NCT00413452已完成3 期
Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.
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
- 224
- 主要终点
- Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)
研究概览
简要总结
Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
- •Naïve to etanercept therapy
- •Able to self-inject investigational product or have a designee who can do so
- •Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria
- •Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
- •Receipt of MTX witin 30 days of 1st dose of investigational product
- •Receipt of an other investigational drug within 30 days of 1st dose
- •Receipt of TNF inhibitor therapy within 90 days of 1st dose
- •Receipt of cyclophosphamide within 6 mo of 1st dose
- •Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
- •Current use of insulin
- •gnificant concurrent medical condition
排除标准
- 未提供
研究组 & 干预措施
50 mg
Experimental
50 mg once weekly
干预措施: Etanercept (Drug)
结局指标
主要结局
Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP)
时间窗: 24 weeks
次要结局
- Etanercept seroreactivity response to etanercept (manufactured using the SFP)(week 12)
- neutralizing antibodies to etanercept(week 12 and 24)
- Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments(week 24)
研究者
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