Phase 4
N=1,001
Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01895335 ↗Enrolled (actual)
1,001
Serious AEs
12.7%
Results posted
Dec 2016
Primary outcome: Primary: Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 — 68.17 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Teriflunomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 |
68.17 | — |
| SECONDARY Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 |
21.35; 16.55; 12.02; 10.19; 24.31; 19.95 | — |
| SECONDARY Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 |
-1.34; 1.76; -5.44; 0.33 | — |
| SECONDARY Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48 |
-0.01 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48 |
-0.61; -0.06 | — |
| SECONDARY Annualized Treated Relapse Rate |
0.200 | — |
| SECONDARY Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48 |
1.8; 9.4; 15.5 | — |
| SECONDARY Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48 |
0.00 | — |
| SECONDARY Overview of Adverse Events (AEs) |
82.3; 12.7; 0.4; 10.9 | — |
| SECONDARY Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period |
98.2 | — |
| SECONDARY Duration of Teriflunomide Treatment Exposure |
301.6 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48 |
0.99 | — |
| SECONDARY Change From Baseline in Stern Leisure Activity Scale at Week 48 |
0.07 | — |
| SECONDARY Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48 |
3.05; 3.05 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01895335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.