Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score
研究概览
简要总结
Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.
- Etanercept alone treatment group (25mg, twice/week, s.c.)
- Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had to be at least 18 years of age
- •fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)
- •met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints
- •either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)
- •be ACR functional class I-III
- •have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment
排除标准
- •Patients who required concurrent use of prednisone (PSL) >10 mg/day, or its equivalent, were excluded from study entry
- •the start of dose increment of PSL equivalents within 3 months of the study enrollment
- •experience of antirheumatic therapy except for MTX and PSL equivalents
- •previous treatment with ETN or any other biological treatment
研究组 & 干预措施
ETN Alone
etanercept (25mg, twice/week, s.c.)
干预措施: ETN Alone (Drug)
ETN+MTX
etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)
干预措施: ETN+MTX (Drug)
结局指标
主要结局
Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score
时间窗: at 52 weeks
The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively. Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet. For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, \<50% of the original joint space; 3=general, \>50% of the original joint space or subluxation; 4=ankylosis.
EULAR Good Response
时间窗: at 24 weeks
EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by \> 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 \< 3.2 is regarded as low disease activity.
ACR50 Response Rate
时间窗: at 24 weeks
ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).
次要结局
未报告次要终点
研究者
Hideto Kameda
Professor, Toho University
Japan Biological Agent Study Integrated Consortium