CompletedPhase 4Relapsing MSNCT018953352013-001439-34

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

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

GroupValueIntervalNumber analysed
Teriflunomide68.17 units on a scale27.66 (Standard Deviation)889

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Teriflunomide1000127 (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)Safety
  • Assessment 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)Safety
  • Change From Week 4 in TSQM Scores in Naïve Participants to Week 48

    Week 4, Week 48

    Quality of life (reported by participants)Safety
  • Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48

    Baseline, Week 48

    Walking and mobility
  • Change 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 function
  • Annualized Treated Relapse Rate

    Baseline up to end of treatment (up to Week 48)

    Relapses
  • 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)

    Relapses
  • Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48

    Baseline, Week 48

    Thinking and memory
  • 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
  • Percentage 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

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History

    1. Started

      Jun 2013

    2. Main results due

      Nov 2015

    3. Finished

      Nov 2015

    4. Results posted

      Dec 2016

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