The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).
Subjects in each treatment group will continue to take their concomitant oral weekly dose of methotrexate (MTX) in addition to daily ASP015K or matching placebo, taken orally with food, daily for 12 weeks after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
379
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
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
The Talbert Group
Huntington Beach, California, United States
University of California San Diego
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Pacific Arthritis Center Medical Group
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Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, United States
Arthritis Associates
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Illinois Bone & Joint
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Center for Arthritis and Osteoporosis
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