JPRN-jRCT2080222228已完成3 期
A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III)
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 667 人开始时间: 2013年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 667
研究概览
简要总结
When AMG 162 60 mg was subcutaneously administrated every 6 months or 3 months for 12 months to rheumatoid arthritis patients on DMARDs, both regimens demonstrated significant inhibitory effects, compared with placebo, on the progression of joint destruction, with the change in TSS being smaller for Q3M than for Q6M. Both AMG 162 regimens demonstrated a safety profile similar to that of placebo, indicating that AMG 162 Q6M and Q3M were well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis
排除标准
- •Functional class IV according by the ACR revised classification (1991)
研究者
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