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Enzyme Inhibitor

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

Phase 4

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3 and month 6 combined (weeks 10, 12, 14, 20, 22, and 24)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone in adults with uncontrolled gout.

Eligible Conditions

Gout

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3 and month 6 combined (weeks 10, 12, 14, 20, 22, and 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3 and month 6 combined (weeks 10, 12, 14, 20, 22, and 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 and month 6 combined (weeks 10, 12, 14, 20, 22, and 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Serum Uric Acid (sUA < 6 mg/dL) Responders During Month 6

Secondary study objectives

Mean Change in sUA From Pegloticase Baseline to Weeks 14, 24, 36, 52

Percentage of Serum Uric Acid (sUA < 5 mg/dL) Overall Responders

Percentage of Serum Uric Acid (sUA < 5 mg/dL) Responders During Month 3

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pegloticase With Methotrexate (MTX)Experimental Treatment5 Interventions

Run-In Period: oral MTX at a dose of 15 mg weekly for 4 weeks prior to the first dose of pegloticase. Pegloticase + Immunomodulator (IMM) Period: pegloticase 8 mg administered intravenously (IV) every 2 weeks from Day 1 through the Week 50 Visit for a total of 26 infusions. MTX 15 mg weekly on the same day each week, within 1 to 3 days prior to each pegloticase infusion and one additional weekly dose after the last infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Gout Flare Prophylaxis

2018

Completed Phase 4

~20

Infusion Reaction (IR) Prophylaxis

2018

Completed Phase 4

~20