EUCTR2018-001618-13-PL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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1. Previously randomized 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
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •There are no exclusion criteria for this study.
研究者
相似试验
进行中（未招募）
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A study to look at samples from knee and hip replacements in studies with fasinumab for treatment of adults with pain from osteoarthritis of the knee or hipPain 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: 100000004859EUCTR2018-001618-13-GBRegeneron Pharmaceuticals, Inc.50
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