EUCTR2008-006226-34-FR进行中（未招募）不适用
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 sclerosis - TENERE
sanofi-aventis Recherche & Dévelopment0 个研究点目标入组 300 人开始时间: 2009年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- •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
研究者
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