临床试验/NCT03193957

NCT03193957已完成2 期

An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Samsung Bioepis Co., Ltd.1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2017年5月15日最近更新: 2017年10月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Samsung Bioepis Co., Ltd.
入组人数: 50
试验地点: 1
主要终点: The change in Injection site pain score at immediately post injection (within 1 minute)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with 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: Other
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects are male or female aged 18-55 years at the time of signing the informed consent form.

排除标准

•Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.

研究组 & 干预措施

SB4

Experimental

SB4 (etanercept) 50 mg/mL

干预措施: Etanercept (Drug)

SB4

Experimental

SB4 (etanercept) 50 mg/mL

干预措施: Autoinjector (Device)

结局指标

主要结局

The change in Injection site pain score at immediately post injection (within 1 minute)

时间窗: at Week 1 and Week 3

The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale

次要结局

未报告次要终点

研究者

发起方

Samsung Bioepis Co., Ltd.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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