NCT00542022已完成2 期
A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 主要终点
- MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count
研究概览
简要总结
To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
- •Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
- •Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
排除标准
- •Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
- •Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
- •Female patient is pregnant or breast-feeding
结局指标
主要结局
MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count
时间窗: 12 weeks
次要结局
- MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients(12 weeks)
研究者
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