ClinicalTrials.gov record
Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT04762498

Public ClinicalTrials.gov record NCT04762498. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 1:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4, Open-Label, Multicenter, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout (FORWARD Open-Label [OL] Trial)

Study identification

NCT ID
NCT04762498
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Amgen
Industry
Enrollment
54 participants

Conditions and interventions

Interventions

  • Methotrexate (MTX) Drug
  • Pegloticase Biological

Drug · Biological

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 25, 2021
Primary completion
May 17, 2023
Completion
Dec 19, 2023
Last update posted
May 18, 2026

2021 – 2023

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Orthopedic Physicians Alaska Anchorage Alaska 99508
Arizona Arthritis & Rheumatology Research, PLLC Glendale Arizona 85306
East Bay Rheumatology Medical Group, Inc. San Leandro California 94578
ProHealth Research Center Doral Florida 33166
Napa Research Center Pompano Beach Florida 33064
GCP Clinical Research Tampa Florida 33064
The Center for Rheumatology and Bone Research Wheaton Maryland 20902
Shelby Clinical Research, LLC Shelby North Carolina 28150
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
Biopharma Informatic, LLC Houston Texas 77043
Arthritis Clinic: Western Washington Medical Group Bothell Washington 98021
Arthritis Northwest PLLC Spokane Washington 99204

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04762498, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 18, 2026 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04762498 live on ClinicalTrials.gov.

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