Page last updated: 2024-10-19

niacinamide and Infections

niacinamide has been researched along with Infections in 7 studies

nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.

Infections: Invasion of the host organism by microorganisms or their toxins or by parasites that can cause pathological conditions or diseases.

Research Excerpts

Excerpt	Relevance	Reference
"Pellagra is a curable dietary illness that unchecked leads to dementia, diarrhoea, dermatitis and death due to lack of the precursors for NAD(H)."	3.74	Pellagra: A clue as to why energy failure causes diseases? ( Ramsden, DB; Williams, AC, 2007)
" Secondary endpoints (assessed throughout) included ACR20, ACR50 and ACR70 response, changes from baseline in disease activity scores (DAS)28 and ACR core parameters, adverse events (AEs) and changes in clinical or laboratory measurements."	2.90	Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). ( Akazawa, R; Chen, YH; Iwasaki, M; Izutsu, H; Kaneko, Y; Kawakami, A; Lee, SH; Rokuda, M; Shiomi, T; Song, YW; Takeuchi, T; Tanaka, S; Tanaka, Y; Ushijima, S; Wei, JC; Yamada, E, 2019)

Research

Studies (7)

Timeframe	Studies, this research(%)	All Research%
pre-1990	3 (42.86)	18.7374
1990's	0 (0.00)	18.2507
2000's	2 (28.57)	29.6817
2010's	2 (28.57)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Takeuchi, T	2
Tanaka, Y	2
Tanaka, S	2
Kawakami, A	2
Iwasaki, M	2
Katayama, K	1
Rokuda, M	2
Izutsu, H	2
Ushijima, S	2
Kaneko, Y	2
Shiomi, T	2
Yamada, E	2
van der Heijde, D	1
Song, YW	1
Chen, YH	1
Wei, JC	1
Lee, SH	1
Akazawa, R	1
Williams, AC	1
Ramsden, DB	1
Rennen, HJ	1
Laverman, P	1
van Eerd, JE	1
Oyen, WJ	1
Corstens, FH	1
Boerman, OC	1
Heeley, AF	1
Heeley, ME	1
Hardy, J	1
Soothill, JF	1
Clerens, J	1
Pietranera, P	1

Clinical Trials (2)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX[NCT02305849]	Phase 3	519 participants (Actual)	Interventional	2014-07-25	Completed
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs[NCT02308163]	Phase 3	509 participants (Actual)	Interventional	2014-08-08	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in CRP at Week 12

Higher CRP indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	mg/dL (Mean)
Placebo	-0.001
Peficitinib 100 mg	-1.499
Peficitinib 150 mg	-1.421

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	-0.51
Peficitinib 100 mg	-1.66
Peficitinib 150 mg	-2.12

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	-0.51
Peficitinib 100 mg	-1.70
Peficitinib 150 mg	-2.09

Change From Baseline in ESR at Week 12

Higher ESR indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	mm/h (Mean)
Placebo	-2.42
Peficitinib 100 mg	-18.90
Peficitinib 150 mg	-22.17

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	0.01
Peficitinib 100 mg	-0.22
Peficitinib 150 mg	-0.37

Change From Baseline in mTSS at Week 28

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 28 (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. (NCT02305849)
Timeframe: Baseline and week 28/ET

Intervention	units on a scale (Mean)
Placebo	3.37
Peficitinib 100 mg	1.62
Peficitinib 150 mg	1.03

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. (NCT02305849)
Timeframe: Baseline and week 52/ET

Intervention	units on a scale (Mean)
Placebo	6.27
Peficitinib 100 mg	2.12
Peficitinib 150 mg	1.54

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	percent overall work impairment (Mean)
Placebo	-2.75
Peficitinib 100 mg	-11.58
Peficitinib 150 mg	-16.91

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	-11.88
Peficitinib 100 mg	-28.83
Peficitinib 150 mg	-35.96

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	-4.90
Peficitinib 100 mg	-15.66
Peficitinib 150 mg	-19.57

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	1.07
Peficitinib 100 mg	3.28
Peficitinib 150 mg	2.50

Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12

Intervention	units on a scale (Mean)
Placebo	-0.09
Peficitinib 100 mg	2.30
Peficitinib 150 mg	3.90

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	-7.11
Peficitinib 100 mg	-21.09
Peficitinib 150 mg	-26.57

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	units on a scale (Mean)
Placebo	-6.64
Peficitinib 100 mg	-21.09
Peficitinib 150 mg	-26.87

Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12

Intervention	units on a scale (Mean)
Placebo	0.57
Peficitinib 100 mg	6.60
Peficitinib 150 mg	9.02

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	swollen joint count (Mean)
Placebo	-2.2
Peficitinib 100 mg	-5.9
Peficitinib 150 mg	-7.6

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	tender joint count (Mean)
Placebo	-2.1
Peficitinib 100 mg	-6.9
Peficitinib 150 mg	-9.1

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	percent work time missed (Mean)
Placebo	-0.82
Peficitinib 100 mg	0.36
Peficitinib 150 mg	-1.46

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	percent activity impairment (Mean)
Placebo	-2.50
Peficitinib 100 mg	-13.98
Peficitinib 150 mg	-19.35

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	percent work impairment (Mean)
Placebo	-2.42
Peficitinib 100 mg	-11.71
Peficitinib 150 mg	-15.96

Number of Participants Who Withdrew Due to Lack of Efficacy

Participants who discontinued due to lack of efficacy have been reported. (NCT02305849)
Timeframe: Up to week 52

Intervention	Participants (Count of Participants)
Peficitinib 100 mg	10
Peficitinib 150 mg	6
Placebo / Peficitinib 100 mg	3
Placebo / Peficitinib 150 mg	9

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). (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	0.6
Peficitinib 100 mg	5.8
Peficitinib 150 mg	9.9

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	7.7
Peficitinib 100 mg	31.4
Peficitinib 150 mg	35.1

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	12.4
Peficitinib 100 mg	47.1
Peficitinib 150 mg	57.9

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	2.4
Peficitinib 100 mg	12.8
Peficitinib 150 mg	19.3

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	4.7
Peficitinib 100 mg	25.0
Peficitinib 150 mg	36.3

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	0.6
Peficitinib 100 mg	7.0
Peficitinib 150 mg	14.0

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	32.0
Peficitinib 100 mg	74.4
Peficitinib 150 mg	78.9

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	4.1
Peficitinib 100 mg	23.8
Peficitinib 150 mg	34.5

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. (NCT02305849)
Timeframe: Week 12/ET

Intervention	percentage of participants (Number)
Placebo	10.1
Peficitinib 100 mg	43.0
Peficitinib 150 mg	55.6

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12

Intervention	percentage of participants (Number)
Placebo	35.5
Peficitinib 100 mg	77.9
Peficitinib 150 mg	84.8

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	percentage of participants (Number)
Placebo	7.6
Peficitinib 100 mg	29.9
Peficitinib 150 mg	46.0

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. (NCT02305849)
Timeframe: Baseline and week 12/ET

Intervention	percentage of participants (Number)
Placebo	2.4
Peficitinib 100 mg	12.1
Peficitinib 150 mg	23.6

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12

ACR20 response: greater than and equal to (≥) 20 percent (%) 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. (NCT02305849)
Timeframe: Baseline and week 12/Early termination (ET)

Intervention	percentage of participants (Number)
Placebo	21.8
Peficitinib 100 mg	58.6
Peficitinib 150 mg	64.4

Change From Baseline in CRP Through Week 52

Higher CRP indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	mg/dL (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-1.055	-1.207	-1.532	-1.666	-1.660	-1.774	-1.803	-1.844	-1.832	-1.833	-1.815	-1.771	-1.841	-1.545
Peficitinib 150 mg	-1.411	-1.569	-1.458	-1.513	-1.660	-1.721	-1.721	-1.640	-1.696	-1.716	-1.725	-1.751	-1.912	-1.629

Change From Baseline in DAS28-CRP Through Week 52

,,,,,

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-1.11	-1.48	-1.72	-2.01	-2.21	-2.40	-2.42	-2.50	-2.55	-2.66	-2.65	-2.62	-2.67	-2.43
Peficitinib 150 mg	-1.39	-1.87	-2.15	-2.40	-2.53	-2.71	-2.70	-2.77	-2.83	-2.86	-2.88	-2.92	-2.96	-2.76
Placebo / Peficitinib 100 mg at Week 12	-0.28	-0.21	0.24	-1.11	-1.69	-2.01	-2.24	-2.49	-2.49	-2.66	-2.68	-2.86	-2.80	-2.61
Placebo / Peficitinib 100 mg at Week 28	-0.82	-0.94	-1.34	-1.37	-1.38	-1.41	-1.53	-2.18	-2.22	-2.62	-2.63	-2.66	-2.70	-2.72
Placebo / Peficitinib 150 mg at Week 12	-0.30	-0.10	0.27	-1.37	-1.76	-2.26	-2.51	-2.72	-2.70	-2.72	-2.72	-2.90	-2.74	-2.52
Placebo / Peficitinib 150 mg at Week 28	-0.74	-0.90	-1.20	-1.31	-1.48	-1.64	-1.71	-2.47	-2.57	-2.73	-2.87	-2.96	-2.89	-2.87

