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Could a quicker infusion tame tough gout?

NCT ID NCT04511702

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving the gout drug pegloticase over a shorter time is safe and works well for people with uncontrolled gout. About 191 adults with hard-to-treat gout received methotrexate before and during pegloticase infusions for up to 24 weeks. The main goal was to see how many had infusion reactions, and a key measure was whether uric acid levels stayed low.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pegloticase with methotrexate
What this could lead to
If successful, this could make pegloticase infusions faster and more convenient for people with uncontrolled gout.
What could go wrong
This is a completed Phase 4 study, but results may not apply to all patients. Shorter infusions might still cause infusion reactions or anaphylaxis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

191 people

The number who actually took part.

Started

Oct 2020

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult men or women ≥18 years of age. 2. 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 3. 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. Exclusion Criteria: 1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis. 2. 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. 3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit). 4. 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. 5. 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. 6. 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. 7. Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug. 8. Currently receiving systemic or radiologic treatment for ongoing cancer. 9. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic uncontrolled gout Gout Uncontrolled gout

Contacts and locations

Locations

  • Abigail Rebecca Neiman, MD, PA

    Houston, Texas, 77024, United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Amicis Research Center

    Northridge, California, 91324, United States

  • Arizona Arthritis & Rheumatology Research

    Gilbert, Arizona, 85297, United States

  • Arizona Arthritis & Rheumatology Research

    Phoenix, Arizona, 85037, United States

  • Arthritis & Rheumatology Research

    Mesa, Arizona, 85210, United States

  • Arthritis Northwest

    Spokane, Washington, 99204, United States

  • Bradenton Research Center

    Bradenton, Florida, 34205, United States

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451, United States

  • Chattanooga Research & Medicine PLLC (CHARM)

    Chattanooga, Tennessee, 37404, United States

  • ClinPro Research Solutions

    Tampa, Florida, 33609, United States

  • D&H National Research Centers

    Miami, Florida, 33155, United States

  • D&H Tamarac Research Centers

    Tamarac, Florida, 33321, United States

  • Denver Arthritis Clinic

    Denver, Colorado, 80230, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • GCP Clinical Research

    Tampa, Florida, 33064, United States

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324, United States

  • LIFE Clinical Trials

    Margate, Florida, 33063, United States

  • Long Island Arthritis & Osteoporosis Care

    Babylon, New York, 11702, United States

  • MD Medical Research

    Oxon Hill, Maryland, 20745, United States

  • MedPharmics, LLC

    Metairie, Louisiana, 70006, United States

  • Medvin Clinical Research

    Covina, California, 91722, United States

  • Medvin Clinical Research

    Thousand Oaks, California, 91360, United States

  • Medvin Clinical Research

    Tujunga, California, 91042, United States

  • Napa Research Center

    Pompano Beach, Florida, 33064, United States

  • Orthopedic Physicians Alaska

    Anchorage, Alaska, 99508, United States

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602, United States

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144, United States

  • Pioneer Research Solutions Inc - Houston

    Houston, Texas, 77099, United States

  • Prohealth Research Center

    Doral, Florida, 33166, United States

  • Providence Saint John's Health Center

    Santa Monica, California, 90404, United States

  • Research Carolina Elite

    Denver, North Carolina, 28037, United States

  • Santa Fe Rheumatology

    Santa Fe, New Mexico, 87505, United States

  • Shelby Clinical Research, LLC

    Shelby, North Carolina, 28150, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Colorado Division of Rheumatology

    Aurora, Colorado, 80045, United States

  • Velocity Clinical Research Cincinnati

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Western Washington Medical Group

    Bothell, Washington, 98021, United States

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