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

Официальное название

A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease

Обзор

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.

Вмешательства

• Препарат Colchicine Pill
  Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily
• Препарат Placebo
  Placebo capsule, taken by mouth once daily

Первичные конечные точки

• Interleukin 18 (IL-18) [Срок оценки: Baseline and Week 24]

Вторичные конечные точки (12)

• Serum IL-1b [Срок оценки: Baseline and Week 24]
• Serum IL-17A [Срок оценки: Baseline and Week 24]
• High-sensitivity C-reactive protein (hsCRP) [Срок оценки: Baseline and Week 24]
• IL-1b gene signature expression in PBMCs [Срок оценки: Baseline and Week 24]
• Immune cell population frequencies [Срок оценки: Baseline and Week 24]
• Pain visual analog scale (pain VAS) [Срок оценки: Baseline, Week 12, Week 24]
• Brief Pain Inventory (Short Form) [Срок оценки: Baseline, Week 12, Week 24]
• Pain in the past week (PEG [pain intensity [P], interference with enjoyment of life [E], and interference with general activity [G]) [Срок оценки: Baseline, Week 12, Week 24]
• Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function [Срок оценки: Baseline, Week 12, Week 24]
• Patient Global Assessment of Response to Treatment [Срок оценки: Week 12, Week 24]
• Patient Global Assessment [Срок оценки: Baseline, Week 12, Week 24]
• Physician Global Assessment [Срок оценки: Baseline, Week 12, Week 24]

Критерии участия

Критерии включения

• Provide written informed consent
• Fulfill ACR/EULAR 2023 CPPD classification criteria
• Acute or chronic joint inflammation currently or in the past 3 months, not attributable to another condition (Joint Inflammation defined as: At least 1 joint this is swollen, red, or warm to the touch; with or without corresponding tenderness)
• Pain visual analog scale (pain VAS) >=30 at screening

Критерии исключения

• Age <40 years
• Chronic diarrhea
• Gout, rheumatoid arthritis, psoriatic arthritis, or 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, tocilizumab or canakinumab in the past 4 weeks
• Use of anakinra, oral glucocorticoid, or intra-articular steroid in the past 1 week
• Ongoing use of strong CYP3A4 inhibitors per FDA package insert for colchicine
• Ongoing use of P-glycoprotein inhibitors per FDA package insert for colchicine
• Known allergy to colchicine
• Planned joint surgery in the next 6 months
• CPPD clinical presentation isolated to Crowned Dens Syndrome with no additional peripheral joint involvement
• Screening labs with any of the following:

• Hemoglobin < 9 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)
• Patient is considered by investigator to be an unsuitable candidate for the study for any reason

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Alabama - Birmingham — Birmingham
• University of California - Los Angeles — Los Angeles
• Boston University Medical Center/Boston Medical Center — Boston
• Brigham and Women's Hospital — Boston
• Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT06855433 · 2024P003512

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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