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A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

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Amarillo, Anchorage, Ann Arbor, Aurora, Austin, Aventura, Birmingham, Chandler, Charlotte, Chicago, Cincinnati, Cleveland, Colorado Springs, Covina, Covington, Denver, Doral, Duncansville, Flagstaff, Gainesville, Gilbert, Greensboro, Greenville, Hemet, Hickory, Highland Park, Hinsdale, Houston, Lansing, Leland, Louisville, Margate, Mesa, Miami, Naples, New Albany, New Orleans, Newnan, North Hollywood, Oklahoma City, Phoenix, Plano, Plantation, Pompano Beach, Portsmouth, Rock Hill, Saint Clair Shores, San Antonio, San Diego, San Leandro, Santa Fe, Santa Monica, Shelby, Spokane, Sugar Land, Summerville, Sun City, Tamarac, Tampa, Temecula, Tucson, Tujunga, Vestal, West Jordan és Whittier (Egyesült Államok)Mind a 74 helyszín megnézése
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4. fázis

Helyszínek itt: Egyesült Államok

  • Amarillo Center for Clinical Research, Ltd.Amarillo, Egyesült ÁllamokNo longer taking part
  • Orthopedic Physicians Alaska - Rheumatology and InfusionAnchorage, Egyesült ÁllamokNo longer taking part
  • Michigan MedicineAnn Arbor, Egyesült ÁllamokNo longer taking part
  • University of Colorado DenverAurora, Egyesült ÁllamokNo longer taking part
  • Clinical Trial NetworkAustin, Egyesült ÁllamokNo longer taking part
  • Arthritis & Rheumatic DiseaseAventura, Egyesült ÁllamokNo longer taking part
  • The University of Alabama at Birmingham (UAB)Birmingham, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis and Rheumatology Associates - ChandlerChandler, Egyesült ÁllamokNo longer taking part
  • Onsite Clinical Solutions, LLCCharlotte, Egyesült ÁllamokNo longer taking part
  • Conquest Research - Anesthesiology/Pain MedicineChicago, Egyesült ÁllamokNo longer taking part
  • Great Lakes Clin. TrialsChicago, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research- CincinattiCincinnati, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research, ClevelandCleveland, Egyesült ÁllamokNo longer taking part
  • Lynn Institute of the RockiesColorado Springs, Egyesült ÁllamokNo longer taking part
  • Covina Arthritis ClinicCovina, Egyesült ÁllamokNo longer taking part
  • Velocity CR - New OrleansCovington, Egyesült ÁllamokNo longer taking part
  • Denver Arthritis Clinic - RheumatologyDenver, 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 and Rheumatology ReseFlagstaff, Egyesült ÁllamokNo longer taking part
  • Arthritis Center of North GeorgiaGainesville, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis & Rheumatology Research, PLLCGilbert, Egyesült ÁllamokNo longer taking part
  • Triad Clinical Trials - GastroenterologyGreensboro, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research, Spartanburg - PulmonologyGreenville, Egyesült ÁllamokNo longer taking part
  • Medvin Clinical Research- RiversideHemet, Egyesült ÁllamokNo longer taking part
  • Accellacare of HickoryHickory, Egyesült ÁllamokNo longer taking part
  • Great Lakes Clinical Trials - GurneeHighland Park, Egyesült ÁllamokNo longer taking part
  • Crowley CORE - Illinois Bone and Joint InstituteHinsdale, Egyesült ÁllamokNo longer taking part
  • Pioneer Research Solutions, Inc.Houston, Egyesült ÁllamokNo longer taking part
  • Synergy Groups Medical LLCHouston, Egyesült ÁllamokNo longer taking part
  • June DO, PCLansing, Egyesült ÁllamokNo longer taking part
  • Cape Fear Arthritis CareLeland, Egyesült ÁllamokNo longer taking part
  • L-MARC Research CenterLouisville, Egyesült ÁllamokNo longer taking part
  • Life Clinical TrialsMargate, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis & Rheumatology Research, PLLCMesa, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis and Rheumatology Research PLLCMesa, Egyesült ÁllamokNo longer taking part
  • D&H National Research Centers, IncMiami, Egyesült ÁllamokNo longer taking part
  • Felicidad Medical Research, LLCMiami, Egyesült ÁllamokNo longer taking part
  • Homestead Associates in Research Inc.Miami, Egyesült ÁllamokNo longer taking part
  • Well PharmaMiami, Egyesült ÁllamokNo longer taking part
  • New Generation Of Medical ResearchNaples, Egyesült ÁllamokNo longer taking part
  • Lake Cumberland Rheumatology, PLLCNew Albany, Egyesült ÁllamokNo longer taking part
  • Velocity CR - New OrleansNew Orleans, Egyesült ÁllamokNo longer taking part
  • Vista Clinical Research, LLCNewnan, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - Boise - ERN - PPDSNorth Hollywood, Egyesült ÁllamokNo longer taking part
  • Lynn Health Science InstituteOklahoma City, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis and Rheumatology ResearchPhoenix, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis and Rheumatology Research PLLCPhoenix, Egyesült ÁllamokNo longer taking part
  • AIM Trials - Internal MedicinePlano, Egyesült ÁllamokNo longer taking part
  • IRIS Research & DevelopmentPlantation, Egyesült ÁllamokNo longer taking part
  • D & H Pompano Research CenterPompano Beach, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research-PortsmouthPortsmouth, Egyesült ÁllamokNo longer taking part
  • Premier Clinics Pa - Rock Hill, ScRock Hill, Egyesült ÁllamokNo longer taking part
  • Clinical Research Institute of Michigan, LLCSaint Clair Shores, Egyesült ÁllamokNo longer taking part
  • Clinical Trials of Texas IncSan Antonio, Egyesült ÁllamokNo longer taking part
  • Triwest Research AssociatesSan Diego, Egyesült ÁllamokNo longer taking part
  • Precision Comprehensive Clinical Research SolutionsSan Leandro, Egyesült ÁllamokNo longer taking part
  • Inspire Santa Fe Medical GroupSanta Fe, Egyesült ÁllamokNo longer taking part
  • Saint John's Health Center - Providence St John's Health CtrSanta Monica, Egyesült ÁllamokNo longer taking part
  • Shelby Clinical Research - Family MedicineShelby, Egyesült ÁllamokNo longer taking part
  • Arthritis Northwest, PLLC - ResearchSpokane, Egyesült ÁllamokNo longer taking part
  • Texas Research CenterSugar Land, Egyesült ÁllamokNo longer taking part
  • Low Country RheumatologySummerville, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis & Rheumatology Research, PLLCSun City, Egyesült ÁllamokNo longer taking part
  • D&H Tamarac Research CenterTamarac, Egyesült ÁllamokNo longer taking part
  • ClinPro Research Solutions LLCTampa, Egyesült ÁllamokNo longer taking part
  • GCP Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
  • C.V. Mehta MD Medical CorporationTemecula, Egyesült ÁllamokNo longer taking part
  • Arizona Arthritis and RheumatologyTucson, Egyesült ÁllamokNo longer taking part
  • Foothill ArthritisTujunga, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - VestalVestal, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - Salt Lake City (West Jordan)West Jordan, Egyesült ÁllamokNo longer taking part
  • Medvin Clinical ResearchWhittier, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
Amgen
Azonosító
NCT06229145
A regiszteradat frissítve
2026. szeptember 17.
Eredeti leírás
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout.A teljes eredeti leírásKevesebb

