Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229145
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-01-19
Brief Title:
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks Q4W With MTX Compared With Every 2 Weeks Q2W With MTX in Participants With Uncontrolled Refractory Gout
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 4 Randomized Double-blind Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA Pegloticase Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate Followed by an Open-label Extension in Participants With Uncontrolled Refractory Gout FORWARD II
Status:
RECRUITING
Status Verified Date:
2024-10
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 study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX followed by a 24-week open-label extension of pegloticase Q4W with MTX in participants with uncontrolled refractory gout
The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX on the response rate during Month 6 as measured by the sustained normalization of sUA to 6 mgdL for at least 80 of the time
The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX on the response rate during Month 6 as measured by the sustained normalization of sUA to 6 mgdL for at least 80 of the time
Detailed Description:
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