To qualify for this study, participants must:
Be 18 years of age or older
Have been diagnosed with gout and are experiencing a gout flare that began within the 96 hours prior to the first study visit
What are Gout Flares?
Gout flares are episodes of intense pain and inflammation that occur in individuals with gout, a form of arthritis. Gout is caused by the accumulation of urate crystals in the joints, typically due to high levels of uric acid in the blood. When these crystals form, they can trigger sudden and severe bouts of pain known as gout flares.
During a gout flare, the affected joint becomes extremely painful, swollen, red, and tender to the touch. The pain is often described as excruciating and may come on suddenly, typically during the night. Gout commonly affects the joint at the base of the big toe, but it can also occur in other joints such as the ankles, knees, wrists, fingers, and elbows.
What is clinical research?
Clinical research is how we get new therapies, devices and medications to the general public. Clinical trials test the safety and effectiveness of the medicines and devices created by biopharmaceutical companies. The Food and Drug Administration (FDA) approves all medicines and devices before they become available to consumers.
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It depends on the trial and what the pharmaceutical company has approved. It does not cost the participant any money to participate in a clinical trial. Some clinical trial sponsors will pay for participants’ travel costs. Javara partners with Uber Health to provide prepaid patient transportation to study visits to make clinical research more convenient.
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While studies have strict protections, there is always a balance of risk and reward to any clinical study. Be sure to discuss your concerns with the research study team as well as your physician. If you decide to enroll in a trial, you will receive all the information necessary to give permission prior to any procedure or treatment. The informed consent documents also include a description of the procedure or treatment, potential risks or benefits, probable duration of any incapacitation, and alternatives.
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Health insurance plans are required by federal law to cover routine patient care costs in clinical trials if certain conditions are met. These conditions include:
- Trial participants must meet certain eligibility requirements to participate in the trial.
- Clinical trials must be approved.
- Out-of-network doctors and hospitals are not included in the trial if your insurance plan does not cover out-of-network care.
Additionally, most health plans cannot deny you benefits or refuse to let you participate in an approved clinical trial. (source cancer.gov)
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The research study team should be able to tell you the details of the trial schedule if you are considering taking part in a clinical trial. The duration of some trials may last a few years, but the number of visits may only be a few times per year. For other trials, participants may need to visit more frequently or keep a journal between visits. Consider the benefits of participation versus how much time you may need to devote. Learn how long each study visit will take and what you’ll be doing during your visit from the study team.