A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES

INTERVENTION: Product Name: Teriflunomide Product Code: HMR1726 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Teriflunomide CAS Number: 108605‐62‐5 Current Sponsor code: HMR1726 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Teriflunomide Product Code: HMR1726 Pharmaceutical Form: Tablet INN or Proposed INN: Teriflunomide CAS Number: 108605‐62‐5 Current Sponsor code: HMR1726 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 14‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Multiple sclerosis ; MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders PRIMARY OUTCOME: 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). Primary end point(s): Annualized relapse rate (number of confirmed relapses per patient‐year) 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. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range