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

Purpose

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.

Condition

  • CPPD - Calcium Pyrophosphate Deposition Disease

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Data Coordinating Center

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Colchicine 		Colchicine
  • Drug: Colchicine Pill
    Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Placebo capsule, taken by mouth once daily

Recruiting Locations

Boston University Medical Center/Boston Medical Center
Boston, Massachusetts 02118
Contact:
Sayali Dhamne, Clinical Research Coordinator
(617) 358-9655
scdhamne@bu.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Brenna Sharp de Flores, Senior Research Coordinator
617-732-6277
bsharp@bwh.harvard.edu