EUCTR2017-002631-42-IT进行中（未招募）1 期
A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis - .
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MERCK KGAA
- 入组人数
- 270
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
- •Male or female subjects = 18 years old
- •Highly active RMS as defined by:
- •-One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
- •-Two or more relapses in the previous year, whether on DMD treatment or not
- •EDSS score =5.0
- •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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab
- •Positive test for hepatitis C or positive tests for hepatitis B infection: either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti HBcAb) confirmed by a positive viral polymerase chain reaction (PCR)
- •Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
- •Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids
- •History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
- •Presence of signs of PML detected by MRI, clinical and/or biomarker evaluations
- •Active malignancy
- •lymphocyte count not within normal limits of the local hospital lab before initiation of first treatment course
研究者
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