Clinical trial NCT06855433: Colchicine to Reduce Your SympToms and Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
Official title: A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: CPPD - Calcium Pyrophosphate Deposition Disease
Keywords: colchicine
CPPD disease
calcium pyrophosphate
pseudogout
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2025-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in the past 3 months, not attributable to another condition
* Pain visual analog scale (pain VAS) \>=30 at screening

Exclusion Criteria:

* age \<40 years
* chronic diarrhea
* gout, rheumatoid arthritis, or psoriatic arthritis
* 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, or anakinra in the past month
* use of oral glucocorticoid in the past week
* use of strong CYP3A4 inhibitors per FDA package insert for colchicine
* use of P-glycoprotein inhibitors per FDA package insert for colchicine
* known allergy to colchicine

Screening labs with any of the following:

* hemoglobin \< 11.5 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)

Primary outcomes:
measure: Interleukin 18 (IL-18)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Serum IL-1b
timeFrame: Baseline and Week 24
measure: Serum IL-17A
timeFrame: Baseline and Week 24
measure: High-sensitivity C-reactive protein (hsCRP)
timeFrame: Baseline and Week 24
measure: IL-1b gene signature expression in PBMCs
timeFrame: Baseline and Week 24
measure: Immune cell population frequencies
timeFrame: Baseline and Week 24
measure: Pain visual analog scale (pain VAS)
timeFrame: Baseline, Week 12, Week 24
measure: Patient Reported Outcome Measurement Information System (PROMIS)-Pain Interference
timeFrame: Baseline, Week 12, Week 24
measure: Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function
timeFrame: Baseline, Week 12, Week 24
measure: Patient Global Assessment of Response to Treatment
timeFrame: Week 12, Week 24
measure: Patient Global Assessment
timeFrame: Baseline, Week 12, Week 24
measure: Assessor Global Assessment
timeFrame: Baseline, Week 12, Week 24
measure: Flare count
timeFrame: Week 12, Week 24
measure: Adverse events
timeFrame: Week 12, Week 24
Other outcomes:
Locations:
Study officials:
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