EUCTR2018-004730-15-PL进行中（未招募）1 期
A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients with Pain due to Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
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
- •1. Generally in good health at the screening visit
- •2. Body mass index (BMI) =39 kg/m2 at the screening visit
- •3. Clinical diagnosis of OA of the knee based on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score =2) at the index joint at the screening visit
- •4. Moderate-to-severe pain in the index joint
- •5. A history of inadequate pain relief from or intolerance to analgesics used for OA
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •1. Diagnosis of systemic diseases that may affect joints
- •2. History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation
- •(prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or
- •MRI as assessed by the central imaging reader.
- •3. Is scheduled for a joint replacement surgery to be performed during the study period
- •4. Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
- •5. Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit(topical, intranasal, or inhaled corticosteroids are permitted).
- •6. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
- •7. Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient’s participation in the study
- •8. History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit
- •Note: Other protocol defined inclusion/exclusion criteria apply
研究者
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