Gout Clinical Trial
Official title:
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)
| Verified date | June 2024 |
| Source | Amgen |
| Contact | Amgen Call Center |
| Phone | 866-572-6436 |
| medinfo[@]amgen.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | May 31, 2026 |
| Est. primary completion date | September 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Adult men or women = 18 years of age 2. 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 3. 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 4. Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4. 5. 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 Criteria: 1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis 2. 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) 3. History of any transplant surgery requiring maintenance immunosuppressive therapy 4. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity 5. Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative 6. Known history of human immunodeficiency virus (HIV) positivity 7. G6PD deficiency (quantitative test at the Screening Visit centrally or locally) 8. 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 9. 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 10. Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug 11. Unable to tolerate MTX 15 mg orally during the MTX Run-in Period 12. Chronic liver disease 13. White blood cell count < 4,000/µL, hematocrit < 32% or platelet count < 75,000/µL 14. Currently receiving systemic or radiologic treatment for ongoing cancer 15. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix 16. Diagnosis of osteomyelitis 17. Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome 18. 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) 19. Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Amarillo Center for Clinical Research, Ltd. | Amarillo | Texas |
| United States | Orthopedic Physicians Alaska - Rheumatology and Infusion | Anchorage | Alaska |
| United States | Arthritis & Rheumatic Disease | Aventura | Florida |
| United States | Velocity Clinical Research, Cleveland | Beachwood | Ohio |
| United States | The University of Alabama at Birmingham (UAB) | Birmingham | Alabama |
| United States | Arizona Arthritis and Rheumatology | Chandler | Arizona |
| United States | OnSite Clinical Solutions, LLC | Charlotte | North Carolina |
| United States | Great Lakes Clin. Trials | Chicago | Illinois |
| United States | Velocity Clinical Research - Cincinnati | Cincinnati | Ohio |
| United States | Lynn Institute of the Rockies | Colorado Springs | Colorado |
| United States | Covina Arthritis Clinic | Covina | California |
| United States | Denver Arthritis Clinic | Denver | Colorado |
| United States | Research Carolina Elite, LLC | Denver | North Carolina |
| United States | D&H Pompano Research Center | Doral | Florida |
| United States | Prohealth Research Center | Doral | Florida |
| United States | Arizona Arthritis and Rheumatology Rese | Flagstaff | Arizona |
| United States | Arizona Arthritis & Rheumatology | Gilbert | Arizona |
| United States | Triad Clinical Trials | Greensboro | North Carolina |
| United States | Velocity Clinical Research, Greenville | Greenville | South Carolina |
| United States | Great Lakes Clinical Trials - Gurnee | Gurnee | Illinois |
| United States | Crowley CORE | Hinsdale | Illinois |
| United States | Clinical Trial Network | Houston | Texas |
| United States | Pioneer Research Solutions, Inc. | Houston | Texas |
| United States | Synergy Groups Medical LLC | Houston | Texas |
| United States | June DO, PC | Lansing | Michigan |
| United States | Cape Fear Arthritis Care | Leland | North Carolina |
| United States | L-MARC Research Center | Louisville | Kentucky |
| United States | Life Clinical Trials | Margate | Florida |
| United States | Velocity Clinical Research - Boise | Meridian | Idaho |
| United States | Arizona ArthritisRheumatology Resea | Mesa | Arizona |
| United States | D&H National Research Centers, Inc. | Miami | Florida |
| United States | Homestead Associates in Research,Inc | Miami | Florida |
| United States | New Generation Of Medical Research | Naples | Florida |
| United States | Vista Clinical Research, LLC | Newnan | Georgia |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Arizona Arthritis & Rheumatology | Phoenix | Arizona |
| United States | Arizona Arthritis & Rheumatology | Phoenix | Arizona |
| United States | AIM Trials - Internal Medicine | Plano | Texas |
| United States | IRIS | Plantation | Florida |
| United States | Velocity Clin Research-Portsmouth | Portsmouth | Virginia |
| United States | Premier Clinics Pa | Rock Hill | South Carolina |
| United States | Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | TriWest Research Associates | San Diego | California |
| United States | PCCRS | San Leandro | California |
| United States | Inspire Santa Fe Medical Group | Santa Fe | New Mexico |
| United States | Saint John's Health Center | Santa Monica | California |
| United States | Shelby Clinical Research | Shelby | North Carolina |
| United States | Arthritis Northwest, PLLC - Research | Spokane | Washington |
| United States | Low Country Rheumatology | Summerville | South Carolina |
| United States | Arizona Arthritis & Rheumatology | Sun City | Arizona |
| United States | D&H Tamarac Research Center | Tamarac | Florida |
| United States | ClinPro Research Solutions, LLC | Tampa | Florida |
| United States | GCP Clinical Research | Tampa | Florida |
| United States | Medvin Clinical Research- Riverside | Temecula | California |
| United States | Arizona Arthritis and Rheumatology | Tucson | Arizona |
| United States | Foothill Arthritis | Tujunga | California |
| United States | Velocity Clinical Research-Vestal | Vestal | New York |
| United States | Velocity Clinical Research - Salt Lake City | West Jordan | Utah |
| United States | Conquest Research | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Participants achieving and maintaining serum uric acid (sUA) < 6 mg/dL at least 80% of the time | Month 6 | ||
| Secondary | Proportion of Participants with complete resolution of = 1 tophus | Week 24 |
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