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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pegloticase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegloticase 8 mg i.v. | Drug | pegloticase 8 mg i.v. every 2 weeks for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Profile | Number of participants reporting events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago- Dept. Biological Services | Chicago | Illinois | 60637 | United States | ||
| The Center for Rheumatology and Bone Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegloticase 8 mg Every 2 Wks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegloticase 8 mg Every 2 Wks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Event Profile | Number of participants reporting events | Posted | Number | Number of participants | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pegloticase 8 mg Every 2 Wks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion-Related Reaction | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Savient Pharmaceuticals, Inc. | 732-418-9300 |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C031545 | Pegloticase |
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| Wheaton |
| Maryland |
| 20902 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Portland Rheumatology Clinic, L.L.C. | Lake Oswego | Oregon | 97035 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | ITT population | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 3 and Week 7 |
|
|
|
| 2 |
| 7 |
| 7 |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gout (flare) | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Nausea | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Diabete Mellitus Non-Insulin Dependent | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| New Tophus | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Wound Drainage | Surgical and medical procedures | MedDRA (9.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Title |
|---|
| Measurements |
|---|
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