NCT00446784已完成1 期
A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Incidence and severity of adverse events throughout the study
研究概览
简要总结
CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Adults patients with rheumatoid arthritis
- •Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)
排除标准
- •History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
- •Any current or known malignancy or history of malignancy within the previous 5 years
- •Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study
结局指标
主要结局
Incidence and severity of adverse events throughout the study
次要结局
- Pharmacokinetics of CE 224,535 on Days 7 and 8
- Pharmacokinetics of Methotrexate on Days 1 and 8
研究者
研究点 (6)
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