Recruiting
Phase 2

Colchicine

Sponsor:

Brigham and Women's Hospital

Code:

NCT06855433

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Colchicine Pill

Placebo

Study Details

Brief summary:

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.

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease

Study ID

NCT06855433

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Colchicine

Colchicine

placebo comparator: Placebo

Placebo

Interventions

Colchicine Pill

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

Placebo

Placebo capsule, taken by mouth once daily

Primary outcome measure

  • Interleukin 18 (IL-18) [ Time Frame: Baseline and Week 24 ]

Central Contacts and Locations

Central contacts

Brenna Sharp de Flores, Senior Research Coordinator

617-732-6277bsharp@bwh.harvard.edu

Sara Tedeschi, MD, MPH

stedeschi1@bwh.harvard.edu

Locations

University of Alabama - Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Shelby Gontarz, Clinical Research Coordinator

sgontarz@uab.edu

Clementino Vong Do Rosario, Clinical Research Coordinator

(205) 975-6410cvongdorosario@uabmc.edu

Principal Investigator:

Angelo Gaffo, MD, MsPH

University of California - Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Michelle Ramirez, Clinical Research Coordinator

(310) 825-9956MichelleRa@mednet.ucla.edu

Aima Ohiwerei, Clinical Research Coordinator

(310) 825-2598AOhiwerei@mednet.ucla.edu

Principal Investigator:

John Fitzgerald, MD, PhD

Boston University Medical Center/Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Sayali Dhamne, Clinical Research Coordinator

(617) 358-9655scdhamne@bu.edu

Sneha Sinha, Clinical Research Coordinator

sneha@bu.edu

Principal Investigator:

Tuhina Neogi, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Brenna Sharp de Flores, Senior Research Coordinator

617-732-6277bsharp@bwh.harvard.edu

Principal Investigator:

Sara Tedeschi, MD, MPH

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kiley Timler, Clinical Research Coordinator

(414) 955-6875ktimler@mcw.edu

Principal Investigator:

Ann Rosenthal, MD, FACP

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • colchicine
  • CPPD disease
  • calcium pyrophosphate
  • pseudogout

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-09.