Status:
COMPLETED
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Lead Sponsor:
Amgen
Conditions:
Chronic Uncontrolled Gout
Gout
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 methotrexat...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2024
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT04511702
Start Date
October 2 2020
End Date
March 25 2024
Last Update
October 17 2025
Active Locations (39)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Orthopedic Physicians Alaska
Anchorage, Alaska, United States, 99508
3
Arizona Arthritis & Rheumatology Research
Gilbert, Arizona, United States, 85297
4
Arthritis & Rheumatology Research
Mesa, Arizona, United States, 85210