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L'essai clinique NCT06229145 pour Goutte est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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AmgenA 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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L'essai clinique NCT06229145 est conçu pour étudier le treatment de Goutte. Il s'agit d'un essai interventionnel en Phase IV. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 18 mars 2024 et vise à recruter 262 participants. Dirigé par Amgen, l'essai devrait être terminé d'ici le 9 avril 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 26 août 2025.
Résumé succinct
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.
Description détaillée
Acquired from Horizon in 2024.
Titre officiel
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)
Conditions
GoutteAutres identifiants de l'essai
- HZNP-KRY-409
Numéro NCT
Date de début (réel)
2024-03-18
Dernière mise à jour publiée
2025-08-26
Date de fin (estimée)
2026-04-09
Inscription (estimée)
262
Type d'essai
Interventionnel
PHASE
Phase IV
Statut
Actif, pas en recrutement
Mots clés
Uncontrolled Gout
pegloticase
Krystexxa
Methotrexate
Chronic Gout
pegloticase
Krystexxa
Methotrexate
Chronic Gout
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPegloticase + Methotrexate Q4W 16 mg pegloticase will be administered intravenously every 4 weeks for 24 weeks during double blind treatment and 24 weeks during open label. | Pegloticase IV infusion Methotrexate Oral |
ExpérimentalPegloticase + Methotrexate Q2W 8 mg pegloticase will be administered intravenously every 2 weeks for 24 weeks during double blind treatment and 16 mg pegloticase every 4 weeks for 24 weeks during open label. | Pegloticase IV infusion Methotrexate Oral |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Proportion of Participants achieving and maintaining serum uric acid (sUA) < 6 mg/dL at least 80% of the time | Month 6 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Proportion of Participants with complete resolution of ≥ 1 tophus | Week 24 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
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.
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis
- 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)
- 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
- G6PD deficiency (quantitative test at the Screening Visit centrally or locally)
- 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
- 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
- Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug
- Unable to tolerate MTX 15 mg orally during the MTX Run-in Period
- Chronic liver disease
- White blood cell count < 4,000/μL, hematocrit < 32% or platelet count < 75,000/μL
- Currently receiving systemic or radiologic treatment for ongoing cancer
- History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix
- Diagnosis of osteomyelitis
- Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome
- 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)
- Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening.
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74 Centres de l'essai dans 1 pays
Alabama
The University of Alabama at Birmingham (UAB), Birmingham, Alabama, 35233, United States
Alaska
Orthopedic Physicians Alaska - Rheumatology and Infusion, Anchorage, Alaska, 99508-5234, United States
Arizona
Arizona Arthritis and Rheumatology Associates - Chandler, Chandler, Arizona, 85225-2915, United States
Arizona Arthritis and Rheumatology Rese, Flagstaff, Arizona, 86001, United States
Arizona Arthritis & Rheumatology Research, PLLC, Gilbert, Arizona, 85297, United States
Arizona Arthritis & Rheumatology Research, PLLC, Mesa, Arizona, 85032, United States
Arizona Arthritis and Rheumatology Research, PLLC, Mesa, Arizona, 85210, United States
Arizona Arthritis and Rheumatology Research, PLLC, Phoenix, Arizona, 85037-4403, United States
Arizona Arthritis and Rheumatology Research, Phoenix, Arizona, 85037, United States
Arizona Arthritis & Rheumatology Research, PLLC, Sun City, Arizona, 85351, United States
Arizona Arthritis and Rheumatology, Tucson, Arizona, 85704, United States
California
Covina Arthritis Clinic, Covina, California, 91722, United States
Medvin Clinical Research- Riverside, Hemet, California, 92543, United States
Velocity Clinical Research - Boise - ERN - PPDS, North Hollywood, California, 83642, United States
TriWest Research Associates, San Diego, California, 92108, United States
