An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Concentration of Triamcinolone Acetonide in Synovial Fluid
研究概览
简要总结
The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
详细描述
This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee.
Patients were enrolled sequentially with 8 patients per cohort, as follows:
Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12
Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
- •Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
- •Index knee pain for >15 days over the last month
- •Body mass index (BMI) ≤ 40 kg/m2
- •Ambulatory and in good general health
排除标准
- •History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
- •History of arthritides due to crystals (e.g., gout, pseudogout)
- •History of infection in the index joint
- •Clinical signs and symptoms of active knee infection or crystal disease of the index knee
- •Presence of surgical hardware or other foreign body in the index knee
- •Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening
- •IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
- •IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- •Oral corticosteroids (investigational or marketed) within 1 month of Screening
- •Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- •Any other IA investigational drug/biologic within 6 months of Screening
- •Prior use of FX006
- •Prior arthroscopic or open surgery of the index knee within 12 months of Screening
- •Planned/anticipated surgery of the index knee during the study period
- •Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
研究组 & 干预措施
FX006 10 mg
Single 3 mL intra-articular (IA) injection
干预措施: FX006 10 mg (Drug)
FX006 40 mg
Single 3 mL intra-articular (IA) injection
干预措施: FX006 40 mg (Drug)
TCA IR 40 mg
Single 1 mL intra-articular (IA) injection
干预措施: TCA IR 40 mg (Drug)
结局指标
主要结局
Concentration of Triamcinolone Acetonide in Synovial Fluid
时间窗: 12 to 20 weeks
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (\< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).
次要结局
- Plasma Drug Concentrations by Time(Weeks 6, 12, 16 and 20)