Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325195
Status:
COMPLETED
Last Update Posted:
2011-02-28
First Post:
2006-05-10
Brief Title:
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
Sponsor:
Savient Pharmaceuticals
Organization:
Savient Pharmaceuticals
Study Overview
Official Title:
Randomized Multicenter Double-blind Placebo-controlled Efficacy and Safety Study of 8 mg PEG-uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Status:
COMPLETED
Status Verified Date:
2011-02
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:
These are two replicate studies to evaluate the safety and efficacy of PEG polyethylene glycol-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies or for whom those therapies have been unsuccessful in controlling their uric acid level
Detailed Description:
The primary objective of each of the studies is to demonstrate superiority in the response rate control of uric acid levels to below 6 mgdL in the PEG-uricase treatment groups compared to the placebo-control group
While reduction or resolution of tophi have been reported in the setting of prolonged urate-lowering therapy there is photographic and additional anecdotal evidence from the Phase 2 PEG-uricase study of resolution or significant reduction of tophi after 3 months of therapy Therefore an assessment of changes in tophi over time will be conducted through the use of digital photographs obtained in a standardized manner from all subjects during the study The effect on other clinical outcomes including quality of life health-related disability measures gout flares and the number of swollen and tender joints will also be compared between the treatment groups and control group Subjects will be randomized to one of the three treatment arms in a 221 ratio 8 mg PEG-uricase every 2 weeks 8 mg PEG-uricase every 4 weeks or placebo All subjects will receive an intravenous infusion PEG-uricase or placebo every two weeks in order to maintain the blind throughout the study Study duration is approximately 26 weeks including two weeks for screening and 24 weeks 6 months of treatment
While reduction or resolution of tophi have been reported in the setting of prolonged urate-lowering therapy there is photographic and additional anecdotal evidence from the Phase 2 PEG-uricase study of resolution or significant reduction of tophi after 3 months of therapy Therefore an assessment of changes in tophi over time will be conducted through the use of digital photographs obtained in a standardized manner from all subjects during the study The effect on other clinical outcomes including quality of life health-related disability measures gout flares and the number of swollen and tender joints will also be compared between the treatment groups and control group Subjects will be randomized to one of the three treatment arms in a 221 ratio 8 mg PEG-uricase every 2 weeks 8 mg PEG-uricase every 4 weeks or placebo All subjects will receive an intravenous infusion PEG-uricase or placebo every two weeks in order to maintain the blind throughout the study Study duration is approximately 26 weeks including two weeks for screening and 24 weeks 6 months of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None