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150 Participants NeededMy employer runs this trial

Colchicine for Pseudogout

(CRYSTALLIZE Trial)

Recruiting at 4 trial locations
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Overseen ByBrenna Sharp de Flores, Senior Research Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with CPPD disease (pseudogout) who have had joint inflammation in the past 3 months and currently have moderate or worse pain. Participants must be able to give consent and meet specific medical criteria for CPPD.

Inclusion Criteria

Provide written informed consent
I have had unexplained joint swelling, redness, or warmth in the past 3 months.
My pain level is at least moderate during screening.
See 1 more

Exclusion Criteria

Patient is considered by investigator to be an unsuitable candidate for the study for any reason
Known allergy to colchicine
My CPPD only affects my neck and not other joints.
See 11 more

What Are the Treatments Tested in This Trial?

Interventions

  • Colchicine

Trial Overview

The study compares a daily colchicine pill to a placebo over 6 months to see if colchicine lowers inflammation markers in the blood and reduces joint pain in people with CPPD. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ColchicineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Rheumatology Research Foundation

Collaborator

Trials
14
Recruited
8,200+

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