증상과 낮은 수준의 염증을 줄이기위한 콜히친, 효과적인 CPPD 질병 치료에 대한 제로 (CRYSTALLIZE)
칼슘 피로 포스페이트 증착 질환에서 콜히친의 무작위, 이중 맹검, 다중 사이트 위약 제어 시험
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Sara Tedeschi, MD, MPH
- 이메일: stedeschi1@bwh.harvard.edu
연구 연락처 백업
- 이름: Brenna Sharp de Flores, Senior Research Coordinator
- 전화번호: 617-732-6277
- 이메일: bsharp@bwh.harvard.edu
연구 장소
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-
Alabama
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Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama - Birmingham
-
연락하다:
- Shelby Gontarz, Clinical Research Coordinator
- 이메일: sgontarz@uab.edu
-
연락하다:
- Clementino Vong Do Rosario, Clinical Research Coordinator
- 전화번호: (205) 975-6410
- 이메일: cvongdorosario@uabmc.edu
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수석 연구원:
- Angelo Gaffo, MD, MsPH
-
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California
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Los Angeles, California, 미국, 90095
- 모병
- University of California - Los Angeles
-
연락하다:
- Michelle Ramirez, Clinical Research Coordinator
- 전화번호: (310) 825-9956
- 이메일: MichelleRa@mednet.ucla.edu
-
연락하다:
- Aima Ohiwerei, Clinical Research Coordinator
- 전화번호: (310) 825-2598
- 이메일: AOhiwerei@mednet.ucla.edu
-
수석 연구원:
- John Fitzgerald, MD, PhD
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- 모병
- Boston University Medical Center/Boston Medical Center
-
연락하다:
- Sayali Dhamne, Clinical Research Coordinator
- 전화번호: (617) 358-9655
- 이메일: scdhamne@bu.edu
-
연락하다:
- Sneha Sinha, Clinical Research Coordinator
- 이메일: sneha@bu.edu
-
수석 연구원:
- Tuhina Neogi, MD
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부수사관:
- Maureen Dubreil, MD
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Boston, Massachusetts, 미국, 02118
- 모병
- Brigham and Women's Hospital
-
연락하다:
- Brenna Sharp de Flores, Senior Research Coordinator
- 전화번호: 617-732-6277
- 이메일: bsharp@bwh.harvard.edu
-
수석 연구원:
- Sara Tedeschi, MD, MPH
-
-
Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- 모병
- Medical College of Wisconsin
-
연락하다:
- Kiley Timler, Clinical Research Coordinator
- 전화번호: (414) 955-6875
- 이메일: ktimler@mcw.edu
-
수석 연구원:
- Ann Rosenthal, MD, FACP
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부수사관:
- Viktoriya Sabchyshyn, DO
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
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Age <40 years
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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
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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
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Known allergy to colchicine
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Planned joint surgery in the next 6 months
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo
Placebo |
Placebo capsule, taken by mouth once daily |
|
실험적: Colchicine
Colchicine |
Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Interleukin 18 (IL-18)
기간: Baseline and Week 24
|
Serum IL-18 |
Baseline and Week 24
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum IL-1b
기간: Baseline and Week 24
|
Serum IL-1b |
Baseline and Week 24
|
|
Serum IL-17A
기간: Baseline and Week 24
|
Serum IL-17A |
Baseline and Week 24
|
|
High-sensitivity C-reactive protein (hsCRP)
기간: Baseline and Week 24
|
High-sensitivity C-reactive protein in blood |
Baseline and Week 24
|
|
IL-1b gene signature expression in PBMCs
기간: 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
기간: Baseline and Week 24
|
Immune cell clusters among PBMCs |
Baseline and Week 24
|
|
Pain visual analog scale (pain VAS)
기간: 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)
기간: 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])
기간: 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
기간: 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
기간: Week 12, Week 24
|
5 point Likert scale |
Week 12, Week 24
|
|
Patient Global Assessment
기간: Baseline, Week 12, Week 24
|
Patient Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Physician Global Assessment
기간: Baseline, Week 12, Week 24
|
Physician's Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Flare count
기간: Week 12, Week 24
|
Number of acute calcium pyrophosphate crystal arthritis flares |
Week 12, Week 24
|
|
Adverse events
기간: Week 12, Week 24
|
Number of expected adverse events and unexpected adverse events |
Week 12, Week 24
|
|
Tender Joint Count
기간: Baseline, Week 12, Week 24
|
Tender Joint Count |
Baseline, Week 12, Week 24
|
|
Swollen Joint Count
기간: Baseline, Week 12, Week 24
|
Swollen Joint Count |
Baseline, Week 12, Week 24
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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