NCT02963402已完成不适用
Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年11月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Treg phenotype
研究概览
简要总结
We can speculate that the best responders to tocilizumab should have multiple related elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play its beneficial role. The study of these elements and its pathways could help identify the best responders to tocilizumab treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all sexes, aged ≥ 18 years.
- •RA Patients (according to ACR / EULAR criteria 2010) of moderate to severe activity (DAS 28> 3.2 or SDAI> 11), and 6 months or more of evolution, starting treatment with ACTEMRA (tocilizumab) or with an anti-TNF, according to the product data.
- •Patients with body weight ≤ 150 kg.
- •Patients who have received written information about the study and gave their informed consent to participate in the study
排除标准
- •Patients with a history of autoimmune disease or inflammatory joint disease other than RA.
- •Patients treated with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is greater) before starting treatment with tocilizumab
研究组 & 干预措施
Tocilizumab treated
干预措施: Tocilizumab (Drug)
Anti-TNF treated
干预措施: Adalimumab (Drug)
结局指标
主要结局
Treg phenotype
时间窗: Baseline to 6 months change
ATP (adenosine triphosphate)
时间窗: Baseline to 6 months change
次要结局
未报告次要终点
研究者
研究点 (1)
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