Colchicine for the Treatment of Osteoarthritis of the Knee

NCT ID: NCT03913442

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2024-01-11

Brief Summary

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.

Conditions

Osteoarthritis; Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo in capsule identical to study drug

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Colchicine

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.

Group Type: EXPERIMENTAL

Colchicine 0.8 mg or 0.6 mg orally once daily

Intervention Type: DRUG

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)

Interventions

Colchicine 0.8 mg or 0.6 mg orally once daily

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)

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Pillinger, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-01796

Identifier Type: -

Identifier Source: org_study_id