2024-511359-16-00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 – the ECHO trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 6
- 主要终点
- Time from randomization to the first incident of TKR/THR
研究概览
简要总结
To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip OA on the incidence of first occurrence of knee or hip replacement.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee or hip OA
- •45 ≤ age ≤ 80
- •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
- •Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (upper limit of normal)
- •Lowered blood cell counts: anaemia (haemoglobin <8.0 mmol/l in males or <7.0 mmol/l in females), leukopenia (< 3.5e9 leucocytes per litre), and/or thrombocytopenia (< 100e9 thrombocytes per litre)
- •High frailty (Clinical Frailty Scale ≥ 7) or predicted life expectancy < 5 years
- •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), use of immunosuppressant (i.e. ciclosporine)
- •Intolerance to colchicine
- •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
- •Peripheral neuritis, myositis or marked myo-sensitivity to statins
- •Current use of colchicine for another indication
- •Current enrollment in another trial
- •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
结局指标
主要结局
Time from randomization to the first incident of TKR/THR
Time from randomization to the first incident of TKR/THR
次要结局
- Course of pain from randomization over the trial period
- Course of physical function over the trial period
- Radiological progression over the trial period
- Change in low-grade inflammation at 1 year and end of the study
- Course of quality of life over the trial period
- Clinical or radiological onset of OA in new joint group other than hip and/or knee over the trial period
- Use of pain medication during the study over the trial period
- Onset of new cardiovascular events, defined as myocardial infarction, peripheral artery disease, ischemia-driven coronary revascularization, ischemic stroke, or cardiovascular death
- Direct and indirect costs related to treatment and disease burden due osteoarthritis
- Incidence and severity of adverse events throughout the study
研究者
Tim Massa
Scientific
Sint Maartenskliniek
研究点 (6)
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