A 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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

March 18, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

April 9, 2026

Conditions
Gout
Interventions
BIOLOGICAL

Pegloticase

IV infusion

DRUG

Methotrexate

Oral

Trial Locations (74)

13850

Velocity Clinical Research-Vestal, Vestal

16635

Altoona Center for Clinical Research, Duncansville

27410

Triad Clinical Trials - Gastroenterology, Greensboro

28037

Research Carolina Elite, Denver

28152

Shelby Clinical Research - Family Medicine, Shelby

28226

OnSite Clinical Solutions, LLC, Charlotte

28602

Accellacare of Hickory, Hickory

29615

Velocity Clinical Research, Spartanburg - Pulmonology, Greenville

29732

Premier Clinics Pa - Rock Hill, Sc, Rock Hill

30265

Vista Clinical Research, LLC, Newnan

30501

Arthritis Center of North Georgia, Gainesville

33064

D&H Pompano Research Center, Pompano Beach

33155

D&H National Research Centers, Inc., Miami

33166

Prohealth Research Center, Doral

33173

Well Pharma, Miami

33184

Felicidad Medical Research, LLC., Miami

33321

D&H Tamarac Research Center, Tamarac

33324

IRIS Research & Development, Plantation

33609

GCP Clinical Research, Tampa

33613

ClinPro Research Solutions, LLC, Tampa

34104

New Generation Of Medical Research, Naples

35233

The University of Alabama at Birmingham (UAB), Birmingham

40213

L-MARC Research Center, Louisville

44122

Velocity Clinical Research - Cleveland, Cleveland

45242

Velocity Clinical Research- Cincinatti, Cincinnati

47150

Lake Cumberland Rheumatology, PLLC, New Albany

48081

Clinical Research Institute of Michigan, LLC, Saint Clair Shores

48109

Michigan Medicine, Ann Arbor

48911

June DO,PC, Lansing

60035

Great Lakes Clinical Trials - Gurnee, Highland Park

60521

Crowley CORE - Illinois Bone and Joint Institute, Hinsdale

60625

Great Lakes Clin. Trials, Chicago

60637

Conquest Research - Anesthesiology/Pain Medicine, Chicago

70433

Velocity CR - New Orleans, Covington

75093

AIM Trials - Internal Medicine, Plano

77061

Synergy Groups Medical LLC, Houston

77099

Pioneer Research Solutions, Inc., Houston

77479

Texas Research Center, Sugar Land

78229

Clinical Trials of Texas, Inc., San Antonio

78750

Clinical Trial Network, Austin

79124

Amarillo Center for Clinical Research, Ltd., Amarillo

80045

University of Colorado Denver, Aurora

80230

Denver Arthritis Clinic - Rheumatology, Denver

80918

Lynn Institute of the Rockies, Colorado Springs

83642

Velocity Clinical Research - Boise - ERN - PPDS, North Hollywood

84088

Velocity Clinical Research - Salt Lake City (West Jordan), West Jordan

85032

Arizona Arthritis & Rheumatology Research, PLLC, Mesa

85037

Arizona Arthritis and Rheumatology Research, Phoenix

85210

Arizona Arthritis and Rheumatology Research, PLLC, Mesa

85297

Arizona Arthritis & Rheumatology Research, PLLC, Gilbert

85351

Arizona Arthritis & Rheumatology Research, PLLC, Sun City

85704

Arizona Arthritis and Rheumatology, Tucson

86001

Arizona Arthritis and Rheumatology Rese, Flagstaff

87505

Inspire Santa Fe Medical Group, Santa Fe

90404

Saint John's Health Center - Providence St John's Health Ctr, Santa Monica

90602

Medvin Clinical Research, Whittier

91042

Foothill Arthritis, Tujunga

91722

Covina Arthritis Clinic, Covina

92108

TriWest Research Associates, San Diego

92543

Medvin Clinical Research- Riverside, Hemet

92592

C.V. Mehta MD Medical Corporation, Temecula

99204

Arthritis Northwest, PLLC - Research, Spokane

99508-5234

Orthopedic Physicians Alaska - Rheumatology and Infusion, Anchorage

85225-2915

Arizona Arthritis and Rheumatology Associates - Chandler, Chandler

85037-4403

Arizona Arthritis and Rheumatology Research, PLLC, Phoenix

94578-2630

Precision Comprehensive Clinical Research Solutions, San Leandro

33180-1204

Arthritis & Rheumatic Disease, Aventura

33063-5675

Life Clinical Trials, Margate

33032-8225

Homestead Associates in Research,Inc, Miami

70121-2429

Velocity CR - New Orleans, New Orleans

28451-4168

Cape Fear Arthritis Care, Leland

73111-3324

Lynn Health Science Institute, Oklahoma City

29486-7887

Low Country Rheumatology, Summerville

23703-3200

Velocity Clinical Research-Portsmouth, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT06229145 - A 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 | Biotech Hunter | Biotech Hunter