NCT06578182招募中3 期
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements: a Randomized, Double-blind, Multicentre Study in Symptomatic Knee or Hip Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,410
- 试验地点
- 1
- 主要终点
- Time to first knee or hip replacement
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on the incidence of first occurrence of knee or hip replacement. The main question it aims to answer is:
Does colchicine lower the number of knee or hip replacements in participants with osteoarthritis?
Researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine works to treat osteoarthritis.
Participants will:
- take colchicine every day for 3 tot 4.5 years
- visit the clinic every year for check-up and tests such as blood samples and x-rays
- fill in questionnaires every 3 months
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)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of knee or hip OA
- •45 ≤ age ≤ 80 (upper age limit is similar to that in the LoDoCo2 trial and takes in consideration the lower number of joint replacements in people older than 80 years)
- •documented radiographic changes typical for advanced knee/hip OA (Kellgren & Lawrence score ≥ 2), or at least 2-year history of complaints due to OA in the hip and/or knee
排除标准
- •On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
- •Any absolute contraindication for knee or hip replacement in the future
- •More than one previous hip or knee replacements
- •Other known medical disease that may affect joints
- •Known generalized pain syndromes such as fibromyalgia
- •Renal impairment as evidenced by serum creatinine >150µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
- •Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (upper limit of normal)
- •Blood dyscrasia
- •High frailty (clinical frailty scale ≥ 7) or predicted life expectancy < 5 years
- •Peripheral neuritis, myositis or marked myo-sensitivity to statins
- •Current use of colchicine for another indication
- •Intolerance to colchicine
- •use of macrolide antibiotics (i.e. clarithromycin, erythromycin, azithromycin), antimycotics (i.e. ketoconazole, itraconazole and voriconazole), protease inhibitors & anti-retroviral drugs (i.e. ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat), anti-arrhythmic drugs (i.e. verapamil, diltiazem), or immunosuppressant (i.e. cyclosporine)
- •Current enrollment in another trial
- •Incapacitated patients
- •Pregnant or breastfeeding female
- •Fertile female participants not taking sufficient anti-conception
- •Male participants unwilling to use effective contraception during the study to prevent pregnancy
研究组 & 干预措施
Colchicine
Experimental
干预措施: Colchicine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first knee or hip replacement
时间窗: From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years
次要结局
- Course of pain as assessed by NRS (numeric rating scale)(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Course of pain as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index)(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Course of physical function as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index)(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Course of joint space narrowing on X-ray(From baseline until the date of first documented knee or hip replacement or study end, whichever comes first, assessed up to 4.5 years)
- Course of low-grade inflammation as assessed by hs-CRP(At enrolment, at baseline, 1 year thereafter, and at study completion (approximately 4.5 years))
- Course of quality of life as assessed by EQ-5D-5L (European Quality of Life 5 Dimensions)(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Number of participants with clinical or radiological onset of OA in new joint group other than present at baseline over the trial period(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Time to clinical or radiological onset of OA in new joint group other than present at baseline over the trial period(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Number of participants using pain medication during the study registered per drug type (e.g. paracetamol, NSAIDs, opioids)(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Onset of new cardiovascular events, defined as myocardial infarction, peripheral artery disease, ischemia-driven coronary revascularization, ischemic stroke, or cardiovascular death(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
- Direct and indirect costs related to treatment and disease burden due osteoarthritis(From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years)
研究者
研究点 (1)
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