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NCT06855433
Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
Conditions: CPPD - Calcium Pyrophosphate Deposition Disease
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 150
Sponsor: Brigham and Women's Hospital
Location: University of Alabama - Birmingham Birmingham Alabama
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
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 \
Source: ClinicalTrials.gov (NCT06855433). StuddyBuddy aggregates publicly available trial information.