A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

May 18, 2023

Study Completion Date

December 20, 2023

Conditions
Uncontrolled GoutChronic Gout
Interventions
BIOLOGICAL

Pegloticase

IV dose of pegloticase q4 weeks co-administered with weekly oral methotrexate

DRUG

Methotrexate (MTX)

15 mg oral dose methotrexate administered weekly

Trial Locations (12)

16635

Altoona Center for Clinical Research, Duncansville

20902

The Center for Rheumatology and Bone Research, Wheaton

28150

Shelby Clinical Research, LLC, Shelby

33064

Napa Research Center, Pompano Beach

GCP Clinical Research, Tampa

33166

ProHealth Research Center, Doral

77043

Biopharma Informatic, LLC, Houston

85306

Arizona Arthritis & Rheumatology Research, PLLC, Glendale

94578

East Bay Rheumatology Medical Group, Inc., San Leandro

98021

Arthritis Clinic: Western Washington Medical Group, Bothell

99204

Arthritis Northwest PLLC, Spokane

99508

Orthopedic Physicians Alaska, Anchorage

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY