EUCTR2020-004897-22-CZ进行中（未招募）1 期
A 5-year, randomized, double-blind, placebo-controlled, multi-center study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043 versus placebo in patients with symptomatic knee osteoarthritis - ONWARDS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Males and females between 40 and 75 years of age
- •-Body mass index (BMI) < 40 kg/m2
- •-Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
- •-and other criteria as specified by the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •-Participants with radiographic knee OA K-L grade = 4 on the non-target knee
- •-Arthroscopy of the target knee within the 6 months prior to Screening
- •-Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/µL
- •-and other criteria as specified by the protocol
研究者
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