Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

Completed · Phase 4

Conditions studied: Chronic Uncontrolled Gout, Gout, Uncontrolled Gout

In brief

The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.

Key facts

Study ID

NCT04511702

Run by

Amgen

People needed

191

Starts

2020-10-02

Expected to finish

2024-03-25

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult men or women ≥18 years of age.
• Uncontrolled gout, defined as meeting the following criteria:
• Hyperuricemia during the screening period defined as sUA ≥6 mg/dL
• Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with intolerable side effects or a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview.
• Symptoms of gout including at least 1 of the following:
• Presence of at least one tophus
• Recurrent flares defined as 2 or more flares in the past 12 months prior to screening
• Presence of chronic gouty arthritis
• Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX dosing at Week -4 and remain off of urate lowering therapy when receiving pegloticase infusions during the study.

You may not qualify if…

• Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
• Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (defined as 3 months or longer) would also meet exclusion criteria.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit).
• Severe chronic renal impairment (estimated glomerular filtration rate <40 mL/min/1.73 m2) at the Screening Visit based on 4 variable-Modification of Diet in Renal Disease [MDRD] formula or currently on dialysis.
• Non-compensated congestive heart failure or hospitalization for congestive heart failure or treatment for acute coronary syndrome (myocardial infarction or unstable angina) within 3 months of the Screening Visit, or current uncontrolled arrhythmia, or current uncontrolled blood pressure (BP) (>160/100 mmHg) prior to Week -4.
• Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner, or not on an effective form of birth control, as determined by the Investigator.
• Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug.
• Currently receiving systemic or radiologic treatment for ongoing cancer.
• History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Orthopedic Physicians Alaska — Anchorage, Alaska, United States
• Arizona Arthritis & Rheumatology Research — Gilbert, Arizona, United States
• Arthritis & Rheumatology Research — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research — Phoenix, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• Amicis Research Center — Northridge, California, United States
• Providence Saint John's Health Center — Santa Monica, California, United States
• Medvin Clinical Research — Thousand Oaks, California, United States
• Medvin Clinical Research — Tujunga, California, United States
• University of Colorado Division of Rheumatology — Aurora, Colorado, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Prohealth Research Center — Doral, Florida, United States
• LIFE Clinical Trials — Margate, Florida, United States
• D&H National Research Centers — Miami, Florida, United States
• IRIS Research and Development, LLC — Plantation, Florida, United States
• Napa Research Center — Pompano Beach, Florida, United States
• D&H Tamarac Research Centers — Tamarac, Florida, United States
• GCP Clinical Research — Tampa, Florida, United States
• ClinPro Research Solutions — Tampa, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• MedPharmics, LLC — Metairie, Louisiana, United States
• MD Medical Research — Oxon Hill, Maryland, United States
• Santa Fe Rheumatology — Santa Fe, New Mexico, United States

Full record on ClinicalTrials.gov

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