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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006021-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen Biotech, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.
This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP015K | Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peficitinib | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by recording of adverse events and clinical laboratory evaluations | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US3218 | Birmingham | Alabama | 35216 | United States | ||
| Site US828 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31410787 | Derived | Genovese MC, Greenwald MW, Gutierrez-Urena SR, Cardiel MH, Poiley JE, Zubrzycka-Sienkiewicz A, Codding CE, Wang A, He W, Amos R, Vinueza R, Wang X, Garg JP, Kivitz AJ. Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study. Rheumatol Ther. 2019 Dec;6(4):503-520. doi: 10.1007/s40744-019-00167-6. Epub 2019 Aug 13. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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| La Jolla |
| California |
| 92093-0943 |
| United States |
| Site US3227 | Palm Desert | California | 92260 | United States |
| Site US219 | Palo Alto | California | 94304 | United States |
| Site US3332 | Santa Maria | California | 93454 | United States |
| Site US3331 | Colorado Springs | Colorado | 80920 | United States |
| Site US1894 | Jacksonville | Florida | 32216 | United States |
| Site US3232 | Orlando | Florida | 32804 | United States |
| Site US702 | Morton Grove | Illinois | 60053 | United States |
| Site US3226 | Vernon Hills | Illinois | 60061 | United States |
| Site US3329 | Elizabethtown | Kentucky | 42701 | United States |
| Site US291 | Wheaton | Maryland | 20902 | United States |
| Site US3298 | Hickory | North Carolina | 28602 | United States |
| Site US3300 | Oklahoma City | Oklahoma | 73103 | United States |
| Site US345 | Duncansville | Pennsylvania | 16635 | United States |
| Site US3304 | Wyomissing | Pennsylvania | 19610 | United States |
| Site US3306 | Knoxville | Tennessee | 37909 | United States |
| Site US3319 | Austin | Texas | 78705 | United States |
| Site US3327 | Chesapeake | Virginia | 23320 | United States |
| Site US3320 | Clarksburg | West Virginia | 26301 | United States |
| Site BE3387 | Brussels | 1070 | Belgium |
| Site BE3314 | Brussels | 1190 | Belgium |
| Site BG3613 | Burgas | 8000 | Bulgaria |
| Site BG3217 | Plovdiv | 4003 | Bulgaria |
| Site BG3303 | Sofia | 1612 | Bulgaria |
| Site CO3326 | Barranquilla, Atlantico | Colombia |
| Site CO3297 | Bogotá | Colombia |
| Site CO2826 | Bucamaranga | Colombia |
| Site CO3450 | Bucaramanga | Colombia |
| Site CO3451 | Cali | Colombia |
| Site CZ3388 | Prague | 128 50 | Czechia |
| Site CZ3376 | Praha-Nusle | 140 00 | Czechia |
| Site CZ3225 | Uherské Hradiště | 68601 | Czechia |
| Site CZ3449 | Zlín | 760 01 | Czechia |
| Site HU3461 | Balatonfüred | 8230 | Hungary |
| Site HU3398 | Békéscsaba | 5600 | Hungary |
| Site HU3302 | Budapest | 1027 | Hungary |
| Site HU3448 | Budapest | 1027 | Hungary |
| Site HU3462 | Budapest | 1027 | Hungary |
| Site HU3447 | Debrecen | H-4043 | Hungary |
| Site MX3238 | Guadalajara | 44650 | Mexico |
| Site MX3307 | Guadalajara, Jalisco | 44280 | Mexico |
| Site MX3310 | México | 6700 | Mexico |
| Site MX3317 | Morelia | 58070 | Mexico |
| Site PL3233 | Bialystok | Polska | 15-351 | Poland |
| Site PL3391 | Bialystok | 15-879 | Poland |
| Site PL2893 | Bydgoszcz | 85-168 | Poland |
| Site PL3603 | Krakow | 31-637 | Poland |
| Site PL3601 | Lublin | 20-582 | Poland |
| Site PL3600 | Warsaw | 02-118 | Poland |
| Site PL3599 | Warsaw | 02-653 | Poland |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
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