A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Peficitinib

Registration Number: NCT01638013

Lead Sponsor: Astellas Pharma Inc

Brief Summary: This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.

Detailed Description: This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K \[015K-CL-RAJ1 (hereinafter referred to as study RAJ1)\], Phase III Study of ASP015K \[015K-CL-RAJ3 (RAJ3)\], or Phase III Study of ASP015K \[015K-CL-RAJ4 (RAJ4)\]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study".

Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy.

The duration of treatment with the study drug was differed depending upon the participants.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 843

Inclusion Criteria

Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria

There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants who completed 015K-CL-RAJ1	Peficitinib	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Participants who completed 015K-CL-RAJ3	Peficitinib	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Participants who completed 015K-CL-RAJ4	Peficitinib	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Baseline up to end of study (EOS) (up to week 376)	AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an ACR70-CRP Response Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Percentage of Participants With an ACR50-ESR Response Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT.
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	Higher CRP indicates greater disease activity.
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	Higher ESR indicates greater disease activity.
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in this outcome measure.
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in the outcome measure.
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Percentage of Participants With an ACR50-CRP Response Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission, DAS28-ESR \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity.
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission.
Percentage of Participants With an ACR70-ESR Response Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission, DAS28-CRP \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity.
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372	Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Number of Participants Who Withdrew Due to Lack of Efficacy	Baseline up to week 372	Participants who discontinued due to lack of efficacy have been reported.
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission.
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3.
Change From Baseline of Preceding Study in SDAI Score Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372	Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8.
Change From Baseline of Preceding Study CDAI Score Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOS	FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue.
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. Negative values indicate improvement from baseline.
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372	Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Change From Baseline of Preceding Study in HAQ-DI Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly.
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372	Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS	The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372	Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372	Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372	Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372	Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372	Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.

