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This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR882 50 mg | Experimental | AR882 50 mg taken once daily for 12 months |
|
| AR882 75 mg | Experimental | AR882 75 mg taken once daily for 12 months |
|
| Placebo | Placebo Comparator | AR882 matching placebo taken once daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR882 50 mg | Drug | Solid Oral Capsule |
| |
| AR882 75 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 | Comparison of the treatment groups for the 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 12 | Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method |
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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 (620) | Birmingham | Alabama | 35215 | United States | ||
| Arthrosi Investigative Site (616) |
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| Drug |
Solid Oral Capsule |
|
| Placebo | Drug | Matching Solid Oral Capsule Placebo |
|
| 48 weeks |
| Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12 | 12 weeks |
| No gout flares from the end of month 9 to the end of month 12 | Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12 | 12 weeks |
| Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence | 56 weeks |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Arthrosi Investigative Site (680) | Peoria | Arizona | 85381 | United States |
| Arthrosi Investigative Site (640) | Phoenix | Arizona | 85018 | United States |
| Arthrosi Investigative Site (617) | Little Rock | Arkansas | 72205 | United States |
| Arthrosi Investigative Site (614) | Garden Grove | California | 92844 | United States |
| Arthrosi Investigative Site (618) | La Mesa | California | 91942 | United States |
| Arthrosi Investigative Site (687) | La Mesa | California | 91942 | United States |
| Arthrosi Investigative Site (655) | La Palma | California | 90623 | United States |
| Arthrosi Investigative Site (632) | Lincoln | California | 95648 | United States |
| Arthrosi Investigative Site (605) | Lomita | California | 90717 | United States |
| Arthrosi Investigative Site (675) | Long Beach | California | 90806 | United States |
| Arthrosi Investigative Site (603) | Santa Monica | California | 90404 | United States |
| Arthrosi Investigative Site (672) | Tarzana | California | 91356 | United States |
| Arthrosi Investigative Site (656) | Thousand Oaks | California | 91360 | United States |
| Arthrosi Investigative Site (660) | Aurora | Colorado | 80012 | United States |
| Arthrosi Investigative Site (669) | Colorado Springs | Colorado | 80909 | United States |
| Arthrosi Investigative Site (612) | Fort Collins | Colorado | 80528 | United States |
| Arthrosi Investigative Site (665) | Cooper City | Florida | 33024 | United States |
| Arthrosi Investigative Site (613) | Jupiter | Florida | 33458 | United States |
| Arthrosi Investigative Site (611) | Miami | Florida | 33173 | United States |
| Arthrosi Investigative Site (644) | Miami | Florida | 33176 | United States |
| Arthrosi Investigative Site (694) | Palmetto Bay | Florida | 33157 | United States |
| Arthrosi Investigative Site (615) | Sanford | Florida | 32771 | United States |
| Arthrosi Investigative Site (600) | Tampa | Florida | 33609 | United States |
| Arthrosi Investigative Site (673) | Atlanta | Georgia | 30329 | United States |
| Arthrosi Investigative Site (652) | Marietta | Georgia | 30060 | United States |
| Arthrosi Investigative Site (658) | Honolulu | Hawaii | 96814 | United States |
| Arthrosi Investigative Site (676) | Boise | Idaho | 83713 | United States |
| Arthrosi Investigative Site (634) | Meridian | Idaho | 83642 | United States |
| Arthrosi Investigative Site (657) | Chicago | Illinois | 60602 | United States |
| Arthrosi Investigative Site (648) | Melrose Park | Illinois | 60160 | United States |
| Arthrosi Investigative Site (678) | Indianapolis | Indiana | 46202 | United States |
| Arthrosi Investigative Site (679) | Overland Park | Kansas | 66209 | United States |
| Arthrosi Investigative Site (674) | Louisville | Kentucky | 40205 | United States |
