Chronic Gout Refractory to Conventional Therapy Clinical Trial
Official title:
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.
| Verified date | June 2011 |
| Source | Savient Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | April 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Previous treatment in studies of pegloticase i.v. - Last exposure to pegloticase i.v. greater than one year prior to study entry - Symptomatic gout - Documented hyperuricemic (SUA = 7 mg/dL) Exclusion Criteria: - Prior exposure to Elitek® (rasburicase) - Unstable angina - Uncontrolled arrhythmia or hypertension - Non-compensated congestive heart failure - End stage renal disease requiring dialysis - Concomitant use of SUA lowering agents and use of other investigational drugs |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Chicago- Dept. Biological Services | Chicago | Illinois |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Portland Rheumatology Clinic, L.L.C. | Lake Oswego | Oregon |
| United States | The Center for Rheumatology and Bone Research | Wheaton | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Savient Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse Event Profile | Number of participants reporting events | 6 months | Yes |
| Secondary | Mean Plasma Uric Acid | This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion. | Baseline, Week 3 and Week 7 | No |