Befejeződött4. fázis

Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

A legfontosabb adatok

Ki végzi: Amgen
Hol: Anchorage, Aurora, Babylon, Birmingham, Bothell, Bradenton, Chattanooga, Cincinnati, Covina, Denver, Doral, Duncansville, Gilbert, Hickory, Houston, Leland, Margate, Mesa, Metairie, Miami, Northridge, Oxon Hill, Phoenix, Plantation, Pompano Beach, Salisbury, Santa Fe, Santa Monica, Shelby, Spokane, Tamarac, Tampa, Thousand Oaks, Tujunga és West Jordan (Egyesült Államok)Mind a 39 helyszín megnézése
Azonosító: NCT04511702
Állapot: Befejeződött
Fázis: 4. fázis
Résztvevők: 191 fő vett részt
Kezdés: 2020. okt. 2.
Befejezés: 2024. márc. 25.
A vizsgálat típusa: Beavatkozással járó, 3 csoport
A vizsgált kezelések: Pegloticase with MTX
A regiszteradat frissítve: 2025. október 20.

Ki vehet részt

Életkor: 18 év felett
Nem: Nők és férfiak
Egészséges önkéntesek: Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

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
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
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
Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis
History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix
Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit)
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

Helyszínek itt: Egyesült Államok

Orthopedic Physicians AlaskaAnchorage, Egyesült ÁllamokNo longer taking part
University of Colorado Division of RheumatologyAurora, Egyesült ÁllamokNo longer taking part
Long Island Arthritis & Osteoporosis CareBabylon, Egyesült ÁllamokNo longer taking part
University of Alabama at BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
Western Washington Medical GroupBothell, Egyesült ÁllamokNo longer taking part
Bradenton Research CenterBradenton, Egyesült ÁllamokNo longer taking part
Chattanooga Research & Medicine PLLC (CHARM)Chattanooga, Egyesült ÁllamokNo longer taking part
Velocity Clinical Research - CincinnatiCincinnati, Egyesült ÁllamokNo longer taking part
Medvin Clinical ResearchCovina, Egyesült ÁllamokNo longer taking part
Denver Arthritis ClinicDenver, Egyesült ÁllamokNo longer taking part
Research Carolina EliteDenver, Egyesült ÁllamokNo longer taking part
Prohealth Research CenterDoral, Egyesült ÁllamokNo longer taking part
Altoona Center For Clinical ResearchDuncansville, Egyesült ÁllamokNo longer taking part
Arizona Arthritis & Rheumatology ResearchGilbert, Egyesült ÁllamokNo longer taking part
PMG Research of Hickory, LLCHickory, Egyesült ÁllamokNo longer taking part
Abigail Rebecca Neiman, MD, PAHouston, Egyesült ÁllamokNo longer taking part
Pioneer Research Solutions Inc - HoustonHouston, Egyesült ÁllamokNo longer taking part
Cape Fear Arthritis CareLeland, Egyesült ÁllamokNo longer taking part
Life Clinical TrialsMargate, Egyesült ÁllamokNo longer taking part
Arthritis & Rheumatology ResearchMesa, Egyesült ÁllamokNo longer taking part
MedPharmics, LLCMetairie, Egyesült ÁllamokNo longer taking part
D&H National Research CentersMiami, Egyesült ÁllamokNo longer taking part
Amicis Research CenterNorthridge, Egyesült ÁllamokNo longer taking part
MD Medical ResearchOxon Hill, Egyesült ÁllamokNo longer taking part
Arizona Arthritis & Rheumatology ResearchPhoenix, Egyesült ÁllamokNo longer taking part
IRIS Research and Development LLCPlantation, Egyesült ÁllamokNo longer taking part
Napa Research CenterPompano Beach, Egyesült ÁllamokNo longer taking part
PMG Research of Salisbury, LLCSalisbury, Egyesült ÁllamokNo longer taking part
Santa Fe RheumatologySanta Fe, Egyesült ÁllamokNo longer taking part
Providence Saint John's Health CenterSanta Monica, Egyesült ÁllamokNo longer taking part
Shelby Clinical Research, LLCShelby, Egyesült ÁllamokNo longer taking part
Arthritis NorthwestSpokane, Egyesült ÁllamokNo longer taking part
D&H Tamarac Research CentersTamarac, Egyesült ÁllamokNo longer taking part
ClinPro Research SolutionsTampa, Egyesült ÁllamokNo longer taking part
ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
GCP Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
Medvin Clinical ResearchThousand Oaks, Egyesült ÁllamokNo longer taking part
Medvin Clinical ResearchTujunga, Egyesült ÁllamokNo longer taking part
Velocity Clinical Research, Salt Lake CityWest Jordan, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 3 csoportja

Pegloticase 60 Minute Infusion with methotrexate (MTX)A vizsgált kezelés
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
Kezelés: Pegloticase with MTX
Pegloticase 45 Minute Infusion with methotrexate (MTX)A vizsgált kezelés
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
Kezelés: Pegloticase with MTX
Pegloticase 30 Minute Infusion with methotrexate (MTX)A vizsgált kezelés
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
Kezelés: Pegloticase with MTX

Adatok és források

Regiszteradat

ClinicalTrials.gov NCT04511702

Szerepel a ClinicalTrials.gov-on.

Hivatalos cím

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

A regiszteradat frissítve

2025. október 20.