NCT04875702 Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
| NCT ID | NCT04875702 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Gout |
| Study Type | INTERVENTIONAL |
| Enrollment | 650 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 650 participants in total. It began in 2024-02-22 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Hyon K Choi, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04875702 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Gout. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04875702 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04875702 currently recruiting?
Yes, NCT04875702 is actively recruiting participants. Contact the research team at adfernandes@mgh.harvard.edu for enrollment information.
Where is the NCT04875702 trial being conducted?
This trial is being conducted at South Birmingham, United States, Santa Monica, United States, Boston, United States, Boston, United States and 3 additional locations.
Who is sponsoring the NCT04875702 clinical trial?
NCT04875702 is sponsored by Massachusetts General Hospital. The principal investigator is Hyon K Choi, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 650 participants.