Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511702
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2020-08-11
Brief Title:
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 4 Multicenter Open-Label Infusion Duration Study To Assess Safety Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate
Detailed Description:
Approximately 180 participants will be enrolled After a 4-week methotrexate run-in period participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions Up to three pegloticase infusion durations will be assessed in the study 60-minute infusion 45-minute infusion and 30-minute infusion Safety evaluations will be performed regularly throughout the course of the study
Acquired from Horizon in 2024
Acquired from Horizon in 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None