TRUST: Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Study Details
Study Description
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 CV-metabolic-renal endpoints.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: 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.
Drug: Antiinflammatory Agent for Gout Flare Prophylaxis
naproxen, colchicine and/or prednisone as flare prophylaxis
|
| Active Comparator: 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. |
Drug: 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.
Drug: Antiinflammatory Agent for Gout Flare Prophylaxis
naproxen, colchicine and/or prednisone as flare prophylaxis
|
Outcome Measures
Primary Outcome Measures
- Frequency of gout flare [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
Secondary Outcome Measures
- Quality of life assessment [baseline to two years of follow up]
SF-36 questionnaire
Eligibility Criteria
Criteria
To be eligible to be enrolled in the study, each patient must:
- Be 18 years or older; 2. Be in a participating primary care practice with at least one visit in the previous 36 months; 3. Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm; 4. Have experienced at least one gout flare attributed in the previous 12 months; and 5. Have a baseline inter-critical serum urate (SU) ≥ 7.0 mg/dL (in the previous 6 months).
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;
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Two or more episodes of renal colic in the past 5 years;
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Unable to provide a written informed consent;
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ALT > 3 × upper limit of normal (ULN) (within 6 months of entry);
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Pregnancy, planning pregnancy, or breastfeeding;
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Taking mercaptopurine (PURINETHOL®) or azathioprine (IMURAN®);
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Unlikely to survive 2 years because of comorbidities; or
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Currently taking > 200 mg per day of allopurinol. 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P000517