NCT00913432已完成2 期
A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha
AB Science0 个研究点目标入组 20 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- American College of Rheumatology Score 50
研究概览
简要总结
A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.
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
- •Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA.
- •ACR functional class I-III
- •Have active RA
- •Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha
排除标准
- •Patient had a major surgery within 2 weeks prior to study entry.
- •Life expectancy < 6 months.
研究组 & 干预措施
masitinib 3 mg
Experimental
masitinib 3 mg/kg/day
干预措施: masitinib (Drug)
masitinib 6 mg
Experimental
masitinib 6 mg/kg/day
干预措施: masitinib (Drug)
结局指标
主要结局
American College of Rheumatology Score 50
时间窗: week 12
次要结局
- DAS28(week 4, 8 and 12)
研究者
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