Your session is about to expire
← Back to Search
Xanthine Oxidase Inhibitor
Treat-to-Target vs Symptom Management for Gout (TRUST Trial)
Phase 4
Recruiting
Led By Hyon K Choi, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to two years of follow up
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Summary
"This trial is comparing two different treatments for gout to see which one is better for patients in terms of gout symptoms and other related health issues like heart, metabolism, and kidney problems."
Who is the study for?
This trial is for adults aged 18-90 with chronic kidney disease stage 3B or worse, at least one gout flare in the past year, and high serum urate levels. They must have had two episodes of renal colic within five years and more than one tophus. Participants need to be able to swallow pills and agree to birth control measures if applicable.
What is being tested?
The TRUST study compares two gout treatment strategies: Treat-to-Target Serum Urate (TTT) versus Treat-to-Avoid Symptoms (TTASx). It aims to find out which approach is better for patient-centered outcomes and cardiovascular-metabolic-renal health.
What are the potential side effects?
Possible side effects include stomach issues from Naproxen, digestive problems from Colchicine, mood swings or increased appetite from Prednisone, and skin reactions or liver issues from Allopurinol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to two years of follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to two years of follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of gout flare
Secondary study objectives
Quality of life assessment
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Active Control
Group I: TTASxActive Control5 Interventions
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.
Group II: TTT-SUActive Control3 Interventions
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.
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,368 Total Patients Enrolled
1 Trials studying Gout
280 Patients Enrolled for Gout
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,170 Total Patients Enrolled
3 Trials studying Gout
383 Patients Enrolled for Gout
Hyon K Choi, MD, PhDPrincipal InvestigatorMassachusetts General Hospital