Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
研究概览
简要总结
The main purpose of this study was to measure the serum levels of cytokines and chemokines that are known to increase during multiple sclerosis relapses.
Cytokines are a broad and loose category of small proteins that are important in cell signaling.
The second purpose of the study was to test the cytokine/chemokine changes measured in the 3rd and 6th months on the efficacy parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before the beginning of te study
- •Nonresponder RRMS patients
- •Last relapse of the patient should be at least 2 months before study entry.
- •Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry.
排除标准
- •Patients with secondary progressive MS.
- •Patients with known contraindications for fingolimod treatment.
- •Other coexistent autoimmune diseases
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
FTY720
干预措施: Fingolimod 0.5 mg (Drug)
结局指标
主要结局
Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients
时间窗: Baseline
baseline peripheral blood flow cytometric analysis in study participants
Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA
时间窗: Baseline
Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.
Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline
时间窗: Baseline
Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.
次要结局
- Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits(Baseline, month 3, month 6)
- Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients(Baseline, Month 3, Month 6)
- Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients(Baseline, Month 3, Month 6)
- Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients(Baseline, Month 3, Month 6)