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New treatment option for CPPD - Calcium Pyrophosphate Deposition Disease
Official title Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
ClinicalTrials.gov ID: NCT06855433
What this study is testing
What is Colchicine Pill?
Colchicine Pill is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cppd - calcium pyrophosphate deposition disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- Pain visual analog scale (pain VAS) \>=30 at screening
You likely can't join if
- 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...
- Pregnant or breast-feeding
- Use of methotrexate, hydroxychloroquine, tocilizumab or canakinumab in the past 4 weeks
See the full eligibility 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...
- Pain visual analog scale (pain VAS) \>=30 at screening
- 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:
- Hemoglobin \< 9 g/dL
- WBC \<3 x 10\^9/L
- Platelets \<110 x10\^9/L
- Creatinine clearance (CrCl) \<30 mL/min
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Boston, Massachusetts, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.