Multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
sanofi-aventis recherche et development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with relapsing forms of multiple sclerosis (MS) treated with Interferon beta (IFN-ß) defined by: - Stable dose of IFN-ß for at least 6 months prior to randomization, and - Disease activity in the 12 months prior to randomization and after first 3 months of IFN-ß treatment (at least one relapse supported by Expanded Disability status Scale (EDSS) or equivalent neurological examination, or, at least one brain or spinal cord Magnetic Resonance Imaging (MRI) with at least one T1 gadolinium enhancing lesion). 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 1455 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 5.5 at randomization visit. A relapse within 30 days prior randomization. Human Immunodeficiency Virus (HIV) positive patient. Prior use within 6 months preceding randomization or concomitant use of nataluzimab and any other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate or fingolimod. Prior use in the 3 months preceding randomization of cytokine therapy (except baseline IFN-ß), glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments. Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone. Pregnant or breast-feeding women or those who plan to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effect of Teriflunomide in comparison to placebo on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-ß).;Secondary Objective: Assess the effect of Teriflunomide in comparison to placebo when added to interferon beta (IFN-ß) on: . Disease activity as measured by brain Magnetic Resonance Imaging (MRI), . Disability progression, . Burden of disease and disease progression as measured by brain MRI. Evaluate the safety and tolerability of Teriflunomide when added to IFN-ß therapy. Assess the pharmacokinetics of Teriflunomide in use in addition to baseline IFN-ß therapy. Assess associations between variations in genes and clinical outcomes (safety and efficacy) Assess other measures of efficacy of teriflunomide in comparison to placebo such as: - Fatigue - Health related quality of life Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to ICU);Primary end point(s): Annualized relapse rate (number of confirmed relapses per patient-year);Timepoint(s) of evaluation of this end point: yearly | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Brain MRI measure of number of gadolinium enhancing (Gdenhancing) T1-weighted hypointense lesions (T1)-lesions. - Time to disability progression (12 weeks), defined as a 1.0-point increase in expanded disability status scale (EDSS) score (or 0.5-point increase for baseline EDSS =5.5) confirmed after at least 12 weeks;Timepoint(s) of evaluation of this end point: defined in protocol | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Korea, Republic of, Lithuania, Netherlands, Norway, Portugal, Russian Federation, Slovakia, Spain, Sweden, Tunisia, Turkey, United Kingdom, United States
Contacts
Public ContactClinical trial manager
Sanofi-aventis the Netherlands BV
Outcome results
None listed