Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment (CRYSTALLIZE)

Mass General Brigham

Status and phase: Begins enrollment in 2 months; Phase 2

Conditions: CPPD - Calcium Pyrophosphate Deposition Disease

Treatments: Drug: Colchicine Pill; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06855433

2024P003512

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Colchicine

Experimental group

Description:

Colchicine

Treatment:

Drug: Colchicine Pill

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo