A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
- Registration Number
- NCT01711814
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP015K peficitinib Experimental
- Primary Outcome Measures
Name Time Method Safety assessed by recording of adverse events and clinical laboratory evaluations 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Site BE3314
🇧🇪Brussels, Belgium
Site CO3297
🇨🇴Bogota, Colombia
Site PL3603
🇵🇱Krakow, Poland
Site CZ3449
🇨🇿Zlin, Czechia
Site US3232
🇺🇸Orlando, Florida, United States
Site US828
🇺🇸La Jolla, California, United States
Site US219
🇺🇸Palo Alto, California, United States
Site US702
🇺🇸Morton Grove, Illinois, United States
Site US345
🇺🇸Duncansville, Pennsylvania, United States
Site BG3217
🇧🇬Plovdiv, Bulgaria
Site BG3303
🇧🇬Sofia, Bulgaria
Site CO3326
🇨🇴Barranquilla, Atlantico, Colombia
Site HU3461
🇭🇺Balatonfüred, Hungary
Site CZ3388
🇨🇿Praha 2, Czechia
Site CZ3376
🇨🇿Praha-Nusle, Czechia
Site CZ3225
🇨🇿Uherske Hradiste, Czechia
Site HU3447
🇭🇺Debrecen, Hungary
Site PL3233
🇵🇱Bialystok, Polska, Poland
Site HU3448
🇭🇺Budapest, Hungary
Site US3227
🇺🇸Palm Desert, California, United States
Site US3332
🇺🇸Santa Maria, California, United States
Site US1894
🇺🇸Jacksonville, Florida, United States
Site US3331
🇺🇸Colorado Springs, Colorado, United States
Site US3226
🇺🇸Vernon Hills, Illinois, United States
Site US3329
🇺🇸Elizabethtown, Kentucky, United States
Site US291
🇺🇸Wheaton, Maryland, United States
Site US3298
🇺🇸Hickory, North Carolina, United States
Site US3304
🇺🇸Wyomissing, Pennsylvania, United States
Site US3300
🇺🇸Oklahoma City, Oklahoma, United States
Site US3319
🇺🇸Austin, Texas, United States
Site US3306
🇺🇸Knoxville, Tennessee, United States
Site US3327
🇺🇸Chesapeake, Virginia, United States
Site BE3387
🇧🇪Brussels, Belgium
Site US3320
🇺🇸Clarksburg, West Virginia, United States
Site BG3613
🇧🇬Burgas, Bulgaria
Site CO2826
🇨🇴Bucamaranga, Colombia
Site CO3451
🇨🇴Cali, Colombia
Site CO3450
🇨🇴Bucaramanga, Colombia
Site HU3302
🇭🇺Budapest, Hungary
Site HU3398
🇭🇺Bekescsaba, Hungary
Site HU3462
🇭🇺Budapest, Hungary
Site MX3238
🇲🇽Guadalajara, Mexico
Site MX3317
🇲🇽Morelia, Mexico
Site MX3307
🇲🇽Guadalajara, Jalisco, Mexico
Site MX3310
🇲🇽Mexico, Mexico
Site PL2893
🇵🇱Bydgoszcz, Poland
Site PL3391
🇵🇱Bialystok, Poland
Site PL3601
🇵🇱Lublin, Poland
Site PL3599
🇵🇱Warszawa, Poland
Site PL3600
🇵🇱Warszawa, Poland
Site US3218
🇺🇸Birmingham, Alabama, United States