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
Key facts
- Where
- 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, and Whittier, United StatesSee the 74 sites
- Phase
- Phase 4
Where in United States
- Amarillo Center for Clinical Research, Ltd.Amarillo, United StatesNo longer taking part
- Orthopedic Physicians Alaska - Rheumatology and InfusionAnchorage, United StatesNo longer taking part
- Michigan MedicineAnn Arbor, United StatesNo longer taking part
- University of Colorado DenverAurora, United StatesNo longer taking part
- Clinical Trial NetworkAustin, United StatesNo longer taking part
- Arthritis & Rheumatic DiseaseAventura, United StatesNo longer taking part
- The University of Alabama at Birmingham (UAB)Birmingham, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology Associates - ChandlerChandler, United StatesNo longer taking part
- Onsite Clinical Solutions, LLCCharlotte, United StatesNo longer taking part
- Conquest Research - Anesthesiology/Pain MedicineChicago, United StatesNo longer taking part
- Great Lakes Clin. TrialsChicago, United StatesNo longer taking part
- Velocity Clinical Research- CincinattiCincinnati, United StatesNo longer taking part
- Velocity Clinical Research, ClevelandCleveland, United StatesNo longer taking part
- Lynn Institute of the RockiesColorado Springs, United StatesNo longer taking part
- Covina Arthritis ClinicCovina, United StatesNo longer taking part
- Velocity CR - New OrleansCovington, United StatesNo longer taking part
- Denver Arthritis Clinic - RheumatologyDenver, United StatesNo longer taking part
- Research Carolina EliteDenver, United StatesNo longer taking part
- Prohealth Research CenterDoral, United StatesNo longer taking part
- Altoona Center For Clinical ResearchDuncansville, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology ReseFlagstaff, United StatesNo longer taking part
- Arthritis Center of North GeorgiaGainesville, United StatesNo longer taking part
- Arizona Arthritis & Rheumatology Research, PLLCGilbert, United StatesNo longer taking part
- Triad Clinical Trials - GastroenterologyGreensboro, United StatesNo longer taking part
- Velocity Clinical Research, Spartanburg - PulmonologyGreenville, United StatesNo longer taking part
- Medvin Clinical Research- RiversideHemet, United StatesNo longer taking part
- Accellacare of HickoryHickory, United StatesNo longer taking part
- Great Lakes Clinical Trials - GurneeHighland Park, United StatesNo longer taking part
- Crowley CORE - Illinois Bone and Joint InstituteHinsdale, United StatesNo longer taking part
- Pioneer Research Solutions, Inc.Houston, United StatesNo longer taking part
- Synergy Groups Medical LLCHouston, United StatesNo longer taking part
- June DO, PCLansing, United StatesNo longer taking part
- Cape Fear Arthritis CareLeland, United StatesNo longer taking part
- L-MARC Research CenterLouisville, United StatesNo longer taking part
- Life Clinical TrialsMargate, United StatesNo longer taking part
- Arizona Arthritis & Rheumatology Research, PLLCMesa, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology Research PLLCMesa, United StatesNo longer taking part
- D&H National Research Centers, IncMiami, United StatesNo longer taking part
- Felicidad Medical Research, LLCMiami, United StatesNo longer taking part
- Homestead Associates in Research Inc.Miami, United StatesNo longer taking part
- Well PharmaMiami, United StatesNo longer taking part
- New Generation Of Medical ResearchNaples, United StatesNo longer taking part
- Lake Cumberland Rheumatology, PLLCNew Albany, United StatesNo longer taking part
- Velocity CR - New OrleansNew Orleans, United StatesNo longer taking part
- Vista Clinical Research, LLCNewnan, United StatesNo longer taking part
- Velocity Clinical Research - Boise - ERN - PPDSNorth Hollywood, United StatesNo longer taking part
- Lynn Health Science InstituteOklahoma City, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology ResearchPhoenix, United StatesNo longer taking part
- Arizona Arthritis and Rheumatology Research PLLCPhoenix, United StatesNo longer taking part
- AIM Trials - Internal MedicinePlano, United StatesNo longer taking part
- IRIS Research & DevelopmentPlantation, United StatesNo longer taking part
- D & H Pompano Research CenterPompano Beach, United StatesNo longer taking part
- Velocity Clinical Research-PortsmouthPortsmouth, United StatesNo longer taking part
- Premier Clinics Pa - Rock Hill, ScRock Hill, United StatesNo longer taking part
- Clinical Research Institute of Michigan, LLCSaint Clair Shores, United StatesNo longer taking part
- Clinical Trials of Texas IncSan Antonio, United StatesNo longer taking part
- Triwest Research AssociatesSan Diego, United StatesNo longer taking part
- Precision Comprehensive Clinical Research SolutionsSan Leandro, United StatesNo longer taking part
- Inspire Santa Fe Medical GroupSanta Fe, United StatesNo longer taking part
- Saint John's Health Center - Providence St John's Health CtrSanta Monica, United StatesNo longer taking part
- Shelby Clinical Research - Family MedicineShelby, United StatesNo longer taking part
- Arthritis Northwest, PLLC - ResearchSpokane, United StatesNo longer taking part
- Texas Research CenterSugar Land, United StatesNo longer taking part
- Low Country RheumatologySummerville, United StatesNo longer taking part
- Arizona Arthritis & Rheumatology Research, PLLCSun City, United StatesNo longer taking part
- D&H Tamarac Research CenterTamarac, United StatesNo longer taking part
- ClinPro Research Solutions LLCTampa, United StatesNo longer taking part
- GCP Clinical ResearchTampa, United StatesNo longer taking part
- C.V. Mehta MD Medical CorporationTemecula, United StatesNo longer taking part
- Arizona Arthritis and RheumatologyTucson, United StatesNo longer taking part
- Foothill ArthritisTujunga, United StatesNo longer taking part
- Velocity Clinical Research - VestalVestal, United StatesNo longer taking part
- Velocity Clinical Research - Salt Lake City (West Jordan)West Jordan, United StatesNo longer taking part
- Medvin Clinical ResearchWhittier, United StatesNo longer taking part
Trial details
- Who runs it
- Amgen
- Trial code
- NCT06229145
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
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.
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 ≥ 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.
Exclusion: 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.