JPRN-jRCT2080221226已完成2 期
A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II)
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 346 人开始时间: 2010年9月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 346
研究概览
简要总结
In a placebo-controlled study, AMG 162 60 mg was subcutaneously administered for 12 months in RA patients on MTX therapy. AMG 162 showed a significant inhibitory effect on progression of bone erosion compared with that of placebo, and the change in bone erosion score were the smallest in the Q2M group, followed by the Q3M and Q6M groups. In the safety assessment, AMG 162 60 mg was well tolerated in the Q6M, Q3M and Q2M regimens.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Ambulatory outpatients who are diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision)
排除标准
- •-Functional class IV according by the ACR revised classification (1991)
研究者
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