EUCTR2018-001411-71-PL进行中（未招募）1 期
Study to Evaluate Synovial Fluid 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
- 200
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. Eligible for and have signed the informed consent form (ICF) for R475-PN-1523, R475-OA-1611, or R475-OA-1688
- •2. Index joint is the knee
- •3. Baseline K-L score of 2 or 3 in index knee joint
- •4. Effusion of index knee joint at baseline, evident on screening MRI from parent study
- •5. Willing to undergo 2 ultrasound guided joint aspirations of index knee joint
- •6. Willing and able to comply with clinic visits and study-related procedures
- •7. 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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Screen failed for the parent study prior to randomization visit, after having signed the ICFs for both the parent study and study R475-OA-1815
- •2. Effusion no longer present at time of ultrasound guided aspiration
研究者
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