NCT00110903已完成3 期
Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 主要终点
- Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.
研究概览
简要总结
The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.
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
- •Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate:
- •AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL;
- •Platelet count greater than or equal to 125,000/cm3;
- •White blood cell count (WBC) greater than or equal to 3500 cells/cm3;
- •Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study
排除标准
- •Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease
结局指标
主要结局
Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.
次要结局
- Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes
- Measurements from safety laboratory assessments.
研究者
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