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

Phase 2RecruitingNCT06855433

Brigham and Women's Hospital150 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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: 1. Hemoglobin \< 9 g/dL 2. WBC \<3 x 10\^9/L 3. Platelets \<110 x10\^9/L 4. Creatinine clearance (CrCl) \<30 mL/min 5. 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

Locations (5)

University of Alabama - Birmingham

Birmingham, Alabama, United States

RECRUITING

University of California - Los Angeles

Los Angeles, California, United States

RECRUITING

Boston University Medical Center/Boston Medical Center

Boston, Massachusetts, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Interleukin 18 (IL-18)

Serum IL-18

Time frame: Baseline and Week 24

Secondary Outcomes

Serum IL-1b

Time frame: Baseline and Week 24

Serum IL-17A

Time frame: Baseline and Week 24

High-sensitivity C-reactive protein (hsCRP)

High-sensitivity C-reactive protein in blood

Time frame: Baseline and Week 24

IL-1b gene signature expression in PBMCs

Expression of a panel of genes involved in IL-1b production or signaling, as percentage of total gene expression per cell

Time frame: Baseline and Week 24

Immune cell population frequencies

Immune cell clusters among PBMCs

Time frame: Baseline and Week 24

Pain visual analog scale (pain VAS)

Severity of pain from CPPD disease/pseudogout, both at rest and with activity, in the past 7 days (range 0-100mm, with 0 indicating no pain)

Time frame: Baseline, Week 12, Week 24

Brief Pain Inventory (Short Form)

Brief Pain Inventory includes two sub-scores: Pain Severity Score (range 0-10, with 0 indicating no pain in the past 24 hours) and Pain Interference Score (range 0-10, with 0 indicating no interference in the past 24 hours)

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])

3 question instrument, range 0-10, with 0 indicating no pain and no interference in the past week

Time frame: Baseline, Week 12, Week 24

Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function

PROMIS-Physical Function Short Form 10a (T-score range 0-100, with higher scores indicating better physical function)

Time frame: Baseline, Week 12, Week 24

Patient Global Assessment of Response to Treatment

5 point Likert scale

Time frame: Week 12, Week 24

Patient Global Assessment

Patient Global Assessment of CPPD Disease Activity (range: 0-10)

Time frame: Baseline, Week 12, Week 24

Physician Global Assessment

Physician's Global Assessment of CPPD Disease Activity (range: 0-10)

Time frame: Baseline, Week 12, Week 24

Flare count

Number of acute calcium pyrophosphate crystal arthritis flares

Time frame: Week 12, Week 24

Adverse events

Number of expected adverse events and unexpected adverse events

Time frame: Week 12, Week 24

Tender Joint Count

Time frame: Baseline, Week 12, Week 24

Swollen Joint Count

Time frame: Baseline, Week 12, Week 24

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts