NCT06855433招募中2 期
A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Interleukin 18 (IL-18)
研究概览
简要总结
The goal of this clinical trial is to learn if colchicine reduces levels of proteins indicating inflammation in the blood in individuals with calcium pyrophosphate deposition (CPPD) disease. The trial will also test the effect of colchicine on joint symptoms in CPPD disease. The main questions it aims to answer are:
- Does colchicine reduce the level of interleukin 18 (IL-18) in the blood of individuals with CPPD disease?
- Does colchicine reduce pain scores in individuals with CPPD disease?
Researchers will compare colchicine once daily to a placebo (a look-alike pill that contains no drug) to see if colchicine works to treat CPPD disease.
Participants will:
- Take colchicine or a placebo every day for 6 months
- Visit the clinic 3 times in 6 months for joint examinations, surveys, and blood tests. Each visit will last 2-3 hours.
- Speak on the telephone with researchers for about 4 times over 6 months. Each phone call will last about 5 minutes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data Coordinating Center
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
- •Provide written informed consent
- •Fulfill ACR/EULAR 2023 CPPD classification criteria
- •Acute or chronic joint inflammation currently or in the past 3 months, not attributable to another condition (Joint Inflammation defined as: At least 1 joint this is swollen, red, or warm to the touch; with or without corresponding tenderness)
- •Pain visual analog scale (pain VAS) >=30 at screening
排除标准
- •Age <40 years
- •Chronic diarrhea
- •Gout, rheumatoid arthritis, psoriatic arthritis, or cirrhosis
- •Ongoing use of colchicine and unwilling to undergo a 30-day wash-out period (note: patients using colchicine at screening can enroll if they agree to a 30-day wash-out before randomization)
- •Pregnant or breast-feeding
- •Use of methotrexate, hydroxychloroquine, tocilizumab or canakinumab in the past 4 weeks
- •Use of anakinra, oral glucocorticoid, or intra-articular steroid in the past 1 week
- •Ongoing use of strong CYP3A4 inhibitors per FDA package insert for colchicine
- •Ongoing use of P-glycoprotein inhibitors per FDA package insert for colchicine
- •Known allergy to colchicine
- •Planned joint surgery in the next 6 months
- •CPPD clinical presentation isolated to Crowned Dens Syndrome with no additional peripheral joint involvement
- •Screening labs with any of the following:
- •Hemoglobin < 9 g/dL
- •WBC <3 x 10^9/L
- •Platelets <110 x10^9/L
- •Creatinine clearance (CrCl) <30 mL/min
- •ALT or AST >3x upper limit of normal (ULN)
- •Patient is considered by investigator to be an unsuitable candidate for the study for any reason
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Colchicine
Experimental
Colchicine
干预措施: Colchicine Pill (Drug)
结局指标
主要结局
Interleukin 18 (IL-18)
时间窗: Baseline and Week 24
Serum IL-18
次要结局
- Pain visual analog scale (pain VAS)(Baseline, Week 12, Week 24)
- Patient Global Assessment of Response to Treatment(Week 12, Week 24)
- Tender Joint Count(Baseline, Week 12, Week 24)
- Swollen Joint Count(Baseline, Week 12, Week 24)
- Brief Pain Inventory (Short Form)(Baseline, Week 12, Week 24)
- Pain in the past week (PEG [pain intensity [P], interference with enjoyment of life [E], and interference with general activity [G])(Baseline, Week 12, Week 24)
- Physician Global Assessment(Baseline, Week 12, Week 24)
- Serum IL-1b(Baseline and Week 24)
- Serum IL-17A(Baseline and Week 24)
- High-sensitivity C-reactive protein (hsCRP)(Baseline and Week 24)
- IL-1b gene signature expression in PBMCs(Baseline and Week 24)
- Immune cell population frequencies(Baseline and Week 24)
- Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function(Baseline, Week 12, Week 24)
- Patient Global Assessment(Baseline, Week 12, Week 24)
- Flare count(Week 12, Week 24)
- Adverse events(Week 12, Week 24)
研究者
Sara Tedeschi, M.D., M.P.H.
Assistant Professor of Medicine
Brigham and Women's Hospital
研究点 (5)
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