clinical trial · NCT03994731
Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
Amgen·phase4·completed·n = 152
GoutPegloticasemethotrexateplacebofolic acidgout flare prophylaxis regimenfexofenadineacetaminophenmethylprednisolone
brief summary
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.
started
Jun 13, 2019
primary completion
Mar 17, 2021
completion
Apr 11, 2022
last updated
Jun 26, 2024
detailed description
Study acquired from Horizon in 2024.
official title
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])
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol