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An open label phase 3 study
Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TILD q12 weeks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TILD sub-cutaneous (SC) injection | Drug | 1 mL injection of study medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and intensity of Adverse Events (AEs) recorded through the study period | Week 124 | |
| Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | ACR20 response is an aggregate of: 1. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments:
| Week 124 |
| Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50 | ACR50 response is an aggregate of: 1. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments:
| Week 124 |
| Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70 | ACR70 response is an aggregate of: 1. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments:
| Week 124 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunpharma site no 50 | Dothan | Alabama | 36305 | United States | ||
| Sunpharma site no 80 |
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| Gilbert |
| Arizona |
| 85297 |
| United States |
| Sunpharma site no 65 | Mesa | Arizona | 85210 | United States |
| Sunpharma site no 105 | Phoenix | Arizona | 85032 | United States |
| Sunpharma site no. 30 | Covina | California | 91722 | United States |
| Sunpharma site no 110 | Encino | California | 91436 | United States |
| Sunpharma site no. 17 | Fountain Valley | California | 92708 | United States |
| Sunpharma site no. 15 | Thousand Oaks | California | 91320 | United States |
| Sunpharma site no 113 | Avon Park | Florida | 33825 | United States |
| Sunpharma site no. 21 | Clearwater | Florida | 33765 | United States |
| Sunpharma site no. 02 | Hialeah | Florida | 33016 | United States |
| Sunpharma site no 71 | Kissimmee | Florida | 34744 | United States |
| Sunpharma site no 107 | Margate | Florida | 33063 | United States |
| Sunpharma site no. 05 | New Port Richey | Florida | 34652 | United States |
| Sunpharma site no 32 | Ocoee | Florida | 34751 | United States |
| SunPharma Site no 22 | Tamarac | Florida | 33321 | United States |
| Sunpharma site no 52 | Gainesville | Georgia | 30501 | United States |
| Sunpharma site no 51 | Orland Park | Illinois | 60467 | United States |
| Sunpharma site no 49 | Schaumburg | Illinois | 60195 | United States |
| Sunpharma site no 47 | Skokie | Illinois | 60076 | United States |
| Sunpharma site no. 20 | Wichita | Kansas | 67207 | United States |
| Sunpharma site no. 14 | Springfield | Missouri | 65807 | United States |
| Sunpharma site no 104 | St Louis | Missouri | 63119 | United States |
| Sunpharma site no 48 | Kalispell | Montana | 59901 | United States |
| Sunpharma Site no 27 | Lincoln | Nebraska | 68516 | United States |
| Sunpharma site no 33 | Voorhees Township | New Jersey | 08043 | United States |
| Sunpharma site no 34 | Charlotte | North Carolina | 28204 | United States |
| Sunpharma site no 111 | Leland | North Carolina | 28451 | United States |
| Sunpharma site no 53 | Wilmington | North Carolina | 28401 | United States |
| Sunpharma site no 35 | Minot | North Dakota | 58701 | United States |
| Sunpharma site no. 11 | Middleburg Heights | Ohio | 44130 | United States |
| Sunpharma site no 31 | Greenville | South Carolina | 29601 | United States |
| Sunpharma site no. 08 | Baytown | Texas | 77521 | United States |
| Sunpharma site no. 13 | Baytown | Texas | 77521 | United States |
| Sunpharma Site no 28 | Lubbock | Texas | 79410 | United States |
| Sunpharma site no 109 | Mesquite | Texas | 75150 | United States |
