NCT01310166已完成4 期
A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 1
- 主要终点
- Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
研究概览
简要总结
The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
排除标准
- •Patients with a manifestation of MS other than relapsing remitting MS
- •Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome
- •History or presence of malignancy in the last 5 years
- •Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients
- •Diagnosis of macular edema during Screening Phase
- •Patients with active systemic bacterial, viral or fungal infections
- •Negative for varicella-zoster virus IgG antibodies at Screening
- •Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time
- •History of cardiovascular disorder
- •Women of child-baring potential and inadequate contraception
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Fingolimod
Experimental
干预措施: Fingolimod (Drug)
结局指标
主要结局
Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
时间窗: 6 months
Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)
时间窗: 6 months
Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)
时间窗: 6 months
Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)
时间窗: 6 months
Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)
时间窗: 6 Months
次要结局
- Change from baseline of Natural Killer cells(6 months)
- Change from baseline of B-lymphocytes(6 months)
- Change from baseline of monocytes(6 months)
研究者
研究点 (1)
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