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| Name | Class |
|---|---|
| Rheumatology Research Foundation | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Colchicine |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine Pill | Drug | Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 18 (IL-18) | Serum IL-18 | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IL-1b | Serum IL-1b | Baseline and Week 24 |
| Serum IL-17A | Serum IL-17A | Baseline and Week 24 |
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Inclusion Criteria:
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:
Patient is considered by investigator to be an unsuitable candidate for the study for any reason
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brenna Sharp de Flores, Senior Research Coordinator | Contact | 617-732-6277 | bsharp@bwh.harvard.edu | |
| Sara Tedeschi, MD, MPH | Contact | stedeschi1@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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Data Coordinating Center
| Placebo | Drug | Placebo capsule, taken by mouth once daily |
|
| High-sensitivity C-reactive protein (hsCRP) | High-sensitivity C-reactive protein in blood | Baseline and Week 24 |
| 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 | Baseline and Week 24 |
| Immune cell population frequencies | Immune cell clusters among PBMCs | Baseline and Week 24 |
| Pain visual analog scale (pain VAS) | Severity of pain from CPPD disease/pseudogout, both at rest and with activity, in the past 7 days (range 0-100mm, with 0 indicating no pain) | Baseline, Week 12, Week 24 |
| Brief Pain Inventory (Short Form) | Brief Pain Inventory includes two sub-scores: Pain Severity Score (range 0-10, with 0 indicating no pain in the past 24 hours) and Pain Interference Score (range 0-10, with 0 indicating no interference in the past 24 hours) | Baseline, Week 12, Week 24 |
| Pain in the past week (PEG [pain intensity [P], interference with enjoyment of life [E], and interference with general activity [G]) | 3 question instrument, range 0-10, with 0 indicating no pain and no interference in the past week | Baseline, Week 12, Week 24 |
| Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function | PROMIS-Physical Function Short Form 10a (T-score range 0-100, with higher scores indicating better physical function) | Baseline, Week 12, Week 24 |
| Patient Global Assessment of Response to Treatment | 5 point Likert scale | Week 12, Week 24 |
| Patient Global Assessment | Patient Global Assessment of CPPD Disease Activity (range: 0-10) | Baseline, Week 12, Week 24 |
| Physician Global Assessment | Physician's Global Assessment of CPPD Disease Activity (range: 0-10) | Baseline, Week 12, Week 24 |
| Flare count | Number of acute calcium pyrophosphate crystal arthritis flares | Week 12, Week 24 |
| Adverse events | Number of expected adverse events and unexpected adverse events | Week 12, Week 24 |
| Tender Joint Count | Tender Joint Count | Baseline, Week 12, Week 24 |
| Swollen Joint Count | Swollen Joint Count | Baseline, Week 12, Week 24 |
| University of California - Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
|
| Boston University Medical Center/Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02118 | United States |
|
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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