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Treat-to-Target Serum Urat versus Treat-to-Ungå-symptomer ved gikt (TRUST)

4. november 2026 oppdatert av: Hyon Choi, Massachusetts General Hospital

Treat-to-Target serum-urat versus Treat-to-ungå-symptomer i gikt: En randomisert kontrollert prøvelse

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

650

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • South Birmingham, Alabama, Forente stater, 35233
        • Har ikke rekruttert ennå
        • The University of Alabama at Birmingham
        • Ta kontakt med:
        • Ta kontakt med:
    • California
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Hovedetterforsker:
          • Hyon K Choi, MD, DrPH
        • Ta kontakt med:
      • Boston, Massachusetts, Forente stater, 02115
      • Boston, Massachusetts, Forente stater, 02119
        • Har ikke rekruttert ennå
        • Boston Medical Center (BMC)
        • Ta kontakt med:
    • New York
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • Har ikke rekruttert ennå
        • West Virginia University (Including Mobile Clinical Trials Unit)
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Sarah Hansen, MD
        • Underetterforsker:
          • Kimberly Houchin, MD
        • Underetterforsker:
          • Joanna Bailey, MD
        • Underetterforsker:
          • Mathew Weimer, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

To be eligible to be enrolled in the study, each patient must:

  1. Provide signed written or electronic informed consent.
  2. Be between 18 and 90 years old.
  3. Be in a participating primary care practice with at least one visit in the previous 36 months.
  4. Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.
  5. Have experienced at least one gout flare attributed in the previous 12 months.
  6. Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening)
  7. Be able to swallow pills.
  8. 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:

  1. Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening
  2. More than one subcutaneous tophus on clinical examination at screening
  3. Two or more episodes of renal colic in the past 5 years
  4. Unable to provide informed consent.
  5. AST/ALT > 3 × upper limit of normal (ULN) (within 6 months of entry).
  6. Pregnancy, planning pregnancy, or breastfeeding.
  7. 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.
  8. Unlikely to survive 2 years because of comorbidities.
  9. 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.
  10. Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated.
  11. 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: Allopurinol

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.

Andre navn:
  • Aloprim, Zyloprim
Legemiddel: Naproxen 250 MG

Naproxen 250 mg p.o. twice daily

Andre navn:
  • Profylakse
Legemiddel: Colchicine 0.6 mg

Colchicine 0.6 mg p.o. once daily

Andre navn:
  • Profylakse
Aktiv komparator: 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.
Legemiddel: Allopurinol

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.

Andre navn:
  • Aloprim, Zyloprim
Legemiddel: Naproxen 250 MG

Naproxen 250 mg p.o. twice daily

Andre navn:
  • Profylakse
Legemiddel: Colchicine 1.2 mg

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.

Andre navn:
  • Flare
Legemiddel: Naproxen 500 Mg

dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.

Andre navn:
  • Flare
Legemiddel: Prednisone 40 mg

For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.

Andre navn:
  • Flare

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Frequency of gout flare
Tidsramme: baseline to two years of follow up

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of life assessment
Tidsramme: baseline to two years of follow up

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Etterforskere

  • Hovedetterforsker: Hyon K Choi, MD, PhD, Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. februar 2024

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

31. oktober 2028

Datoer for studieregistrering

Først innsendt

3. mai 2021

Først innsendt som oppfylte QC-kriteriene

3. mai 2021

Først lagt ut (Faktiske)

6. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2021P000517
  • 1U01AR080985-01A1 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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