152
Participants
Start Date
June 13, 2019
Primary Completion Date
March 17, 2021
Study Completion Date
April 11, 2022
Pegloticase
IV pegloticase 8 mg Q2W
methotrexate
Oral MTX 15 mg weekly
placebo
Oral placebo for MTX
folic acid
Folic acid 1 mg orally every day beginning at Week -6 until prior to the Week 52 Visit.
gout flare prophylaxis regimen
Prior to beginning the Pegloticase + IMM Period, participants must have been taking at least 1 protocol-standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day) for ≥ 1 week before the first dose of pegloticase and to continue flare prophylaxis per American College of Rheumatology guidelines \[Khanna D et al. 2012\] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA \< 6 mg/dL) for participants with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA \< 5 mg/dL) for participants with one or more tophi detected on initial physical exam that then resolved.
fexofenadine
For IR prophylaxis, fexofenadine (180 mg orally) taken the day before each infusion and on the morning of each infusion.
acetaminophen
For IR prophylaxis, acetaminophen (1000 mg orally) taken the morning of each infusion.
methylprednisolone
For IR prophylaxis, methylprednisolone (125 mg IV) given over an infusion duration between 10 - 30 minutes, immediately prior to each infusion.
Long Island Arthritis & Osteoporosis Care, Babylon
Buffalo Rheumatology and Medicine, Orchard Park
Altoona Center for Clinical Research, Duncansville
MD Medical Research, Oxon Hill
The Center for Rheumatology and Bone Research, Wheaton
Medication Management, LLC, Greensboro
NorthEast Rheumatology/Atrium Health, Concord
NorthEast Rheumatology, Concord
ClinEdge PMG Research of Salisbury, LLC, Salisbury
Shelby Clinical Research, LLC, Shelby
PMG Research of Wilmington, LLC, Wilmington
ClinEdge PMG Research of Hickory, LLC, Hickory
Articularis Healthcare Group, Summerville
Piedmont Arthritis Clinic, Greenville
Avail Clinical Research, DeLand
Omega Research Maitland, Orlando
Napa Research Center, Pompano Beach
Prohealth Research Center, Doral
Florida Medical Clinic, LLC, Zephyrhills
GCP Clinical Research, Tampa
DMI Research, Pinellas Park
University of Alabama, Birmingham
Ramesh C. Gupta, M.D., Memphis
West Tennessee Research Institute, Jackson
Clinical Research Source Inc., Perrysburg
Paramount Medical Research & Consulting, LLC, Middleburg Heights
Premier Clinical/STAT Research - Springboro, Springboro
Premier Clinical/STAT Research, Dayton
Clinical Research Institute of Michigan, LLC, Saint Clair Shores
Infusion Associates, Grand Rapids
Rheumatic Disease Center, Glendale
Benefis Hospital, Great Falls
Physician Research Collaboration, LLC, Lincoln
Applied Research Center of Arkansas, Inc, Little Rock
Arthritis & Osteoporosis Clinic - Waco, Waco
Diagnostic and Interventional Nephrology Of Houston, Houston
Research Consultants - Frostwood, Houston
Research Consultants - Astoria, Houston
Clear Lake Specialties, Webster
Arthritis Clinic of Central Texas, San Marcos
University of Colorado Division of Rheumatology, Aurora
Denver Arthritis Clinic, Denver
St. Luke's Clinic - Rheumatology, Meridian
Arizona Arthritis and Rheumatology Research, PLLC-East, Mesa
Arizona Arthritis and Rheumatology Research, PLLC-West, Glendale
Arizona Arthritis and Rheumatology Research, PLLC - Flagstaff, Flagstaff
Santa Fe Rheumatology, Santa Fe
Axis Clinical Trials, Los Angeles
Advanced Investigative Medicine, Inc., Hawthorne
Providence St. John's Health Clinic, Santa Monica
Medvin Clinical Research, Tujunga
San Fernando Valley Health Institute, Van Nuys
TriWest Research Associates, El Cajon
ACRC Studies, Poway
Ventura Clinical Trials, Ventura
East Bay Rheumatology Medical Group, Inc., San Leandro
ClinEdge Sierra Rheumatology, Inc., Roseville
Western Washington Arthritis Clinic, Bothell
Arthritis Northwest, Spokane
Orthopedic Physicians Alaska, Anchorage
Lead Sponsor
Amgen
INDUSTRY