NCT04293861已完成不适用
Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®
Fidia Farmaceutici s.p.a.16 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Assess the variation of type II collagen-specific biomarkers (Coll2-1, Coll2-1NO2 & CTX-II) after HYMOVIS® treatment versus baseline
研究概览
简要总结
This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurements of biological and MRI-based imaging markers.
详细描述
This study is a post-marketing, open-label, prospective and multicentric pilot study in 50 patients suffering from knee OA. Investigators will be rheumatologists or articular disease specialists from public or academic hospitals located in Belgium and France. In each investigating center, the same injector will perform all the VS.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the age of 40 and 80 with BMI ≤ 40
- •Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee OA associated or not with femoropatellar knee OA
- •Responding to clinical and radiological criteria of the American College of Rheumatology (ACR) (Appendix 1)
- •Symptomatic for more than 6 months in the most painful knee
- •Radiological Kellgren & Lawrence (K&L) II or III in radiographs from less than 12 months (Appendix 2)
- •Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40 (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the half-life of the drug (Appendix 4). The most painful knee is considered.
- •Able to follow the instructions of the study
- •Having signed an ICF
排除标准
- •Related to the OA pathology
- •Bilateral (except asymptomatic and grade I) OA of the knee
- •Radiological K&L grade I or IV (Appendix 2)
- •Chondromatosis or villonodular synovitis of the knee
- •Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
- •Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix 5)
- •Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis….
- •Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis
- •Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)
- •Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic)
- •Related to treatments
- •Corticosteroids injection in the target knee in the last month before first injection
- •Hyaluronan injection in the target knee in the last 6 months before first injection
- •Arthroscopy and surgery in the target knee in the last 6 months before first injection
- •Oral corticotherapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first injection
- •OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection
- •Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy unsaponifiables in the last 3 months before first injection
- •Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug, Appendix 4).
- •Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection
- •An anticipated need for any forbidden OA treatments during the trial
- •Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site.
- •Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection
- •Anticoagulant (coumarinic compound) and heparin
- •Related to associated diseases
- •Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….)
- •Allergy or contra-indication to hyaluronan
- •Severe alteration of mobility enabling functional evaluation
- •High risk of hemorrhage and risk of infection at the site of injection
- •Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- •Related to patients
- •Participation to a therapeutic clinical trial in the last 3 months before first injection
- •Under guardianship or judicial protection
- •Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy
- •Related to MRI counter-indication
- •Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
- •Patient with a ferromagnetic splinter in the body, or having wire sutures
- •Serious mobility problem (Parkinson, tremors),
- •Claustrophobia
结局指标
主要结局
Assess the variation of type II collagen-specific biomarkers (Coll2-1, Coll2-1NO2 & CTX-II) after HYMOVIS® treatment versus baseline
时间窗: Variation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
Measure of the level of Coll2-1, Coll2-1NO2 and CTX-II biomarkers in biological fluids.
次要结局
- Variation in MRI markers after HYMOVIS® treatment vs. baseline(trough 1 year follow up)
- Variation in biomarkers related to cartilage homeostasis (synthesis/degradation balance) after HYMOVIS® treatment vs. baseline(ariation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8))
- Responder to treatment(trough 1 year follow up)
- Tolerance and satisfaction(trough 1 year follow up)
- Variation in pain and function(trough 1 year follow up)
研究者
研究点 (16)
Loading locations...
相似试验
尚未招募
不适用
Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM AdministrationDegenerative ArthritisKnee ArthritisNCT04821102R-Bio21
已完成
不适用
Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.Osteoarthritis, KneeNCT06433492Biovico Sp. z o.o.50
招募中
不适用
This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage LesionsCartilage DamageNCT05660161Ente Ospedaliero Cantonale, Bellinzona20
已完成
不适用
Effect of Glucosamine on Joint Structure and Quality of Life (JOG)OsteoarthritisNCT00377286University of Pittsburgh201
已完成
2 期
Safety and Efficacy of RHH646 for Knee OsteoarthritisOsteoarthritis, KneeNCT05816395Novartis Pharmaceuticals82