NCT00293826已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.
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
- Amgen
- 入组人数
- 813
- 主要终点
- ACR20 response
研究概览
简要总结
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
- •Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening
排除标准
- •Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
- •Presence of serious infection
- •Class IV rheumatoid arthritis
- •Prior or current history of tuberculosis infection or exposure
- •Any other DMARDs other than methotrexate within 6 weeks of screening
- •Pregnant or nursing
- •Receipt of live vaccines within 3 months
- •Felty's syndrome
研究组 & 干预措施
3
Experimental
196 subjects
干预措施: AMG 108 (Drug)
1
Experimental
196 subjects
干预措施: AMG 108 (Drug)
2
Experimental
196 subjects
干预措施: AMG 108 (Drug)
4
Placebo Comparator
196 subjects
干预措施: Placebo (Drug)
结局指标
主要结局
ACR20 response
时间窗: 24 Weeks
次要结局
- Change in subject reported outcomes(24 Weeks)
- ACRn, AUC ACRn, ACR50, ACR70, and DAS28(24 Weeks)
- PK parameters(24 Weeks)
- Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status(24 Weeks)
研究者
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