Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 446
- 主要终点
- Responders OARSI 2004 at the End of Follow-up
研究概览
简要总结
The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.
详细描述
To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 45 years of age
- •Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
- •Joint Space Width (JSW) > 2mm
- •Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation
排除标准
- •Overweight patients (body mass index > 32).
- •Pregnant and lactating women. Women of child-bearinge age not using effective contraception
- •Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
- •AINE administration within the 14 days prior to their inclusion in the study.
- •Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
- •Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
- •Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
- •Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
- •Patients with severely impaired central nervous system.
- •Patients with coagulation alterations, despite receiving treatment.
- •Patients with secondary osteoarthritis of the knee
- •Patients having previously received surgery, including arthroscopy
- •Patients with articular inflammatory disease
结局指标
主要结局
Responders OARSI 2004 at the End of Follow-up
时间窗: 40 months
Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS. The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.
次要结局
- Responders OARSI 2004 at 27 Months Follow-up Visit(27 months (12 months after third cycle))
- Overall Pain Reduction 20% (10mm) at the End of Follow-up(40 months)
- Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up(40 months)
- Responders OARSI 2004 at 7 Months Follow-up Visit(7 months (6 months after first cycle))
- Responders OARSI 2004 at 34 Months Follow-up Visit(34 months (6 months after fourth cycle))
- Responders OARSI 2004 at 14 Months Follow-up Visit(14 months (6 months after second cycle))
- Responders OARSI 2004 at 21 Months Follow-up Visit(21 months (6 months after third cycle))
- Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up(40 months)
- Function Improvement 20% (10mm) at the End of Follow-up(40 months)
- Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis(Throughout the study, an average of 40 months)
- Mean Daily Dose of Paracetamol Consumption(Throughout the study, an average of 40 months)