EUCTR2017-002632-17-ES进行中（未招募）1 期
A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
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
- 445
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 445
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Positive hepatitis C or hepatitis B surface antigen test and/or core
- •antibody test for immunoglobulin G (IgG) and/or immunoglobulin M
- •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 PML in MRI
- •Active malignancy and history of malignancy
- •Hypersensitivity to Mavenclad® or to any of the excipients listed in the
- •Presence or suspect of PML or other (than MS) major Central Nervous
- •System disease clinically diagnosed or evidences in screening MRI
- •Moderate or severe renal impairment (creatinine clearance <60
研究者
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