At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7 enrolled
Drug / intervention
pegloticase 8 mg i.v.drug
Likely dose
pegloticase 8 mg i.v.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
In Brief
A Phase 3 clinical trial evaluating pegloticase 8 mg i.v. for Chronic Gout Refractory to Conventional Therapy. Completed, enrolled 7 participants across 4 sites.
Detailed Summary
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry. This study is limited to four study centers in the US.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedMay 2008
Primary CompletionJan 2009
Study CompletionApr 2009
TodayJul 2026
First PostedMay 8, 2008
Enrollment StartMay 1, 2008
Primary CompletionJan 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.2 years ago
Interventions
pegloticase 8 mg i.v.drug
pegloticase 8 mg i.v. every 2 weeks for 24 weeks