NCT02951026已完成不适用
A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 703
- 试验地点
- 1
- 主要终点
- Incidence rate of serious adverse events (SAEs)
研究概览
简要总结
This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies
- •Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
- •Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
排除标准
- •Unable to undergo the radiograph procedures detailed within the protocol
- •Partial or complete joint replacement in the target knee
- •Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
- •Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
结局指标
主要结局
Incidence rate of serious adverse events (SAEs)
时间窗: Month 60
Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60
次要结局
- Incidence and incidence rate of total knee replacement (TKR)(Month 60)
- Adverse events (AEs) of interest(Month 6)
- AEs of interest(Month 60)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score(Baseline and Month 6)
- Change in joint space width (JSW)(Baseline and Month 60)
- Change in WOMAC total score(Baseline and Month 60)
- Change in WOMAC function subscore(Baseline and Month 60)
- Change in WOMAC pain subscore(Baseline and Month 60)
- Change in Physician Global Assessment(Baseline and Month 60)
- Change in Patient Global Assessment(Baseline and Month 60)
研究者
研究点 (1)
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