Colchicine om uw symptomen en lagere niveaus van ontsteking te verminderen, nul te maken op een effectieve behandeling met CPPD -ziekten (CRYSTALLIZE)
Een gerandomiseerde, dubbelblinde, multi-site placebo-gecontroleerde studie van colchicine in calciumpyrofosfaatafzettingziekte
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Sara Tedeschi, MD, MPH
- E-mail: stedeschi1@bwh.harvard.edu
Studie Contact Back-up
- Naam: Brenna Sharp de Flores, Senior Research Coordinator
- Telefoonnummer: 617-732-6277
- E-mail: bsharp@bwh.harvard.edu
Studie Locaties
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten, 35233
- Werving
- University of Alabama - Birmingham
-
Contact:
- Shelby Gontarz, Clinical Research Coordinator
- E-mail: sgontarz@uab.edu
-
Contact:
- Clementino Vong Do Rosario, Clinical Research Coordinator
- Telefoonnummer: (205) 975-6410
- E-mail: cvongdorosario@uabmc.edu
-
Hoofdonderzoeker:
- Angelo Gaffo, MD, MsPH
-
-
California
-
Los Angeles, California, Verenigde Staten, 90095
- Werving
- University of California - Los Angeles
-
Contact:
- Michelle Ramirez, Clinical Research Coordinator
- Telefoonnummer: (310) 825-9956
- E-mail: MichelleRa@mednet.ucla.edu
-
Contact:
- Aima Ohiwerei, Clinical Research Coordinator
- Telefoonnummer: (310) 825-2598
- E-mail: AOhiwerei@mednet.ucla.edu
-
Hoofdonderzoeker:
- John Fitzgerald, MD, PhD
-
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Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Boston University Medical Center/Boston Medical Center
-
Contact:
- Sayali Dhamne, Clinical Research Coordinator
- Telefoonnummer: (617) 358-9655
- E-mail: scdhamne@bu.edu
-
Contact:
- Sneha Sinha, Clinical Research Coordinator
- E-mail: sneha@bu.edu
-
Hoofdonderzoeker:
- Tuhina Neogi, MD
-
Onderonderzoeker:
- Maureen Dubreil, MD
-
Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Brigham and Women's Hospital
-
Contact:
- Brenna Sharp de Flores, Senior Research Coordinator
- Telefoonnummer: 617-732-6277
- E-mail: bsharp@bwh.harvard.edu
-
Hoofdonderzoeker:
- Sara Tedeschi, MD, MPH
-
-
Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Werving
- Medical College of Wisconsin
-
Contact:
- Kiley Timler, Clinical Research Coordinator
- Telefoonnummer: (414) 955-6875
- E-mail: ktimler@mcw.edu
-
Hoofdonderzoeker:
- Ann Rosenthal, MD, FACP
-
Onderonderzoeker:
- Viktoriya Sabchyshyn, DO
-
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
-
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
-
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
Placebo |
Placebo capsule, taken by mouth once daily |
|
Experimenteel: Colchicine
Colchicine |
Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Interleukin 18 (IL-18)
Tijdsspanne: Baseline and Week 24
|
Serum IL-18 |
Baseline and Week 24
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Serum IL-1b
Tijdsspanne: Baseline and Week 24
|
Serum IL-1b |
Baseline and Week 24
|
|
Serum IL-17A
Tijdsspanne: Baseline and Week 24
|
Serum IL-17A |
Baseline and Week 24
|
|
High-sensitivity C-reactive protein (hsCRP)
Tijdsspanne: Baseline and Week 24
|
High-sensitivity C-reactive protein in blood |
Baseline and Week 24
|
|
IL-1b gene signature expression in PBMCs
Tijdsspanne: 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
Tijdsspanne: Baseline and Week 24
|
Immune cell clusters among PBMCs |
Baseline and Week 24
|
|
Pain visual analog scale (pain VAS)
Tijdsspanne: 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)
Tijdsspanne: 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])
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Week 12, Week 24
|
5 point Likert scale |
Week 12, Week 24
|
|
Patient Global Assessment
Tijdsspanne: Baseline, Week 12, Week 24
|
Patient Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Physician Global Assessment
Tijdsspanne: Baseline, Week 12, Week 24
|
Physician's Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Flare count
Tijdsspanne: Week 12, Week 24
|
Number of acute calcium pyrophosphate crystal arthritis flares |
Week 12, Week 24
|
|
Adverse events
Tijdsspanne: Week 12, Week 24
|
Number of expected adverse events and unexpected adverse events |
Week 12, Week 24
|
|
Tender Joint Count
Tijdsspanne: Baseline, Week 12, Week 24
|
Tender Joint Count |
Baseline, Week 12, Week 24
|
|
Swollen Joint Count
Tijdsspanne: Baseline, Week 12, Week 24
|
Swollen Joint Count |
Baseline, Week 12, Week 24
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024P003512
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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