A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 13
- 主要终点
- Number of Participants Classified as Responders
研究概览
简要总结
This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee.
详细描述
A Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee
There will be a 7-day screening period for each subject followed by a 12-week participation period.
The primary trial objective is to evaluate the clinical efficacy of Ampion using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) (using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3.1 Index and Patient's Global Assessment as assessments).
The secondary trial objectives are to evaluate the safety of a single intra-articular injection (4 mL) of Ampion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent to participate in the study;
- •Willing and able to comply with all study requirements and instructions of the site study staff;
- •Must be ambulatory;
- •Study knee must have a clinical diagnosis of osteoarthritis (OA) supported by radiological evidence (Kellgren Lawrence Grade IV) which is assessed locally (x-rays within the past 6 months of screening are acceptable);
- •Moderate to moderately-severe OA pain in the study knee (rating of at least 1.5 on the WOMAC A, 5-point Likert Pain Subscale);
- •Moderate to moderately-severe OA function in the study knee (rating of at least 1.5 on the WOMAC C, 5-point Likert Function Subscale);
- •WOMAC A, 5-point Likert pain subscale <1.5 in the contralateral knee;
- •Ability to discontinue non-steroidal anti-inflammatory drug (NSAID) use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low-dose aspirin (81 mg) is allowed during the study);
- •No analgesia (including acetaminophen) taken 24 hours prior to an efficacy measure;
- •No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).
排除标准
- •As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study
- •A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
- •A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
- •Presence of tense effusions
- •Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
- •Isolated patella femoral syndrome, also known as chondromalacia
- •Any other disease or condition interfering with the free use and evaluation of the study knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
- •Major injury to the study knee within the 12 months prior to screening
- •Severe hip osteoarthritis ipsilateral to the study knee
- •Any pain that could interfere with the assessment of study knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
- •Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
- •Pregnancy or planning to become pregnant during the study
- •Use of the following medications:
- •No intra-articular (IA) injected medications in the study knee during the study (or 12 weeks prior to Baseline).
- •No analgesics containing opioids.
- •NSAIDs are not permitted during the study; acetaminophen is available as a rescue medication during the study from the provided supply.
- •No topical treatment on the study knee during the study
- •No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as low-dose Aspirin (81 mg) and Plavix are allowed)
- •No systemic treatments that may interfere with safety or efficacy assessments during the study
- •No immunosuppressants
- •No use of systemic or intra-articular corticosteroids
- •No human albumin treatment in the 3 months before randomization or throughout the duration of the study
研究组 & 干预措施
AMPION™ 4 mL dose
4 mL injection of Ampion
干预措施: 4 mL injection of Ampion (Biological)
Placebo 4 mL dose
4 mL injection of Placebo
干预措施: 4 mL Injection of Placebo (Drug)
结局指标
主要结局
Number of Participants Classified as Responders
时间窗: Determined from Baseline to 12 Weeks
Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of WOMAC A Pain subscore, WOMAC C Function subscore, and PGA as composite endpoints. A patient in this study will be considered a responder for the purpose of efficacy analysis if the following criteria are met: (1) demonstration of ≥ 50% improvement AND a 1.0-unit change in pain OR 1.0-unit change in function OR If the patient does not meet this criterion, then the patient must demonstrate at least 2 of the following: * Improvement in pain (WOMAC A) ≥20% and a 0.5 point absolute change in pain from Baseline on the 5-point Likert scale * Improvement in function (WOMAC C) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale * Improvement in patient global assessment (PGA) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale
次要结局
未报告次要终点