Precision Comprehensive Clinical Research Solutions, San Leandro, California, 94578-2630, United States
Saint John's Health Center - Providence St John's Health Ctr, Santa Monica, California, 90404, United States
C.V. Mehta MD Medical Corporation, Temecula, California, 92592, United States
Foothill Arthritis, Tujunga, California, 91042, United States
Medvin Clinical Research, Whittier, California, 90602, United States
Colorado
University of Colorado Denver, Aurora, Colorado, 80045, United States
Lynn Institute of the Rockies, Colorado Springs, Colorado, 80918, United States
Denver Arthritis Clinic - Rheumatology, Denver, Colorado, 80230, United States
Florida
Arthritis & Rheumatic Disease, Aventura, Florida, 33180-1204, United States
Prohealth Research Center, Doral, Florida, 33166, United States
Life Clinical Trials, Margate, Florida, 33063-5675, United States
Homestead Associates in Research,Inc, Miami, Florida, 33032-8225, United States
D&H National Research Centers, Inc., Miami, Florida, 33155, United States
Well Pharma, Miami, Florida, 33173, United States
Felicidad Medical Research, LLC., Miami, Florida, 33184, United States
New Generation Of Medical Research, Naples, Florida, 34104, United States
IRIS Research & Development, Plantation, Florida, 33324, United States
D&H Pompano Research Center, Pompano Beach, Florida, 33064, United States
D&H Tamarac Research Center, Tamarac, Florida, 33321, United States
GCP Clinical Research, Tampa, Florida, 33609, United States
ClinPro Research Solutions, LLC, Tampa, Florida, 33613, United States
Georgia
Arthritis Center of North Georgia, Gainesville, Georgia, 30501, United States
Vista Clinical Research, LLC, Newnan, Georgia, 30265, United States
Illinois
Great Lakes Clin. Trials, Chicago, Illinois, 60625, United States
Conquest Research - Anesthesiology/Pain Medicine, Chicago, Illinois, 60637, United States
Great Lakes Clinical Trials - Gurnee, Highland Park, Illinois, 60035, United States
Crowley CORE - Illinois Bone and Joint Institute, Hinsdale, Illinois, 60521, United States
Indiana
Lake Cumberland Rheumatology, PLLC, New Albany, Indiana, 47150, United States
Kentucky
L-MARC Research Center, Louisville, Kentucky, 40213, United States
Louisiana
Velocity CR - New Orleans, Covington, Louisiana, 70433, United States
Velocity CR - New Orleans, New Orleans, Louisiana, 70121-2429, United States
Michigan
Michigan Medicine, Ann Arbor, Michigan, 48109, United States
June DO,PC, Lansing, Michigan, 48911, United States
Clinical Research Institute of Michigan, LLC, Saint Clair Shores, Michigan, 48081, United States
New Mexico
Inspire Santa Fe Medical Group, Santa Fe, New Mexico, 87505, United States
New York
Velocity Clinical Research-Vestal, Vestal, New York, 13850, United States
North Carolina
OnSite Clinical Solutions, LLC, Charlotte, North Carolina, 28226, United States
Research Carolina Elite, Denver, North Carolina, 28037, United States
Triad Clinical Trials - Gastroenterology, Greensboro, North Carolina, 27410, United States
Accellacare of Hickory, Hickory, North Carolina, 28602, United States
Cape Fear Arthritis Care, Leland, North Carolina, 28451-4168, United States
Shelby Clinical Research - Family Medicine, Shelby, North Carolina, 28152, United States
Ohio
Velocity Clinical Research- Cincinatti, Cincinnati, Ohio, 45242, United States
Velocity Clinical Research - Cleveland, Cleveland, Ohio, 44122, United States
Oklahoma
Lynn Health Science Institute, Oklahoma City, Oklahoma, 73111-3324, United States
Pennsylvania
Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States
South Carolina
Velocity Clinical Research, Spartanburg - Pulmonology, Greenville, South Carolina, 29615, United States
Premier Clinics Pa - Rock Hill, Sc, Rock Hill, South Carolina, 29732, United States
Low Country Rheumatology, Summerville, South Carolina, 29486-7887, United States
Texas
Amarillo Center for Clinical Research, Ltd., Amarillo, Texas, 79124, United States
Clinical Trial Network, Austin, Texas, 78750, United States
Synergy Groups Medical LLC, Houston, Texas, 77061, United States
Pioneer Research Solutions, Inc., Houston, Texas, 77099, United States
AIM Trials - Internal Medicine, Plano, Texas, 75093, United States
Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States
Texas Research Center, Sugar Land, Texas, 77479, United States
Utah
Velocity Clinical Research - Salt Lake City (West Jordan), West Jordan, Utah, 84088, United States
Virginia
Velocity Clinical Research-Portsmouth, Portsmouth, Virginia, 23703-3200, United States
Washington
Arthritis Northwest, PLLC - Research, Spokane, Washington, 99204, United States