NCT02903212尚未招募1 期
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Tolerance of apoptotic cells injection
研究概览
简要总结
The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Rheumatoid arthritis
- •Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
- •Disease Activity Score (DAS) DAS28 ≥ 3.2
- •Subject has provided written informed consent
排除标准
- •Pregnant or lactating women
- •Inflammatory arthritis other than rheumatoid arthritis
- •History of invasive cancer
- •Immunodeficiency (HIV infection, Immunosuppressive therapy)
- •Active bacterial or viral infections, in particular HCV or HBV.
- •Surgery not older than 4 weeks.
- •Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
- •Contraindication to an apheresis
结局指标
主要结局
Tolerance of apoptotic cells injection
时间窗: 12 weeks
Side effects are taken into account to assess tolerance.
次要结局
未报告次要终点
研究者
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