Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
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ClinicalTrials.gov Identifier: NCT04511702 |
Recruitment Status :
Recruiting
First Posted : August 13, 2020
Last Update Posted : December 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chronic Uncontrolled Gout Gout Uncontrolled Gout | Biological: Pegloticase with MTX | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Three different infusion durations may be used. 60-minute infusion, 45-minute infusion and 30-minute. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 2, 2020 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
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Experimental: Pegloticase 60 Minute Infusion with methotrexate (MTX)
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
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Biological: Pegloticase with MTX
Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period
Other Name: Methotrexate |
Experimental: Pegloticase 45 Minute Infusion with methotrexate (MTX)
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
|
Biological: Pegloticase with MTX
Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period
Other Name: Methotrexate |
Experimental: Pegloticase 30 Minute Infusion with methotrexate (MTX)
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
|
Biological: Pegloticase with MTX
Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period
Other Name: Methotrexate |
- The incidence of participants experiencing Infusion Reactions (IRs), including anaphylaxis related to pegloticase [ Time Frame: Day 1 through Week 24. ]
- The proportion of Month 6 (Weeks 20, 22 and 24) responders, defined as subjects achieving and maintaining sUA<6mg/dL for at least 80% of the time during Month 6. [ Time Frame: Day 1 to Week 24 ]A participant meets the Individual participant sUA Discontinuation Criteria if he or she has a pre-infusion sUA level >6 mg/dL at 2 consecutive study visits beginning with the Week 2 Visit. When this occurs, the participants must discontinue treatment, with the option to continue on the study.
- Time to any of the following events: infusion reaction leading to discontinuation of treatment, anaphylaxis, or meeting Individual participant sUA Discontinuation Criteria. [ Time Frame: Day 1 to Week 24 ]A participant meets the Individual participant sUA Discontinuation Criteria if he or she has a pre-infusion sUA level >6 mg/dL at 2 consecutive study visits beginning with the Week 2 Visit. When this occurs, the participants must discontinue treatment, with the option to continue on the study.
- Time to any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting individual Subject sUA Discontinuation Criteria (two consecutive pre-infusion sUAs > 6mg/dL. [ Time Frame: Day 1 to Week 24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult men or women ≥18 years of age.
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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.
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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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511702
Contact: Horizon Therapeutics DAC | 1-866-479-6742 | clinicaltrials@horizontherapeutics.com |

Study Director: | Supra Verma, MD | Horizon Therapeutics Ireland DAC |
Responsible Party: | Horizon Therapeutics Ireland DAC |
ClinicalTrials.gov Identifier: | NCT04511702 |
Other Study ID Numbers: |
HZNP-KRY-403 |
First Posted: | August 13, 2020 Key Record Dates |
Last Update Posted: | December 6, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
gout uncontrolled gout |
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