Study of KRYSTEXXA (Pegloticase) Plus Methotrexate in Patients With Uncontrolled Gout

    Not Recruiting
  • participants needed
  • sponsor
    Horizon Therapeutics Ireland DAC
Updated on 20 May 2022
Uric Acid Test
xanthine oxidase inhibitor


Approximately 135 participants will be randomized. Study duration will be approximately 86 weeks.

The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with MTX to pegloticase co-administered with placebo for MTX in adults with uncontrolled gout.


This study is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of pegloticase with MTX vs. pegloticase with placebo for MTX in adult participants with uncontrolled gout.

Condition Arthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), Gout, Gout (Hyperuricemia), Arthritis and Arthritic Pain, Gout (Hyperuricemia), Arthritis and Arthritic Pain (Pediatric)
Treatment Pegloticase with MTX, Pegloticase with placebo for MTX
Clinical Study IdentifierNCT03994731
SponsorHorizon Therapeutics Ireland DAC
Last Modified on20 May 2022

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