Multiple sclerosis MedDRA version: 15.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Teriflunomide
Product Code: HMR 1726D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with relapsing forms of Multiple Sclerosis meeting McDonald’s criteria for MS diagnosis at time of screening, and EDSS scores of = 5.5 at screening. Experienced at least 1 relapse in the previous 12 months preceeding randomization, or at least 2 relapses in the 24 months preceeding randomization visit. Patients who have provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of approved therapies available for relapsing forms of MS. The patient must have been offered these therapies and must choose to join the study instead of accepting therapy outside of the study. 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 1110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • <18 years of age or =56 years of age • Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia • Persistent significant or severe infection • Liver function impairment or persisting elevations (confirmed by retest) of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal • Known history of hepatitis • Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization • Human immunodeficiency virus (HIV) positive patients • Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate • Prior or concomitant use of natalizumab (Tysabri®) • Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To assess the effect of 2 doses of teriflunomide in comparison to placebo, on frequency of multiple sclerosis (MS) relapses in patients with relapsing MS.;Secondary Objective: Key secondary -To assess the effect of 2 doses of teriflunomide in comparison to placebo, on disability progression in patients with relapsing MS. Other secondary -To assess other measures of efficicacy of 2 doses of teriflunomide in comparison to placebo, on: o Fatigue, o Health-related quality of life, a measure of the impact of the patient's health on his or her overall well being. -To evaluate the safety and tolerability of teriflunomide ;Primary end point(s): Annualized relapse rate, defined as the number of relapses per patient-year.;Timepoint(s) of evaluation of this end point: Average of 2 years (between 1 and 3 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Time to disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS) 2) Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS) 3) Change from baseline in Short Form generic health survey [36 items] (SF-36) scale;Timepoint(s) of evaluation of this end point: 1) Average of 2 years (between 1 and 3 years) 2/3) 48 weeks | — |
Countries
Australia, Austria, Belarus, Belgium, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Greece, Mexico, Netherlands, Philippines, Poland, Romania, Slovakia, Spain, Sweden, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactMedical Information
Sanofi-aventis recherche & développement
Outcome results
None listed