NCT04762498

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy.

Detailed description

The primary objective is to choose a dose for further investigation by assessing the effect of up to 2 dose levels of pegloticase administered IV Q4 weeks, co-administered with weekly doses of oral MTX, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6 and the duration of sUA to \< 6 mg/dL over 24 week treatment period in adult participants with chronic gout refractory to conventional therapy. Acquired from Horizon in 2024.

Conditions

• Uncontrolled Gout
• Chronic Gout

Interventions

Type	Name	Description
BIOLOGICAL	Pegloticase	IV dose of pegloticase q4 weeks co-administered with weekly oral methotrexate
DRUG	Methotrexate (MTX)	15 mg oral dose methotrexate administered weekly

Timeline

• Start date: 2021-01-26
• Primary completion: 2023-05-18
• Completion: 2023-12-20
• First posted: 2021-02-21
• Last updated: 2025-10-01

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study