A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- American College of Rheumatology (ACR) 20 response at week 16
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).
排除标准
- •Any significant health problem other than rheumatoid arthritis
- •Any clinically significant laboratory abnormalities
- •Any prior use of B cell-depleting therapy
研究组 & 干预措施
Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
干预措施: ATN-103 (Drug)
Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
干预措施: Methotrexate (Drug)
Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
干预措施: ATN-103 (Drug)
Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
干预措施: Methotrexate (Drug)
Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
干预措施: ATN-103 (Drug)
Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
干预措施: Methotrexate (Drug)
Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
干预措施: ATN-103 (Drug)
Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
干预措施: Methotrexate (Drug)
Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
干预措施: ATN-103 (Drug)
Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
干预措施: Methotrexate (Drug)
Treatment Group 6
Placebo every 4 weeks
干预措施: Placebo (Drug)
Treatment Group 6
Placebo every 4 weeks
干预措施: Methotrexate (Drug)
结局指标
主要结局
American College of Rheumatology (ACR) 20 response at week 16
时间窗: 6 months
次要结局
- Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments(6 months)