NCT00249041已完成3 期
Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)
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
- Amgen
- 入组人数
- 447
- 主要终点
- Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
研究概览
简要总结
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
详细描述
The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Must be able to self-inject or have someone who can do so for them
- •Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value
排除标准
- •Any prior biologic therapy for inflammatory disease
- •Any prior cyclophosphamide therapy
- •Not using adequate contraception
- •Pregnant or breast-feeding or any significant concurrent medical condition
研究组 & 干预措施
Etanercept liquid
Experimental
干预措施: 50 mg Etanercept (Drug)
Etanercept liquid
Experimental
干预措施: Enbrel liquid (Drug)
结局指标
主要结局
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
时间窗: 24 weeks
次要结局
- Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.(12 weeks and 24 weeks)
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