The following clinical trials represent a selection of key clinical trials that are currently recruiting patients with gout for inclusion in investigations of new therapies and regimens of available therapies for patients with gout. Each clinical trial description includes the NLM Identifier to be used as a reference for ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.
2 The Link Between Purine Metabolism and Uric Acid Production
The purpose of this study is to determine the relationship between purine metabolism enzyme single-nucleotide polymorphisms and uric acid production. Response to xanthine oxidase inhibitors will also be evaluated. Men and women aged ≥18 years may be eligible for study inclusion if he or she has had asymptomatic hyperuricemia (serum uric acid level, >7 mg/dL) on ≥2 isolated occasions, or been clinically diagnosed with gout. People with neither of the preceding 2 criteria can be included as part of the control group.
The primary outcome measure is single-nucleotide polymorphism’s association with gout, hyperuricemia, and xanthine oxidase inhibitor doses needed to reach a goal serum uric acid level of <6 mg/dL, during a 2-year time frame. Other outcome measures are determining the frequency of single-nucleotide polymorphisms tested during that same time frame, as well as the relationship of xanthine oxidase single-nucleotide polymorphism 2107A>G and several hypoxanthine phosphoribosyltransferase 1 single-nucleotide polymorphisms to hyperuricemia and gout.
The study expects to enroll 500 participants at the Keesler Medical Center, Biloxi, MS. For more information, contact Matthew B. Carroll, MD, at 228-376-3629 or firstname.lastname@example.org. The NLM Identifier is NCT01830725.
4 Assessing the Effect of a High Zone Tolerizing Regimen of Pegloticase
Researchers are conducting an exploratory, open-label, multicenter study evaluating the effectiveness of a high zone tolerance regimen of pegloticase on response therapy in adult patients with refractory gout who are hyperuricemic. Men and women aged ≥18 years with chronic gout that is refractory to conventional therapy, who are of non-childbearing potential, may be eligible for enrollment if other criteria are met.
Patients will receive a tolerizing dose of pegloticase 8 mg intravenously each week for the first 3 weeks of dosing, followed by an 8-mg intravenous dose administered every 2 weeks for a total of 10 doses. The primary outcome measure is the responder rate for patients with refractory gout in the experimental group from baseline to 17 weeks. During that time frame, the investigators will also be evaluating several secondary measures, including changes in serum uric acid level from baseline to week 17, as well as the proportion of patients with serum uric acid level <5 mg/dL at 17 weeks.
Approximately 20 patients will be recruited in the study at multiple locations across the United States. For more information, contact Maggie Pugh, MS, at 404-892-7002 or email@example.com. The NLM Identifier is NCT02598596.
6 Using Febuxostat to Counteract Metabolic Syndrome in Patients with Gout
Researchers are conducting a phase 4, interventional, open-label, safety and efficacy study to evaluate whether febuxostat can improve insulin resistance and other aspects of metabolic syndrome—including high blood pressure—by lowering the uric acid level of patients with gout and hyperuricemia. Men and women aged >21 years may be eligible for inclusion if other criteria are met. Eligible patients also need to be diagnosed with gout and have serum uric acid levels of >7.0 mg/dL and >6.0 mg/dL in men and women, respectively.
For 6 months, patients in the experimental group will receive a 40-mg febuxostat tablet once daily. The primary end point of the trial is insulin sensitivity at 6 months; secondary outcome measures are ambulatory blood pressure, fasting urine pH, and fasting serum glucose, triglycerides, and high-density lipoprotein cholesterol.
An estimated 30 patients are being enrolled in the study at The University of Texas Southwestern Medical Center, Dallas. For more information, contact Naim M. Maalouf, MD, at 214-648-2954 or firstname.lastname@example.org. The NLM Identifier is NCT01654276.
8 Rheumatology Informatics System for Effectiveness (RISE) Registry
This patient registry seeks to collect data from patients with gout, osteoarthritis, and rheumatoid arthritis to improve several aspects of care, including quality reporting and drug safety. Men and women aged ≥18 years may be eligible for inclusion if other criteria are met, including diagnosis of 1 of these 3 conditions.
The Rheumatology Informatics System for Effectiveness (RISE) registry will provide patients with quality-enhancing activities to improve patient outcomes and population management. The primary outcome measure of interest is adequately controlled high blood pressure during a 1-year time span.
The registry will include a large number of patients, and be conducted by the American College of Rheumatology, Atlanta, GA. For more information, contact Melissa D. Francisco at 404-633-3777 (ext. 102) or email@example.com. The NLM Identifier is NCT02230943.
10 Combination Therapy with Pegsiticase in Patients with Elevated Uric Acid Levels
Investigators are conducting a phase 1, randomized, safety and efficacy study to evaluate the safety and pharmacodynamics of SEL-212 use among patients with elevated blood uric acid levels. Men and women aged 21 to 70 years may be eligible for study inclusion if other criteria are met; these include serum uric acid levels ≥6 mg/dL in patients with or without a history of gout, uric acid level–lowering therapy with allopurinol, febuxostat, or probenecid, as well as adequate venous access and the ability to receive intravenous therapy.
In the first part of the study, patients will receive 1 intravenous dose of a nonparticle containing rapamycin (SEL-110). Safety, pharmacokinetics, pharmacodynamics, and immunogenicity will then be evaluated following a single intravenous dose of SEL-212, and SEL-037 (pegsiticase) plus SEL-110. The primary outcome measurements of interest are the safety and tolerability of the intravenous injections, assessed via frequency and severity of drug-related adverse events. Secondary outcomes of interest are the pharmacokinetics of SEL-110 in 30 days, and the pharmacokinetics, pharmacodynamics, and immunogenicity of SEL-037, within the same time frame.
An estimated 53 patients are being enrolled in this trial at locations in Arkansas, Maryland, Pennsylvania, Minnesota, and Florida. For more information, contact Earl Sands, MD, at 617-923-1400 (ext. 8122) or firstname.lastname@example.org. The NLM Identifier is NCT02648269.