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.
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.
Principal Investigators
Michael Barry, MD
Massachusetts General Hospital
Internal Medicine
Hyon Choi, MD, DrPH
Massachusetts General Hospital
Rheumatology
Daniel Solomon, MD, MPH
Brigham and Women’s Hospital
Rheumatology
Boston Medical Center
Tuhina Neogi, MD, PhD
Julien Dedier, MD, MPH
Massachusetts General Hospital
Chio Yokose, MD, MSc
Rheumatology
Steve Atlas, MD, MPH
Primary Care
Brigham and Womens Hospital
Zoe Tseng, MD
Primary Care
New York University
David Wei, MD
Internal Medicine
Michael Toprover, MD
Rheumatology
Michael Pillinger, MD
Rheumatology
University of Alabama – Birmingham
Kenneth Saag, MD
Rheumatology
Kevin Riggs, MD
Internal Medicine
University of California – Los Angeles
John Fitzgerald, MD, PhD, MBA
Rheumatology
Paul Shekelle, MD, PhD
Internal Medicine
Co-morbidity Specialists
Deborah Wexler, MD
Massachusetts General Hospital
Endocrinology
Brendan Everett, MD
Brigham and Women’s Hospital
Cardiology
John Forman, MD
Brigham and Women’s Hospital
Nephrology
Central Research and Administrative Staff
Misti Paudel, MPH, PhD
Statistician & DCC Coordinator
Shravani Chitineni, MS
Analyst
Ana Fernandes, M.A.
Research Manager
Kiara Tan, B.A.
Primary Research Coordinator
Shreya Billa, B.S.
Primary Research Coordinator
Natalie McCormick, PhD
Recent Updates
Transforming Gout Care
The medical community has yet to reach a consensus on how to treat gout, but providers are working together to address this problem head on.
About Gout
Gout stands out as one of the more common types of inflammatory arthritis. This condition emerges due to higher levels of uric acid in the body, known as hyperuricemia, causing uric acid crystals to build up in the joints. Typically, individuals who have gout might experience intense gout attacks, also called gout flares. During these episodes, the affected joints become extremely painful and swollen, red, and limit movement. Managing this condition involves various approaches, including treatments to lower uric acid, medications for pain and inflammation, dietary adjustments, and other strategies focused on overall well-being.