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Rheumatology Practice Management June 2016 Vol 4 No 3 - Clinical Trials Tracker

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.

1 Identifying Genetic Variations in Patients Exposed to Allopurinol

As part of this interventional, single-group, open-label trial, the investigators seek to evaluate genetic variations in patients with gout. In particular, they are looking at how the variations in the genetic transporters may influence the disposition of serum uric acid in response to allopurinol, as well as the nature of its active metabolite, oxipurinol. Men and women aged ≥18 years may be eligible for enrollment in the study if other criteria are met, including a self-reported history of gout, history of active use of xanthine oxidase inhibitors, or evident serum uric acid levels ≥6 mg/dL. Criteria for exclusion include pregnant women; estimated creatinine clearance <30 mL/min; elevated liver enzymes; contraindication to receiving allopurinol; and active participation in other clinical trials.

Patients participating in this trial will undergo uric acid measurement twice daily at baseline, and after 14 days. Primary outcomes of interest are percent change from baseline in serum uric acid level, and steady-state oxipurinol area under the serum concentration-time curve at 14 days. Secondary outcomes of interest are percent change from baseline in uric acid fractional excretion and renal clearance, during the same time frame.

Approximately 100 patients will be enrolled in this trial at the University of Minnesota, Minneapolis. For more information, contact Robert J. Straka, PharmD, at 612-624-5663 or strak001@umn.edu. The NLM Identifier is NCT02371421.

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 matthew.carroll.1@us.af.mil. The NLM Identifier is NCT01830725.

3 Safety and Efficacy of Bucillamine Tablet Regimens

To assess the safety and efficacy of 2 regimens of bucillamine 100-mg tablets, investigators are conducting a randomized, multicenter, phase 2, open-label active-comparator trial in patients with moderate-to-severe gout. Men and women aged 18 to 80 years may be eligible for enrollment if they meet other criteria, including a confirmed diagnosis of gout, ≥1 acute gouty arthritic attacks within the 12 months prior to study randomization, and no contraindication to colchicine.

Patients in this study will be randomized to receive bucillamine 900 mg or 1800 mg during the course of 7 days, or colchicine 1.8 mg in 2 doses, 1 hour apart. Composite measurement of adverse events, physical examinations, electrocardiograms, vital signs, clinical laboratory evaluations, medical history, and/or prior or simultaneous medications are the primary outcomes of interest, as well as a ≥50% reduction in target joint pain score from baseline without use of the rescue drug.

The estimated number of patients to be enrolled in this trial is 66, at West Coast Research, San Ramon, CA, and Texas Physicians Medical Research Group, Arlington, TX. For more information, contact Revive Therapeutics Ltd, at 888-454-2565 or clinical@revivethera.com. The NLM identifier is NCT02330796.

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 mpugh@ind2results.com. The NLM Identifier is NCT02598596.

5 Cardiovascular Safety of Febuxostat and Allopurinol

As part of this study, investigators are evaluating the cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities. Men and women aged ≥50 years may be eligible for study enrollment if they meet several other criteria, including having a history of myocardial infarction, hospitalization for unstable angina, cardiac or cerebrovascular revascularization, and stroke.

Patients in the experimental group will receive febuxostat 40 mg or 80 mg, depending on serum uric acid levels, whereas patients in the control group will receive allopurinol 200 mg to 600 mg, depending on their renal function. Both arms will receive treatment orally via capsules once daily for ≤60 months. The primary outcome measure is the first incidence of an event from the predefined Major Adverse Cardiovas­cular Events composite. Secondary outcomes of interest include the first time any Antiplatelet Trialists’ Collaboration events or cardiovascular deaths occur.

An estimated 7500 people are being enrolled in this study at multiple sites across the United States. For more information, contact the Takeda Study Registration Call Center at 888-361-3630 or ctgovinfo@goutstudynow.com. The NLM Identifier is NCT01101035.

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 naim.maalouf@utsouthwestern.edu. The NLM Identifier is NCT01654276.

7 Efficacy and Timing of Allopurinol Administration to Lower Uric Acid Levels

In this phase 4, open-label, interventional efficacy study, investigators are assessing whether administering allopurinol after dialysis is more efficacious than giving it beforehand to lower uric acid levels in patients with gout who have renal insufficiency. Men and women who receive chronic treatments of hemodialysis, and have taken allopurinol for ≥1 months may be eligible for study inclusion if other criteria are met.

As part of this trial, eligible patients will receive allopurinol at bedtime at the same dosage that was previously prescribed. Change in uric acid levels from baseline to 6 weeks is the primary outcome measure.

Fifty patients will be enrolled in the trial at Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada. For more information, contact Michel Vallée, MD, PhD, at mvallee@ssss.gouv.qc.ca. The NLM Identifier is NCT02477488.

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 mfrancisco@rheumatology.org. The NLM Identifier is NCT02230943.

9 Using Elastography to Determine the Outcome of Patients with Gouty Arthritis

As part of this observational, case-only, prospective study, investigators are seeking to evaluate changes in patients with gouty arthritis who are taking—or about to begin taking—urate-lowering therapies. Men and women aged 18 through 99 years may be eligible for inclusion in the trial if other criteria are met, including having gouty arthritis, as determined by the American College of Rheumatology 1977 classification, and having a single, palpable tophus detectable through one of several clinical parameters.

The primary outcome measure is changes observed in gouty arthritis via elastography over a 1-year time frame. Approximately 10 patients will be enrolled in this trial at the Center for Rheumatology and Bone Research, Wheaton, MA. For more information, contact Theresa Bass-Goldman at 301-942-6610 or tbgoldman@arapc.com. The NLM Identifier is NCT02471261.

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 ssands@selectabio.com. The NLM Identifier is NCT02648269.

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Last modified: July 7, 2016
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