A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate
To assess tolerability of Pegloticase administered with shorter infusion duration in subjects with uncontrolled gout receiving methotrexate.
Approximately 80-100 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study.More
1. Adult men or women 2. Uncontrolled gout 3. Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX when receiving pegloticase infusions during the study.
1. Adult men or women 18 years of age or more. 2. Uncontrolled gout, defined as meeting the following criteria: Hyperuricemia during the screening period defined as sUA more to equal to 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.
Barbara Davis Center
University of Colorado Hospital
Christopher Striebich, MD, PhD
Protocol Number: 22-1077
More information available at ClinicalTrials.gov: NCT04511702
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