Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Savient Pharmaceuticals |
---|---|
Information provided by: | Savient Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00325195 |
These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.
Condition | Intervention | Phase |
---|---|---|
Gout |
Other: placebo Biological: pegloticase |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of 8 mg PEG-Uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout |
Estimated Enrollment: | 212 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
8 mg pegloticase every 2 weeks
|
Biological: pegloticase
8 mg pegloticase by intravenous infusion
|
2: Experimental
8 mg pegloticase every 4 weeks (alternating with placebo every 4 weeks)
|
Biological: pegloticase
8 mg pegloticase by intravenous infusion
|
3: Placebo Comparator
placebo every 2 weeks
|
Other: placebo
placebo by intravenous infusion every 2 weeks
|
The primary objective of each of the studies is to demonstrate superiority in the response rate (control of uric acid levels to below 6 mg/dL) in the PEG-uricase treatment groups compared to the placebo-control group.
While reduction or resolution of tophi have been reported in the setting of prolonged urate-lowering therapy, there is photographic and additional anecdotal evidence from the Phase 2 PEG-uricase study of resolution or significant reduction of tophi after 3 months of therapy. Therefore, an assessment of changes in tophi over time will be conducted through the use of digital photographs obtained in a standardized manner from all subjects during the study. The effect on other clinical outcomes, including quality of life, health-related disability measures, gout flares and the number of swollen and tender joints will also be compared between the treatment groups and control group. Subjects will be randomized to one of the three treatment arms in a 2:2:1 ratio: 8 mg PEG-uricase every 2 weeks; 8 mg PEG-uricase every 4 weeks; or placebo. All subjects will receive an intravenous infusion (PEG-uricase or placebo) every two weeks in order to maintain the blind throughout the study. Study duration is approximately 26 weeks, including two weeks for screening and 24 weeks (6 months) of treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Savient Pharmaceuticals, Inc ( Savient Pharmaceuticals, Inc ) |
Study ID Numbers: | C0405 & C0406 |
Study First Received: | May 10, 2006 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00325195 |
Health Authority: | United States: Food and Drug Administration |
Metabolism, Inborn Errors Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis |
Hyperuricemia Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout |
Pathologic Processes |