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Table 1 Inclusion and exclusion criteria for colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA)

From: Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial

Inclusion Criteria • Symptomatic KOA meeting American College of Rheumatology (ACR) criteria
• Radiographic criteria for KOA with Kellgren-Lawrence (KL) stage of ≥ 2 in at least one knee
• Response positive to the question "do you have pain, aching or stiffness of the knee on most days of the past month
• Score of ≥ 40 out of 100 on a visual analogue scale (VAS) for knee pain
• Age 21 years or above
• Male and female subjects and all ethnicities included
• Patients to agree to avoid consuming grapefruit and grapefruit juice while using colchicine
• Ability to provide informed consent
Exclusion Criteria • Exposure to a corticosteroid (either parenteral or oral) within 3 months prior to the study enrolment
• Knee arthroscopic surgery within 6 months prior to the study enrolment
• Known history of avascular necrosis, inflammatory arthritis (e.g. Rheumatoid Arthritis), Paget's disease, joint infection, periarticular fracture, neuropathic arthropathy, reactive arthritis, or gout involving the knee
• Contraindication to arthrocentesis (warfarin use, bleeding disorder, skin rash or skin infection of signal knee)
• Knee joint replacement in either knee
• History of podagra, active gout or treatment for gout
• Pregnancy or lactation - women of childbearing potential will have serum pregnancy testing (ßHCG) at time of entry prior to any imaging studies (radiographic or MRI); female subjects of childbearing potential must agree to use some form of contraception during the 16 week trial and for 1 week after the end of the trial (over 6 half-life equivalents)
• Renal failure with serum creatinine > 150 mmol/L (1.7 mg/dL);
• Hepatic impairment defined by serum alanine transaminase (ALT) above the upper limit of normal (ULN) for the clinical laboratory performing the screening test
• Muscle impairment defined by elevated serum creatine phosphokinase (CPK) above the ULN for the clinical laboratory performing the screening test
• Personnel directly affiliated with this study or their immediate family members (defined as a spouse, parent, child or sibling, whether biological or legally adopted)
• Current enrollment in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study
• Inability to understand and cooperate with the investigators or to give valid consent;
• Contraindication for magnetic resonance imaging (MRI) - this is exclusion only for the subset of individuals selected for this imaging procedure
• Anticipation of need for joint replacement within 4 months of the start of the intervention
• Current treatment with drugs known to inhibit CYP3A4 isoforms and/or P-glycoprotein (P-gp) that increase the risk of colchicine-induced toxic effects