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 US3218
🇺🇸Birmingham, Alabama, United States
Site US828
🇺🇸La Jolla, California, United States
Site US3227
🇺🇸Palm Desert, California, United States
Site US219
🇺🇸Palo Alto, California, United States
Site US3332
🇺🇸Santa Maria, California, United States
Site US3331
🇺🇸Colorado Springs, Colorado, United States
Site US1894
🇺🇸Jacksonville, Florida, United States
Site US3232
🇺🇸Orlando, Florida, United States
Site US702
🇺🇸Morton Grove, Illinois, United States
Site US3226
🇺🇸Vernon Hills, Illinois, United States
Scroll for more (41 remaining)Site US3218🇺🇸Birmingham, Alabama, United States