Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Participants by Degree of Cartilage Loss
研究概览
简要总结
The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Previously randomized to R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or R475-OA-1688 (NCT03304379) and received at least 1 dose of study drug
- •Notified the site that they are planning a knee or hip arthroplasty during the parent study between randomization and 24 weeks after the last dose of subcutaneous (SC) study drug
- •Patient's surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery
排除标准
- •Note: Other protocol Inclusion criteria apply
研究组 & 干预措施
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
干预措施: Fasinumab (Drug)
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
干预措施: Naproxen (Drug)
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
干预措施: Diclofenac (Drug)
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
干预措施: Celecoxib (Drug)
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants by Degree of Cartilage Loss
时间窗: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Number of Participants by Degree of Bony Changes
时间窗: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis \[Lamellar/Mixed\], Subarticular Fracture/Collapse).
Number of Participants by Degree of Synovial Lymphocytic Inflammation
时间窗: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
次要结局
未报告次要终点