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
    Not Recruiting
Updated on 22 June 2022

Summary

The purpose of this study is to obtain information on the safety, tolerability and effectiveness of administering an immunosuppressive therapy (Methotrexate) (MTX) in combination with KRYSTEXXA (also called pegloticase) to prevent immunogenicity against pegloticase, in adults with uncontrolled gout.
In the current study, MTX will be evaluated for its ability to reduce anti drug antibodies against pegloticase that lead to loss of response and that are associated with AEs including IRs. 
This may allow you to receive a longer course of therapy or repeated courses of therapy, as needed.
 

Description

  • 52wks
  • 36 visits
  • 26 Infusions Q2wks
  • Infusions are 4-5 hrs in length.

Details
Condition Gout (Hyperuricemia)
Clinical Study IdentifierTX230589
Last Modified on22 June 2022

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