NCT02715908已完成3 期
A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- DAS28-ESR
研究概览
简要总结
To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX
详细描述
this study is to evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX for additional 48 weeks (a total of 100 weeks including 52 weeks of the treatment period in Study LG-ECCL002) in the subjects who have completed the treatment period of phase III clinical study for LBEC0101 (Study No. LG-ECCL002).
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed the treatment period of Study LG-ECCL002
- •Patients requiring continuous treatment for rheumatoid arthritis upon the investigator's discretion
- •For childbearing female patients or surgically non-sterile male patients, those who agreed to avoid pregnancy using proper contraceptive methods during the study.
- •Patients who made a voluntary decision to participate in this clinical study and gave a voluntary written consent to comply with all the instructions with full understanding after being informed of the study
排除标准
- •Patients deemed difficult to participate in this extension study due to the adverse events which occurred in Study LG-ECCL002, upon the investigator's discretion at screening
- •Patients with at least 10 swollen joints (out of the total 66 assessing joints) or at least 12 tender joints (out of the total 68 assessing joints) at screening
- •Women in pregnancy or lactation, or patients planning to be pregnant during the study period
- •Patients ineligible for this clinical study upon the investigator's discretion
研究组 & 干预措施
LBEC0101
Experimental
Etanercept 50mg
干预措施: LBEC0101 (Drug)
结局指标
主要结局
DAS28-ESR
时间窗: 48 weeks
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
次要结局
- DAS28-CRP(48 weeks)
- ACR 20, 50, 70(48 weeks)
- Remission rate(48 weeks)
- EULAR response(48 weeks)
研究者
研究点 (1)
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