 0.432 to 0.581 | relapses per year | |
| Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate | Teriflunomide 7 mg | 0.389 | 95% Confidence Interval 0.332 to 0.457 | relapses per year | |
| Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate | Teriflunomide 14 mg | 0.319 | 95% Confidence Interval 0.267 to 0.381 | relapses per year | |
| Core Treatment Period: Time to Disability Progression | Placebo | Probability of disability progression at 24 weeks | 8.0 | 95% Confidence Interval 5.2 to 10.7 | percent probability |
| Core Treatment Period: Time to Disability Progression | Teriflunomide 7 mg | Probability of disability progression at 24 weeks | 5.3 | 95% Confidence Interval 3.0 to 7.6 | percent probability |
| Core Treatment Period: Time to Disability Progression | Teriflunomide 14 mg | Probability of disability progression at 24 weeks | 2.7 | 95% Confidence Interval 0.9 to 4.4 | percent probability |
| Core Treatment Period: Time to Disability Progression | Placebo | Probability of disability progression at 48 weeks | 14.2 | 95% Confidence Interval 10.6 to 17.9 | percent probability |
| Core Treatment Period: Time to Disability Progression | Teriflunomide 7 mg | Probability of disability progression at 48 weeks | 12.1 | 95% Confidence Interval 8.7 to 15.5 | percent probability |
| Core Treatment Period: Time to Disability Progression | Teriflunomide 14 mg | Probability of disability progression at 48 weeks | 7.8 | 95% Confidence Interval 4.9 to 10.8 | percent probability |
| Core Treatment Period: Time to Disability Progression | Placebo | Probability of disability progression at 108 weeks | 19.7 | 95% Confidence Interval 15.2 to 24.1 | percent probability |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Treatment Period | STARTED | Placebo / Teriflunomide 14 mg | 389 | |
| Core Treatment Period | STARTED | Teriflunomide 7 mg / 14 mg | 408 | |
| Core Treatment Period | STARTED | Teriflunomide 14 mg / 14 mg | 372 | |
| Core Treatment Period | Treated | Placebo / Teriflunomide 14 mg | 388 | |
| Core Treatment Period | Treated | Teriflunomide 7 mg / 14 mg | 407 | |
| Core Treatment Period | Treated | Teriflunomide 14 mg / 14 mg | 370 | |
| Core Treatment Period | COMPLETED | Placebo / Teriflunomide 14 mg | 263 | |
| Core Treatment Period | COMPLETED | Teriflunomide 7 mg / 14 mg | 273 | |
| Core Treatment Period | COMPLETED | Teriflunomide 14 mg / 14 mg | 244 | |
| Core Treatment Period | NOT COMPLETED | Placebo / Teriflunomide 14 mg | 126 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,362
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 | Nasopharyngitis | Infections and infestations | Placebo | 65 | 385 | |
| other | Nasopharyngitis | Infections and infestations | Teriflunomide 7 mg | 51 | 409 | |
| other | Nasopharyngitis | Infections and infestations | Teriflunomide 14 mg | 44 | 371 | |
| other | Nasopharyngitis | Infections and infestations | Placebo / 14 mg | 22 | 251 | |
| other | Nasopharyngitis | Infections and infestations | Teriflunomide 7 mg / 14 mg | 21 | 267 | |
| other | Nasopharyngitis | Infections and infestations | Teriflunomide 14 mg / 14 mg | 22 | 233 | |
| other | Influenza | Infections and infestations | Placebo | 19 | 385 | |
| other | Influenza | Infections and infestations | Teriflunomide 7 mg | 22 | 409 | |
| other | Influenza | Infections and infestations | Teriflunomide 14 mg | 22 | 371 | |
| other | Influenza | Infections and infestations | Placebo / 14 mg | 8 | 251 |
1 to 10 of 1,362Source ClinicalTrials.gov
See all 1,362 adverse eventsAdverse event totals18
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, all-cause mortality | Placebo / 14 mg | ||
| Total, all-cause mortality | Teriflunomide 7 mg / 14 mg | ||
| Total, all-cause mortality | Teriflunomide 14 mg / 14 mg | ||
| Total, other adverse events | Placebo | 247 | 385 |
| Total, other adverse events | Teriflunomide 7 mg | 270 | 409 |
| Total, other adverse events | Teriflunomide 14 mg | 254 | 371 |
| Total, other adverse events | Placebo / 14 mg | 152 | 251 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
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
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