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Completed Phase 4 Interventional Results available

Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout

ClinicalTrials.gov ID: NCT03635957

Public ClinicalTrials.gov record NCT03635957. 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 Jul 23, 2026, 1:45 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 Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Open-Label [OL])

Study identification

NCT ID
NCT03635957
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Amgen
Industry
Enrollment
14 participants

Conditions and interventions

Conditions

Interventions

  • Pegloticase Biological
  • Methotrexate (MTX) Drug
  • Standard Gout Flare Prophylaxis Drug
  • Infusion Reaction (IR) Prophylaxis Drug
  • Folic Acid Dietary Supplement

Biological · Drug · Dietary Supplement

Eligibility (public fields only)

Age range
18 Years to 65 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
Sep 25, 2018
Primary completion
Oct 22, 2019
Completion
Oct 25, 2020
Last update posted
Jun 25, 2024

2018 – 2020

United States locations

U.S. sites
6
U.S. states
4
U.S. cities
6
Facility City State ZIP Site status
Orthopedic Physicians Alaska Anchorage Alaska 99508
Arizona Arthritis & Rheumatology -West Valley Glendale Arizona 85306
Arizona Arthritis & Rheumatology -East Valley Mesa Arizona 85210
Avail Clinical Research DeLand Florida 32720
Western Washington Arthritis Clinic 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 NCT03635957, 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 Jun 25, 2024 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03635957 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →