NCT02833714终止不适用
Characterization of Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Percent Inhibition of activated/memory B-cells derived from RRMS patients.
研究概览
简要总结
The purpose of this research is to characterize the effect of teriflunomide on the activation of B-cells, as well as its capacity to modify B-cell cytokine secretion. The in-vitro identified effects of teriflunomide on the expression of B-cell activation markers, costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with this medication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •confirmed diagnosis of RRMS according to McDonald's diagnostic criteria,
- •age 18-55,
- •an extended disability status score (EDSS) of 1.5-5.5.
排除标准
- •Previous treatment with DMT.
结局指标
主要结局
Percent Inhibition of activated/memory B-cells derived from RRMS patients.
时间窗: 1 year
次要结局
- Change in Cytokine Secretion Profile of T-cells stimulated by teriflunomide treatment(1 year)
- Measure the effect of oral teriflunomide on the cytokine secretion as measured in the ex-vivo obtained longitudinal samples from the treated patients.(1 year)
- Measure the effect of oral teriflunomide on the B cell activation as measured in the ex-vivo obtained longitudinal samples from the treated patients.(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Mechanistic Studies of Teriflunomide in RRMSRelapsing Remitting Multiple SclerosisNCT03464448University of Michigan30
已完成
不适用
Teriflunomide Observational Effectiveness StudyRelapsing Remitting Multiple SclerosisNCT02490982Centre hospitalier de l'Université de Montréal (CHUM)106
招募中
3 期
The safety and effect of Teriflunomide in patients with HTLV-1-induced myelopathyIRCT20180618040127N3Mashhad University of Medical Sciences22
已完成
2 期
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisNCT01487096Sanofi179
已完成
3 期
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisNCT02201108Genzyme, a Sanofi Company166