Multiple sclerosis
Conditions
Sponsors
Sanofi-aventis U.S. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of both gender aged 18 to 55 years with a diagnosis of multiple sclerosis (as defined by McDonald's criteria) who are ambulatory (Expanded Disability Status Scale [EDSS] of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *disease related: -cancer, lymphoproliferative disease or lymphoïd irradiation -Impaired bone marrow function; significant anemia, leukopenia, or thrombocytopenia -Congenital or acquired severe immunodeficiency, HIV positive subjects, persistent significant or severe infection, tuberculosis -Liver function impairment or persisting elevation of alanine transaminase(ALT) aspartate transferase (AST), or direct bilirubine >1.5 fold the upper limit of normal (ULN) - Persisting elevations of serum amylase or lipase greater to 2-fold the upper limit of normal -chronic pancreatic disease or pancreatitis, chronic active hepatitis -Hypoprotéinemia -Moderate to severe impairment of renal function -Clinically relevant cardiovascular, hypertensive, hepatic, neurological, endocrine, or other systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participing in the study *Prior or concomitant use or likelihood of requiring treatment during the study period with drugs not permitted - cladribine, mitoxantrone, azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate. - St.John's Wort, phenytoin, warfarin, tolbutamide or cholestyramine; adrenocorticotropic hormone (ACTH) or systemic corticosteroids within 4 weeks prior to randomization (minimum 4 weeks before randomization) -natalizumab TYSABRI -glatiramer acetate or cytokine therapy, immunoglobins or any investigational drug in the preceding 24 weeks - Previous treatment with teriflunomide or leflunomide (ARAVA) *Contra-indicating for MRI *Other -Pregnancy, breastfeeding, wishing to parent children -History of drug or alcohol abuse -Mental condition rendering the subject unable to understand the nature, scope, and possible consequence of the study -Subject unlikely to comply with protocol -Subject involved in the conduct of protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the tolerability and safety of a 7 mg and a 14 mg dose of teriflunomide administered once daily for 24 weeks, compared with placebo in subjects with multiple sclerosis who are concurrently on a stable dose of interferon-beta.;Secondary Objective: *Effects of teriflunomide 7 and 14 mg, compared with placebo, in combination with a stable dose of IFN-béta on : - total number of gadolinium enhancing lesions per T1-weighted MRI scan over the study period - burden of disease ( defined as total volume of all lesions as measured by T2-weighted MRI scans) - relapse rate (defined as number of annualized relapses per year) and the proportion of subjects who experience objective relapses during the study - subject reported fatigue as measured by the Fatigue Impact Scale (FIS) *Population pharmacokinetic analyses of teriflunomide following 7 mg and 14 mg doses, in combination with a stable dose of IFN-béta. *Effects of teriflunomide 7 and 14 mg, compared with placebo, in combination with a stable dose of IFN-béta, on interferon neutralising antibodies;Primary end point(s): Safety (adverse event reports; physical examination and laboratory evaluation) | — |
Countries
Germany, Italy, Spain
Outcome results
None listed