NCT01617590Unknown不适用
A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis
Shanxi Medical University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- ACR20
研究概览
简要总结
This study was intended to assess the efficacy and safety of different Disease-Modifying Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA patients：
- •Male and female patients aged 18 - 75 years (inclusive).
- •Body weight between 50 and 100 kg (inclusive).
- •Post menopausal or surgically sterile female patients are allowed. Female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. Additional birth control details to be provided at screening. Male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.
- •Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
- •Active disease evaluation (DAS 28 > 3.2).
- •Patients who using steroids before enrollment, the dose should not be more than 30mg/d, and remain unchanged for more than 30days.
- •Without use of other disease activity controlling drugs.
- •Get the informed consent.
排除标准
- •Advanced patients with severe joints disability.
- •Pregnant or breast- feeding female patients.
- •Patients with severe primary disease or impairment of heart, brain, lung, liver (ALT or AST > 1.5 normal value), kidney (sCr > normal value), endocrine, and hematology system.
- •Concomitant with other rheumatic disease.
- •Alcohol taken or drug abusing patients.
- •Patients with congestive heart failure, QT prolongation syndrome or poorly controlled diabetes mellitus. Patients with a history of QTc prolongation will be excluded.
- •Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.
研究组 & 干预措施
leflunomide
Experimental
Leflunomide 10-20 mg/d
干预措施: leflunomide (Drug)
methotrexate
Active Comparator
MTX 7.5-15 mg/week
干预措施: methotrexate (Drug)
结局指标
主要结局
ACR20
时间窗: 48 weeks
Percentage of subjects who meet the response rate of ACR20 at each post-dose visit
次要结局
- ACR50(48 weeks)
- ACR70(48week)
- EULAR response：good response(48 week)
- EULAR response ：moderate response(48 week)
研究者
Li Xiaofeng
dean
Shanxi Medical University
研究点 (1)
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