Change From Baseline in DAS28-ESR Score Through Week 52

,,,,,

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-1.07	-1.47	-1.68	-1.98	-2.23	-2.43	-2.47	-2.56	-2.59	-2.70	-2.71	-2.64	-2.70	-2.47
Peficitinib 150 mg	-1.37	-1.88	-2.18	-2.46	-2.60	-2.78	-2.79	-2.87	-2.91	-2.96	-3.00	-3.01	-3.07	-2.86
Placebo / Peficitinib 100 mg at Week 12	-0.26	-0.24	0.24	-1.01	-1.61	-1.94	-2.11	-2.39	-2.45	-2.60	-2.63	-2.80	-2.77	-2.60
Placebo / Peficitinib 100 mg at Week 28	-0.87	-1.00	-1.40	-1.47	-1.45	-1.47	-1.63	-2.27	-2.38	-2.71	-2.74	-2.72	-2.79	-2.80
Placebo / Peficitinib 150 mg at Week 12	-0.26	-0.12	0.25	-1.38	-1.78	-2.24	-2.48	-2.68	-2.71	-2.78	-2.76	-2.88	-2.78	-2.56
Placebo / Peficitinib 150 mg at Week 28	-0.67	-0.85	-1.10	-1.21	-1.37	-1.56	-1.62	-2.37	-2.54	-2.68	-2.78	-2.93	-2.85	-2.82

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. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET

Intervention	units on a scale (Mean)
	Week 28/ET	Week 52/ET
Peficitinib 100 mg	0.63	0.82
Peficitinib 150 mg	0.18	0.32
Placebo	1.35	2.52

Change From Baseline in ESR Through Week 52

Higher ESR indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	mm/h (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-11.09	-14.96	-19.14	-21.42	-23.22	-25.35	-26.03	-26.92	-25.95	-25.86	-27.13	-25.63	-26.86	-24.00
Peficitinib 150 mg	-16.59	-21.10	-22.92	-24.29	-26.20	-27.36	-27.88	-27.21	-27.25	-27.74	-27.99	-27.83	-29.12	-26.11

Change From Baseline in HAQ-DI Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-0.08	-0.18	-0.23	-0.30	-0.33	-0.36	-0.36	-0.37	-0.39	-0.42	-0.45	-0.44	-0.43	-0.36
Peficitinib 150 mg	-0.21	-0.32	-0.38	-0.41	-0.47	-0.48	-0.51	-0.53	-0.53	-0.56	-0.54	-0.56	-0.56	-0.51

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. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET

Intervention	units on a scale (Mean)
	Week 28/ET	Week 52/ET
Peficitinib 100 mg	0.99	1.30
Peficitinib 150 mg	0.82	1.19
Placebo	1.90	3.55

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. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-18.36	-25.79	-29.07	-33.60	-36.18	-37.13	-38.72	-40.04	-39.35	-41.04	-41.47	-41.55	-41.49	-38.41
Peficitinib 150 mg	-22.94	-31.54	-36.55	-38.86	-41.44	-43.67	-42.43	-43.96	-44.37	-44.32	-46.00	-45.84	-45.46	-43.33

Change From Baseline in SDAI Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-11.02	-14.60	-15.94	-18.75	-20.24	-21.62	-21.89	-22.61	-22.89	-23.55	-23.55	-23.23	-23.67	-21.48
Peficitinib 150 mg	-13.79	-18.36	-20.08	-22.21	-23.03	-24.68	-24.57	-25.38	-25.55	-26.14	-26.44	-26.50	-26.63	-24.72

Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	1.45	2.72	3.44	3.06	2.62	2.21
Peficitinib 150 mg	1.33	2.44	2.67	3.12	1.85	1.67

Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	3.84	4.92	6.68	9.89	11.27	9.92
Peficitinib 150 mg	5.77	7.91	9.32	12.44	12.45	11.51

Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	1.41	2.50	2.32	4.06	4.30	3.49
Peficitinib 150 mg	1.70	3.30	3.92	4.81	7.17	5.88

Change From Baseline in SGA Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-13.80	-19.11	-21.59	-25.20	-26.94	-29.00	-30.04	-31.92	-32.38	-32.80	-33.49	-33.69	-33.18	-29.34
Peficitinib 150 mg	-17.59	-24.97	-27.40	-30.14	-31.20	-32.79	-34.25	-33.46	-34.01	-34.24	-35.31	-35.33	-36.16	-34.05

Change From Baseline in SGAP Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-12.94	-19.10	-21.27	-24.03	-25.57	-27.34	-28.54	-31.32	-31.95	-32.17	-32.73	-33.60	-33.34	-28.94
Peficitinib 150 mg	-16.18	-24.98	-27.81	-28.42	-30.63	-32.72	-34.18	-33.74	-32.66	-34.07	-34.88	-35.07	-35.00	-32.68

Change From Baseline in SJC (66 Joints) Through Week 52

Intervention	swollen joint count (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-4.3	-5.6	-6.0	-7.5	-8.1	-8.8	-8.8	-9.0	-9.0	-9.4	-9.4	-9.2	-9.6	-8.8
Peficitinib 150 mg	-5.3	-7.1	-7.8	-8.9	-9.2	-9.9	-9.8	-10.3	-10.5	-10.7	-10.8	-11.0	-11.0	-10.3

Change From Baseline in TJC (68 Joints) Through Week 52

Intervention	tender joint count (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	-5.1	-6.8	-7.1	-8.1	-9.1	-9.9	-9.6	-9.7	-10.4	-10.8	-10.6	-10.5	-10.8	-9.8
Peficitinib 150 mg	-6.3	-8.3	-9.3	-10.5	-10.8	-11.3	-11.4	-12.1	-11.8	-11.9	-12.1	-12.1	-11.9	-11.2

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. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Intervention	percent activity impairment (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	-9.23	-13.07	-13.71	-22.17	-24.10	-21.58
Peficitinib 150 mg	-10.65	-17.44	-19.88	-26.99	-26.71	-23.47

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. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Intervention	percent work impairment (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	-10.00	-12.50	-11.97	-20.00	-22.97	-17.35
Peficitinib 150 mg	-6.56	-13.98	-16.29	-21.40	-22.41	-20.43

Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52

Intervention	percent overall work impairment (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	-10.61	-13.13	-12.15	-20.76	-22.48	-17.43
Peficitinib 150 mg	-7.51	-14.67	-17.15	-22.49	-23.40	-21.59

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. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Intervention	percent work time missed (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52	EOT
Peficitinib 100 mg	-0.90	-1.48	-0.70	-0.58	-1.93	-1.76
Peficitinib 150 mg	0.02	-1.73	-1.97	-3.49	-1.66	-1.66

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 (NCT02305849)
Timeframe: Week 12 to week 28

,,,,

Intervention	Participants (Count of Participants)
	TEAEs	Drug-related TEAEs	TEAEs leading to death	Serious TEAEs	Drug-related serious TEAEs	≥ Grade 3 TEAEs	TEAEs leading to permanent discontinuation	Drug-Related TEAE leading to permanent dicont.
Peficitinib 100 mg	95	63	0	5	3	7	4	3
Peficitinib 150 mg	104	72	0	3	1	6	1	1
Placebo	50	27	0	2	2	5	4	3
Placebo / Peficitinib 100 mg at Week 12	21	16	0	0	0	1	0	0
Placebo / Peficitinib 150 mg at Week 12	25	11	0	0	0	1	0	0

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. (NCT02305849)
Timeframe: Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

,,,,,

Intervention	Participants (Count of Participants)
	TEAEs	Drug-related TEAEs	TEAEs leading to death	Serious TEAEs	Drug-related serious TEAEs	≥ Grade 3 TEAEs	TEAEs leading to permanent discontinuation
Peficitinib 100 mg	114	72	0	10	4	15	4
Peficitinib 150 mg	112	74	0	8	5	15	6
Placebo / Peficitinib 100 mg at Week 12	22	14	0	2	2	2	3
Placebo / Peficitinib 100 mg at Week 28	25	17	1	1	0	2	2
Placebo / Peficitinib 150 mg at Week 12	27	18	0	1	1	2	2
Placebo / Peficitinib 150 mg at Week 28	26	17	0	1	1	2	0

