TERI-PRO
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
Results by group
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48
Week 48
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Teriflunomide | 68.17 units on a scale | 27.66 (Standard Deviation) | 889 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Teriflunomide | 1000 | 127 (12.7%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48
Week 48
Quality of life (reported by participants)SafetyAssessment at 48 weeks (W48/EOT) of global satisfaction with teriflunomide treatment, measured by the Treatment Satisfaction Questionnaire for Medicine (TSQM) version 1.4 score
Quality of life (reported by participants)
Other measures (14)
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
Quality of life (reported by participants)SafetyChange From Week 4 in TSQM Scores in Naïve Participants to Week 48
Week 4, Week 48
Quality of life (reported by participants)SafetyChange From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48
Baseline, Week 48
Walking and mobilityChange From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48
Baseline, Week 24, Week 48
VisionThinking and memoryFatigueWalking and mobilityArm and hand functionSpasticityBladder, bowel and sexual functionAnnualized Treated Relapse Rate
Baseline up to end of treatment (up to Week 48)
RelapsesTime 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)
RelapsesChange From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48
Baseline, Week 48
Thinking and memoryOverview 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
SafetyPercentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period
Baseline up to end of treatment (up to Week 48)
Duration of Teriflunomide Treatment Exposure
Baseline up to end of treatment (up to Week 48)
Who could take part
Relapsing MS · 18 and over
Inclusion criteria: Participants with a relapsing form of multiple sclerosis (RMS) having signed written informed consent. Exclusion criteria: * According to local labelling, * Less than 18 years of age, * Current or history of receiving teriflunomide, * Previous treatment with leflunomide within 6 months prior to baseline, * Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN), * Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice), * Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections, * Women who were pregnant or breast-feeding, * Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study, * Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study, * Additional exclusion criteria applicable for Europe (EU) countries (in accordance with contraindications of EU summary of product characteristics [SmPC]): * Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia, * Participants with severe active infection until resolution, * Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group, * Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome. * Hypersensitivity to the active substance or to any of the excipients, * Other additional contraindications per local labeling. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant. To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.
Papers
Results
Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study.Mult Scler Relat Disord · 2019
Results
Patient-reported outcomes in patients with relapsing forms of MS switching to teriflunomide from other disease-modifying therapies: Results from the global Phase 4 Teri-PRO study in routine clinical practice.Mult Scler Relat Disord · 2018
Results
Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Brette S, Robinson M, Gold R; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6.
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Related trials
History
Started
Jun 2013
Main results due
Nov 2015
Finished
Nov 2015
Results posted
Dec 2016
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