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

Phase 2Not Yet RecruitingNCT06855433

Brigham and Women's Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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)