NCT03106259Unknown不适用
Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年6月29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
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety of FURESTEM-RA Inj.
研究概览
简要总结
Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.
详细描述
This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis.
Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.
[NCT02221258]
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- •Subject who understands and voluntarily sign an informed consent form
排除标准
- •In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period
研究组 & 干预措施
Non-Interventional Study
Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
干预措施: FURESTEM-RA Inj. (Drug)
结局指标
主要结局
Safety of FURESTEM-RA Inj.
时间窗: 5 years
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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