NCT04511702

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

A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 180 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study. Acquired from Horizon in 2024.

Conditions

• Chronic Uncontrolled Gout
• Gout
• Uncontrolled Gout

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-02
• Primary completion: 2024-01-18
• Completion: 2024-03-25
• First posted: 2020-08-13
• Last updated: 2025-10-20
• Results posted: 2025-01-07

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study