Percentage of Participants With an ACR20-CRP Response Through Week 52
ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 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 or week 52.
Percentage of Participants With an ACR50-CRP Response at Week 12
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 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-CRP Response Through Week 52
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 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 ACR70-CRP Response at Week 12
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 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 ACR70-CRP Response Through Week 52
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 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 in mTSS at Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in JSN Score at Week 28 and Week 52
JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity.
Change From Baseline in Erosion Score at Week 28 and Week 52
The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.
Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
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.
Change From Baseline in DAS28-CRP Through Week 52
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.
Change From Baseline in DAS28-ESR at Week 12
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.
Change From Baseline in DAS28-ESR Score Through Week 52
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.
Change From Baseline in TJC (68 Joints) at Week 12
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), 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.
Change From Baseline in TJC (68 Joints) Through Week 52
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), 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.
Change From Baseline in SJC (66 Joints) at Week 12
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 in SJC (66 Joints) Through Week 52
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.
Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12
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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52
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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12
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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52
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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12
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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52
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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12
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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52
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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Change From Baseline in CRP at Week 12
Higher CRP indicates greater disease activity.
Change From Baseline in CRP Through Week 52
Higher CRP indicates greater disease activity.
Change From Baseline in ESR at Week 12
Higher ESR indicates greater disease activity.
Change From Baseline in ESR Through Week 52
Higher ESR indicates greater disease activity.
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
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-CRP Through Week 52
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 Good or Moderate EULAR Response Using DAS28-CRP at Week 12
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 Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
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 EULAR Good Response Using DAS28-ESR at Week 12
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 Response Using DAS28-ESR Through Week 52
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 or Moderate Response Using DAS28-ESR at Week 12
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 EULAR Good or Moderate Response Using DAS28-ESR Through Week 52
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 Achieving ACR / EULAR Remission at Week 12
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 Achieving ACR / EULAR Remission Through Week 52
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 Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12
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. SDAI Remission was defined as SDAI score ≤ 3.3.
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52
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. SDAI Remission was defined as SDAI score ≤ 3.3.
Change From Baseline in SDAI Score at Week 12
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.
Change From Baseline in SDAI Score Through Week 52
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.
Change From Baseline in PGA at Week 12
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
Change From Baseline in PGA Through Week 52
The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
Change From Baseline in SGA at Week 12
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 in SGA Through Week 52
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 in SGAP at Week 12
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 in SGAP Through Week 52
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.
Number of Participants Who Withdrew Due to Lack of Efficacy
Participants who discontinued due to lack of efficacy have been reported.
Change From Baseline in HAQ-DI at Week 12
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 in HAQ-DI Through Week 52
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 in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12
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 Roll/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 in SF-36v2 Physical Component Summary Score Through Week 52
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 Roll/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 in SF-36v2 Mental Component Summary Score at Week 12
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 Roll/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 in SF-36v2 Mental Component Summary Score Through Week 52
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 Roll/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 in SF-36v2 Role/Social Component Summary Score at Week 12
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 Roll/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 in SF-36v2 Role/Social Component Summary Score Through Week 52
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 Roll/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 in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
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 in WPAI Percent Work Time Missed Through Week 52
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 in WPAI Percent Impairment While Working at Week 12
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 in WPAI Percent Impairment While Working Through Week 52
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 calculates as Q5/10. Negative values indicate improvement from baseline.
Change From Baseline in Percent Overall Work Impairment at Week 12
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 in WPAI Percent Overall Work Impairment Through Week 52
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 in WPAI Percent Activity Impairment at Week 12
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.
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Number of Participants With TEAEs From Week 12 to Week 28
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE
Number of Participants With TEAEs From Week 28 to Week 52
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.