Trial Locations

Locations (175): JP00131
🇯🇵
Fukuoka, Japan
JP00164
🇯🇵
Fukuoka, Japan
JP00176
🇯🇵
Fukui, Japan
JP00146
🇯🇵
Suita, Osaka, Japan
JP00066
🇯🇵
Okazaki, Aichi, Japan
JP00037
🇯🇵
Nagoya, Aichi, Japan
JP00136
🇯🇵
Itami, Hyogo, Japan
JP00138
🇯🇵
Yotsukaido, Chiba, Japan
JP00109
🇯🇵
Nagoya, Aichi, Japan
JP00075
🇯🇵
Ureshino, Saga, Japan
JP00140
🇯🇵
Toyoake, Aichi, Japan
JP00170
🇯🇵
Toyohashi, Aichi, Japan
JP00094
🇯🇵
Kashihara, Nara, Japan
JP00011
🇯🇵
Hannan, Osaka, Japan
JP00033
🇯🇵
Takasaki, Gunma, Japan
JP00002
🇯🇵
Sapporo, Hokkaido, Japan
JP00031
🇯🇵
Sapporo, Hokkaido, Japan
JP00181
🇯🇵
Hitachinaka, Ibaraki, Japan
JP00153
🇯🇵
Sasebo, Nagasaki, Japan
JP00169
🇯🇵
Osaki, Miyagi, Japan
JP00090
🇯🇵
Hakodate, Hokkaido, Japan
JP00105
🇯🇵
Sendai, Miyagi, Japan
JP00004
🇯🇵
Sendai, Miyagi, Japan
JP00027
🇯🇵
Sendai, Miyagi, Japan
JP00158
🇯🇵
Sapporo, Hokkaido, Japan
JP00137
🇯🇵
Sakai, Osaka, Japan
JP00019
🇯🇵
Koshi, Kumamoto, Japan
JP00012
🇯🇵
Kobe, Hyogo, Japan
JP00057
🇯🇵
Tamana, Kumamoto, Japan
JP00141
🇯🇵
Sagamihara, Kanagawa, Japan
JP00086
🇯🇵
Suita, Osaka, Japan
JP00060
🇯🇵
Kawagoe, Saitama, Japan
JP00062
🇯🇵
Kawaguchi, Saitama, Japan
JP00052
🇯🇵
Sayama, Saitama, Japan
JP00129
🇯🇵
Matsumoto, Nagano, Japan
JP00161
🇯🇵
Kawagoe, Saitama, Japan
JP00077
🇯🇵
Kanuma, Tochigi, Japan
JP00133
🇯🇵
Kakegawa, Shizuoka, Japan
JP00021
🇯🇵
Sumida-ku, Tokyo, Japan
JP00035
🇯🇵
Fukuoka, Japan
JP00065
🇯🇵
Kagoshima, Japan
JP00159
🇯🇵
Kyoto, Japan
JP00010
🇯🇵
Takaoka, Toyama, Japan
JP00018
🇯🇵
Fukuoka, Japan
JP00020
🇯🇵
Fukuoka, Japan
JP00093
🇯🇵
Kochi, Japan
JP00112
🇯🇵
Nagasaki, Japan
JP00167
🇯🇵
Kagoshima, Japan
JP00046
🇯🇵
Kumamoto, Japan
JP00099
🇯🇵
Chiyoda-ku, Tokyo, Japan
JP00130
🇯🇵
Nagoya, Aichi, Japan
JP00156
🇯🇵
Toyota, Aichi, Japan
JP00068
🇯🇵
Yatomi, Aichi, Japan
JP00166
🇯🇵
Funabashi, Chiba, Japan
JP00108
🇯🇵
Toyohashi, Aichi, Japan
JP00180
🇯🇵
Asahi, Chiba, Japan
JP00040
🇯🇵
Kitakyushu, Fukuoka, Japan
JP00163
🇯🇵
Higashihiroshima, Hiroshima, Japan
JP00106
🇯🇵
Kurume, Fukuoka, Japan
JP00124
🇯🇵
Tomakomai, Hokaido, Japan
JP00168
🇯🇵
Yokkaichi, Mie, Japan
JP00151
🇯🇵
Sendai, Miyagi, Japan
JP00050
🇯🇵
Hyuga, Miyazaki, Japan
JP00162
🇯🇵
Isehaya, Nagasaki, Japan
JP00051
🇯🇵
Setouchi, Okayama, Japan
JP00064
🇯🇵
Beppu, Oita, Japan
JP00126
🇯🇵
Gyoda, Saitama, Japan
JP00007
🇯🇵
Hiki-gun, Saitama, Japan
JP00015
🇯🇵
Hiroshima, Japan
JP00076
🇯🇵
Fukuoka, Japan
JP00085
🇯🇵
Kyoto, Japan
JP00123
🇯🇵
Kyoto, Japan
JP00174
🇯🇵
Nagano, Japan
JP00032
🇯🇵
Shinjuku-ku, Tokyo, Japan
JP00165
🇯🇵
Fukushima, Japan
JP00175
🇯🇵
Nagoya, Aichi, Japan
JP00102
🇯🇵
Kamagaya, Chiba, Japan
JP00071
🇯🇵
Kurume, Fukuoka, Japan
JP00120
🇯🇵
Iizuka, Fukuoka, Japan
JP00115
🇯🇵
Narashino, Chiba, Japan
JP00026
🇯🇵
Asahikawa, Hokkaido, Japan
JP00125
🇯🇵
Kushiro, Hokkaido, Japan
JP00001
🇯🇵
Sapporo, Hokkaido, Japan
JP00003
🇯🇵
Sapporo, Hokkaido, Japan
JP00056
🇯🇵
Akashi, Hyogo, Japan
JP00069
🇯🇵
Himeji, Hyogo, Japan
JP00042
🇯🇵
Kobe, Hyogo, Japan
JP00041
🇯🇵
Kato, Hyogo, Japan
JP00154
🇯🇵
Kobe, Hyogo, Japan
JP00092
🇯🇵
Kobe, Hyogo, Japan
JP00117
🇯🇵
Nishinomiya, Hyogo, Japan
JP00073
🇯🇵
Koga, Ibaraki, Japan
JP00054
🇯🇵
Mito, Ibaraki, Japan
JP00039
🇯🇵
Tsukuba, Ibaraki, Japan
JP00034
🇯🇵
Komatsu, Ishikawa, Japan
JP00028
🇯🇵
Morioka, Iwate, Japan
JP00084
🇯🇵
Isehara, Kanagawa, Japan
JP00179
🇯🇵
Komatsu, Ishikawa, Japan
JP00088
🇯🇵
Kida-gun, Kagawa, Japan
JP00049
🇯🇵
Morioka, Iwate, Japan
JP00058
🇯🇵
Kawasaki, Kanagawa, Japan
JP00045
🇯🇵
Zushi, Kanagawa, Japan
JP00096
🇯🇵
Yokohama, Kanagawa, Japan
JP00036
🇯🇵
Sendai, Miyagi, Japan
JP00023
🇯🇵
Miyagi-gun, Miyagi, Japan
JP00078
🇯🇵
Kawachinagano, Osaka, Japan
JP00101
🇯🇵
Omura, Nagasaki, Japan
JP00103
🇯🇵
Omura, Nagasaki, Japan
JP00025
🇯🇵
Nagaoka, Niigata, Japan
JP00144
🇯🇵
Shibata, Niigata, Japan
JP00134
🇯🇵
Higashiosaka, Osaka, Japan
JP00070
🇯🇵
Suita, Osaka, Japan
JP00008
🇯🇵
Tokorozawa, Saitama, Japan
JP00145
🇯🇵
Shimotsuke, Tochigi, Japan
JP00149
🇯🇵
Bunkyo-ku, Tokyo, Japan
JP00152
🇯🇵
Bunkyo-ku, Tokyo, Japan
JP00095
🇯🇵
Chiyoda-ku, Tokyo, Japan
JP00142
🇯🇵
Chuo-ku, Tokyo, Japan
JP00053
🇯🇵
Kiyose, Tokyo, Japan
JP00063
🇯🇵
Hachioji, Tokyo, Japan
JP00072
🇯🇵
Meguro-ku, Tokyo, Japan
JP00083
🇯🇵
Meguro-ku, Tokyo, Japan
JP00100
🇯🇵
Setagaya-ku, Tokyo, Japan
JP00047
🇯🇵
Shunan, Yamaguchi, Japan
JP00155
🇯🇵
Nishimuro-gun, Wakayama, Japan
JP00104
🇯🇵
Shimonoseki, Yamaguchi, Japan
JP00148
🇯🇵
Ota-ku, Tokyo, Japan
JP00059
🇯🇵
Fukuoka, Japan
JP00013
🇯🇵
Hiroshima, Japan
JP00014
🇯🇵
Hiroshima, Japan
JP00022
🇯🇵
Kumamoto, Japan
JP00122
🇯🇵
Miyazaki, Japan
JP00080
🇯🇵
Nagano, Japan
JP00006
🇯🇵
Niigata, Japan
JP00017
🇯🇵
Oita, Japan
JP00098
🇯🇵
Nagasaki, Japan
JP00147
🇯🇵
Nagasaki, Japan
JP00118
🇯🇵
Okayama, Japan
JP00044
🇯🇵
Shizuoka, Japan
JP00150
🇯🇵
Osaka, Japan
JP00157
🇯🇵
Osaka, Japan
JP00009
🇯🇵
Toyama, Japan
JP00089
🇯🇵
Shizuoka, Japan
JP00135
🇯🇵
Shizuoka, Japan
KR00505
🇰🇷
Gwangju, Korea, Republic of
KR00504
🇰🇷
Daegu, Korea, Republic of
KR00506
🇰🇷
Incheon, Korea, Republic of
JP00139
🇯🇵
Toyama, Japan
KR00508
🇰🇷
Jeonju, Korea, Republic of
KR00501
🇰🇷
Seoul, Korea, Republic of
KR00511
🇰🇷
Seoul, Korea, Republic of
TW00709
🇨🇳
Kaohsiung, Taiwan
TW00712
🇨🇳
Tainan, Taiwan
TW00701
🇨🇳
Taipei, Taiwan
TW00702
🇨🇳
Taipei, Taiwan
TW00703
🇨🇳
Taoyuan, Taiwan
JP00119
🇯🇵
Kitakyushu, Fukuoka, Japan
JP00114
🇯🇵
Sapporo, Hokkaido, Japan
JP00172
🇯🇵
Kitami, Hokkaido, Japan
JP00171
🇯🇵
Kobe, Hyogo, Japan
KR00509
🇰🇷
Seoul, Korea, Republic of
JP00055
🇯🇵
Hiroshima, Japan
JP00038
🇯🇵
Sapporo, Hokkaido, Japan
JP00016
🇯🇵
Hiroshima, Japan
KR00502
🇰🇷
Seoul, Korea, Republic of
JP00107
🇯🇵
Hitachi, Ibaraki, Japan
JP00074
🇯🇵
Kagoshima, Japan
JP00061
🇯🇵
Toyonaka, Osaka, Japan
KR00507
🇰🇷
Suwon, Korea, Republic of
TW00711
🇨🇳
Taipei, Taiwan
JP00043
🇯🇵
Bunkyo-ku, Tokyo, Japan
JP00024
🇯🇵
Bunkyo-ku, Tokyo, Japan
JP00081
🇯🇵
Shibuya-ku, Tokyo, Japan
TW00710
🇨🇳
Taichung, Taiwan
JP00143
🇯🇵
Bunkyo-ku, Tokyo, Japan