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout.

The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time.

Bevonási feltételek: Adult men or women ≥ 18 years of age; Uncontrolled gout, defined as meeting the following criteria:; Hyperuricemia during the Screening Period, defined as sUA ≥ 7 mg/dL, and; Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or participant interview, and; Symptoms of gout; Willing to discontinue any oral ULT for at least 7 days prior to MTX dosing at Week -4 and continue not receiving any oral ULT when receiving pegloticase/placebo for pegloticase infusions; Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4; Men who are not vasectomized must agree to use appropriate contraception, so as to not impregnate a female partner of reproductive potential during the trial.

Kizáró feltételek: 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 (3 months or longer); Non-compensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina) or uncontrolled blood pressure (> 160/100 mmHg) prior to Week -4; Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug; Currently receiving systemic or radiologic treatment for ongoing cancer; A known intolerance to all protocol-standard gout flare prophylaxis regimens (i.e., participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day); Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis; History of any transplant surgery requiring maintenance immunosuppressive therapy; Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity; Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative; Known history of human immunodeficiency virus (HIV) positivity; Chronic liver disease; History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix; Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome; Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening; White blood cell count < 4,000/μL, hematocrit < 32% or platelet count < 75,000/μL; G6PD deficiency (quantitative test at the Screening Visit centrally or locally); 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; Unable to tolerate MTX 15 mg orally during the MTX Run-in Period; Diagnosis of osteomyelitis.

ClinicalTrials.gov NCT06229145