Pegloticase + Methotrexate for Gout

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must be taking: Methotrexate

Must not be taking: Recombinant uricase

Disqualifiers: G6PD deficiency, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, 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.

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for individuals with uncontrolled gout. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided in the information given.

Inclusion Criteria

I am willing and able to follow the trial's treatment and check-up plan.

Participant has provided informed consent before initiation of any trial-specific activities/procedures

I am at least 18 years old or the legal age in my country.

Exclusion Criteria

Known intolerance to MTX

I do not have a G6PD deficiency.

My liver enzyme levels are higher than normal or my albumin is below normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pegloticase with methotrexate every two weeks, either subcutaneously or intravenously

24 weeks

Bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pegloticase

Trial Overview

The study is testing the effectiveness of pegloticase administered subcutaneously (under the skin) versus intravenously (through a vein), both combined with methotrexate, on maintaining normal uric acid levels in people with gout over six months.

How Is the Trial Designed?

Group I: Pegloticase SC with MTX Experimental Treatment 2 Interventions

Participants will receive pegloticase SC every two weeks with MTX.

Group II: Pegloticase IV with MTX Experimental Treatment 2 Interventions

Participants will receive pegloticase IV every two weeks with MTX.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London