Multiple Sclerosis MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligra
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a relapsing form of MS (RMS) - Having signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 930 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - ACCORDING TO LOCAL LABELING - 18 years of age - Current or history of receiving teriflunomide - Previous treatment with leflunomide within 6 months prior to baseline - Patients 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 and guidelines (including skin or blood test, as appropriate) or according to local labeling - Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections - Women who are pregnant or breast-feeding - Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use reliable contraception throughout the course of the study - Male patients (only when required according to local labeling): unwilling to use reliable contraception during the course of the study - Additional exclusion criteria applicable for EU countries (in accordance with contraindications of EU SmPC) * Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia * Patients with severe active infection until resolution * Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group * Patients 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of PROs ;Secondary Objective: - To describe disease progression using PRO - To describe clinical outcomes (ie treated relapses) in teriflunomide treated patients - To describe the change in cognition in teriflunomide treated patients - To describe safety of teriflunomide in patients treated (based on adverse event 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 patient determined disease steps (PDDS) (1) and expanded disability status scale (EDSS) (2) in assessing MS disease progression ;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Change in TSQM version 1.4 from baseline to W4 and to W48/EOT of teriflunomide treatment in patients switching from another DMT 2 - Change in TSQM version 1.4 from W4 to W48/EOT in naïve patients 3 - Disease progression: change from baseline to W48/EOT of teriflunomide treatment, measured by the Patient Determined Disease Steps (PDDS) scale 4 - Disease progression: change from baseline to W24 and to W48/EOT of teriflunomide treatment, measured by the Multiple Sclerosis Performance Scale (MSPS) score (4, 5) 5 - Clinical outcomes: treated relapse, time to first treated relapse 6 - Change in cognition: change from baseline to W48/EOT of teriflunomide treatment as measured by the Symbol Digit Modalities Test (SDMT) score 7 - Occurrence of adverse events (AEs) based on AE reporting at each visit 8 - Adherence (ie, compliance) and persistence (ie, duration of exposure) to teriflunomide treatment over 48 weeks 9 - Quality of life: change from baseline to W48/EOT of teriflunomide treatment, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) score (6) and Stern leisure activity scale (7). 10 - EDSS score at baseline and at W48/EOT ;Timepoint(s) of evaluation of this end point: 1 - Baseline to W4 and W4 to W48 2 - W4 to W48 3 - Baseline to W48 4 - Baseline to W24 and W24 to W48 5 - Over 48 weeks 6 - Baseline to W48 7/8 - Over 48 weeks 9 - Baseline to W48 10 - At baseline and at W48 | — |
Countries
Austria, Belgium, Canada, Chile, Finland, Germany, Greece, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Study Unit
Sanofi-aventis Oy
Outcome results
None listed