Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
A legfontosabb adatok
- Hol
- Boston, Morgantown, New York, Santa Monica és South Birmingham (Egyesült Államok)Mind a 7 helyszín megnézése
- Fázis
- 4. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 90 év között vagy?
Forrás: NCT04875702: ki vehet részt
Helyszínek itt: Egyesült Államok
- Boston Medical Center (BMC)Boston, Egyesült ÁllamokContact: Julien J Dedier, MD, MPHToborzás még nem indult
- Brigham and Women's Hospital (BWH)Boston, Egyesült ÁllamokContact: Daniel H Solomon, MD, MPHRésztvevőt keres
- Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Ana D Fernandes, MARésztvevőt keres
- West Virginia University (Including Mobile Clinical Trials Unit)Morgantown, Egyesült ÁllamokContact: Sally Hodder, MDToborzás még nem indult
- NYU LangoneNew York, Egyesült ÁllamokContact: Michael Pillinger, MDRésztvevőt keres
- UCLA HealthSanta Monica, Egyesült ÁllamokContact: John Fitzgerald, MD, PhDToborzás még nem indult
- The University of Alabama at BirminghamSouth Birmingham, Egyesült ÁllamokContact: Kenneth Saag, MD, MScToborzás még nem indult
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Massachusetts General Hospital
- Azonosító
- NCT04875702
- A regiszteradat frissítve
- 2026. november 6.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial
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.
Kizáró feltételek: 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; 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; Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening; AST/ALT > 3 × upper limit of normal (ULN) (within 6 months of entry); Candidates who meet any of the following criteria will be excluded from the study:; 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; Pregnancy, planning pregnancy, or breastfeeding; Unlikely to survive 2 years because of comorbidities; 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.
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.