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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04511702
Other study ID # HZNP-KRY-403
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2, 2020
Est. completion date March 25, 2024

Study information

Verified date May 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 191
Est. completion date March 25, 2024
Est. primary completion date January 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult men or women =18 years of age. 2. 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 3. 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: 1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis. 2. 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. 3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit). 4. 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. 5. 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. 6. 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. 7. Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug. 8. Currently receiving systemic or radiologic treatment for ongoing cancer. 9. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Orthopedic Physicians Alaska Anchorage Alaska
United States University of Colorado Division of Rheumatology Aurora Colorado
United States Long Island Arthritis & Osteoporosis Care Babylon New York
United States University of Alabama at Birmingham Birmingham Alabama
United States Western Washington Medical Group Bothell Washington
United States Bradenton Research Center Bradenton Florida
United States Chattanooga Research & Medicine PLLC (CHARM) Chattanooga Tennessee
United States Velocity Clinical Research Cincinnati Cincinnati Ohio
United States Medvin Clinical Research Covina California
United States Denver Arthritis Clinic Denver Colorado
United States Research Carolina Elite Denver North Carolina
United States Prohealth Research Center Doral Florida
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Arizona Arthritis & Rheumatology Research Gilbert Arizona
United States PMG Research of Hickory, LLC Hickory North Carolina
United States Abigail Rebecca Neiman, MD, PA Houston Texas
United States Pioneer Research Solutions Inc - Houston Houston Texas
United States Cape Fear Arthritis Care Leland North Carolina
United States LIFE Clinical Trials Margate Florida
United States Arthritis & Rheumatology Research Mesa Arizona
United States MedPharmics, LLC Metairie Louisiana
United States D&H National Research Centers Miami Florida
United States Amicis Research Center Northridge California
United States MD Medical Research Oxon Hill Maryland
United States Arizona Arthritis & Rheumatology Research Phoenix Arizona
United States IRIS Research and Development, LLC Plantation Florida
United States Napa Research Center Pompano Beach Florida
United States PMG Research of Salisbury, LLC Salisbury North Carolina
United States Santa Fe Rheumatology Santa Fe New Mexico
United States Providence Saint John's Health Center Santa Monica California
United States Shelby Clinical Research, LLC Shelby North Carolina
United States Arthritis Northwest Spokane Washington
United States D&H Tamarac Research Centers Tamarac Florida
United States ClinPro Research Solutions Tampa Florida
United States ForCare Clinical Research Tampa Florida
United States GCP Clinical Research Tampa Florida
United States Medvin Clinical Research Thousand Oaks California
United States Medvin Clinical Research Tujunga California
United States Velocity Clinical Research, Salt Lake City West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of participants experiencing Infusion Reactions (IRs), including anaphylaxis related to pegloticase Day 1 through Week 24.
Secondary Proportion of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6 Responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6. Participants meeting the sUA discontinuation criteria (pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit) were counted as non-responders. Month 6 (Weeks 20, 22, 24)
Secondary The proportion of participants who experienced any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting Individual participant sUA Discontinuation Criteria. 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, and continues on the study. Day 1 to Week 24
Secondary Time to any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting individual participant sUA Discontinuation Criteria (two consecutive pre-infusion sUAs > 6mg/dL). 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, and continues on the study. Day 1 to Week 24
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