치료 대상 혈청 요산염 대 통풍의 치료 방지 증상 (TRUST)
통풍의 치료 대상 혈청 요산염 대 회피 치료 증상: 무작위 대조 시험
The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This trial aims to answer a fundamental question in the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine which is most beneficial for a range of patient-centered gout outcomes, as well as relevant CV-metabolic-renal endpoints.
Designing a scientifically valid and pragmatic clinical trial involves numerous tradeoffs in study design, subject eligibility criteria, and outcome measurement. We have come together as primary care physicians and rheumatologists to consider several alternative designs. We first considered the target study population. Since most rheumatologists believe that the TTT approach is superior, it would be difficult to recruit from rheumatology practices. Thus, we aimed to design a trial that would be feasible to conduct in primary care practices, with an intervention that could primarily be run by nurses and physician assistants. This design would be pragmatic and generalizable to primary care practices outside of the setting of a randomized controlled trial. The trial also needs to incorporate the perspectives of rheumatologists, primary care clinicians, allied specialists, and patients when deciding the key issues to be addressed and how best to answer these questions.76 We convened a modified Delphi Panel (mDP) to solicit input using a formal process of voting and discussion. The Delphi Panel is a commonly used approach in health care for areas where there is less than perfect data to make decisions. It also has been used in the social sciences as a method for formalizing input from multiple parties, using voting and discussion.77,78 We selected a broadly representative group of mDP panelists from four categories of constituents who could inform the trial design: patients, nurses, primary care physicians, and rheumatologists. Two voting rounds were held, including a video conference meeting to discuss all the voting questions and re-vote on items where no consensus had been reached on the first round.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ana D Fernandes, MA
- 전화번호: 617-643-2140
- 이메일: adfernandes@mgh.harvard.edu
연구 장소
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Alabama
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South Birmingham, Alabama, 미국, 35233
- 아직 모집하지 않음
- The University of Alabama at Birmingham
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연락하다:
- Kenneth Saag, MD, MSc
- 이메일: ksagg@uabmc.edu
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연락하다:
- Kevin Riggs, MD, MPH
- 이메일: kriggs@uab.edu
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California
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Santa Monica, California, 미국, 90404
- 아직 모집하지 않음
- UCLA Health
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연락하다:
- John Fitzgerald, MD, PhD
- 이메일: Jfitzgerald@mednet.ucla.edu
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연락하다:
- Paul Shekelle, MD,PhD
- 이메일: Paul.Shekelle@va.gov
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts General Hospital
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수석 연구원:
- Hyon K Choi, MD, DrPH
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연락하다:
- Ana D Fernandes, MA
- 전화번호: 617-643-2140
- 이메일: adfernandes@mgh.harvard.edu
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Boston, Massachusetts, 미국, 02115
- 모병
- Brigham and Women's Hospital (BWH)
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연락하다:
- Daniel H Solomon, MD, MPH
- 이메일: dsolomon@bwh.harvard.edu
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연락하다:
- Jacklyn Stratton
- 이메일: jstratton1@bwh.harvard.edu
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Boston, Massachusetts, 미국, 02119
- 아직 모집하지 않음
- Boston Medical Center (BMC)
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연락하다:
- Julien J Dedier, MD, MPH
- 이메일: Julien.Dedier@bmc.org
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New York
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New York, New York, 미국, 10010
- 모병
- NYU Langone
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연락하다:
- Michael Pillinger, MD
- 이메일: Michael.pillinger@nyulangone.org
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연락하다:
- David Wei, MD
- 이메일: David.Wei@nyulangone.org
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West Virginia
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Morgantown, West Virginia, 미국, 26506
- 아직 모집하지 않음
- West Virginia University (Including Mobile Clinical Trials Unit)
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연락하다:
- Sally Hodder, MD
- 전화번호: 304-581-1842
- 이메일: slhodder@hsc.wvu.edu
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연락하다:
- Maggie Childers-Kakos, MS
- 전화번호: 304-293-1426
- 이메일: margaret.childers@hsc.wvu.edu
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부수사관:
- Sarah Hansen, MD
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부수사관:
- Kimberly Houchin, MD
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부수사관:
- Joanna Bailey, MD
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부수사관:
- Mathew Weimer, MD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
To be eligible to be enrolled in the study, each patient must:
- Provide signed written or electronic informed consent.
- Be between 18 and 90 years old.
- Be in a participating primary care practice with at least one visit in the previous 36 months.
- Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.
- Have experienced at least one gout flare attributed in the previous 12 months.
- Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening)
- Be able to swallow pills.
- Agree to practice effective measures of birth control if of reproductive potential.
Exclusion Criteria
Candidates who meet any of the following criteria will be excluded from the study:
- Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening
- More than one subcutaneous tophus on clinical examination at screening
- Two or more episodes of renal colic in the past 5 years
- Unable to provide informed consent.
