A Two-stage 6-month Multicentre, Randomised, Double-blind, Controlled Study on the Safety and Efficacy Intra-articular Administration of JTA-004 in Patients With Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 主要终点
- Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
研究概览
简要总结
Osteoarthritis (OA) is the most common joint disease affecting millions of people around the world, for which there is unfortunately no cure. Among existing therapies, viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an established place in the symptomatic treatment of knee OA.
The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in two phases. With results obtained in the first phase the best dose of JTA-004 is determined, and the efficacy of the selected dose will then be confirmed in the second phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory
- •Diagnosed with primary knee osteoarthritis, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
- •Pain ≥ 40 mm on a 0-100 mm VAS during the 3 days preceding the date of the screening visit
- •Morning stiffness not exceeding 30 minutes
- •Kellgren-Lawrence grade II or III
- •Insufficient / failed response to analgesic and / or NSAIDs
- •No physical therapy of the knee, and knee braces for the entire duration of study
- •Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
排除标准
- •Current symptoms and/or signs related to the disease under study:
- •Isolated symptomatic femoropatellar OA of the target knee
- •History of trauma or surgery or arthroscopy at the target knee within 6 months before inclusion
- •Concomitant inflammatory disease or other condition affecting the joints (e.g., rheumatoid arthritis, septic arthritis, inflammatory joint disease, metabolic bone disease, psoriasis, gout, microcrystalline arthropathies/chondrocalcinosis, Paget's disease)
- •Any musculoskeletal condition (such as hip osteoarthritis, amputation, neurologic disorder) that would impede measurement of efficacy at target knee
- •Target knee prosthesis planned within 12 months after the Screening Visit
- •Current or previous diagnoses, signs and/or symptoms:
- •Uncontrolled diabetes mellitus, end-stage hepatic or renal disease
- •Current (or within the last 5 years prior to entering the study) history of solid or haematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
- •Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
- •Current or past history of coagulation disorders, as judged by the Investigator
- •Hypersensitivity to any components of HA-based injection products
- •History of hypersensitivity to human biological material including blood and blood derived products, potential excipients and residues from manufacturing process documented clinically or by laboratory tests
- •Hypersensitivity to avian proteins
- •Life expectancy less than 6 months
- •Current or previous treatment:
- •Participation in another clinical study within 6 months prior to Screening
- •Patients previously treated with JTA-004
- •Treatment:
- •Within 6 months prior to Screening: intra-articular hyaluronic acid injection at the target knee
- •Within 2 months prior to Screening: intra-articular glucocorticoids at the target knee
- •Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
- •Current anti-hypertensive medication the effects of which are known to be potentiated by a single dose of clonidine
- •Current (or within 6 months prior to Screening) illicit drug abuse
- •Safety aspects concerning female subjects of childbearing potential:
- •Females who are pregnant, lactating or woman with childbearing potential (last menstrual bleeding less than 12 months ago) unwilling to use medically acceptable contraception, or women with childbearing potential unwilling to perform a pregnancy test before administration of study treatment.
- •Other exclusion criteria:
- •Body Mass Index (BMI) of 35 kg/m2 or greater
研究组 & 干预措施
JTA-004 100 (2 ml)
Sodium hyaluronate, plasma proteins and clonidine
干预措施: JTA-004 intra-articular injection (Drug)
Reference product
Hylan G-F 20
干预措施: Reference product intra-articular injection (Device)
JTA-004 50 (2 ml)
Sodium hyaluronate, plasma proteins and clonidine
干预措施: JTA-004 intra-articular injection (Drug)
JTA-004 50 (4 ml)
Sodium hyaluronate, plasma proteins and clonidine
干预措施: JTA-004 intra-articular injection (Drug)
结局指标
主要结局
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
时间窗: Baseline and 6 months
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
次要结局
- WOMAC® Pain Subscale at Month 3(Baseline and 3 months)
- WOMAC® Total Score Over Time(Baseline and 6 months)