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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 28 Feb 2025

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At a glance

  • Drugs Methotrexate (Primary) ; Pegloticase (Primary)
  • Indications Gout; Gouty arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms MIRROR RCT
  • Sponsors Amgen
  • Most Recent Events

    • 01 Jul 2024 Results assessing dual-energy CT (DECT) findings during pegloticase treatment in a larger number of patients from a randomized controlled trial to confirm bone-erosion remodeling that follows MSU depletion with pegloticase published in the Joint Bone Spine.
    • 15 Nov 2023 Results of analysis assessing potential baseline factors that may influence urate-lowering response to pegloticas using data from Phase 3 pegloticase registration and MIRROR RCT2 trials presented at the ACR Convergence 2023
    • 15 Nov 2023 Results of post-hoc pooled analysis of C0405, C0406, MIRROR OL and MIRROR RCT trials assessing cardiovascular /thromboembolic events after pegloticase initiation, presented at the ACR Convergence 2023.

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