EUCTR2018-001618-13-GB
进行中（未招募）
1 期
Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
适应症Pain due to osteoarthritis of the knee or hipMedDRA version: 20.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Pain due to osteoarthritis of the knee or hip
- 发起方
- Regeneron Pharmaceuticals, Inc.
- 入组人数
- 50
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Previously randomised to R475\-PN\-1523, R475\-OA\-1611, or R475\-OA\-1688 and received at least 1 dose of study drug
- •2\. 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 SC study drug
- •3\. Patient’s surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery
- •4\. Willing and able to comply with clinic visits and study\-related procedures
- •5\. Provide informed consent signed by study patient or legally acceptable representative
- •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 25
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
未指定
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