EUCTR2013-001439-34-FI进行中（未招募）1 期
A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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 a relapsing form of MS (RMS)
- •- Having signed written informed consent
- •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 930
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •- ACCORDING TO LOCAL LABELING
- •- 18 years of age
- •- Current or history of receiving teriflunomide
- •- Previous treatment with leflunomide within 6 months prior to baseline
- •- Patients with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN)
- •- Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice and guidelines (including skin or blood test, as appropriate) or according to local labeling
- •- Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections
- •- Women who are pregnant or breast-feeding
- •- Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use reliable contraception throughout the course of the study
- •- Male patients (only when required according to local labeling): unwilling to use reliable contraception during the course of the study
- •- Additional exclusion criteria applicable for EU countries (in accordance with contraindications of EU SmPC)
- •* Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia
- •* Patients with severe active infection until resolution
- •* Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group
- •* Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome
- •- Hypersensitivity to the active substance or to any of the excipients
- •- Other additional contraindications per local labeling
研究者
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