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Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients (TERI-PRO)

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ClinicalTrials.gov Identifier: NCT01895335
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 10, 2013
Results First Submitted Date  ICMJE October 10, 2016
Results First Posted Date  ICMJE December 6, 2016
Last Update Posted Date December 6, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
Assessment at 48 weeks of global satisfaction with teriflunomide treatment, measured by the Treatment Satisfaction Questionnaire for Medicine (TSQM) version 1.4 score [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 [ Time Frame: 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 .
  • Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 [ Time Frame: 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.
  • Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48 [ Time Frame: 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.
  • Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48 [ Time Frame: 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.
  • Annualized Treated Relapse Rate [ Time Frame: 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.
  • Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48 [ Time Frame: 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.
  • Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48 [ Time Frame: 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.
  • Overview of Adverse Events (AEs) [ Time Frame: 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.
  • Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period [ Time Frame: 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.
  • Duration of Teriflunomide Treatment Exposure [ Time Frame: Baseline up to end of treatment (up to Week 48) ]
    Duration of exposure was defined as last dose date - first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).
  • Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
    The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.
  • Change From Baseline in Stern Leisure Activity Scale at Week 48 [ Time Frame: Baseline, Week 48 ]
    The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant's participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.
  • Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48 [ Time Frame: Baseline, Week 48 ]
    EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • Change in Treatment Satisfaction Questionnaire for Medicine (TSQM) from baseline to week 4 (W4) and to week 48 (W48) in patients switching from another Disease Modifying Therapy (DMT) [ Time Frame: Baseline to W4 and W4 to W48 ]
  • Change in Treatment Satisfaction Questionnaire for Medicine (TSQM) from W4 to W48 in naïve patients [ Time Frame: W4 to W48 ]
  • Change in disease progression from baseline to week 24 (W24) and to W48 of teriflunomide treatment, measured by the Patient Determined Disease Steps (PDDS) [ Time Frame: Baseline to W48 ]
  • Change in disease progression from baseline to W24 and to W48 of teriflunomide treatment, measured by the Multiple Sclerosis Performance Scale (MSPS) score [ Time Frame: Baseline to W24 and W24 to W48 ]
  • Clinical outcomes: treated relapses, time to first treated relapse [ Time Frame: Over 48 weeks ]
  • Change in cognition from baseline to W48 of teriflunomide treatment, measured by the Symbol Digit Modalities Test (SDMT) score [ Time Frame: Baseline to W48 ]
  • Overview of adverse events (AEs) based on AE reporting at each visit [ Time Frame: Over 48 weeks ]
  • Adherence (ie, compliance) and persistence (ie, duration of exposure) to teriflunomide treatment [ Time Frame: Over 48 weeks ]
  • Quality of life: change from baseline to W48 of teriflunomide treatment, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) score and Stern Leisure Activity Scale [ Time Frame: Baseline to W48 ]
  • Expanded Disability Status Scale (EDSS) score [ Time Frame: At baseline and at W48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
Official Title  ICMJE A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients
Brief Summary

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.

Detailed Description

The total duration of the study per participant was up to 50 or 54 weeks (if accelerated elimination procedure performed):

Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed

An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment was possible and it was particularly recommended for women of child-bearing potential.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: Teriflunomide
Pharmaceutical form: film-coated tablet; Route of administration: oral
Other Names:
  • HMR1726
  • Aubagio®
Study Arms  ICMJE Experimental: Teriflunomide
Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
Intervention: Drug: Teriflunomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2015)
1001
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2013)
1000
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Chile,   Finland,   France,   Germany,   Greece,   Italy,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01895335
Other Study ID Numbers  ICMJE LPS13567
U1111-1139-8730 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP