The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects
Subjects will take ASP015K or matching placebo orally with food for 12 weeks after randomization. Potential subjects who have previously used disease-modifying antirheumatic drugs (DMARDs) and/or biologic agents may be eligible to participate after completing a washout period. Subjects who complete the 12-week dosing period in this study may be eligible to participate in a long-term, open-label Extension Study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
289
oral
oral
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response
Time frame: Week 12
Trough plasma concentration of ASP015K and metabolite(s)
Time frame: up to Week 12 (6 time points)
Percentage of subjects achieving ACR 50 response
Time frame: Week 12
Percentage of subjects achieving ACR 70 response
Time frame: Week 12
Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP)
Time frame: Baseline and Week 12
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
University of California San Diego
La Jolla, California, United States
Desert Medical Advances
Palm Desert, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Arthritis Associates
Orlando, Florida, United States
Illinois Bone & Joint Institute; LLC
Morton Grove, Illinois, United States
Deerbrook Medical Asssociates
Vernon Hills, Illinois, United States
...and 28 more locations