The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
NCT Number: NCT06578182
Acronym: ECHO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Osteoarthritis, Knee|Osteoarthritis, Hip
Interventions: DRUG: Colchicine|DRUG: Placebo
Sponsor: Sint Maartenskliniek
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development|RSMK|Tiofarma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-03-31

Summary:
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

Primary Outcome Measures: Time to first knee or hip replacement, 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 5 years
Secondary Outcome Measures: Course of pain as assessed by NRS (numeric rating scale), The 11-point NRS ranges from '0' ("no pain") to '10' ("worst pain imaginable"), 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 5 years|Course of pain as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index), 5 items are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores indicate more pain, 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 5 years|Course of physical function as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index), 17 items are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores indicate more functional limitations, 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 5 years|Radiological progression on X-ray, From baseline until the date of first documented knee or hip replacement or study end, whichever comes first, assessed up to 5 years|Change in low-grade inflammation as assessed by hs-CRP, At enrolment, at baseline, 1 year thereafter, and at study completion (approximately 5 years)|Course of quality of life as assessed by EQ-5D-5L (European Quality of Life 5 Dimensions), The EQ-5D-5L comprises 5 dimensions with each dimension having 5 response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to/extreme problems (5). EQ-5D-5L health states can be represented by a single summary number (index value) (range -0.624 to 1.000). Higher scores equals better quality of life, 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 5 years|Number of participants with clinical or radiological onset of OA in new joint group other than hip and/or knee 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 5 years|Time to clinical or radiological onset of OA in new joint group other than hip and/or knee 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 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 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 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 5 years