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A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout

RecruitingPhase 3Ages 18 Years - anyAllAmgen
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In plain words

What the trial is, and whether it could suit you

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Participant has provided informed consent before initiation of any trial-specific activities/procedures. * Age โ‰ฅ 18 years or โ‰ฅ legal age within the country if it is older than 18 years. * Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. * Participants with uncontrolled gout, as meeting the protocol defined criteria. Exclusion Criteria * Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit). * Liver transaminase levels (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) \> 1.25 x upper limit of normal (ULN) or albumin \< the lower limit of normal (LLN) at the screening visit. * Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) \> 8%. * Known intolerance to MTX. * Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug. * A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone โ‰ค 10 mg/day or equivalent dose of other corticosteroid). * Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations \< 40 mL/min/1.73 m\^2 or currently on dialysis.
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What it tests

  • Pegloticase
  • Methotrexate
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Where

75 sites
University of Alabama at Birmingham
Birmingham, United States
Orthopedic Physicians Alaska
Anchorage, United States
Unity Health Searcy Medical Center
Searcy, United States
Precision Rheumatology
Anaheim, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates
Chula Vista, United States
Veterans Affairs Long Beach Health Care System
Long Beach, United States
Solace Clinical Research
Tustin, United States
Jiva Health
Walnut Creek, United States

โ€ฆand 67 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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