Colchicine for the Treatment of Osteoarthritis of the Knee

NYU Langone Health120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Osteoarthritis Osteo Arthritis Knee

Interventions

Colchicine 0.8 mg or 0.6 mg orally once dailyDRUG

Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)

Placebo oral capsuleDRUG

Placebo 0.8 mg or 0.6 mg orally once daily for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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).

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Change in Visual Analog Scale (VAS) Pain Score

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.