Comparing subcutaneous versus intravenous pegloticase with methotrexate for uncontrolled gout

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with uncontrolled gout are randomized in a double-blind, phase 3 trial to receive either pegloticase 18 mg subcutaneously every two weeks with methotrexate or pegloticase 8 mg intravenously every two weeks with methotrexate. The primary endpoint is the response rate at Month 6, defined as serum uric acid below 6 mg/dL for at least 80% of the time during that month. Safety and pharmacokinetics are monitored throughout, and participants must meet inclusion/exclusion criteria such as no G6PD deficiency, acceptable liver tests, and methotrexate tolerance. Dosing and laboratory visits occur at participating clinical sites in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Participant has provided informed consent before initiation of any trial-specific activities/procedures.
* Age ≥ 18 years or ≥ 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 ≤ 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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Orthopedic Physicians Alaska
  Anchorage, Alaska, United States Recruiting
• Unity Health Searcy Medical Center
  Searcy, Arkansas, United States Recruiting
• Precision Rheumatology
  Anaheim, California, United States Recruiting
• Advanced Clinical Research Center, LLC dba TriWest Research Associates
  Chula Vista, California, United States Recruiting
• Veterans Affairs Long Beach Health Care System
  Long Beach, California, United States Recruiting

+25 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.