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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called colchicine can help reduce inflammation and joint pain in people with a condition known as calcium pyrophosphate deposition (CPPD) disease. The researchers want to find out if colchicine can lower the levels of a specific protein in the blood, called interleukin 18 (IL-18), and if it can help reduce pain in those affected by CPPD. To do this, participants will take either colchicine or a placebo (a harmless look-alike pill) every day for six months. They will also visit the clinic three times during this period for joint checks, surveys, and blood tests, and they will have a few short phone calls with the research team.

To join the trial, participants need to be at least 40 years old, have had joint inflammation recently, and report a certain level of pain. They should not have other specific health conditions or be taking certain medications that could interfere with the study. This trial is not yet recruiting participants, but it offers an opportunity for eligible individuals to contribute to important research about CPPD disease and potentially benefit from a new treatment option.

Gender

ALL

Eligibility criteria

• 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)