The Effect of ColcHicine on the Incidence of Knee or Hip Replacements

Course of pain as assessed by NRS (numeric rating scale)

The 11-point NRS ranges from '0' ("no pain") to '10' ("worst pain imaginable")

Time frame: 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)

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

Time frame: 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)

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

Time frame: 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

Time frame: 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

Time frame: 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)

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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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