COLCHICINE for Osteoarthritis | Knee osteoarthritis | Hip osteoarthritis

Inclusion criteria

• {"criterion_text":"- Clinical diagnosis of knee or hip OA\n- 45 ≤ age ≤ 80\n- 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

• {"criterion_text":"- On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause\n- Male participants unwilling to use effective contraception during the study to prevent pregnancy\n- Peripheral neuritis, myositis or marked myo-sensitivity to statins\n- Current use of colchicine for another indication\n- Current enrollment in another trial\n- Any absolute contraindication for knee or hip replacement in the future\n- More than one previous hip or knee replacements\n- Other known medical disease that may affect joints\n- Known generalized pain syndromes such as fibromyalgia\n- Renal impairment as evidenced by serum creatinine >150µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2\n- Inability to speak, read, or write in Dutch\n- Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (upper limit of normal)\n- 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)\n- High frailty (Clinical Frailty Scale ≥ 7) or predicted life expectancy < 5 years\n- 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)\n- Intolerance to colchicine\n- Incapacitated patients\n- Pregnant or breastfeeding female\n- Fertile female participants not taking sufficient anti-conception"}

Primary endpoints

• {"endpoint_text":"- Time from randomization to the first incident of TKR/THR","definition_or_measurement_approach":"Time-to-event endpoint: time from randomization to the first occurrence of total knee replacement (TKR) or total hip replacement (THR) (incidence of first occurrence of knee or hip replacement)."}

Secondary endpoints

• {"endpoint_text":"- Course of pain from randomization over the trial period\n- Course of physical function over the trial period\n- Radiological progression over the trial period\n- Change in low-grade inflammation at 1 year and end of the study\n- Course of quality of life over the trial period\n- Clinical or radiological onset of OA in new joint group other than hip and/or knee over the trial period\n- Use of pain medication during the study over the trial period\n- Onset of new cardiovascular events, defined as myocardial infarction, peripheral artery disease, ischemia-driven coronary revascularization, ischemic stroke, or cardiovascular death\n- Direct and indirect costs related to treatment and disease burden due osteoarthritis\n- Incidence and severity of adverse events throughout the study","definition_or_measurement_approach":"Where specified: 'Change in low-grade inflammation' measured at 1 year and at end of study; 'Onset of new cardiovascular events' is defined as myocardial infarction, peripheral artery disease, ischemia-driven coronary revascularization, ischemic stroke, or cardiovascular death. Other secondary endpoints are longitudinal/course measures over the trial period (e.g., course of pain, physical function, quality of life, radiological progression, medication use, costs, adverse events) measured according to trial-specified instruments and timepoints (details in protocol/patient-facing documents)."}

Methods

• Outpatient Clinic recruitment flyer (K2_Recruitment material Outpatient Clinic recruitment flyer) — channel: outpatient clinics at participating sites in the Netherlands.
• General Practitioner recruitment letter (K2_Recruitment material General Practitioner recruitment letter) — channel: invitations/referrals via GPs in the Netherlands.
• Orthopaedic Surgery recruitment letter (K2_Recruitment material Orthopaedic Surgery recruitment letter) — channel: invitations/referrals via orthopaedic surgeons in the Netherlands.
• General recruitment arrangements documented in K1_Recruitment arrangements (central recruitment coordination for participating Netherlands sites).

Netherlands

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

498

Number Of Sites

7

Number Of Participants

1200

Primary sponsor

Full Name

Sint Maartenskliniek

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands