Phase 4 Gout Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing and able to sign a consent form agreeing to take part in the study.
• You are between 18 and 90 years old.
• You are a patient at one of the participating primary care clinics and have had at least one visit there in the past 3 years.
• You have been diagnosed with gout using a specific scoring system called the 2015 ACR/EULAR criteria, with a score of 8 or more points (confirm with trial site).
• You have had at least one gout flare (a painful gout attack) in the past 12 months.
• A blood test has shown that your uric acid level is 6.0 mg/dL or higher, either at your screening appointment or within the 30 days before it.
• You are able to swallow pills.
• If you are able to have children, you agree to use effective birth control during the study.

Who may not be able to join:

• You have moderate-to-severe kidney disease (specifically CKD Stage 3B or worse, meaning your kidneys are working at less than 45% of normal capacity).
• You have more than one visible gout lump (called a tophus) under your skin, found during your screening examination.
• You have had two or more kidney stones causing severe pain (renal colic) in the past 5 years.
• You are not able to give informed consent to take part.
• A recent blood test (within the past 6 months) has shown that your liver enzyme levels are more than 3 times higher than the normal range.
• You are currently pregnant, planning to become pregnant, or breastfeeding.
• You have taken certain immune-suppressing medicines called thiopurines — including mercaptopurine, azathioprine, or thioguanine — in the past 12 months, or you are currently taking them.
• You are not expected to survive for at least 2 years due to other serious health conditions.
• You are currently taking more than 200 mg per day of allopurinol (a gout medication), or any amount of febuxostat (another gout medication). If you take 200 mg or less of allopurinol daily, you may still be eligible, as long as your dose has not been increased in the past 6 months and you meet the other eligibility requirements.
• You have had a known allergic or severe reaction to allopurinol in the past and are unwilling to try febuxostat instead if needed during the study.
• You have tested positive for a specific gene marker called HLA-B*5801, which is linked to a serious skin reaction to allopurinol, and you are unwilling to use febuxostat instead if required. People of Black/African American, Asian (except Japanese), Native Hawaiian, or Pacific Islander descent will be tested for this gene marker at screening.

Important: Always verify eligibility with the trial site directly before applying.