The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Oral administration for 12 or 36 weeks
Oral administration for 12 or 36 weeks
Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)
Taiho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Proportion of participants achieving American College of Rheumatology 20% (ACR20) response
Time frame: Week 12
Proportion of participants who achieve ACR20 response
Time frame: Up to Week 36, except for Week 12
Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response
Time frame: Up to Week 36
Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission
Time frame: Baseline, Week 12
Change from baseline in DAS28-CRP and DAS28-ESR score
Time frame: Up to Week 36
Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission
Time frame: Baseline, Week 12
Change from baseline in CDAI and SDAI score
Time frame: Up to Week 36
Change from baseline in patient assessment score of arthritis pain
Time frame: Up to Week 36
Change from baseline in patient global assessment score of arthritis
Time frame: Up to Week 36
Change from baseline in physician's global assessment score of arthritis
Time frame: Up to Week 36
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Change from baseline in modified total sharp score
Time frame: Baseline, Week 2, 4, 12
Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels
Time frame: Up to Week 36
Change from baseline in rheumatoid factor levels
Time frame: Up to Week 36
Maximum observed plasma concentration for TAS5315
Time frame: Baseline, Week 2, 4, 12
Time to reach the maximum plasma concentration for TAS5315
Time frame: Baseline, Week 2, 4, 12
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315
Time frame: Baseline, Week 2, 4, 12
Incidence of adverse events and side effects as safety
Time frame: Up to Week 36