A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 54
- 主要终点
- Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
研究概览
简要总结
The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Highly active RMS as defined by:
- •One relapse in the previous year and at least 1 T1 Gadolinium (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.
- •Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.
- •Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
- •Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
- •Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
- •History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
- •Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
- •Active malignancy or history of malignancy.
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Mavenclad®
干预措施: Mavenclad® (Drug)
结局指标
主要结局
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
时间窗: Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
CUA lesions were measured by using MRI scans.
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 2 (Month 2-6)
时间窗: Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
CUA lesions were measured by using MRI scans.
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6)
时间窗: Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
CUA lesions were measured by using MRI scans.
次要结局
- Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24(Baseline, Month 3, 6, 12, 15, 18 and 24)
- Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24(Baseline, Month 3, 6, 12, 15, 18 and 24)
- Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24(Baseline, Month 3, 6, 12, 15, 18 and 24.)