Arthritis, Rheumatoid Clinical Trial
Official title:
A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
| Verified date | May 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 611 |
| Est. completion date | March 25, 2016 |
| Est. primary completion date | March 25, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid Arthritis studies within the previous 14 days. - Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation Exclusion Criteria: - Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety - Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study - Subject is scheduled to receive a prohibited medication - Subject has a planned major surgery - Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study - Subject has out of range laboratory values within 14 days of the Day 1 study dosing - Absolute lymphocyte count (ALC) < 500/mm3 - Creatine Phosphokinase (CPK) > 1.5 x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Site BE3314 | Brussels | |
| Belgium | Site BE3387 | Brussels | |
| Bulgaria | Site BG3613 | Burgas | |
| Bulgaria | Site BG3217 | Plovdiv | |
| Bulgaria | Site BG3303 | Sofia | |
| Colombia | Site CO3326 | Barranquilla, Atlantico | |
| Colombia | Site CO3297 | Bogota | |
| Colombia | Site CO2826 | Bucamaranga | |
| Colombia | Site CO3450 | Bucaramanga | |
| Colombia | Site CO3451 | Cali | |
| Czechia | Site CZ3388 | Praha 2 | |
| Czechia | Site CZ3376 | Praha-Nusle | |
| Czechia | Site CZ3225 | Uherske Hradiste | |
| Czechia | Site CZ3449 | Zlin | |
| Hungary | Site HU3461 | Balatonfüred | |
| Hungary | Site HU3398 | Bekescsaba | |
| Hungary | Site HU3302 | Budapest | |
| Hungary | Site HU3448 | Budapest | |
| Hungary | Site HU3462 | Budapest | |
| Hungary | Site HU3447 | Debrecen | |
| Mexico | Site MX3238 | Guadalajara | |
| Mexico | Site MX3307 | Guadalajara, Jalisco | |
| Mexico | Site MX3310 | Mexico | |
| Mexico | Site MX3317 | Morelia | |
| Poland | Site PL3233 | Bialystok | Polska |
| Poland | Site PL3391 | Bialystok | |
| Poland | Site PL2893 | Bydgoszcz | |
| Poland | Site PL3603 | Krakow | |
| Poland | Site PL3601 | Lublin | |
| Poland | Site PL3599 | Warszawa | |
| Poland | Site PL3600 | Warszawa | |
| United States | Site US3319 | Austin | Texas |
| United States | Site US3218 | Birmingham | Alabama |
| United States | Site US3327 | Chesapeake | Virginia |
| United States | Site US3320 | Clarksburg | West Virginia |
| United States | Site US3331 | Colorado Springs | Colorado |
| United States | Site US345 | Duncansville | Pennsylvania |
| United States | Site US3329 | Elizabethtown | Kentucky |
| United States | Site US3298 | Hickory | North Carolina |
| United States | Site US1894 | Jacksonville | Florida |
| United States | Site US3306 | Knoxville | Tennessee |
| United States | Site US828 | La Jolla | California |
| United States | Site US702 | Morton Grove | Illinois |
| United States | Site US3300 | Oklahoma City | Oklahoma |
| United States | Site US3232 | Orlando | Florida |
| United States | Site US3227 | Palm Desert | California |
| United States | Site US219 | Palo Alto | California |
| United States | Site US3332 | Santa Maria | California |
| United States | Site US3226 | Vernon Hills | Illinois |
| United States | Site US291 | Wheaton | Maryland |
| United States | Site US3304 | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Global Development, Inc. | Janssen Biotech, Inc. |
United States, Belgium, Bulgaria, Colombia, Czechia, Hungary, Mexico, Poland,
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|---|---|---|---|---|
| Primary | Safety assessed by recording of adverse events and clinical laboratory evaluations | 2 years |
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