None listed
Conditions
Interventions
Group 1 Type of group
Teriflunomide 7 mg once daily during 48 weeks
Group name:Group 3 Type of group
Placebo (for teriflunomide) once daily for 48 weeks
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: • Patients with multiple sclerosis recurrence varieties that meet McDonald´s criteria for the diagnosis of MS at the time of the selection visit and EDSS 55.5 score at the selection visit • At least one relapse in the 12 months preceding the random assignment or at least 2 relapses in the 24 months preceding the random assignment visit • Provide signed informed consent in the form of informed consent
Exclusion criteria
Exclusion criteria: • 56 years of age • Patients with significant bone marrow dysfunction or significant anemia, leukopenia or thrombocytopenia • Persistent, significant or severe infection • Impaired hepatic function or persistent elevations (confirmed by a second test) of serum glutamic pyruvic transaminase (SGPT / ALT), serum glutamicoxalastic transaminase (SGOT / AST) or direct bilirubin greater than 1.5-times the upper limit of normal • Known history of hepatitis • Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization • Patients positive for human immunodeficiency virus (HIV) • Prior or concomitant use of cladribine, mitoxantrone or other immunosuppressive agents, such as azathioprine, cyclofosfamide, cyclosporin, methotrexate or mycophenolate • Concomitant or prior use of natalizumab (Tysabri®) • Breastfeeding or pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates). Measure:Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate Timepoints:Core treatment period between 48 - 152 weeks depending on time of enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model. Measure:Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score Timepoints:Baseline (before randomization), Week 12, Week 24 and Week 48 ; Outcome name:Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors). Measure:Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score Timepoints:Baseline (before randomization) and up to Week 152 ; Outcome name:SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Measure:Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores Timepoints:Baseline (before randomization), Week 12, Week 24 and Week 48 ; Outcome name:Baseline adjusted least-squares means at last visit were estimated | — |
Countries
Australia, Austria, Belarus, Belgium, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Greece, Mexico, Netherlands, Philippines, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactPablo Acevedo
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed