The Effect of ColcHicine on the Incidence of Knee or Hip Replacements (ECHO)

Sint Maartenskliniek

Status and phase: Enrolling; Phase 3

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Drug: Placebo; Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT06578182

10140262210012 (Other Grant/Funding Number)

SMaartenskliniek

2024-511359-16-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Enrollment: 1,410 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,410 participants in 2 patient groups, including a placebo group

Colchicine

Experimental group

Treatment:

Drug: Colchicine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo