Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device IRADYN® (Polymerized Polynucleotides) Intra-articularly Administered in Subjects With Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Visual Analogue Scale (VAS) for pain (at rest)
研究概览
简要总结
The benefits of single or repetitive administration (1 to 6) can have similar result in terms of muscular strength and patients' quality of life improvement, benefiting of the advantages of polymerized polynucleotides (IRADYN) formulation.
详细描述
Of all osteoarthritis' localization into human body, knee OA represents the most common OA localization.
On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) has suggested as first step of pharmacological treatment for knee osteoarthritis (OA) a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). In this class of natural compounds, hyaluronic acid (HA) has evidenced its efficacy after intra-articular (IA) administration in patient with mild to moderate knee OA .
The filler used in this clinical investigation is using polymerised polynucleotides (PDRN) that has hydrophilic properties of polyanions; therefore, it can bind water molecules and provide a moisturising and lubricant effect. Its viscoelastic properties allow it to compensate for the loss of synovial fluid viscosity in the event of degenerative or trauma joint alterations. These actions reduce the mechanical stress on joints, thereby decreasing friction. This improves joint function and movement with significant relief of pain commonly associated with this problem. Moreover, the enzymatic degradation of the polynucleotide chain releases nucleotides into the synovial cavity. These nucleotides can bind water molecules and share the same viscoelastic properties as the entire chain, helping extend the duration of the effect.
The benefits of single or repetitive administration (1 to 6) can have similar result in terms of muscular strength and patients' quality of life improvement, benefiting of the advantages of polymerized polynucleotides (IRADYN) formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Aged between 40 and 80 years (inclusive, ≥ 40 and ≤ 80 years);
- •Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria (for subjects with OA at both knees, the most painful one will be included in the study only, respecting Kellgren-Lowrance grade II or III);
- •Ambulant without assistance;
- •Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
- •Visual Analogue Scale (VAS) score knee pain ≥40 at screening and 30 days before;
- •Oral/parenteral corticosteroid or NSAIDs (≤10 mg prednisone) administration at least 30 days before screening.
- •Signed Informed consent
排除标准
- •Unstable knee;
- •Varus or valgus ≥ 15 degrees;
- •Active malignancy;
- •Knee trauma or lose body parts 1 year before screening;
- •Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
- •Use of potent analgesics 15 days (different from ≤ 10 mg prednisone) before screening;
- •Intra-articular HA, polymerized polynucleotides or corticosteroid injection within 6 months before screening;
- •Arthroscopic or knee open surgery within 12 months before screening;
- •Body Mass Index (BMI) ≥ 40 kg/m2;
- •Active infection around the injection site;
- •Use of anticoagulants or history of thrombocytopenia;
- •Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
- •Known sensitivity to polymerized polynucleotides;
- •Pregnancy, breast feeding.
研究组 & 干预措施
IRADYN
One group, all patients will receive IRADYN® (intra-articular administration).
One course of IRADYN® at baseline, consisting of a mono-dose intra-articular administration (2ml).
From week 1 to week 6, injection will be performed, if necessary, during the visit, following the dosage reported in the instruction for use / summary of product characteristic.
干预措施: IRADYN (Device)
结局指标
主要结局
Change in Visual Analogue Scale (VAS) for pain (at rest)
时间窗: 14 weeks compared to baseline
Visual Analogue Scale (VAS) for pain at rest is a 100 mm chart-line scale for the mentioned situation on which the subject must draw a mark on the scale to emphasize the intensity of the pain. Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer.
Change in Range of Motion (ROM)
时间窗: 14 weeks compared with baseline
Change in Range of Motion (ROM) parameters, measured in degrees, using a goniometer (Active Knee Flexion - AKF, Passive Knee Flexion - PKF, Active Knee Extension - AKE, Passive Knee Extension - PKE)
次要结局
- Physician Efficacy Global Evaluation(14 weeks)
- Absolute change in Visual Analogue Scale (VAS) for pain (on moving and on pressing)(Up to 14 weeks)
- Absolute change in Knee injury and Osteoarthritis Outcome Score (KOOS)(6 weeks and 14 weeks compared to baseline)
- Evaluation of NSAIDs consumption at all visits(up to 14 weeks)