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This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR882 75 mg + XOI | Experimental | AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR882 75 mg | Drug | Solid Oral Capsule |
| |
| XOI Low Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 | Proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tophus burden by month 6 | Change in tophus burden by measurement of targeted tophi area at Month 6 | 24 weeks |
| Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Keenan, MD | Arthrosi Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthrosi Investigative Site (105) | Margate | Florida | 33063 | United States | ||
| Arthrosi Investigative Site (102) |
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| Drug |
Solid Oral Tablet |
|
| XOI High Dose | Drug | Solid Oral Tablet |
|
| 56 weeks |
| Miami |
| Florida |
| 33155 |
| United States |
| Arthrosi Investigative Site (109) | Tampa | Florida | 33609 | United States |
| Arthrosi Investigative Site (106) | Jackson | Mississippi | 39202 | United States |
| Arthrosi Investigative Site (108) | Charlotte | North Carolina | 28202 | United States |
| Arthrosi Investigative Site (103) | Duncansville | Pennsylvania | 16635 | United States |
| Arthrosi Investigative Site (104) | West Lake Hills | Texas | 78746 | United States |
| Arthrosi Investigative Site (107) | Bellevue | Washington | 98004 | United States |
| ID | Term |
|---|---|
| D006073 | Gout |
| D015210 | Arthritis, Gouty |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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