The TRUST trial is a clinical trial that is focused on understanding and comparing two methods of treatment. These methods are Treat-to-Target Serum Urate and Treat-to-Avoid Symptoms.
Treat-to-Target Serum Urate:
The Treat-to-Target Serum Urate treatment method works to lower uric acid levels in the blood. Usually, high uric acid levels can cause increased gout attacks and many doctors believe that lowering uric acid levels can reduce the number of gout flares someone has. We will randomize a research participant (similar to flipping a coin) to assign someone to a group. Those who are in this group will be given medications to reduce uric acid levels. These medicines are called allopurinol or febuxostat (taken if you have a reaction to allopurinol). You will also be introduced to gout-friendly daily life practices.
Treat-to-Avoid Symptoms:
The Treat-to-Avoid Symptoms treatment method works by avoiding gout attack symptoms (like redness, swelling, etc). Through reducing the gout flare symptoms, many doctors work to decrease the pain and suffering that comes with gout. Those randomized (similar to flipping a coin) to this group will be given medicines to reduce their symptoms. These medicines are naproxen, ibuprofen, and colchicine. You will also be introduced to gout-friendly daily life practices.
Study Details:
This study is planning to enroll 650 adult patients who have had a gout flare within the last year who have also seen their primary care physician (PCP) in the past three years.
If you agree to participate in this study, here is what you will have to do:
- You will have a screening visit where the study staff will explain all details of the study to you. If you are interested to participate, you will sign a consent document to ensure that you have agreed to the study terms. Next, you will fill out a health screening questionnaire and will have your blood drawn.
- If you are eligible, you have the option to enroll in the study and can schedule a baseline study visit. At this visit, you will be randomized (similar to flipping a coin) to a treatment arm (either the Treat-to-Target Serum Urate or Treat-to-Avoid Symptoms Group).
- In-person study visits will happen at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96. For these visits, you will be asked to have a blood draw, complete questionnaires, do a physical exam, and a check-in for medicines.
- After the baseline visit, study staff will call you biweekly through the end of the study. They will check in with you about your medicines.
You will receive a stipend for each visit. If you have any additional questions, please contact your site-specific staff.