NCT04134169招募中不适用
A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis : 5-year Results From the K0202 Extension Study
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Safety Assessment
研究概览
简要总结
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)
详细描述
A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study
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
- •Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
- •Subjects who understand and voluntarily sign an informed consent form
排除标准
- •Any other condition which the investigator judges would make patient unsuitable for study participation
结局指标
主要结局
Safety Assessment
时间窗: 5 years
(Rate of Adverse Event, Number of Participants with Adverse Event)
次要结局
- change in DAS(Disease activity scores)28-ESR from baseline(5 years)
- change in CDAI (clinical disease activity index) from baseline(5 years)
- change in KHAQ(Korean Health assessment questionnaire) from baseline(5 years)
- change in Modified Sharp/Van der Heijde Socre from baseline(5 years)
- 1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate(5 years)
- 2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate(5 years)
- change in 100mm Pain VAS(Visual analogue scale) from baseline(5 years)
研究者
研究点 (1)
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