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NCT01356498 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
A Phase 3 study of Gout, sponsored by Savient Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT01356498: Completed Phase 3 study of Gout, sponsored by Savient Pharmaceuticals.
NCT01356498 is a Phase 3 study of Gout that has completed, run by Savient Pharmaceuticals. The registered enrollment target is 151 participants, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01356498, a Phase 3 study of Gout, has completed, sponsored by Savient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.
Primary Outcome
Uric acid measured at 3 month-intervals
Conditions Studied
Interventions
- BIOLOGICAL pegloticase
Study Locations (20)
Ohio
- New Horizons Clinical Research - Cincinnati
- The Ohio State University - Columbus
- STAT Research, Inc. - Dayton
- David R. Mandel, MD, Inc. - Mayfield Village
California
- Kaiser Permanente Medical Center, Clinical Trials Unit - San Francisco
- Pacific Arthritis Center Medical Group - Santa Maria
- Agilence Arthritis & Osteoporosis Medical Center - Whittier
Florida
- Arthritis & Rheumatic Disease Specialties - Aventura
- Ocala Rheumatology Research Center - Ocala
- St. Petersburg Arthritis Center - St. Petersburg
Maryland
- Peter A. Holt, M.D. - Baltimore
- Center for Rheumatology and Bone Research - Wheaton
District of Columbia
- Veterans Affairs Medical Center - Washington D.C.
Illinois
- The University of Chicago - Chicago
Kentucky
- Graves Gilbert Clinic - Bowling Green
Michigan
- Justus J. Fiechtner, MD, PC - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT01356498 record still lists
NCT01356498 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 1 intervention - of which pegloticase is the first listed.
NCT01356498 names 20 study sites across 12 states, led by Ohio, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01356498 about?
NCT01356498 is a clinical study titled "Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout". This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies ...
What is the current status of trial NCT01356498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2006-12. Estimated completion is 2010-01.
What conditions does trial NCT01356498 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT01356498?
The interventions under investigation include: pegloticase (BIOLOGICAL).
Who is sponsoring clinical trial NCT01356498?
This trial is sponsored by Savient Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01356498 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01356498's enrollment target sits among peer trials
151 14th of 34 higher than 21 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of Dotinurad Versus Allopurinol in Participants With Gout
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Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
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Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
COMPLETED · Phase 3
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-
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
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