Back to Trials
NCT06855433PHASE2Recruiting

Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment

Brigham and Women's Hospital

Start Date

7/20/2026

Completion Date

9/30/2030

Summary

The goal of this clinical trial is to learn if colchicine reduces levels of proteins indicating inflammation in the blood in individuals with calcium pyrophosphate deposition (CPPD) disease. The trial will also test the effect of colchicine on joint symptoms in CPPD disease. The main questions it aims to answer are: * Does colchicine reduce the level of interleukin 18 (IL-18) in the blood of individuals with CPPD disease? * Does colchicine reduce pain scores in individuals with CPPD disease? Researchers will compare colchicine once daily to a placebo (a look-alike pill that contains no drug) to see if colchicine works to treat CPPD disease. Participants will: * Take colchicine or a placebo every day for 6 months * Visit the clinic 3 times in 6 months for joint examinations, surveys, and blood tests. Each visit will last 2-3 hours. * Speak on the telephone with researchers for about 4 times over 6 months. Each phone call will last about 5 minutes.

Eligibility Criteria

Age Range: 40 years to No maximum

Inclusion Criteria: * Provide written informed consent * Fulfill ACR/EULAR 2023 CPPD classification criteria * Acute or chronic joint inflammation currently or in the past 3 months, not attributable to another condition (Joint Inflammation defined as: At least 1 joint this is swollen, red, or warm to the touch; with or without corresponding tenderness) * Pain visual analog scale (pain VAS) \>=30 at screening Exclusion Criteria: * Age \<40 years * Chronic diarrhea * Gout, rheumatoid arthritis, psoriatic arthritis, or cirrhosis * Ongoing use of colchicine and unwilling to undergo a 30-day wash-out period (note: patients using colchicine at screening can enroll if they agree to a 30-day wash-out before randomization) * Pregnant or breast-feeding * Use of methotrexate, hydroxychloroquine, tocilizumab or canakinumab in the past 4 weeks * Use of anakinra, oral glucocorticoid, or intra-articular steroid in the past 1 week * Ongoing use of strong CYP3A4 inhibitors per FDA package insert for colchicine * Ongoing use of P-glycoprotein inhibitors per FDA package insert for colchicine * Known allergy to colchicine * Planned joint surgery in the next 6 months * CPPD clinical presentation isolated to Crowned Dens Syndrome with no additional peripheral joint involvement * Screening labs with any of the following: 1. Hemoglobin \< 9 g/dL 2. WBC \<3 x 10\^9/L 3. Platelets \<110 x10\^9/L 4. Creatinine clearance (CrCl) \<30 mL/min 5. ALT or AST \>3x upper limit of normal (ULN) * Patient is considered by investigator to be an unsuitable candidate for the study for any reason

Interventions

DRUG

Colchicine Pill

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease

Locations

University of Alabama - Birmingham

Birmingham, Alabama 35233

United States

University of California - Los Angeles

Los Angeles, California 90095

United States

Boston University Medical Center/Boston Medical Center

Boston, Massachusetts 02118

United States

Brigham and Women's Hospital

Boston, Massachusetts 02118

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States