Trial comparing treatments for Gout
Official title Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
ClinicalTrials.gov ID: NCT04875702
What this study is testing
What is Allopurinol?
An investigational medication being studied for the treatment of gout. It is designed to lower uric acid levels in the blood.
Also referred to as Aloprim, Zyloprim.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out which gout treatment strategy, treat‑to‑target or treat‑to‑avoid symptoms, gives better patient outcomes and improves heart, kidney, and metabolic health.
- Who it's for
- People who have gout and are willing to follow a study treatment plan.
- What's involved
- Participants will be randomly assigned to one of two gout treatment plans and will have regular visits and tests to monitor their health and gout symptoms.
- Time commitment
- The study lasts several months, with multiple clinic visits and health checks throughout the period.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Provide signed written or electronic informed consent.
- Be between 18 and 90 years old.
- Be in a participating primary care practice with at least one visit in the previous 36 months.
- Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.
- Have experienced at least one gout flare attributed in the previous 12 months.
You likely can't join if
- 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
- Two or more episodes of renal colic in the past 5 years
- Unable to provide informed consent.
- AST/ALT \> 3 × upper limit of normal (ULN) (within 6 months of entry).
- Pregnancy, planning pregnancy, or breastfeeding.
See the full eligibility criteria
- Provide signed written or electronic informed consent.
- Be between 18 and 90 years old.
- Be in a participating primary care practice with at least one visit in the previous 36 months.
- Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.
- Have experienced at least one gout flare attributed in the previous 12 months.
- Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening)
- Be able to swallow pills.
- Agree to practice effective measures of birth control if of reproductive potential.
- 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
- Two or more episodes of renal colic in the past 5 years
- Unable to provide informed consent.
- AST/ALT \> 3 × upper limit of normal (ULN) (within 6 months of entry).
- Pregnancy, planning pregnancy, or breastfeeding.
- 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.
- Unlikely to survive 2 years because of comorbidities.
- 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...
- Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated.
- people 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States; New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.