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This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Allopurinol once daily for 24 weeks |
|
| Group 2 | Experimental | AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks |
|
| Group 3 | Experimental | AR882 Dose 1 + Allopurinol for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR882 Dose 1 | Drug | Solid Oral Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in tophus area at Months 3 and 6 | Comparison of the treatment groups for tophus area as measured by digital calipers | 12 weeks and 24 weeks |
| Change from baseline in tophus crystal volume at Months 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R Keenan, MD | Arthrosi Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthrosi Investigative Site (410) | Birmingham | Alabama | 35233 | United States | ||
| Arthrosi Investigative Site (403) |
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| AR882 Dose 2 |
| Drug |
Solid Oral Capsule |
|
| Allopurinol Tablet | Drug | Solid tablet |
|
Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
| 24 weeks |
| Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 | 12 weeks |
| Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 | 24 weeks |
| Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence. | 24 weeks |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Arthrosi Investigative Site (416) | Sun City | Arizona | 85351 | United States |
| Arthrosi Investigative Site (417) | Tucson | Arizona | 85704 | United States |
| Arthrosi Investigative Site (402) | Tampa | Florida | 33606 | United States |
| Arthrosi Investigative Site (404) | Boise | Idaho | 83713 | United States |
| Arthrosi Investigative Site (409) | Ann Arbor | Michigan | 48109 | United States |
| Arthrosi Investigative Site (406) | Greensboro | North Carolina | 27410 | United States |
| Arthrosi Investigative Site (408) | Myrtle Beach | South Carolina | 29577 | United States |
| Arthrosi Investigative Site (401) | Dallas | Texas | 75231 | United States |
| Arthrosi Investigative Site (201) | Auckland | 1023 | New Zealand |
| Arthrosi Investigative Site (303) | Taichung | 402 | Taiwan |
| 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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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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