Colchicine for the Treatment of Osteoarthritis of the Knee

A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Colchicine on Pain and Inflammation in Subjects With Knee Osteoarthritis

This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.

Inclusion Criteria:

• Are 40 years old or older
• Continue to experience frequent knee symptoms as defined above
• Have KL grade 2 or 3 on their last knee radiograph done for the parent study
• Have an estimated glomerular filtration rate (eGFR) > 30 ml/min (MDRD equation) and liver transaminases < 2x the upper limit of normal
• Have a BMI ≤ 32 at the time of enrollment
• Agree to be randomized to take colchicine or placebo daily for 3 months

Exclusion Criteria:

• Have received hyaluronic acid or corticosteroid steroid injection within the past 3 months
• Have a diagnosis of gout/pseudogout or other inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthropathy etc).
• Have a diagnosis of diabetes mellitus, chronic infectious disease, congestive heart failure, non-cutaneous cancer within the past 5 years
• Plan on undergoing total knee replacement within the next 3 months
• Be using any medication that is a strong CYP3A4 inhibitor whose metabolism may interact with colchicine (e.g., certain protease inhibitors, certain azole antifungal agents, clarithromycin).