EUCTR2007-004452-36-GB进行中（未招募）1 期
A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,169
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, and EDSS scores of = 5.5 at screening.
- •Experienced at least 1 relapse in the previous 12 months preceeding randomization, or at least 2 relapses in the 24 months preceeding randomization visit.
- •Patients who have provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of approved therapies available for relapsing forms of MS. The patient must have been offered these therapies and must choose to join the study instead of accepting therapy outside of the study.
- •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 1110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •<18 years of age or =56 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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