NCT00371670已完成2 期
A Phase II, 12-month, Double-blind, Placebo-controlled, Dose-finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-ray
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 4
- 主要终点
- Change from baseline in knee cartilage volume in the target compartment after 6 months
研究概览
简要总结
This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray
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
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
- •Significant osteoarthritis pain in the knee
- •Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement
排除标准
- •Women with childbearing potential
- •Secondary osteoarthritis
- •Treatment with intra-articular or systemic steroids
- •Inability to undergo MRI acquisition
- •Other protocol defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline in knee cartilage volume in the target compartment after 6 months
次要结局
- - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
- - Cartilage volume in the different regions of the knee after 6 and 12 months,
- - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
- - Joint space width after 6 and 12 months,
- - Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months
- Change from baseline in:
- - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
研究者
研究点 (4)
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