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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: CPPD - Calcium Pyrophosphate Deposition Disease

In brief

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.

Key facts

Study ID

NCT06855433

Run by

Brigham and Women's Hospital

People needed

150

Starts

2026-07-20

Expected to finish

2030-09-30

Last updated by the study team

2026-07-09

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Hemoglobin < 9 g/dL
• WBC <3 x 10\^9/L
• Platelets <110 x10\^9/L
• Creatinine clearance (CrCl) <30 mL/min
• 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

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States (enrolling)
• University of California - Los Angeles — Los Angeles, California, United States (enrolling)
• Boston University Medical Center/Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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