Colchicine for the Treatment of Osteoarthritis of the Knee (CLOAK)

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis; Osteo Arthritis Knee

Treatments: Drug: Colchicine 0.8 mg or 0.6 mg orally once daily; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03913442

16-01796

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo in capsule identical to study drug

Treatment:

Drug: Placebo oral capsule

Colchicine

Experimental group

Description:

0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses.

Treatment:

Drug: Colchicine 0.8 mg or 0.6 mg orally once daily