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Recruiting NCT06855433

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

Phase II Interventional CPPD - Calcium Pyrophosphate Deposition Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colchicine Pill, Placebo.
Who it may be relevant to
Registry conditions: CPPD - Calcium Pyrophosphate Deposition Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Interleukin 18 (IL-18) [Time frame: Baseline and Week 24]
Secondary outcome measures (12)
  • Serum IL-1b [Time frame: Baseline and Week 24]
  • Serum IL-17A [Time frame: Baseline and Week 24]
  • High-sensitivity C-reactive protein (hsCRP) [Time frame: Baseline and Week 24]
  • IL-1b gene signature expression in PBMCs [Time frame: Baseline and Week 24]
  • Immune cell population frequencies [Time frame: Baseline and Week 24]
  • Pain visual analog scale (pain VAS) [Time frame: Baseline, Week 12, Week 24]
  • Brief Pain Inventory (Short Form) [Time frame: 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]) [Time frame: Baseline, Week 12, Week 24]
  • Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function [Time frame: Baseline, Week 12, Week 24]
  • Patient Global Assessment of Response to Treatment [Time frame: Week 12, Week 24]
  • Patient Global Assessment [Time frame: Baseline, Week 12, Week 24]
  • Physician Global Assessment [Time frame: Baseline, Week 12, Week 24]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • 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

Identifiers

NCT: NCT06855433 · 2024P003512

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