Trial · NCT01895335
Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
NCT01895335, Phase 4, Completed, Sanofi; results first posted 2016-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients. Trials, record NCT01895335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01895335
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
- NCT number
- NCT01895335
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,001 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Multiple Sclerosis
- Interventions
- Teriflunomide
- First posted
- 2013-07-10
- Last updated
- 2016-12-06
- Results first posted
- 2016-12-06
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 | Week 48 | TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain. |
| Secondary | Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Baseline, Week 4, Week 48 | TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction . |
| Secondary | Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 | Week 4, Week 48 | TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction. |
| Secondary | Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48 | Baseline, Week 48 | PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability. |
| Secondary | Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48 | Baseline, Week 24, Week 48 | MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability. |
| Secondary | Annualized Treated Relapse Rate | Baseline up to end of treatment (up to Week 48) | Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. |
| Secondary | Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48 | Baseline up to end of treatment (up to Week 48) | A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks. |
| Secondary | Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48 | Baseline, Week 48 | SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function. |
| Secondary | Overview of Adverse Events (AEs) | From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. |
| Secondary | Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period | Baseline up to end of treatment (up to Week 48) | Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 | Week 48 | Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Baseline, Week 4, Week 48 | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, 'n' signifies number of participants with available data for specified category. | units on a scale | MEAN |
| SECONDARY | Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 | Week 4, Week 48 | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, 'n' signifies number of participants with available data for specified category. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48 | Baseline, Week 48 | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48 | Baseline, Week 24, Week 48 | Analysis was performed on Efficacy population. Here, 'n' signifies number of participants with available data at specified time points. | units on a scale | MEAN |
| SECONDARY | Annualized Treated Relapse Rate | Baseline up to end of treatment (up to Week 48) | Analysis was performed on Efficacy population. | relapses per patient-year | NUMBER |
| SECONDARY | Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48 | Baseline up to end of treatment (up to Week 48) | Analysis was performed on Efficacy population. | percent probability of treated relapse | NUMBER |
| SECONDARY | Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48 | Baseline, Week 48 | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. | units on a scale | MEAN |
| SECONDARY | Overview of Adverse Events (AEs) | From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP | Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period | Baseline up to end of treatment (up to Week 48) | Analysis was performed on Safety population. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 | Teriflunomide | 68.17 | Standard Deviation 27.66 | units on a scale | |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Global Satisfaction Score Change at Week 4 (n=482) | 21.35 | Standard Deviation 27.51 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Global Satisfaction Score Change at Week 48(n=457) | 16.55 | Standard Deviation 34.29 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Effectiveness Score Change at Week 4 (n=477) | 12.02 | Standard Deviation 25.53 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Effectiveness Score Change at Week 48 (n=453) | 10.19 | Standard Deviation 28.90 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Side effects Score Change at Week 4 (n=479) | 24.31 | Standard Deviation 35.47 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Side effects Score Change at Week 48 (n=456) | 19.95 | Standard Deviation 39.00 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Convenience Score Change at Week 4 (n=487) | 34.64 | Standard Deviation 26.37 | units on a scale |
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | Teriflunomide | Convenience Score Change at Week 48 (n=461) | 32.21 | Standard Deviation 27.01 | units on a scale |
| Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 | Teriflunomide | Change in Global Satisfaction Score (n=234) | -1.34 | Standard Deviation 23.59 | units on a scale |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriflunomide | 1,001 | |
| Overall Study | Treated | Teriflunomide | 1,000 | |
| Overall Study | COMPLETED | Teriflunomide | 786 | |
| Overall Study | NOT COMPLETED | Teriflunomide | 215 |
Source ClinicalTrials.gov
Adverse events127
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 | Diarrhoea | Gastrointestinal disorders | Teriflunomide | 172 | 1,000 | |
| other | Nausea | Gastrointestinal disorders | Teriflunomide | 82 | 1,000 | |
| other | Fatigue | General disorders | Teriflunomide | 52 | 1,000 | |
| other | Nasopharyngitis | Infections and infestations | Teriflunomide | 54 | 1,000 | |
| other | Urinary Tract Infection | Infections and infestations | Teriflunomide | 62 | 1,000 | |
| other | Alanine Aminotransferase Increased | Investigations | Teriflunomide | 57 | 1,000 | |
| other | Headache | Nervous system disorders | Teriflunomide | 68 | 1,000 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Teriflunomide | 229 | 1,000 | |
| serious | Neutropenia | Blood and lymphatic system disorders | Teriflunomide | 1 | 1,000 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Teriflunomide | 1 | 1,000 |
1 to 10 of 127Source ClinicalTrials.gov
See all 127 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriflunomide | ||
| Total, other adverse events | Teriflunomide | 498 | 1,000 |
| Total, serious adverse events | Teriflunomide | 127 | 1,000 |
Source ClinicalTrials.gov
Papers2
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
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.
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