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NCT Number: NCT06855433

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

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.

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Key information

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine Pill

Drug

Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily

Placebo

Drug

Placebo capsule, taken by mouth once daily

Primary outcomes

  1. Interleukin 18 (IL-18)

    Time frame: Baseline and Week 24

    Serum IL-18

Secondary outcomes

  1. Serum IL-1b

    Time frame: Baseline and Week 24

    Serum IL-1b

  2. Serum IL-17A

    Time frame: Baseline and Week 24

    Serum IL-17A

  3. High-sensitivity C-reactive protein (hsCRP)

    Time frame: Baseline and Week 24

    High-sensitivity C-reactive protein in blood

  4. IL-1b gene signature expression in PBMCs

    Time frame: 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

  5. Immune cell population frequencies

    Time frame: Baseline and Week 24

    Immune cell clusters among PBMCs

  6. Pain visual analog scale (pain VAS)

    Time frame: Baseline, Week 12, Week 24

    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)

  7. Brief Pain Inventory (Short Form)

    Time frame: Baseline, Week 12, Week 24

    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)

  8. 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

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

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

    Time frame: Baseline, Week 12, Week 24

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

  10. Patient Global Assessment of Response to Treatment

    Time frame: Week 12, Week 24

    5 point Likert scale

  11. Patient Global Assessment

    Time frame: Baseline, Week 12, Week 24

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

  12. Physician Global Assessment

    Time frame: Baseline, Week 12, Week 24

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

  13. Flare count

    Time frame: Week 12, Week 24

    Number of acute calcium pyrophosphate crystal arthritis flares

  14. Adverse events

    Time frame: Week 12, Week 24

    Number of expected adverse events and unexpected adverse events

  15. Tender Joint Count

    Time frame: Baseline, Week 12, Week 24

    Tender Joint Count

  16. Swollen Joint Count

    Time frame: Baseline, Week 12, Week 24

    Swollen Joint Count

Study contacts

Contact information is provided by the study sponsor or research team.

Brenna Sharp de Flores, Senior Research Coordinator

CONTACT

[email protected]

617-732-6277

Sara Tedeschi, MD, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Rheumatology Research Foundation

Registry information

Official study title

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

Acronym: CRYSTALLIZE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 3, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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