Long-Term Follow-Up Study of Patients With Moderate to Severe, Painful Osteoarthritis of the Knee Who Participated in a Randomized, Placebo-Controlled Study of UBX0101
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 161
- 试验地点
- 17
- 主要终点
- Incidence of adverse events up to 1 additional year of follow up.
研究概览
简要总结
A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).
详细描述
This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with knee OA who have completed a randomized placebo-controlled study of UBX
- •Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.
排除标准
- •Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.
- •Patients who are scheduled to undergo knee arthroplasty on either knee during the study.
- •Patients who anticipate arthroscopic surgery on either knee at any time during the study.
- •Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.
- •Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments [e.g., braces, stem cells, and procedures]) during the study.
研究组 & 干预措施
Patients from a randomized placebo-controlled study of UBX0101
Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.
干预措施: UBX0101 or placebo (Drug)
结局指标
主要结局
Incidence of adverse events up to 1 additional year of follow up.
时间窗: 52 weeks
次要结局
未报告次要终点