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

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Amgen

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Principal Investigator

Amgen

Eligibility Criteria

Inclusion Criteria

Willing and able to give informed consent.

Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.

Adult men or women ≥18 to ≤65 years of age.

See 5 more

Treatment Details

Interventions

Methotrexate (Antimetabolite)
Pegloticase (Enzyme Inhibitor)

Participant Groups

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.