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

NCT06855433 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024P003512
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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

Keywords

colchicine; CPPD disease; calcium pyrophosphate; pseudogout

Outcome Measures

Primary Outcomes (1)

• Interleukin 18 (IL-18)

  Serum IL-18

  Baseline and Week 24

Secondary Outcomes (16)

• Serum IL-1b

  Baseline and Week 24

• Serum IL-17A

  Baseline and Week 24

• High-sensitivity C-reactive protein (hsCRP)

  Baseline and Week 24

• IL-1b gene signature expression in PBMCs

  Baseline and Week 24

• Immune cell population frequencies

  Baseline and Week 24

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine

Drug: Colchicine Pill

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Colchicine Pill DRUG

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

Colchicine

Placebo DRUG

Placebo capsule, taken by mouth once daily

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Rheumatology Research Foundation: collaborator

Study Sites (5)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of California - Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Boston University Medical Center/Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02118, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Chondrocalcinosis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Brenna Sharp de Flores, Senior Research Coordinator

CONTACT

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

Sara Tedeschi, MD, MPH

CONTACT

stedeschi1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data Coordinating Center
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 3, 2025
• Study Start: July 20, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

US (5)