NCT03913442

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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)
DRUG	Placebo oral capsule	Placebo 0.8 mg or 0.6 mg orally once daily for 3 months

Timeline

• Start date: 2019-05-15
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2019-04-12
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study