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

sanofi-aventis group0 个研究点目标入组 1,455 人开始时间: 2011年1月27日最近更新: 2014年3月24日

研究概览

暂无简介。

•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,
•- 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

•< 18 years of age or = 56 years of age.
•McDonald’s criteria for MS diagnosis not met at time of screening visit.
•EDSS score > 5.5 at screening visit.
•Not treated with a stable dose of IFN-ß for at least 6 months prior to randomization or not tolerating
•IFN-ß or not expected to remain on IFN-ß for the duration of the study.
•A relapse within 30 days prior randomization.
•Human Immunodeficiency Virus (HIV) positive patient.
•Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as
•azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate or fingolimod in previous 6
•Prior use in the 3 months preceding randomization of cytokine therapy (except baseline IFN-ß),
•glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments.
•Prior or concomitant use of natalizumab (Tysabri®) in previous 6 months.
•Pregnant or breast-feeding women or those who plan to become pregnant during the study.

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