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. (NCT02305849)
Timeframe: Week 0 to week 12

Intervention	Participants (Count of Participants)
	TEAEs	Drug-related TEAEs	TEAEs leading to death	Serious TEAEs	Drug-related serious TEAEs	≥ Grade 3 TEAEs	TEAEs leading to permanent discontinuation	Drug-Related AE leading to permanent discont.
Peficitinib 100 mg	89	57	0	5	3	9	5	3
Peficitinib 150 mg	104	80	0	3	3	16	5	5
Placebo	84	47	0	4	2	8	7	6

Percentage of Participants Achieving ACR / EULAR Remission Through Week 52

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	1.2	1.2	6.0	9.0	11.0	11.8	14.6	17.2	17.0	19.1	16.1	17.6	21.4	19.2
Peficitinib 150 mg	1.2	3.6	10.2	12.1	14.1	18.1	20.1	25.8	27.7	20.9	20.3	21.2	26.5	23.4

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. (NCT02305849)
Timeframe: Baseline and week 28/ET and 52/ET

Intervention	percentage of participants (Number)
	Week 28/ET	Week 52/ET
Peficitinib 100 mg	67.1	64.0
Peficitinib 150 mg	72.6	68.9
Placebo	45.8	42.5

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. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	11.2	19.0	31.0	39.2	45.7	51.6	51.9	54.1	53.6	59.9	57.0	56.1	60.0	56.4
Peficitinib 150 mg	14.7	21.7	36.1	43.0	52.1	56.9	52.8	52.9	53.5	58.8	55.6	60.3	62.6	57.9
Placebo / Peficitinib 100 mg at Week 12	0.0	0.0	0.0	8.1	21.6	27.8	30.6	44.4	50.0	42.9	50.0	54.5	54.5	54.1
Placebo / Peficitinib 100 mg at Week 28	15.4	10.3	20.5	20.5	17.9	20.5	25.6	30.8	35.1	61.1	55.6	62.9	55.9	56.4
Placebo / Peficitinib 150 mg at Week 12	0.0	0.0	0.0	13.5	16.2	33.3	38.9	50.0	48.6	50.0	42.4	54.5	39.4	34.2
Placebo / Peficitinib 150 mg at Week 28	5.9	11.8	11.8	8.8	29.4	32.4	26.5	44.1	54.5	54.5	57.6	66.7	63.6	64.7

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. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	22.4	36.3	47.0	55.4	62.2	67.1	67.7	65.6	69.3	76.3	70.5	73.6	71.7	66.9
Peficitinib 150 mg	24.1	44.0	59.6	63.6	69.9	71.9	76.7	70.3	73.5	80.4	82.4	78.8	77.6	71.3

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. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	4.1	8.9	13.1	18.1	22.6	28.0	30.4	33.8	32.7	37.1	34.0	33.3	38.6	34.9
Peficitinib 150 mg	5.9	12.7	19.9	24.2	33.1	31.3	32.1	41.3	40.0	36.2	37.3	40.4	42.9	38.6
Placebo / Peficitinib 100 mg at Week 12	0.0	0.0	0.0	0.0	5.4	5.6	11.1	22.2	13.9	20.0	17.6	21.2	27.3	24.3
Placebo / Peficitinib 100 mg at Week 28	2.6	2.6	5.1	10.3	7.7	12.8	12.8	15.4	13.5	22.2	25.0	34.3	26.5	25.6
Placebo / Peficitinib 150 mg at Week 12	0.0	0.0	0.0	10.8	10.8	27.8	22.2	30.6	37.1	35.3	24.2	39.4	36.4	31.6
Placebo / Peficitinib 150 mg at Week 28	0.0	2.9	5.9	2.9	5.9	5.9	8.8	26.5	24.2	30.3	30.3	36.4	39.4	41.2

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. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	10.6	17.9	25.6	34.9	44.5	52.2	49.4	52.2	53.6	58.3	53.7	55.8	55.2	50.6
Peficitinib 150 mg	12.9	29.5	37.3	44.2	48.5	57.5	56.0	56.1	56.8	60.5	60.8	62.9	60.5	57.3

Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	1.2	3.0	7.1	14.5	18.3	20.5	22.2	25.5	24.2	31.6	27.5	25.7	30.3	28.5
Peficitinib 150 mg	2.4	8.4	14.5	18.2	20.9	22.5	23.3	28.4	32.9	28.8	30.1	32.5	39.5	35.1

