NCT01554917已完成4 期
A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,759
- 试验地点
- 1
- 主要终点
- Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
研究概览
简要总结
This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.
详细描述
This is a multi-center, open, single arm study.
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
- •Subjects with a diagnosis of RA
- •Subjects who have active RA at the time of screening
- •Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
- •Written informed consent
排除标准
- •Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
- •Pregnant or lactating women
- •ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L
- •WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- •Subjects with uncontrolled infection
- •Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
- •Allergic to any of the study drugs
- •History of alcoholism
- •Subjects receiving live vaccines within 3 months prior to study entry
- •Subjects participating in other clinical study within 3 months prior to study entry
研究组 & 干预措施
Iguratimod
Experimental
干预措施: Iguratimod (Drug)
结局指标
主要结局
Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
时间窗: week 24
Incidence of adverse events
时间窗: up to 28 weeks
次要结局
- Change from baseline in Health Assessment Questionnaire (HAQ)(week 24)
- Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)(week 24)
- Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)(week 24)
- Change from baseline in Disease Activity Score 28 (DAS28)(week 24)
研究者
研究点 (1)
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