NCT01011959已完成1 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 24
- 主要终点
- Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
研究概览
简要总结
This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.
详细描述
This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.
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
- •Patients with an established diagnosis of Rheumatoid Arthritis
- •Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks
排除标准
- •Persistent chronic or current active infections
- •Patients who have taken anakinra within 2 weeks
- •Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
- •Patients who have taken adalimumab within 6 weeks
- •Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
- •Patients who have taken leflunomide or rituximab within 6 months
- •Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication
- •Significant arthritis or other medical condition that could interfere with study evaluations
- •Participation in any clinical research study evaluating another investigational drug within 30 days
结局指标
主要结局
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
时间窗: 10 weeks
次要结局
- To evaluate exploratory efficacy endpoints(over 10 weeks)
研究者
研究点 (24)
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