Colchicine for å redusere symptomene dine og lavere nivåer av betennelse, nullgjøre effektiv CPPD -sykdomsbehandling (CRYSTALLIZE)
En randomisert, dobbeltblind, multisite placebokontrollert studie av kolkisin i kalsiumpyrofosfatavsetningssykdom
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Sara Tedeschi, MD, MPH
- E-post: stedeschi1@bwh.harvard.edu
Studer Kontakt Backup
- Navn: Brenna Sharp de Flores, Senior Research Coordinator
- Telefonnummer: 617-732-6277
- E-post: bsharp@bwh.harvard.edu
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35233
- Rekruttering
- University of Alabama - Birmingham
-
Ta kontakt med:
- Shelby Gontarz, Clinical Research Coordinator
- E-post: sgontarz@uab.edu
-
Ta kontakt med:
- Clementino Vong Do Rosario, Clinical Research Coordinator
- Telefonnummer: (205) 975-6410
- E-post: cvongdorosario@uabmc.edu
-
Hovedetterforsker:
- Angelo Gaffo, MD, MsPH
-
-
California
-
Los Angeles, California, Forente stater, 90095
- Rekruttering
- University of California - Los Angeles
-
Ta kontakt med:
- Michelle Ramirez, Clinical Research Coordinator
- Telefonnummer: (310) 825-9956
- E-post: MichelleRa@mednet.ucla.edu
-
Ta kontakt med:
- Aima Ohiwerei, Clinical Research Coordinator
- Telefonnummer: (310) 825-2598
- E-post: AOhiwerei@mednet.ucla.edu
-
Hovedetterforsker:
- John Fitzgerald, MD, PhD
-
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Boston University Medical Center/Boston Medical Center
-
Ta kontakt med:
- Sayali Dhamne, Clinical Research Coordinator
- Telefonnummer: (617) 358-9655
- E-post: scdhamne@bu.edu
-
Ta kontakt med:
- Sneha Sinha, Clinical Research Coordinator
- E-post: sneha@bu.edu
-
Hovedetterforsker:
- Tuhina Neogi, MD
-
Underetterforsker:
- Maureen Dubreil, MD
-
Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Brigham and Women's Hospital
-
Ta kontakt med:
- Brenna Sharp de Flores, Senior Research Coordinator
- Telefonnummer: 617-732-6277
- E-post: bsharp@bwh.harvard.edu
-
Hovedetterforsker:
- Sara Tedeschi, MD, MPH
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of Wisconsin
-
Ta kontakt med:
- Kiley Timler, Clinical Research Coordinator
- Telefonnummer: (414) 955-6875
- E-post: ktimler@mcw.edu
-
Hovedetterforsker:
- Ann Rosenthal, MD, FACP
-
Underetterforsker:
- Viktoriya Sabchyshyn, DO
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion 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 corresponding tenderness)
- Pain visual analog scale (pain VAS) >=30 at screening
Exclusion Criteria:
-
Age <40 years
-
Chronic diarrhea
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Gout, rheumatoid arthritis, psoriatic arthritis, or cirrhosis
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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)
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Pregnant or breast-feeding
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Use of methotrexate, hydroxychloroquine, tocilizumab or canakinumab in the past 4 weeks
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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
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Ongoing use of P-glycoprotein inhibitors per FDA package insert for colchicine
-
Known allergy to colchicine
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Planned joint surgery in the next 6 months
-
CPPD clinical presentation isolated to Crowned Dens Syndrome with no additional peripheral joint involvement
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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)
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Patient is considered by investigator to be an unsuitable candidate for the study for any reason
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo |
Placebo capsule, taken by mouth once daily |
|
Eksperimentell: Colchicine
Colchicine |
Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Interleukin 18 (IL-18)
Tidsramme: Baseline and Week 24
|
Serum IL-18 |
Baseline and Week 24
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum IL-1b
Tidsramme: Baseline and Week 24
|
Serum IL-1b |
Baseline and Week 24
|
|
Serum IL-17A
Tidsramme: Baseline and Week 24
|
Serum IL-17A |
Baseline and Week 24
|
|
High-sensitivity C-reactive protein (hsCRP)
Tidsramme: Baseline and Week 24
|
High-sensitivity C-reactive protein in blood |
Baseline and Week 24
|
|
IL-1b gene signature expression in PBMCs
Tidsramme: Baseline and Week 24
|
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
Tidsramme: Baseline and Week 24
|
Immune cell clusters among PBMCs |
Baseline and Week 24
|
|
Pain visual analog scale (pain VAS)
Tidsramme: Baseline, Week 12, Week 24
|
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)
Tidsramme: Baseline, Week 12, Week 24
|
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])
Tidsramme: Baseline, Week 12, Week 24
|
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
Tidsramme: Baseline, Week 12, Week 24
|
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
Tidsramme: Week 12, Week 24
|
5 point Likert scale |
Week 12, Week 24
|
|
Patient Global Assessment
Tidsramme: Baseline, Week 12, Week 24
|
Patient Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Physician Global Assessment
Tidsramme: Baseline, Week 12, Week 24
|
Physician's Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Flare count
Tidsramme: Week 12, Week 24
|
Number of acute calcium pyrophosphate crystal arthritis flares |
Week 12, Week 24
|
|
Adverse events
Tidsramme: Week 12, Week 24
|
Number of expected adverse events and unexpected adverse events |
Week 12, Week 24
|
|
Tender Joint Count
Tidsramme: Baseline, Week 12, Week 24
|
Tender Joint Count |
Baseline, Week 12, Week 24
|
|
Swollen Joint Count
Tidsramme: Baseline, Week 12, Week 24
|
Swollen Joint Count |
Baseline, Week 12, Week 24
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024P003512
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