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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

N/A

Inclusion Criteria:

Provide written informed consent
Fulfill ACR/EULAR 2023 CPPD classification criteria
Acute or chronic joint inflammation in the past 3 months, not attributable to another condition
Pain visual analog scale (pain VAS) >=30 at screening

Exclusion Criteria:

age <40 years
chronic diarrhea
gout, rheumatoid arthritis, or psoriatic arthritis
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, or anakinra in the past month
use of oral glucocorticoid in the past week
use of strong CYP3A4 inhibitors per FDA package insert for colchicine
use of P-glycoprotein inhibitors per FDA package insert for colchicine
known allergy to colchicine Screening labs with any of the following:
hemoglobin < 11.5 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)