NCT00944892已完成1 期
A Randomized,Double Blind,Placebo-controlled,Parallel Group,Repeat Dose Study of the Safety and Efficacy of REGN475 in Patients With Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- The incidence of TEAEs in patients treated with REGN475 or placebo, reported between administration of study drug on Day 1 and the completion of study at the end of week 24 (Day 169).
研究概览
简要总结
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 4 treatment arms (3 active and 1 placebo).
Each patient will receive two doses of active medication or placebo, with study drug administered intravenously (IV). The primary goal of the study is to assess the safety and tolerability of repeat administrations of REGN475 compared to placebo in patients with osteoarthritis (OA) of the knee.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 40 and ≤ 75 years of age.
- •Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
- •Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.
排除标准
- •Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
- •Patients with joint replacement in the affected knee.
- •Patients with peripheral neuropathy due to any reason.
研究组 & 干预措施
Dose 3
Experimental
干预措施: REGN475 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Dose 1
Experimental
干预措施: REGN475 (Drug)
Dose 2
Experimental
干预措施: REGN475 (Drug)
结局指标
主要结局
The incidence of TEAEs in patients treated with REGN475 or placebo, reported between administration of study drug on Day 1 and the completion of study at the end of week 24 (Day 169).
时间窗: 24 weeks
次要结局
- Patient assessment of response to treatment over time using the Patient Global Impression of Change.(24 weeks)
- Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).(24 weeks)
- Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) (total score as well as all 3 subscales: pain, stiffness and function).(24 weeks)
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