| Arthrosi Investigative Site (627) | Mandeville | Louisiana | 70471 | United States |
| Arthrosi Investigative Site (650) | New Orleans | Louisiana | 70115 | United States |
| Arthrosi Investigative Site (641) | Prairieville | Louisiana | 70769 | United States |
| Arthrosi Investigative Site (662) | Oxon Hill | Maryland | 20745 | United States |
| Arthrosi Investigative Site (653) | Rockville | Maryland | 20852 | United States |
| Arthrosi Investigative Site (636) | Fall River | Massachusetts | 02721 | United States |
| Arthrosi Investigative Site (628) | Farmington Hills | Michigan | 48334 | United States |
| Arthrosi Investigative Site (645) | Southfield | Michigan | 48076 | United States |
| Arthrosi Investigative Site (633) | Gulfport | Mississippi | 39503 | United States |
| Arthrosi Investigative Site (635) | Jackson | Mississippi | 39202 | United States |
| Arthrosi Investigative Site (693) | Olive Branch | Mississippi | 38654 | United States |
| Arthrosi Investigative Site (637) | Springfield | Missouri | 65807 | United States |
| Arthrosi Investigative Site (626) | Town and Country | Missouri | 63017 | United States |
| Arthrosi Investigative Site (664) | Missoula | Montana | 59808 | United States |
| Arthrosi Investigative Site (610) | Lincoln | Nebraska | 68516 | United States |
| Arthrosi Investigative Site (684) | Omaha | Nebraska | 68114 | United States |
| Arthrosi Investigative Site (651) | Omaha | Nebraska | 68144 | United States |
| Arthrosi Investigative Site (686) | Las Vegas | Nevada | 89102 | United States |
| Arthrosi Investigative Site (661) | Brooklyn | New York | 11215 | United States |
| Arthrosi Investigative Site (663) | Hartsdale | New York | 10530 | United States |
| Arthrosi Investigative Site (625) | Charlotte | North Carolina | 28207 | United States |
| Arthrosi Investigative Site (681) | Charlotte | North Carolina | 28277 | United States |
| Arthrosi Investigative Site (683) | Raleigh | North Carolina | 27607 | United States |
| Arthrosi Investigative Site (649) | Shelby | North Carolina | 28150 | United States |
| Arthrosi Investigative Site (666) | Fargo | North Dakota | 58104 | United States |
| Arthrosi Investigative Site (671) | Mason | Ohio | 45040 | United States |
| Arthrosi Investigative Site (631) | Norman | Oklahoma | 73072 | United States |
| Arthrosi Investigative Site (642) | Tulsa | Oklahoma | 74133 | United States |
| Arthrosi Investigative Site (647) | Horsham | Pennsylvania | 19044 | United States |
| Arthrosi Investigative Site (623) | Philadelphia | Pennsylvania | 19107 | United States |
| Arthrosi Investigative Site (638) | Charleston | South Carolina | 29407 | United States |
| Arthrosi Investigative Site (604) | Fort Mill | South Carolina | 29707 | United States |
| Arthrosi Investigative Site (608) | North Charleston | South Carolina | 29405 | United States |
| Arthrosi Investigative Site (619) | Chattanooga | Tennessee | 37404 | United States |
| Arthrosi Investigative Site (624) | Hendersonville | Tennessee | 37075 | United States |
| Arthrosi Investigative Site (670) | Amarillo | Texas | 79106 | United States |
| Arthrosi Investigative Site (677) | Austin | Texas | 78735 | United States |
| Arthrosi Investigative Site (639) | DeSoto | Texas | 75115 | United States |
| Arthrosi Investigative Site (601) | Houston | Texas | 77074 | United States |
| Arthrosi Investigative Site (688) | Plano | Texas | 75024 | United States |
| Arthrosi Investigative Site (689) | Prosper | Texas | 75078 | United States |
| Arthrosi Investigative Site (646) | Tomball | Texas | 77375 | United States |
| Arthrosi Investigative Site (659) | Tomball | Texas | 77375 | United States |
| Arthrosi Investigative Site (643) | Clinton | Utah | 84015 | United States |
| Arthrosi Investigative Site (609) | Salt Lake City | Utah | 84121 | United States |
| Arthrosi Investigative Site (654) | Salt Lake City | Utah | 84124 | United States |
| Arthrosi Investigative Site (685) | Bellevue | Washington | 98004 | United States |
| Arthrosi Investigative Site (668) | Kenosha | Wisconsin | 53144 | 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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