Colchicine to Reduce Your SympToms and Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment

Phase 2

Not yet recruiting

• Conditions: CPPD - Calcium Pyrophosphate Deposition Disease
• Interventions: Drug: Colchicine Pill; Drug: Placebo

• Registration Number: NCT06855433
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-05
• Study Start: 2025-04-01
• Primary Completion: 2029-04-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine Pill	Colchicine
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Interleukin 18 (IL-18)	Baseline and Week 24	Serum IL-18

Secondary Outcome Measures

Name	Time	Method
Serum IL-1b	Baseline and Week 24	Serum IL-1b
Serum IL-17A	Baseline and Week 24	Serum IL-17A
High-sensitivity C-reactive protein (hsCRP)	Baseline and Week 24	High-sensitivity C-reactive protein in blood
IL-1b gene signature expression in PBMCs	Baseline and Week 24	Expression of a panel of genes involved in IL-1b production or signaling, as percentage of total gene expression per cell
Immune cell population frequencies	Baseline and Week 24	Immune cell clusters among PBMCs
Pain visual analog scale (pain VAS)	Baseline, Week 12, Week 24	Pain VAS (range 0-100mm) reflecting pain in the past 24 hours due to CPPD disease
Patient Reported Outcome Measurement Information System (PROMIS)-Pain Interference	Baseline, Week 12, Week 24	PROMIS-Pain Interference Short Form 6b, assessing pain interference in the past 7 days. (T-score range 0-100, with higher scores indicating greater pain interference)
Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function	Baseline, Week 12, Week 24	PROMIS-Physical Function Short Form 10a (T-score range 0-100, with higher scores indicating better physical function)
Patient Global Assessment of Response to Treatment	Week 12, Week 24	5 point Likert scale
Patient Global Assessment	Baseline, Week 12, Week 24	Patient Global Assessment of CPPD Disease Activity (range: 0-10)
Assessor Global Assessment	Baseline, Week 12, Week 24	Assessor's Global Assessment of CPPD Disease Activity (range: 0-10)
Flare count	Week 12, Week 24	Number of acute calcium pyrophosphate crystal arthritis flares
Adverse events	Week 12, Week 24	Number of expected adverse events and unexpected adverse events