NCT06855433 Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
| NCT ID | NCT06855433 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | CPPD - Calcium Pyrophosphate Deposition Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2026-07-20 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 \<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: 1. Hemoglobin \< 9 g/dL 2. WBC \<3 x 10\^9/L 3. Platelets \<110 x10\^9/L 4. Creatinine clearance (CrCl) \<30 mL/min 5. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06855433 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying CPPD - Calcium Pyrophosphate Deposition Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06855433 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06855433 currently recruiting?
Yes, NCT06855433 is actively recruiting participants. Contact the research team at bsharp@bwh.harvard.edu for enrollment information.
Where is the NCT06855433 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Boston, United States, Boston, United States and 1 additional location.
Who is sponsoring the NCT06855433 clinical trial?
NCT06855433 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 150 participants.