Chronic Uncontrolled GoutPhase 4NCT04511702
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
A Phase 4 study testing Pegloticase with MTX in people with Chronic Uncontrolled Gout and Gout, run by Amgen at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Uncontrolled Gout, Gout, Uncontrolled Gout
- What is being tested?
- Pegloticase with MTX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 39 sitesUnited States
- Study dates
- 2 Oct 2020to 25 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
- 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.
- 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.
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- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Orthopedic Physicians Alaska
Anchorage, Alaska, 99508
University of Colorado Division of Rheumatology
Aurora, Colorado, 80045
Long Island Arthritis & Osteoporosis Care
Babylon, New York, 11702
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Western Washington Medical Group
Bothell, Washington, 98021
Bradenton Research Center
Bradenton, Florida, 34205
Chattanooga Research & Medicine PLLC (CHARM)
Chattanooga, Tennessee, 37404
Velocity Clinical Research Cincinnati
Cincinnati, Ohio, 45242
Medvin Clinical Research
Covina, California, 91722
Denver Arthritis Clinic
Denver, Colorado, 80230
Research Carolina Elite
Denver, North Carolina, 28037
Prohealth Research Center
Doral, Florida, 33166
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arizona Arthritis & Rheumatology Research
Gilbert, Arizona, 85297
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602
Abigail Rebecca Neiman, MD, PA
Houston, Texas, 77024
Pioneer Research Solutions Inc - Houston
Houston, Texas, 77099
Cape Fear Arthritis Care
Leland, North Carolina, 28451
LIFE Clinical Trials
Margate, Florida, 33063
Arthritis & Rheumatology Research
Mesa, Arizona, 85210
MedPharmics, LLC
Metairie, Louisiana, 70006
D&H National Research Centers
Miami, Florida, 33155
Amicis Research Center
Northridge, California, 91324
MD Medical Research
Oxon Hill, Maryland, 20745
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85037
IRIS Research and Development, LLC
Plantation, Florida, 33324
Napa Research Center
Pompano Beach, Florida, 33064
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144
Santa Fe Rheumatology
Santa Fe, New Mexico, 87505
Providence Saint John's Health Center
Santa Monica, California, 90404
Shelby Clinical Research, LLC
Shelby, North Carolina, 28150
Arthritis Northwest
Spokane, Washington, 99204
D&H Tamarac Research Centers
Tamarac, Florida, 33321
GCP Clinical Research
Tampa, Florida, 33064
ClinPro Research Solutions
Tampa, Florida, 33609
ForCare Clinical Research
Tampa, Florida, 33613
Medvin Clinical Research
Thousand Oaks, California, 91360
Medvin Clinical Research
Tujunga, California, 91042
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
About this study
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
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.
Read the detailed description
Approximately 180 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
- Conditions
- Chronic Uncontrolled Gout, Gout, Uncontrolled Gout
- Being tested
- Pegloticase with MTX
- Keywords
- gout, uncontrolled gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegloticase with MTXBiological
Also called Methotrexate
Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period
| Study group | Role | What they receive |
|---|---|---|
| Pegloticase 60 Minute Infusion with methotrexate (MTX) | Experimental | 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 Receives: Biological: Pegloticase with MTX |
| Pegloticase 45 Minute Infusion with methotrexate (MTX) | Experimental | 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 Receives: Biological: Pegloticase with MTX |
| Pegloticase 30 Minute Infusion with methotrexate (MTX) | Experimental | 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 Receives: Biological: Pegloticase with MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Week 24
Secondary outcomes (4)
Percentage of Serum Uric Acid (sUA) Responders at Month 6
Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during month 6.
Responders who met sUA discontinuation criteria (2 consecutive sUA > 6 mg/dL), regardless of treatment status were considered non-responders.
Measured: Up to 6 months
Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria
IRs were defined as any infusion-related AE or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and for 2 hours post-infusion. Other AEs that occurred outside of the 2 hour window following the infusion may have also been categorized as an IR at the Principal Investigator's discretion.
Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.
Meeting individual sUA discontinuation criteria was defined as two consecutive pre-infusion sUAs > 6 mg/dL after Day 1.
Measured: 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
Infusion reactions were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion.
Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.
Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1.
Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. All participants were censored at the date of their last infusion.
Measured: 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
IRs were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion.
Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria.
Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1.
Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. Only participants who experienced an event were included in this analysis.
Measured: Day 1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start2 Oct 2020
- Primary completion18 Jan 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Uncontrolled GoutStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Three different infusion durations may be used. 60-minute infusion, 45-minute infusion and 30-minute.
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511702
- Sponsor's protocol ID
- HZNP-KRY-403
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2020
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04511702
- Acronym / sponsor ID
- HZNP-KRY-403
- Conditions
- Chronic Uncontrolled Gout, Gout, Uncontrolled Gout
- Keywords
- gout, uncontrolled gout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 180 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three different infusion durations may be used. 60-minute infusion, 45-minute infusion and 30-minute.
| Arm | Type | Receives |
|---|---|---|
| Pegloticase 60 Minute Infusion with methotrexate (MTX) | Experimental | Biological: Pegloticase with MTXPegloticase 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) | Experimental | Biological: Pegloticase with MTXPegloticase 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) | Experimental | Biological: Pegloticase with MTXPegloticase 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men or women ≥18 years of age.
- Uncontrolled gout, defined as meeting the following criteria:
- 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.
Key exclusion criteria (9 listed)
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegloticase with MTXAlso: MethotrexateParticipants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period | Biological | Pegloticase 30 Minute Infusion with methotrexate (MTX), Pegloticase 45 Minute Infusion with methotrexate (MTX), Pegloticase 60 Minute Infusion with methotrexate (MTX) |
Primary outcome
Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24
Time frame: 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.
4 secondary outcomes
Percentage of Serum Uric Acid (sUA) Responders at Month 6
Time frame: Up to 6 months
Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria
Time frame: 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
Time frame: 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
Time frame: Day 1 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegloticase with MTX in people with Chronic Uncontrolled Gout and Gout, run by Amgen at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24 (time frame: Day 1 to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.