Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06855433
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- CPPD - Calcium Pyrophosphate Deposition Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Colchicine Pill — DRUGColchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily
- Placebo — DRUGPlacebo capsule, taken by mouth once daily
Study Details
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.
Key Dates
- Start date
- Jul 20, 2026
- Status verified
- Jul 2026
- Primary completion
- Apr 30, 2030
- Completion
- Sep 30, 2030
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ColchicineColchicine
- Placebo Comparator: PlaceboPlacebo
Primary Outcome Measure
Interleukin 18 (IL-18) [ Time Frame: Baseline and Week 24 ]
Central Contacts
- Brenna Sharp de Flores, Senior Research Coordinator617-732-6277
- Sara Tedeschi, MD, MPH
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | Shelby Gontarz, Clinical Research Coordinator Angelo Gaffo, MD, MsPH (PRINCIPAL_INVESTIGATOR) |
| University of California - Los Angeles | Los Angeles | California | 90095 | John Fitzgerald, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Boston University Medical Center/Boston Medical Center | Boston | Massachusetts | 02118 | Sneha Sinha, Clinical Research Coordinator Tuhina Neogi, MD (PRINCIPAL_INVESTIGATOR) Maureen Dubreil, MD (SUB_INVESTIGATOR) |
| Brigham and Women's Hospital | Boston | Massachusetts | 02118 | Sara Tedeschi, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Ann Rosenthal, MD, FACP (PRINCIPAL_INVESTIGATOR) Viktoriya Sabchyshyn, DO (SUB_INVESTIGATOR) |