Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
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
1 other identifier
interventional
191
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2020
Longer than P75 for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedStudy Start
First participant enrolled
October 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2024
CompletedResults Posted
Study results publicly available
January 7, 2025
CompletedOctober 20, 2025
October 1, 2025
3.3 years
August 11, 2020
December 12, 2024
October 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24
IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion.
Day 1 to Week 24
Secondary Outcomes (4)
Percentage of Serum Uric Acid (sUA) Responders at Month 6
Up to 6 months
Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria
Day 1 to Week 24
Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in All Participants
Day 1 to Week 24
Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in Participants With an Event
Day 1 to Week 24
Study Arms (3)
Pegloticase 60 Minute Infusion with methotrexate (MTX)
EXPERIMENTALPegloticase 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
Pegloticase 45 Minute Infusion with methotrexate (MTX)
EXPERIMENTALPegloticase 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
Pegloticase 30 Minute Infusion with methotrexate (MTX)
EXPERIMENTALPegloticase 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
Interventions
Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit).
- 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.
- 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.
- 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.
- History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (39)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Orthopedic Physicians Alaska
Anchorage, Alaska, 99508, United States
Arizona Arthritis & Rheumatology Research
Gilbert, Arizona, 85297, United States
Arthritis & Rheumatology Research
Mesa, Arizona, 85210, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85037, United States
Medvin Clinical Research
Covina, California, 91722, United States
Amicis Research Center
Northridge, California, 91324, United States
Providence Saint John's Health Center
Santa Monica, California, 90404, United States
Medvin Clinical Research
Thousand Oaks, California, 91360, United States
Medvin Clinical Research
Tujunga, California, 91042, United States
University of Colorado Division of Rheumatology
Aurora, Colorado, 80045, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Prohealth Research Center
Doral, Florida, 33166, United States
LIFE Clinical Trials
Margate, Florida, 33063, United States
D&H National Research Centers
Miami, Florida, 33155, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324, United States
Napa Research Center
Pompano Beach, Florida, 33064, United States
D&H Tamarac Research Centers
Tamarac, Florida, 33321, United States
GCP Clinical Research
Tampa, Florida, 33064, United States
ClinPro Research Solutions
Tampa, Florida, 33609, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
MedPharmics, LLC
Metairie, Louisiana, 70006, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Santa Fe Rheumatology
Santa Fe, New Mexico, 87505, United States
Long Island Arthritis & Osteoporosis Care
Babylon, New York, 11702, United States
Research Carolina Elite
Denver, North Carolina, 28037, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602, United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144, United States
Shelby Clinical Research, LLC
Shelby, North Carolina, 28150, United States
Velocity Clinical Research Cincinnati
Cincinnati, Ohio, 45242, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Chattanooga Research & Medicine PLLC (CHARM)
Chattanooga, Tennessee, 37404, United States
Abigail Rebecca Neiman, MD, PA
Houston, Texas, 77024, United States
Pioneer Research Solutions Inc - Houston
Houston, Texas, 77099, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
Western Washington Medical Group
Bothell, Washington, 98021, United States
Arthritis Northwest
Spokane, Washington, 99204, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 13, 2020
Study Start
October 2, 2020
Primary Completion
January 18, 2024
Study Completion
March 25, 2024
Last Updated
October 20, 2025
Results First Posted
January 7, 2025
Record last verified: 2025-10