Esclerosis Múltiple ------------------------ Multiple sclerosis
Conditions
Interventions
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram
Sponsors
sanofi-aventis recherche et development
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 visit, and EDSS score ?5.5 at screening visit. Provided informed consent with signature on informed consent form 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion (key): ? <18 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 effectiveness of 2 doses of teriflunomide in comparison to interferon-beta 1a, evaluated by the time to failure, with failure being defined as either relapse or permanent study treatment discontinuation for any cause whichever comes first.;Secondary Objective: To assess the effect of 2 doses of teriflunomide in comparison to interferon-beta 1a, on: - Frequency of relapses, - Fatigue, - Patient?s satisfaction with treatment. To evaluate the safety and tolerability of 2 doses of teriflunomide in comparison to interferon-beta 1a. An optional Pharmacogenomic Teriflunomide Substudy aims at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes.;Primary end point(s): Time to failure, defined as the first occurrence of relapse or permanent study treatment discontinuation for any cause whichever comes first. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed