A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE

sanofi-aventis recherche et development0 个研究点目标入组 300 人开始时间: 2009年3月19日最近更新: 2016年10月10日

适应症

试验速览

暂无简介。

•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 (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

发起方

sanofi-aventis recherche et development