150 Participants NeededMy employer runs this trial

Colchicine for Pseudogout

(CRYSTALLIZE Trial)

Recruiting at 4 trial locations
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ST
BS
Overseen ByBrenna Sharp de Flores, Senior Research Coordinator
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?

This trial explores whether colchicine can reduce inflammation and pain in individuals with calcium pyrophosphate deposition (CPPD) disease, a condition that often causes joint problems. Participants will take either colchicine or a placebo (a harmless pill with no active drug) daily for six months. Ideal candidates have experienced joint swelling, redness, or warmth in the past three months and struggle with joint pain. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that colchicine is likely to be safe for humans?

Research has shown that colchicine effectively treats certain types of arthritis, such as gout and pseudogout. Studies have found that colchicine can help manage symptoms of these conditions. However, colchicine may not be suitable for everyone. People with severe chronic kidney disease should avoid it. In some studies, about 14% of participants stopped taking the medication due to side effects like diarrhea. While colchicine is generally safe for most, it might cause stomach issues for some. Consulting a doctor is essential to determine if it's appropriate for individual use.12345

Why do researchers think this study treatment might be promising for CPPD?

Most treatments for pseudogout focus on reducing inflammation and managing pain, often using nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. However, colchicine is unique because it specifically targets the inflammatory process by disrupting the activity of certain proteins involved in inflammation. Researchers are excited about colchicine because it offers a different mechanism of action that could lead to more effective management of pseudogout symptoms. Additionally, colchicine has a long history of use for gout, which might translate into a well-understood safety profile for pseudogout treatment as well.

What evidence suggests that colchicine might be an effective treatment for CPPD disease?

Studies have shown that oral colchicine may help reduce flare-ups in people with calcium pyrophosphate deposition (CPPD) disease, also known as pseudogout. Colchicine likely works by reducing inflammation, a part of the body's defense system that can cause pain and swelling. It is already used successfully to treat gout, a condition similar to CPPD. Past research indicates that low doses of colchicine can be safe and effective for managing symptoms in CPPD patients. In this trial, participants will receive either colchicine or a placebo to evaluate its effectiveness in managing CPPD symptoms like joint pain and swelling.678910

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take colchicine or a placebo every day for 6 months

24 weeks
3 visits (in-person), 4 calls (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38251496/

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