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Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

NCT04511702 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2025-10-17

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.

Conditions

  • Chronic Uncontrolled Gout
  • Gout
  • Uncontrolled Gout

Interventions

BIOLOGICAL

Pegloticase with MTX

Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2024-01-18
Completion
2024-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511702 on ClinicalTrials.gov