| Sunpharma site no. 03 | San Antonio | Texas | 78229 | United States |
| Sunpharma site no. 16 | San Antonio | Texas | 78229 | United States |
| Sunpharma site no. 01 | Tomball | Texas | 77375 | United States |
| Sunpharma site no 96 | Salt Lake City | Utah | 84132 | United States |
| Sunpharma site no 66 | Spokane | Washington | 99204 | United States |
| Sunpharma site no 59 | Phillip | Australian Capital Territory | 2606 | Australia |
| Sunpharma site no 58 | Maroochydore | Queensland | 4558 | Australia |
| Sunpharma site no. 24 | Hobart | Tasmania | 7000 | Australia |
| Sunpharma site no 95 | Trois-Rivières | G9A 3X2 | Canada |
| Sunpharma site no 36 | Brno | 638 00 | Czechia |
| Sunpharma site no 67 | Prague | 12800 | Czechia |
| Sunpharma site no 89 | Prague | 140 00 | Czechia |
| Sunpharma site no 82 | Zlín | 760 01 | Czechia |
| Sunpharma site no 44 | Tallinn | 10117 | Estonia |
| Sunpharma site no 39 | Tartu | 50106 | Estonia |
| Sunpharma site no 40 | Tartu | 50708 | Estonia |
| Sunpharma site no 37 | Berlin | 12161 | Germany |
| Sunpharma site no 83 | Herne | 44649 | Germany |
| Sunpharma site no 92 | Surat | Gujarat | 395010 | India |
| Sunpharma site no 101 | Belagavi | Karnataka | 590016 | India |
| Sunpharma site no 91 | Hubli | Karnataka | 580021 | India |
| Sunpharma site no 108 | Pune | Maharashtra | 411004 | India |
| Sunpharma site no 100 | Bangalore | Tamil Nadu | 560010 | India |
| Sunpharma site no 93 | Chennai | Tamil Nadu | 600004 | India |
| Sunpharma site no 103 | Chennai | Tamil Nadu | 600086 | India |
| Sunpharma site no 114 | Pune | 411007 | India |
| Sunpharma site no 102 | Secunderabad | 500003 | India |
| Sunpharma site no 94 | Sevilla | 41014 | India |
| Sunpharma site no 90 | Verona | 37134 | Italy |
| Sunpharma site no 73 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Sunpharma site no 45 | Fukuoka | 802-8561 | Japan |
| Sunpharma site no 84 | Itabashi-ku | 173-8606 | Japan |
| Sunpharma site no 46 | Kumamoto | 860-8556 | Japan |
| Sunpharma site no 72 | Mitaka | 181-8611 | Japan |
| Sunpharma site no 79 | Miyazaki | 889-1692 | Japan |
| Sunpharma site no 64 | Sendai | 545-8586 | Japan |
| Sunpharma site no 63 | Sendai | 980-8574 | Japan |
| Sunpharma site no 87 | Tsu | Japan |
| Sunpharma site no 43 | Bialystok | 15-351 | Poland |
| Sunpharma site no 69 | Bialystok | 15-879 | Poland |
| Sunpharma site no 56 | Krakow | 30-033 | Poland |
| Sunpharma site no 81 | Lublin | 20-607 | Poland |
| Sunpharma site no 55 | Nadarzyn | 05-830 | Poland |
| Sunpharma site no 106 | Olsztyn | Poland |
| Sunpharma site no 68 | Poznan | 61-113 | Poland |
| Sunpharma site no 60 | Torun | 87-100 | Poland |
| Sunpharma site no 61 | Warsaw | 02-118 | Poland |
| Sunpharma site no 112 | Wroclaw | 52-416 | Poland |
| Sunpharma site no 74 | Martin | 036 01 | Slovakia |
| Sunpharma site no 42 | Nové Mesto nad Váhom | 915 01 | Slovakia |
| Sunpharma site no 70 | Seoul | 3080 | South Korea |
| Sunpharma site no 57 | A Coruña | 15006 | Spain |
| SunPharma Site No 23 | Córdoba | 14004 | Spain |
| Sunpharma site no 38 | Córdoba | 14004 | Spain |
| Sunpharma site no 86 | Málaga | 29009 | Spain |
| Sunpharma site no 88 | Santiago de Compostela | 15706 | Spain |
| Sunpharma site no 62 | Seville | 41013 | Spain |
| Sunpharma site no 97 | Valencia | 46010 | Spain |
| Sunpharma site no 76 | Kaohsiung City | 833 | Taiwan |
| Sunpharma site no 54 | Taichung | 402 | Taiwan |
| Sunpharma site no 99 | Taichung | 40705 | Taiwan |
| Sunpharma site no 75 | Tainan | 710 | Taiwan |
| Sunpharma site no 77 | Taipei | 112 | Taiwan |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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