Colchicine to Reduce Inflammation and Joint Symptoms in CPPD Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial will compare daily colchicine to a placebo over six months in adults with CPPD disease. Participants will have three clinic visits for assessments and four brief follow-up phone contacts. The study will measure blood levels of IL-18 and pain scores, along with joint examinations and safety monitoring. Eligibility requires CPPD classification, active or recent joint inflammation, and a pain score of at least 30 on the visual analog scale. Exclusions include age under 40, certain comorbid conditions, and recent use of specific therapies that could confound results.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Brenna Sharp de Flores, Senior Research Coordinator
• Email: bsharp@bwh.harvard.edu
• Phone: 617-732-6277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.