An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 17
- 主要终点
- Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006
研究概览
简要总结
This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee
详细描述
This study is an open-label, repeat administration design of 32 mg FX006. The study will be conducted in male and female patients ≥ 40 years of age with symptomatic OA of the knee.
Eligible patients will be offered participation to receive an initial intra-articular (IA) injection of FX006 administered to the index knee at Day 1.
Patients who receive an initial injection of FX006 will return at Weeks 4 and 8 before being evaluated at 12, 16, 20 and 24 weeks for repeat administration. At the first evaluation where the patient has been determined to meet repeat administration eligibility criteria, the patient will be eligible to receive a second IA injection of FX006.
Patients who are eligible to receive a second injection will be evaluated for a total of 52 weeks post initial injection at: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52, regardless of the time at which they receive their second injection. In addition, X-rays will be completed at Screening and Week 52 or End of Study (EOS) for assessment of safety.
Patients that do not benefit from the initial treatment as determined by evaluation at Week 12 will complete the study at the Week 12 follow-up visit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent to participate in the study
- •Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- •Male or female ≥ 40 years of age
- •Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
- •Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
- •Kellgren-Lawrence (KL) Grade 2, 3 or 4 in the index knee based on X-ray performed during Screening
- •Qualifying score for WOMAC A at Screening and Day 1/Baseline
- •Index knee pain for >15 days over the last month (as reported by the patient)
- •Body mass index (BMI) ≤ 40 kg/m2
- •Ambulatory and in good general health
- •Willingness to abstain from use of protocol-restricted medications during the study
排除标准
- •Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- •History of infection in the index knee joint
- •Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- •Presence of surgical hardware or other foreign body in the index knee
- •Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of Screening
- •IA corticosteroid (investigational or marketed) in index knee within 3 months of Screening
- •IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- •IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
- •Oral corticosteroids (investigational or marketed) within 1 month of Screening
- •Any other IA drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy and amniotic fluid injection)
- •Prior administration of FX006
- •Women of child-bearing potential not using effective contraception or who are pregnant or nursing
研究组 & 干预措施
FX006 32 mg
Single intra-articular injection
干预措施: FX006 32 mg (Drug)
结局指标
主要结局
Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006
时间窗: Up to 52 Weeks
Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE) in patients who received two doses of 32 mg FX006. TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).
次要结局
未报告次要终点