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

  • STATUS
    Not Recruiting
  • End date
    Feb 20, 2022
  • participants needed
    135
  • sponsor
    Horizon Therapeutics Ireland DAC
Updated on 14 April 2021
Uric Acid Test
arthritis
hyperuricemia
pegloticase
xanthine oxidase inhibitor

Summary

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.

Description

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.

Details
Condition Arthritis, Gout, 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 on14 April 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note