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

ConditionCPPD - Calcium Pyrophosphate Deposition Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ColchicineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Interleukin 18 (IL-18)

Serum IL-18

Time frame
Baseline and Week 24

Secondary outcomes

1

Serum IL-1b

Serum IL-1b

Time frame
Baseline and Week 24
2

Serum IL-17A

Serum IL-17A

Time frame
Baseline and Week 24
3

High-sensitivity C-reactive protein (hsCRP)

High-sensitivity C-reactive protein in blood

Time frame
Baseline and Week 24
4

IL-1b gene signature expression in PBMCs

Expression of a panel of genes involved in IL-1b production or signaling, as percentage of total gene expression per cell

Time frame
Baseline and Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Rheumatology Research Foundation

Collaborator

Source ClinicalTrials.gov
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