The primary purpose of this study is to assess the percentage of participants achieving an American College of Rheumatology (ACR) 20 percent (%) Improvement (ACR20) response at Week 12 of the administration of the investigational product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Administered as oral tablets.
Eisai site #11
Anyang-si, South Korea
Eisai site #01
Busan, South Korea
Eisai site #09
Daegu, South Korea
Percentage of Participants Achieving ACR20 Response at Week 12
Time frame: At Week 12
Percentage of Participants Achieving Disease Activity Score for 28 (DAS28) C-reactive Protein (CRP) Less Than or Equal to (<=) 3.2 at Weeks 12 and 24
Time frame: At Weeks 12 and 24
Change From Baseline in DAS28 (CRP) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Percentage of Participants Achieving DAS28 (CRP) Less Than (<) 2.6 at Weeks 12 and 24
Time frame: At Weeks 12 and 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Percentage of Participants Achieving an ACR20 Response at Week 24
Time frame: At Week 24
Percentage of Participants Achieving an ACR50 and ACR70 Responses at Weeks 12 and 24
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving an ACR20, ACR50 and ACR70 Responses at Week 12 and Week 24 Depending on the Prior Treatment Therapy
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving an ACR20, ACR50 and ACR70 Responses at Weeks 12 and 24 Depending on Monotherapy With the Investigational Product and Combination Therapy With Methotrexate (MTX)
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving an ACR20 Response at Week 12 Depending on Demographic Characteristics
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Eisai site #12
Daegu, South Korea
Eisai site #06
Daejeon, South Korea
Eisai site #15
Guri-si, South Korea
Eisai site #02
Gwangju, South Korea
Eisai site #13
Incheon, South Korea
Eisai site #03
Seoul, South Korea
Eisai site #04
Seoul, South Korea
...and 5 more locations
Time frame: At Weeks 12
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 28 weeks