A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 53
- 主要终点
- AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
研究概览
简要总结
This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
50 mg
50 mg 3 times weekly
干预措施: AMG 719 (Drug)
400 mg
400 mg 3 times weekly
干预措施: AMG 719 (Drug)
200 mg
200 mg 3 times weekly
干预措施: AGM 719 (Drug)
Placebo
Placebo comparator associated with each active arm. (3:1 active vs placebo)
干预措施: Placebo (Drug)
Placebo
Placebo comparator associated with each active arm. (3:1 active vs placebo)
干预措施: placebo to AMG 719 (Drug)
结局指标
主要结局
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
时间窗: Week 24
次要结局
- To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA(Week 24)