Phase 3
Completed N=149
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Source: ClinicalTrials.gov NCT01356498 ↗Enrolled (actual)
149
Serious AEs
34.2%
Results posted
Dec 2011
Primary outcomePrimary: Uric Acid (mg/dL) — 1.33; 1.91; 5.06; 9.76 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uric Acid (mg/dL) |
1.33; 1.91; 5.06; 9.76; 9.66; 8.08 | — |
| SECONDARY Tophus Response |
19; 13; 10; 4; 7; 3 | — |
| SECONDARY Patient Reported Outcome: SF-36 Physical Component Summary Score |
34.92; 34.11; 27.55; 33.71; 32.8; 36.2 | — |
| SECONDARY Gout Flare Frequency |
0.4; 0.8; 2.3; 0.6; 1.3; 1.5 | — |
| SECONDARY Gout Flare Incidence |
25.7; 56.0; 65.2; 45.5; 67.9; 68.8 | — |
Eligibility Criteria
Inclusion Criteria
- Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout
Exclusion Criteria
- unstable angina
- uncontrolled arrhythmia
- uncontrolled hypertension
- end stage renal disease requiring dialysis
- anemia
Data sourced from ClinicalTrials.gov (NCT01356498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.