A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Key facts
- Where
- Albuquerque, Anaheim, Anchorage, Aventura, Bay Pines, Bellaire, Bellevue, Birmingham, Boise, Charlotte, Chicago, Chula Vista, Columbia, Columbus, Coral Springs, Dallas, DeLand, Denver, Duncansville, Greensboro, Hamilton, Hialeah, Homestead, Houston, Jackson, Kansas City, Katy, Lansing, Largo, Leland, Lewisville, Long Beach, Mandeville, Marietta, Meridian, Miami, Middleburg Heights, Newnan, Oklahoma City, Orchard Park, Oxon Hill, Plantation, Rapid City, Richmond, Round Rock, Saint Clair Shores, Salisbury, Santa Fe, Searcy, Shelby, Sugar Land, Summerville, Tamarac, Tampa, The Woodlands, Troy, Tustin, Walnut Creek, Willowbrook, and Winter Park, United StatesSee the 74 sites
- Phase
- Phase 3
Where in United States
- Raymond G Murphy Veteran Affairs Medical CenterAlbuquerque, United StatesTaking people
- Precision RheumatologyAnaheim, United StatesTaking people
- Orthopedic Physicians AlaskaAnchorage, United StatesTaking people
- Arthritis and Rheumatic Disease SpecialtiesAventura, United StatesTaking people
- D and H Pompano Research CenterAventura, United StatesTaking people
- Bay Pines Veterans Affairs Healthcare SystemBay Pines, United StatesTaking people
- Pioneer Research Solutions IncBellaire, United StatesTaking people
- Overlake Arthritis and Osteoperosis CenterBellevue, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Greater Chicago Specialty PhysiciansBoise, United StatesTaking people
- Arthritis and Osteoporosis Consultants of the CarolinasCharlotte, United StatesTaking people
- Joint and Muscle Research InstituteCharlotte, United StatesTaking people
- Onsite Clinical Solutions, LLCCharlotte, United StatesTaking people
- Charter ResearchChicago, United StatesTaking people
- Flourish Research RavenswoodChicago, United StatesTaking people
- Advanced Clinical Research Center, LLC dba TriWest Research AssociatesChula Vista, United StatesTaking people
- Kur Research at Columbia Medical PracticeColumbia, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Discovery Health Research CenterCoral Springs, United StatesTaking people
- Southwest RheumatologyDallas, United StatesTaking people
- Hillcrest Medical ResearchDeLand, United StatesTaking people
- Denver Arthritis Clinic PCDenver, United StatesTaking people
- Research Carolina EliteDenver, United StatesTaking people
- Altoona Center For Clinical ResearchDuncansville, United StatesTaking people
- Triad Clinical Trials, LLCGreensboro, United StatesTaking people
- Bioluminux Clinical Research - HamiltonHamilton, United StatesTaking people
- New Generation of Medical ResearchHialeah, United StatesTaking people
- Homestead Associates in Research IncHomestead, United StatesTaking people
- Research Physicians Network, LLCHouston, United StatesTaking people
- West Tennessee Research InstituteJackson, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Biopharma Informatic, LLCKaty, United StatesTaking people
- Texas Arthritis & Rheumatology AssociatesKaty, United StatesTaking people
- June DO, PCLansing, United StatesTaking people
- Decision Management International ResearchLargo, United StatesTaking people
- Cape Fear Arthritis Care, PLLCLeland, United StatesTaking people
- Epic Clinical ResearchLewisville, United StatesTaking people
- Veterans Affairs Long Beach Health Care SystemLong Beach, United StatesTaking people
- Clinical Trials Management, LLC, d/b/a Flourish ResearchMandeville, United StatesTaking people
- Spatium Urgent CareMarietta, United StatesTaking people
- Saint Lukes Intermountain Research CenterMeridian, United StatesTaking people
- Advanced Clinical ResearchMiami, United StatesTaking people
- D and H National Research CentersMiami, United StatesTaking people
- Entrust Clinical ResearchMiami, United StatesTaking people
- Felicidad Medical ResearchMiami, United StatesTaking people
- Pharmax Research ClinicMiami, United StatesTaking people
- Well Pharma Medical Research Corp.Miami, United StatesTaking people
- Paramount Medical Research and Consulting LLCMiddleburg Heights, United StatesTaking people
- Vista Clinical ResearchNewnan, United StatesTaking people
- Lynn Health Science InstituteOklahoma City, United StatesTaking people
- Buffalo Rheumatology and MedicineOrchard Park, United StatesTaking people
- MD Medical ResearchOxon Hill, United StatesTaking people
- Integral Rheumatology And Immunology SpecialistsPlantation, United StatesTaking people
- Health ConceptsRapid City, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- Be Well Clinical StudiesRound Rock, United StatesTaking people
- Clinical Research Institute of MichiganSaint Clair Shores, United StatesTaking people
- Accellacare - SalisburySalisbury, United StatesTaking people
- Inspire Santa Fe Medical GroupSanta Fe, United StatesTaking people
- Unity Health-Searcy Medical CenterSearcy, United StatesTaking people
- Carolina Research Center, IncShelby, United StatesTaking people
- Shelby Clinical ResearchShelby, United StatesTaking people
- Siena Research NetworkSugar Land, United StatesTaking people
- Articularis Healthcare Group Inc dba Low Country RheumatologySummerville, United StatesTaking people
- D and H Tamarac Research CenterTamarac, United StatesTaking people
- ClinPro Research Solutions LLCTampa, United StatesTaking people
- GCP Clinical Research, LLCTampa, United StatesTaking people
- Nodal Medical Center ResearchTampa, United StatesTaking people
- Advanced Rheumatology of HoustonThe Woodlands, United StatesTaking people
- Oakland Medical Research CenterTroy, United StatesTaking people
- Solace Clinical ResearchTustin, United StatesTaking people
- Jiva HealthWalnut Creek, United StatesTaking people
- Willow Rheumatology and WellnessWillowbrook, United StatesTaking people
- Conquest Research-Winter ParkWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Amgen
- Trial code
- NCT07388498
- Record updated
- 19 October 2026
- Original description
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.Read full original descriptionShow less
A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.
Inclusion: Participant has provided informed consent before initiation of any trial-specific activities/procedures; Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years; Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial; Participants with uncontrolled gout, as meeting the protocol defined criteria.
Exclusion: Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug; A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone ≤ 10 mg/day or equivalent dose of other corticosteroid); Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit); Liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 1.25 x upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the screening visit; Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) > 8%; Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations < 40 mL/min/1.73 m\^2 or currently on dialysis; Known intolerance to MTX.