Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762498
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2021-02-12
Brief Title:
A Phase 4 Open-label Study of KRYSTEXXA Pegloticase Co-administered With Methotrexate MTX in Patients With Uncontrolled Gout FORWARD OL
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 4 Open-Label Multicenter Efficacy Safety Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA Pegloticase Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout FORWARD Open-Label OL Trial
Status:
COMPLETED
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:
FORWARD OL
Brief Summary:
This trial is to assess efficacy safety blood levels and bodily effects of up to 2 dose levels of intravenous IV pegloticase KRYSTEXXA infusions at every 4 week intervals Q4 Weeks for up to 6 months Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration when given in combination with weekly oral doses of methotrexate MTX The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy
Detailed Description:
The primary objective is to choose a dose for further investigation by assessing the effect of up to 2 dose levels of pegloticase administered IV Q4 weeks co-administered with weekly doses of oral MTX as measured by the sustained normalization of serum uric acid sUA to 6 mgdL for at least 80 of the time during Month 6 and the duration of sUA to 6 mgdL over 24 week treatment period in adult participants with chronic gout refractory to conventional therapy
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