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Uncontrolled Gout Study: Pegloticase with Methotrexate

This study is for people with uncontrolled gout. It is testing two ways to give a medicine called pegloticase, along with another medicine called methotrexate. Some participants will receive pegloticase as a shot under the skin (subcutaneous or SC), while others will receive it through a vein (intravenous or IV). The main goal is to see if pegloticase, given with methotrexate, can keep your uric acid levels (sUA) below 6 mg/dL for most of the time during the sixth month of treatment. We are looking for 270 participants aged 18 or older who are willing to follow the study plan.

Study design
This is a double-blind, randomized controlled trial, meaning neither you nor your doctor will know which treatment you are receiving. It plans to enroll 270 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for success is taken at Month 6 (Weeks 20, 21, 22, 23, and 24).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07388498

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Amgen
~270 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:PegloticaseMethotrexate

At a glance

Recruiting sites
63 of 63 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Measured over Month 6 (Weeks 20, 21, 22, 23, and 24)

Conditions

Uncontrolled Gout

Explore related trials

Gout

Where it's being run

63 sites across 23 states
Florida18
North Carolina8
Texas8
Illinois4
California3
Georgia2
Maryland2
New Mexico2

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24Month 6 (Weeks 20, 21, 22, 23, and 24)

    Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.