← Back to Search

Xanthine Oxidase Inhibitor

TTASx for Gout (TRUST Trial)

Q: What is the upper limit for the number of participants enrolled in this clinical investigation?

The enrollment goal for this study is set at 650 eligible participants. Interested individuals can choose to enroll in various locations such as Brigham and Women's Hospital (BWH) located in Boston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> or The University of <a href="https://www.withpower.com/clinical-trials/alabama">Alabama</a> at Birmingham situated in Birmingham, Alabama.

Q: Are individuals currently being actively enrolled in this research study?

Indeed, the details available on clinicaltrials.gov indicate an ongoing search for eligible participants in this particular trial. The trial was first listed on 23rd January 2024 and subsequently updated on 12th March 2024. It aims to enroll a total of 650 individuals across six designated sites.

Q: What is the typical application of TTASx in medical practice?

TTASx, primarily indicated for Lesch-Nyhan syndrome, may also be prescribed to manage chemotherapy-induced symptoms, <a href="https://www.withpower.com/clinical-trials/eczema">eczema</a> flare-ups, and the complications of chronic kidney disease (CKD).

Q: Has the TTASx treatment received official approval from the FDA?

The safety rating of TTASx is rated as 3 by our team at Power, as this trial falls under Phase 4 where the treatment has already obtained approval.

Q: How prevalent is the participation of medical centers in this trial within the United States?

Currently, patient enrollment for this study is ongoing at 6 research facilities. These include Boston, Birmingham, and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> among other locations. Opting for a site in close proximity to you will help reduce travel demands should you decide to take part.

Q: What additional research has been conducted on the use of TTASx in medical trials?

TTASx was initially researched in 2018 at Oslo Universitetssykehus Hf. To date, there have been 110 concluded clinical investigations on this compound. Currently, there are 4 ongoing trials, with a significant number of them being conducted in Boston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>.

Q: Is the clinical trial accepting participants who are younger than 80 years old?

This clinical investigation is enrolling individuals who are older than 18 years and younger than 90 years.

Q: Who would be considered the ideal candidates to enroll in this research study?

This medical trial is seeking to enroll 650 individuals aged between 18 and 90 who are currently affected by <a href="https://www.withpower.com/clinical-trials/gout">gout</a>. In addition, eligible participants must meet the subsequent criteria: Confirmation of chronic kidney disease (CKD) Stage 3B or worse (eGFR &#x3C; 45 mL/min/1.73 m2) during screening; Presence of multiple subcutaneous tophi upon clinical evaluation at screening; History of two or more episodes of renal colic within the last five years; Initial intercritical serum urate (SU) level ≥ 7.0 mg/dL either during assessment or in the preceding month before assessment

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

TRUST Trial 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.Check my eligibility

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.See study design

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.

TRUST Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to two years of follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of gout flare

Secondary outcome measures

Quality of life assessment

TRUST 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

485 Previous Clinical Trials

1,086,250 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,197,991 Total Patients Enrolled

1 Trials studying Gout

43 Patients Enrolled for Gout

Hyon K Choi, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of participants enrolled in this clinical investigation?

"The enrollment goal for this study is set at 650 eligible participants. Interested individuals can choose to enroll in various locations such as Brigham and Women's Hospital (BWH) located in Boston, Massachusetts or The University of Alabama at Birmingham situated in Birmingham, Alabama."

Answered by AI

Are individuals currently being actively enrolled in this research study?

"Indeed, the details available on clinicaltrials.gov indicate an ongoing search for eligible participants in this particular trial. The trial was first listed on 23rd January 2024 and subsequently updated on 12th March 2024. It aims to enroll a total of 650 individuals across six designated sites."

Answered by AI

What is the typical application of TTASx in medical practice?

"TTASx, primarily indicated for Lesch-Nyhan syndrome, may also be prescribed to manage chemotherapy-induced symptoms, eczema flare-ups, and the complications of chronic kidney disease (CKD)."

Answered by AI

Has the TTASx treatment received official approval from the FDA?

"The safety rating of TTASx is rated as 3 by our team at Power, as this trial falls under Phase 4 where the treatment has already obtained approval."

Answered by AI

How prevalent is the participation of medical centers in this trial within the United States?

"Currently, patient enrollment for this study is ongoing at 6 research facilities. These include Boston, Birmingham, and New york among other locations. Opting for a site in close proximity to you will help reduce travel demands should you decide to take part."

Answered by AI

What additional research has been conducted on the use of TTASx in medical trials?

"TTASx was initially researched in 2018 at Oslo Universitetssykehus Hf. To date, there have been 110 concluded clinical investigations on this compound. Currently, there are 4 ongoing trials, with a significant number of them being conducted in Boston, Massachusetts."

Answered by AI

Is the clinical trial accepting participants who are younger than 80 years old?

"This clinical investigation is enrolling individuals who are older than 18 years and younger than 90 years."

Answered by AI

Who would be considered the ideal candidates to enroll in this research study?

"This medical trial is seeking to enroll 650 individuals aged between 18 and 90 who are currently affected by gout. In addition, eligible participants must meet the subsequent criteria: Confirmation of chronic kidney disease (CKD) Stage 3B or worse (eGFR < 45 mL/min/1.73 m2) during screening; Presence of multiple subcutaneous tophi upon clinical evaluation at screening; History of two or more episodes of renal colic within the last five years; Initial intercritical serum urate (SU) level ≥ 7.0 mg/dL either during assessment or in the preceding month before assessment"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

Hyon Choi 2024. "Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04875702.

All > Gout