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
Start Date
2/9/2026
Completion Date
6/18/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pegloticase
Methotrexate
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Orthopedic Physicians Alaska
Anchorage, Alaska 99508
United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates
Chula Vista, California 91910
United States
Solace Clinical Research
Tustin, California 92780
United States
Denver Arthritis Clinic PC
Denver, Colorado 80230
United States
D and H Pompano Research Center
Aventura, Florida 33180
United States
Bay Pines Veterans Affairs Healthcare System
Bay Pines, Florida 33744
United States
Hillcrest Medical Research
DeLand, Florida 32720
United States
New Generation of Medical Research
Hialeah, Florida 33016
United States
Homestead Associates In Research Inc
Homestead, Florida 33033
United States
Pharmax Research Clinic
Miami, Florida 33126
United States
Well Pharma Medical Research Corp
Miami, Florida 33143
United States
D and H National Research Centers
Miami, Florida 33155
United States
Advanced Clinical Research
Miami, Florida 33156
United States
Entrust Clinical Research
Miami, Florida 33176
United States
Felicidad Medical Research
Miami, Florida 33184
United States
Decision Management International Research
Pinellas Park, Florida 33782
United States
Integral Rheumatology and Immunology Specialists
Plantation, Florida 33324
United States
D and H Tamarac Research Center
Tamarac, Florida 33321
United States
Nodal Medical Center Research
Tampa, Florida 33607
United States
GCP Clinical Research, LLC
Tampa, Florida 33609
United States
ClinPro Research Solutions LLC
Tampa, Florida 33613
United States
Conquest Research - Winter Park
Winter Park, Florida 32789
United States
Spatium Urgent Care
Marietta, Georgia 30066
United States
Vista Clinical Research
Newnan, Georgia 30265
United States
Charter Research
Chicago, Illinois 60618
United States
Flourish Research Ravenswood
Chicago, Illinois 60640
United States
Greater Chicago Specialty Physicians
Schaumburg, Illinois 60195
United States
Willow Rheumatology and Wellness
Willowbrook, Illinois 60527
United States
Mandeville Private Physicians Group
Mandeville, Louisiana 70471
United States
Kur Research at Columbia Medical Practice
Columbia, Maryland 21045
United States
MD Medical Research
Oxon Hill, Maryland 20745
United States
Raymond G Murphy Veteran Affairs Medical Center
Albuquerque, New Mexico 87108
United States
Buffalo Rheumatology and Medicine
Orchard Park, New York 14127
United States
Joint and Muscle Research Institute
Charlotte, North Carolina 28204
United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina 28211
United States
Research Carolina Elite
Denver, North Carolina 28037
United States
Triad Clinical Trials, LLC
Greensboro, North Carolina 27410
United States
Cape Fear Arthritis Care, PLLC
Leland, North Carolina 28451
United States
Accellacare Salisbury
Salisbury, North Carolina 28144
United States
Carolina Research Center Inc
Shelby, North Carolina 28150
United States
Shelby Clinical Research
Shelby, North Carolina 28150
United States
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio 44130
United States
Lynn Health Science Institute
Oklahoma City, Oklahoma 73111
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United States
Articularis Healthcare Group Inc dba Low Country Rheumatology
Summerville, South Carolina 29486
United States
Southwest Rheumatology
Dallas, Texas 75230
United States
Research Physicians Network, LLC
Houston, Texas 77089
United States
Pioneer Research Solutions Inc
Houston, Texas 77099
United States
Texas Arthritis & Rheumatology Associates
Katy, Texas 77450
United States
Biopharma Informatic, LLC
Katy, Texas 77494
United States
Epic Clinical Research
Lewisville, Texas 75057
United States
Be Well Clinical Studies
Round Rock, Texas 78681
United States
Siena Research Network
Sugar Land, Texas 77479
United States
Overlake Arthritis and Osteoperosis Center
Bellevue, Washington 98004
United States
Arthritis Northwest Professional Limited Liability Company
Spokane, Washington 99204
United States
Caribbean Health Research Center
San Juan, 00917
Puerto Rico