Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-01 @ 12:38 AM
Study NCT ID:
NCT06855433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYSTALLIZE
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: