EUCTR2019-000796-16-CZ进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis - JTA-KOA2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 742
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All subjects must satisfy ALL the following criteria to be included in the study:
- •1. Male/female aged above 40 years
- •2. Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit)
- •3. Diagnosed with primary knee OA, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
- •Pain present for most days of the preceding month
- •Morning stiffness < 30 minutes
- •Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6 months prior to screening Visit)
- •4. Target knee pain = 200 mm and = 400 mm out of 0-500 mm on the WOMAC ® VA3.1 pain questionnaire (sum of 5 questions) at screening and baseline
- •5. Insufficient/failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
- •6. Willing and able to abstain from initiation of physical therapy and knee braces at the target knee up to the 6-month follow up visit (a subject undergoing physical therapy or using knee braces at a stable frequency for at least 2 weeks prior to screening is allowed to continue at same frequency (frequency increase is not allowed)
- •7. Capable to understand and comply with study requirements and to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal pseudo-anonymized data
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 409
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 333
排除标准
- •Current symptoms and/or signs related to the disease under study:
- •1. History of trauma or surgery or arthroscopy at the target knee within 12 months before inclusion
- •2. Concomitant inflammatory disease or other conditions affecting the joints (e.g., infectious arthritis, rheumatoid arthritis, psoriatic arthritis or spondyloarthropathy, Paget’s disease, hemochromatosis…)
- •3. Any target knee abnormality that could impact safety or efficacy assessment.
- •4. Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate disease (pseudo-gout) or gout if believed likely to interfere with the study endpoints, in the opinion of the Investigator
- •5. Clinically significant valgus/varus deformities at the Investigator’s discretion
- •6. Any musculoskeletal condition (such as symptomatic hip osteoarthritis, amputation, neurologic disorder, chronic back pain with or without radiculopathy, sciatica) that would impede measurement of efficacy at target knee
- •7. Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC ® VA3.1 pain questionnaire) at screening and/or baseline
- •8. Knee arthroplasty planned within 12 months after the screening visit
- •Current or previous diagnoses, signs and/or symptoms:
- •9. Uncontrolled diabetes mellitus (hemoglobin A1c [HbA1c] > 10% or > 86 mmol/mol), end-stage hepatic or renal disease (severe and clinically significant abnormalities according to local laboratory ranges) documented in the subject’s file
- •10. Any relevant cardiovascular disease (severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically significant electrocardiogram (ECG) abnormality as judged by the Investigator
- •11. Subject with neuropathic pain or chronic pain syndrome including fibromyalgia
- •12. Current (or within the last 5 years prior to entering the study) history of solid or hematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
- •13. Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
- •14. Current or past history of coagulation disorders (according to local laboratory ranges), as judged by the Investigator
- •15. Hypersensitivity to any components of hyaluronic acid (HA)-based injection products
- •16. Hypersensitivity to human biological material including blood and blood derived products, potential excipients and residues from manufacturing process, documented clinically or by laboratory tests
- •17. Hypersensitivity to avian proteins
- •Current or previous treatment:
- •18. Participation in another clinical trial within 3 months prior to screening (within 1 year prior to screening if disease-modifying OA drug [DMOAD] received and if the Investigator considers it could impact the safety or efficacy assessment)
- •19. Subject previously treated with JTA-004 within 2 years prior to screening
- •20. Subject treated with intra-articular viscosupplement or blood-derived product (e.g., platelet-rich plasma) injection in the target knee within 6 months prior to screening
- •21. Subject treated with intra-articular glucocorticoid injection in the target knee within 4 months prior to screening
- •22. Started the use of slow acting drugs for OA such as glucosamine, glucosamine sulfate, chondroitin sulfate, diacerein, curcumin, soybean/avocado extracts or related products within 1 mon
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