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A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
What is gout?
Gout is a form of arthritis caused by uric acid, a waste product of normal metabolism. When blood levels stay above the point where it dissolves, about 6.8 mg/dL, urate crystals build up in joints and soft tissue, and the immune system reacts to them with sudden, intensely painful swelling, most often in the big toe, foot, ankle, or knee. Attacks usually settle within days, but without treatment they return more often, and over years crystals can form lumps called tophi and damage joints and kidneys. About 9 million US adults have gout, mostly men between 30 and 60 and women after menopause, and it runs with high blood pressure, kidney disease, obesity, and diabetes.
Flares are treated with anti inflammatory medicines such as NSAIDs, colchicine, or steroids. Long term treatment lowers uric acid with daily medicine, most often allopurinol, adjusted until the level stays below 6 mg/dL, a strategy called treat to target that dissolves the crystals over months. For the minority whose gout resists standard pills, an infused enzyme that breaks down uric acid is an option.
Interested in learning more about advanced gout? Read our guide: Gout Tophi: What Tophaceous Gout Lumps Mean and Treatment
Types of gout clinical trials
Uric acid lowering drug trials. New pills and injections that lower urate, including for people who cannot take or do not respond to allopurinol.
Flare treatment and prevention trials. Faster acting anti inflammatory treatments and strategies to prevent the flares that often follow starting urate lowering therapy.
Refractory gout trials. Enzyme based infusions and combinations for gout that persists despite standard treatment, often with large tophi.
Heart and kidney outcome studies. Whether lowering uric acid reduces cardiovascular events or slows kidney disease in people with gout.
Care delivery studies. Nurse led and pharmacist led programs that help people stay on treatment and reach their uric acid target.
Diet and lifestyle studies. Research on alcohol, sugary drinks, and weight loss medicines in people with gout.
Who can participate in gout clinical trials?
Most trials enroll adults with gout confirmed by a doctor, often with crystals seen in joint fluid or on imaging, and a uric acid level above a set value despite treatment or without it. Urate lowering trials usually require a recent flare or tophi, and refractory gout trials require that allopurinol or febuxostat at adequate doses have failed. Flare trials enroll people during an attack, often within a day or two of onset. Many exclude severe kidney disease or require stable kidney function, and some outcome studies enroll people with gout plus heart or kidney conditions. Eligibility always varies by study.
Stages of gout, and why they matter for trials
High uric acid without symptoms. Crystals may be forming but no attacks yet; mostly observational and prevention research.
Acute flares. Sudden painful attacks; flare treatment trials enroll during an attack.
Intercritical gout. Periods between attacks; the setting for most urate lowering drug trials.
Chronic tophaceous gout. Frequent attacks, tophi, and joint damage; refractory gout trials enroll here.
Learn more about gout treatment in our guide!
Do gout trial participants get paid?
Some studies offer compensation for time and travel, and study related care is typically provided at no cost to participants. Compensation varies by trial and is always described during the informed consent process before you agree to anything.
Curious whether clinical trials pay participants? Here's how compensation actually works.
How to enroll in a gout clinical trial
Identify your trial. Use the filters and match the study to your situation: a current flare, starting urate lowering treatment, or gout that has not responded to pills.
Select your preferred location. Enter your city or state; many gout trials run at rheumatology and primary care sites.
Explore study details. Click "Learn More" for uric acid thresholds, flare history required, and current medicine rules.
Complete the health profile. Click "Get started" to begin the 5-step application. Have ready your recent uric acid level, the medicines you take for gout and how long, and your kidney function results if you have them.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.