- AST/ALT > 3 × upper limit of normal (ULN) (within 6 months of entry).
- Pregnancy, planning pregnancy, or breastfeeding.
- Patients who have been treated with thiopurines (mercaptopurine (PURINETHOL®), azathioprine (IMURAN®), or thioguanine) in the past 12 months or currently being treated with thiopurines are not eligible for the study. Usage of the thiopurines (azathioprine and mercaptopurine) with allopurinol has been shown to cause a significant drug-drug interaction.
- Unlikely to survive 2 years because of comorbidities.
- Currently taking > 200 mg of allopurinol per day or any dose of febuxostat. Patients taking 200 mg or less of allopurinol daily may participate, provided they meet the eligibility criteria for flares and current SU, and they have not had a dose escalation in their allopurinol in the previous 6 months.
- Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated.
- Subjects that test positive for HLA-B*5801 allele, a genetic marker for severe cutaneous adverse reactions caused by allopurinol and are unwilling to initiate febuxostat if urate lowering is indicated by the study. Subjects of higher risk, including Black/African American, Asian (except Japanese), native Hawaiian, or Pacific Islander descent will be tested at screening.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: TTT-SU
The participants randomized to the Treat-to-Target-Serum Urate (TTT-SU) group will be counseled about gout, generalized lifestyle and dietary issues and will be provided with a three-month supply of allopurinol as well as a treatment to prophylax against attacks that might occur during the up-titration of urate lowering therapy. Allopurinol dose increases will occur until SU concentrations achieve a target level < 6.0 mg/dL. |
For the TTT-SU group: The dose titration algorithm for allopurinol increases every 4 weeks by 100 mg until the target serum urate of 6 mg/dL is reached or a patient requires 800 mg per day of allopurinol. Subjects will require a blood draw for SU every 4 weeks until reaching the target. For the TTASx group: Subjects randomized to the TTASx group will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone) for up to six flares over the ensuing three months. Urate lowering therapy (ULT) will only be offered after the third flare during the trial.
다른 이름들:
Naproxen 250 mg p.o. twice daily
다른 이름들:
Colchicine 0.6 mg p.o. once daily
다른 이름들:
|
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활성 비교기: TTASx
Subjects randomized to the treat-to-avoid-symptoms (TTASx) group will receive the same education as the TTT-SU group. In addition, they will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone); enough to treat up to six flares over the ensuing three months. |
For the TTT-SU group: The dose titration algorithm for allopurinol increases every 4 weeks by 100 mg until the target serum urate of 6 mg/dL is reached or a patient requires 800 mg per day of allopurinol. Subjects will require a blood draw for SU every 4 weeks until reaching the target. For the TTASx group: Subjects randomized to the TTASx group will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone) for up to six flares over the ensuing three months. Urate lowering therapy (ULT) will only be offered after the third flare during the trial.
다른 이름들:
Naproxen 250 mg p.o. twice daily
다른 이름들:
Dose escalation to 0.6 mg p.o. twice daily for patients experiencing breakthrough flares or a dose decrease (0.6 mg p.o. every other day) for patients experiencing gastrointestinal intolerance.
다른 이름들:
dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
다른 이름들:
For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of gout flare
기간: baseline to two years of follow up
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number of gout flares occurring during two years of follow-up between the TTT-SU and TTASx groups |
baseline to two years of follow up
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life assessment
기간: baseline to two years of follow up
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The Short Form 36 Health Survey Questionnaire (SF-36) questionnaire will be used to assess the health status of study participants by surveying 36 questions in 8 domains of health. A higher score indicates a better health status. For the TRUST study a total physical (score of 10 to 30), functional (a score of 4 to 8) and pain (a score of 2 to 11) will be used as the secondary outcome. |
baseline to two years of follow up
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Hyon K Choi, MD, PhD, Massachusetts General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 수정 관절병증
- 근골격계 질환
- 관절염
- 관절 질환
- 류마티스 질환
- 퓨린-피리미딘 대사, 선천성 이상
- 대사, 선천적 오류
- 유전병, 선천적
- 대사 질환
- 선천성, 유전성, 신생아 질환 및 이상
- 영양 및 대사 질환
- 통풍
- 유기 화학 물질
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 탄화수소
- 탄화수소, 순환
- 물리적 현상
- 알칼로이드
- 나프탈렌
- 다 환식 방향족 탄화수소
- 탄화수소, 방향족
- 다 환식 화합물
- 퓨린
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- Pregnadienediols
- 나프탈렌 반응산
- 천문 현상
- 프레드니손
- 나프록센
- 알로푸리놀
- 콜히친
- 태양 활동
기타 연구 ID 번호
기타 연구 ID 번호
- 2021P000517
- 1U01AR080985-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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