An Open-label Multicenter Postmarketing Extension Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Change in the Total WOMAC Score (WOMAC-T)
研究概览
简要总结
The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.
详细描述
HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility.
The aim of the 6-month OLE was to evaluate the long-term safety and efficacy of one and two courses of IA Polyacrylamide hydrogel with silver ions in patients with knee osteoarthritis who had received at least one IA injection of NOLTREX™ and completed the visit 5 in the IA/PAAG-SI/OA/2019 study.
In OLE patients who had received a course of treatment (one or two weekly intra-articular injections of 4.0 NOLTREX™ depending on the stage of OA and the clinical response to treatment) in the parent study might receive a single repeat course of NOLTREX™ at the visits 1/2 or 3/4 when clinically indicated. The WOMAC was the primary outcome measure.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 50 years of age;
- •Provision of signed informed consent form;
- •Patients met ACR classification criteria for knee osteoarthritis (pain in the knee and at least three of the following: age >50 years, stiffness <30 min, crepitus, bony tenderness, bony enlargement and no palpable warmth);
- •OA grades 2 and 3 on the Kellgren-Lawrence scale with the predominant involvement of the medial tibiofemoral region of the knee joint;
- •Patients from the NOLTREX™ group of the parent study (IA/PAAG-SI/OA/2019) who completed all (5) study visits
排除标准
- •Pregnancy and breastfeeding;
- •History of trauma or surgery on the target knee joint;
- •Instability of the target knee joint;
- •Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
- •History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
- •Seronegative spondyloarthritis and reactive arthritis;
- •Increased rheumatoid factor;
- •Increased uric acid > 360 µmol/l;
- •Intra-articular injection into the target knee joint:
- •hyaluronates - within 12 months prior to patient enrollment in the study;
- •other synovial fluid endoprostheses (except for NOLTREX™ in the IA/PAAG- SI/OA/2019 study) within 24 months;
- •glucocorticoids - within 1 month before enrollment in the study;
- •NSAIDs - intra-articular injection at any time in the history.
- •Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
- •Effusion in the target joint;
- •The presence of inflammation or infection in the target joint, synovitis;
- •The need for continuous use of glucocorticoids in any dosage form;
- •Use of paracetamol within 48 hours prior to Visit 0;
- •A positive blood test result for one or more of the following infections: HIV, hepatitis B and C, syphilis;
- •Severe liver disease, defined as an increase in one of the following: ALT, AST, alkaline phosphatase, total bilirubin, GGT more than 3 times the upper limit of normal;
- •Kidney disease with a glomerular filtration rate as assessed by the Cockcraft-Gault formula less than 60 mL/min/1.73 m2 (stages III-V chronic kidney disease [CKD]);
- •Clinical manifest coxarthrosis;
- •Severe decompensated chronic or acute diseases and other conditions or other causes that, in the investigator's opinion, may prevent the patient from participating in the study or affect the study results ;
- •Participation in any other clinical trial except that IA/PAAG-SI/OA/2019 within 90 days prior to enrollment in the OLE.
研究组 & 干预措施
Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™
Sixty-five (65) patients were included in the study and divided into three groups based on the number of NOLTREX™ courses received:
- Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study.
- Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
- Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study.
干预措施: Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ (Device)
结局指标
主要结局
Change in the Total WOMAC Score (WOMAC-T)
时间窗: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Mean change in WOMAC-T from baseline (visit 0 \[screening\] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
次要结局
- Change in the WOMAC Pain Score (WOMAC-A)(baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23))
- Change in the WOMAC Stiffness (WOMAC-B) Score(baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23))
- Change in the WOMAC Physical Function (WOMAC-C) Score(baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23))
- Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)(baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23))
- Patient's Assessment of the Treatment Efficacy(visits 3 (week 13) and 5 (week 25))
- Investigator's Assessment of the Treatment Efficacy(visits 3 (week 13) and 5 (week 25))
- Total Number of Paracetamol Tablets Taken(visits 3 (week 13) and 5 (week 25))
- Total Number of NSAID Tablets Taken(visits 3 (week 11) and 5 (week 23))
- The JSN in the Target Knee(baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE)