A Multicenter, Prospective, Open-label, Single Arm Study of the Efficacy and Safety of Synvisc® (Hylan G-F 20) in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
研究概览
简要总结
Primary Objective:
- To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score
- To evaluate the safety using the incidence, severity, seriousness, relatedness, and frequency of all treatment emergent Adverse Events (AEs)
Secondary Objectives:
- To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8, and 12
- To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26
- To evaluate the change in Patient Global Assessment (PTGA) score between baseline and weeks 8, 12 and 26
- To evaluate the change in Clinical Observer Global Assessment (COGA) score between baseline and weeks 8, 12 and 26
- To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and between baseline and weeks 1, 2, 8, 12 and 26
详细描述
Duration of study period for each participants was 26-28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Synvisc
Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
干预措施: Hylan G-F 20 (Drug)
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
时间窗: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])
WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Overview of Adverse Events (AE)
时间窗: Up to Week 26
An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study drug until the end of study period). Category "AE" included participant with both serious and non-serious AE.
次要结局
- Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26(Baseline, Week 8, 12 and 26 (missing data imputed by LOCF))
- Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12(Baseline, Week 8 and Week 12 (missing data imputed by LOCF))
- Patient Global Assessment (PTGA) Score(Baseline, Week 8, 12 and 26 (missing data imputed by LOCF))
- Clinical Observer Global Assessment (COGA) Score(Baseline, Week 8, 12 and 26 (missing data imputed by LOCF))
- Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26(Baseline up to Week 26)