CompletedPhase 4
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Key facts
- Who runs it
- Amgen
- Where
- Anchorage, Aurora, Babylon, Birmingham, Bothell, Bradenton, Chattanooga, Cincinnati, Covina, Denver, Doral, Duncansville, Gilbert, Hickory, Houston, Leland, Margate, Mesa, Metairie, Miami, Northridge, Oxon Hill, Phoenix, Plantation, Pompano Beach, Salisbury, Santa Fe, Santa Monica, Shelby, Spokane, Tamarac, Tampa, Thousand Oaks, Tujunga, and West Jordan, United StatesSee the 39 sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 191 people enrolled
- Started
- 2 Oct 2020
- Ended
- 25 Mar 2024
- Type of study
- Interventional, 3 groups
- Treatments tested
- Pegloticase with MTX
- Record updated
- 20 October 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Adult men or women ≥18 years of age
- 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
- 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
Who cannot take part
- 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
- 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
- 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
- Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug
- Currently receiving systemic or radiologic treatment for ongoing cancer
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis
- History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit)
- 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
Where in United States
- Orthopedic Physicians AlaskaAnchorage, United StatesNo longer taking part
- University of Colorado Division of RheumatologyAurora, United StatesNo longer taking part
- Long Island Arthritis & Osteoporosis CareBabylon, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Western Washington Medical GroupBothell, United StatesNo longer taking part
- Bradenton Research CenterBradenton, United StatesNo longer taking part
- Chattanooga Research & Medicine PLLC (CHARM)Chattanooga, United StatesNo longer taking part
- Velocity Clinical Research - CincinnatiCincinnati, United StatesNo longer taking part
- Medvin Clinical ResearchCovina, United StatesNo longer taking part
- Denver Arthritis ClinicDenver, United StatesNo longer taking part
- Research Carolina EliteDenver, United StatesNo longer taking part
- Prohealth Research CenterDoral, United StatesNo longer taking part
- Altoona Center For Clinical ResearchDuncansville, United StatesNo longer taking part
- Arizona Arthritis & Rheumatology ResearchGilbert, United StatesNo longer taking part
- PMG Research of Hickory, LLCHickory, United StatesNo longer taking part
- Abigail Rebecca Neiman, MD, PAHouston, United StatesNo longer taking part
- Pioneer Research Solutions Inc - HoustonHouston, United StatesNo longer taking part
- Cape Fear Arthritis CareLeland, United StatesNo longer taking part
- Life Clinical TrialsMargate, United StatesNo longer taking part
- Arthritis & Rheumatology ResearchMesa, United StatesNo longer taking part
- MedPharmics, LLCMetairie, United StatesNo longer taking part
- D&H National Research CentersMiami, United StatesNo longer taking part
- Amicis Research CenterNorthridge, United StatesNo longer taking part
- MD Medical ResearchOxon Hill, United StatesNo longer taking part
- Arizona Arthritis & Rheumatology ResearchPhoenix, United StatesNo longer taking part
- IRIS Research and Development LLCPlantation, United StatesNo longer taking part
- Napa Research CenterPompano Beach, United StatesNo longer taking part
- PMG Research of Salisbury, LLCSalisbury, United StatesNo longer taking part
- Santa Fe RheumatologySanta Fe, United StatesNo longer taking part
- Providence Saint John's Health CenterSanta Monica, United StatesNo longer taking part
- Shelby Clinical Research, LLCShelby, United StatesNo longer taking part
- Arthritis NorthwestSpokane, United StatesNo longer taking part
- D&H Tamarac Research CentersTamarac, United StatesNo longer taking part
- ClinPro Research SolutionsTampa, United StatesNo longer taking part
- ForCare Clinical ResearchTampa, United StatesNo longer taking part
- GCP Clinical ResearchTampa, United StatesNo longer taking part
- Medvin Clinical ResearchThousand Oaks, United StatesNo longer taking part
- Medvin Clinical ResearchTujunga, United StatesNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
The 3 groups in the trial
- Pegloticase 60 Minute Infusion with methotrexate (MTX)Treatment being tested
Pegloticase 60 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks
Treatment: Pegloticase with MTX
- Pegloticase 45 Minute Infusion with methotrexate (MTX)Treatment being tested
Pegloticase 45 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks
Treatment: Pegloticase with MTX
- Pegloticase 30 Minute Infusion with methotrexate (MTX)Treatment being tested
Pegloticase 30 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks
Treatment: Pegloticase with MTX
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 20 October 2025