NCT06855433 · Brigham and Women's Hospital
Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
(CRYSTALLIZE)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \<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
- Birmingham, Alabama
- Los Angeles, California
- Boston, Massachusetts
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations