This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks.
This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, dose-finding, monotherapy, multi-center study with once daily oral ASP015K or matching placebo in subjects with moderate to severe RA, with or without prior antirheumatic medication, and regardless of responsiveness to the medication. The study is comprised of up to a 4-week Screening period, a 12-week Treatment period and a 4-week Follow-up period. Subjects in each treatment group will take ASP015K or matching placebo orally, once daily, after breakfast for 12 weeks after the screening period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
281
oral
oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response
Time frame: 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
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and clinical labo-tests
Time frame: During 12-week treatment period and 4-week follow-up period
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Unnamed facility
Kyushu, Japan
Unnamed facility
Tōhoku, Japan