At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 191 enrolled
Drug / intervention
Pegloticase with MTXbiological
Likely dose
Not stated in 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.
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
In Brief
A Phase 4 clinical trial evaluating Pegloticase with MTX for Chronic Uncontrolled Gout and 2 related conditions. Completed, enrolled 191 participants across 39 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Uncontrolled Gout, Gout, Uncontrolled Gout
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartOct 2020
Primary CompletionJan 2024
Study CompletionMar 2024
TodayJul 2026
First PostedAug 13, 2020
Enrollment StartOct 2, 2020
Primary CompletionJan 18, 2024
Study CompletionMar 25, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.9 years ago
Interventions
Pegloticase with MTXbiological
Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period