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

Purpose

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.

Condition

  • Uncontrolled Gout

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has provided informed consent before initiation of any trial-specific activities/procedures. - Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. - Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. - Participants with uncontrolled gout, as meeting the protocol defined criteria.

Exclusion Criteria

  • Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit). - Liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 1.25 x upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the screening visit. - Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) > 8%. - Known intolerance to MTX. - Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug. - A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone ≤ 10 mg/day or equivalent dose of other corticosteroid). - Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations < 40 mL/min/1.73 m^2 or currently on dialysis.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pegloticase SC with MTX 		Participants will receive pegloticase SC every two weeks with MTX.
  • Drug: Pegloticase
    Participants will receive pegloticase either SC or IV.
    Other names:
    • KRYSTEXXA
  • Drug: Methotrexate
    MTX will be administered orally.
    Other names:
    • MTX
Experimental
Pegloticase IV with MTX 		Participants will receive pegloticase IV every two weeks with MTX.
  • Drug: Pegloticase
    Participants will receive pegloticase either SC or IV.
    Other names:
    • KRYSTEXXA
  • Drug: Methotrexate
    MTX will be administered orally.
    Other names:
    • MTX

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

Orthopedic Physicians Alaska
Anchorage, Alaska 99508

Solace Clinical Research
Tustin, California 92780

Denver Arthritis Clinic PC
Denver, Colorado 80230

D and H Pompano Research Center
Aventura, Florida 33180

Bay Pines Veterans Affairs Healthcare System
Bay Pines, Florida 33744

Hillcrest Medical Research
DeLand, Florida 32720

New Generation of Medical Research
Hialeah, Florida 33016

Homestead Associates In Research Inc
Homestead, Florida 33033

Pharmax Research Clinic
Miami, Florida 33126

Well Pharma Medical Research Corp
Miami, Florida 33143

D and H National Research Centers
Miami, Florida 33155

Advanced Clinical Research
Miami, Florida 33156

Entrust Clinical Research
Miami, Florida 33176

Felicidad Medical Research
Miami, Florida 33184

Decision Management International Research
Pinellas Park, Florida 33782

Integral Rheumatology and Immunology Specialists
Plantation, Florida 33324

D and H Tamarac Research Center
Tamarac, Florida 33321

Nodal Medical Center Research
Tampa, Florida 33607

GCP Clinical Research, LLC
Tampa, Florida 33609

ClinPro Research Solutions LLC
Tampa, Florida 33613

Conquest Research - Winter Park
Winter Park, Florida 32789

Spatium Urgent Care
Marietta, Georgia 30066

Vista Clinical Research
Newnan, Georgia 30265

Charter Research
Chicago, Illinois 60618

Flourish Research Ravenswood
Chicago, Illinois 60640

Greater Chicago Specialty Physicians
Schaumburg, Illinois 60195

Willow Rheumatology and Wellness
Willowbrook, Illinois 60527

Mandeville Private Physicians Group
Mandeville, Louisiana 70471

Kur Research at Columbia Medical Practice
Columbia, Maryland 21045

MD Medical Research
Oxon Hill, Maryland 20745

Raymond G Murphy Veteran Affairs Medical Center
Albuquerque, New Mexico 87108

Buffalo Rheumatology and Medicine
Orchard Park, New York 14127

Joint and Muscle Research Institute
Charlotte, North Carolina 28204

Onsite Clinical Solutions, LLC
Charlotte, North Carolina 28211

Research Carolina Elite
Denver, North Carolina 28037

Triad Clinical Trials, LLC
Greensboro, North Carolina 27410

Cape Fear Arthritis Care, PLLC
Leland, North Carolina 28451

Accellacare Salisbury
Salisbury, North Carolina 28144

Carolina Research Center Inc
Shelby, North Carolina 28150

Shelby Clinical Research
Shelby, North Carolina 28150

Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio 44130

Lynn Health Science Institute
Oklahoma City, Oklahoma 73111

Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635

Articularis Healthcare Group Inc dba Low Country Rheumatology
Summerville, South Carolina 29486

Research Physicians Network, LLC
Houston, Texas 77089

Pioneer Research Solutions Inc
Houston, Texas 77099

Biopharma Informatic, LLC
Katy, Texas 77494

Epic Clinical Research
Lewisville, Texas 75057

Be Well Clinical Studies
Round Rock, Texas 78681

Overlake Arthritis and Osteoperosis Center
Bellevue, Washington 98004

Arthritis Northwest Professional Limited Liability Company
Spokane, Washington 99204

Caribbean Health Research Center
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com