A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Colchicine on Pain and Inflammation in Subjects With Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 40 years old or older
- •Continue to experience frequent knee symptoms as defined above
- •Have KL grade 2 or 3 on their last knee radiograph done for the parent study
- •Have an estimated glomerular filtration rate (eGFR) > 30 ml/min (MDRD equation) and liver transaminases < 2x the upper limit of normal
- •Have a BMI ≤ 32 at the time of enrollment
- •Agree to be randomized to take colchicine or placebo daily for 3 months
排除标准
- •Have received hyaluronic acid or corticosteroid steroid injection within the past 3 months
- •Have a diagnosis of gout/pseudogout or other inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthropathy etc).
- •Have a diagnosis of diabetes mellitus, chronic infectious disease, congestive heart failure, non-cutaneous cancer within the past 5 years
- •Plan on undergoing total knee replacement within the next 3 months
- •Be using any medication that is a strong CYP3A4 inhibitor whose metabolism may interact with colchicine (e.g., certain protease inhibitors, certain azole antifungal agents, clarithromycin).
研究组 & 干预措施
Placebo
Placebo in capsule identical to study drug
干预措施: Placebo oral capsule (Drug)
Colchicine
0.6 or 0.8 mg orally once daily.
Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses.
干预措施: Colchicine 0.8 mg or 0.6 mg orally once daily (Drug)
结局指标
主要结局
Change in Visual Analog Scale (VAS) Pain Score
时间窗: Baseline, 3 Months
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
次要结局
- Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score(Baseline, 3 Months)
- Change in the KOOS Stiffness Score(Baseline, 3 Months)
- Change in the KOOS Physical Function Score(Baseline, 3 Months)
- Change in the KOOS Quality of Life Score(Baseline, 3 Months)
- Change in the KOOS Sports and Recreational Activities(Baseline, 3 Months)
- Change in the KOOS Total Score(Baseline, 3 Months)
- Number of Participants Who Used Acetaminophen or Other Medications for Pain(3 Months)
- Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain(6 weeks, 3 months)
- Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra)(Baseline, 3 months)
- Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2)(Baseline, 3 months)
- Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion(Baseline, 3 months)
- Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US(Baseline, 3 months)
- Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP)(Baseline, 3 months)
- Change in Inflammatory Plasma Marker: Uric Acid(Baseline, 3 months)