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	55.9	72.0	75.0	80.7	82.3	87.6	88.0	90.4	94.1	92.7	96.6	94.6	93.8	86.0
Peficitinib 150 mg	68.2	76.5	80.1	87.9	92.0	91.9	91.2	92.9	94.8	94.1	94.1	95.4	94.6	90.6

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. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	19.4	30.4	42.9	51.8	59.1	65.2	63.3	63.1	67.3	73.7	65.8	71.6	69.0	64.5
Peficitinib 150 mg	21.8	41.0	57.2	60.0	68.1	70.0	74.2	69.0	72.9	79.1	81.0	78.1	76.9	70.8

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. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	7.6	16.1	24.4	34.3	43.3	51.6	48.1	51.0	53.6	57.6	52.4	53.7	53.8	49.4
Peficitinib 150 mg	12.4	28.3	35.5	43.6	46.0	55.6	54.1	54.8	54.8	58.6	59.5	60.9	59.2	56.1

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	67.1	73.8	78.6	84.3	86.6	89.4	91.1	93.0	94.8	92.8	95.3	95.3	95.2	88.4
Peficitinib 150 mg	77.1	80.1	85.5	89.1	91.4	95.6	93.7	94.2	95.5	96.1	94.1	97.4	94.6	92.4

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. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	38.2	51.2	59.5	70.5	74.4	74.5	79.1	79.6	78.4	80.9	79.9	83.8	84.8	76.4
Peficitinib 150 mg	48.2	62.0	66.3	77.0	79.8	85.0	83.0	85.2	86.5	86.9	86.9	89.4	87.1	81.0
Placebo / Peficitinib 100 mg at Week 12	8.1	10.8	0.0	43.2	59.5	63.9	72.2	77.8	80.6	80.0	76.5	81.8	75.8	73.0
Placebo / Peficitinib 100 mg at Week 28	38.5	33.3	51.3	64.1	61.5	59.0	64.1	84.6	78.4	88.9	88.9	85.7	91.2	92.3
Placebo / Peficitinib 150 mg at Week 12	2.7	0.0	0.0	51.4	67.6	80.6	83.3	86.1	85.7	88.2	90.9	90.9	90.9	78.9
Placebo / Peficitinib 150 mg at Week 28	14.7	29.4	38.2	58.8	61.8	52.9	64.7	76.5	75.8	78.8	87.9	90.9	90.9	91.2

Percentage of Participants With an ACR50-CRP Response Through Week 52

,,,,,

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	10.0	19.6	29.8	46.4	51.2	56.5	53.8	59.2	55.6	61.8	57.7	60.8	66.9	60.3
Peficitinib 150 mg	15.9	33.1	48.2	53.9	54.6	60.6	63.5	65.8	67.7	68.0	71.2	64.9	68.0	62.6
Placebo / Peficitinib 100 mg at Week 12	2.7	2.7	0.0	13.5	35.1	47.2	50.0	52.8	58.3	48.6	52.9	60.6	63.6	62.2
Placebo / Peficitinib 100 mg at Week 28	10.3	12.8	23.1	38.5	35.9	33.3	28.2	56.4	64.9	66.7	72.2	71.4	67.6	69.2
Placebo / Peficitinib 150 mg at Week 12	0.0	0.0	0.0	21.6	37.8	52.8	69.4	61.1	71.4	67.6	72.7	69.7	63.6	55.3
Placebo / Peficitinib 150 mg at Week 28	0.0	2.9	5.9	8.8	29.4	29.4	23.5	52.9	60.6	66.7	63.6	66.7	69.7	70.6

Percentage of Participants With an ACR70-CRP Response Through Week 52

,,,,,

Intervention	percentage of participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Peficitinib 100 mg	1.2	7.7	12.5	24.1	26.2	31.7	29.1	36.3	34.0	34.9	38.3	33.8	39.3	35.1
Peficitinib 150 mg	4.1	13.9	24.7	32.1	35.0	36.0	42.8	43.9	47.1	41.8	48.4	49.0	52.4	48.3
Placebo / Peficitinib 100 mg at Week 12	0.0	0.0	0.0	5.4	8.1	22.2	33.3	33.3	33.3	31.4	41.2	45.5	42.4	40.5
Placebo / Peficitinib 100 mg at Week 28	2.6	2.6	7.7	12.8	12.8	17.9	17.9	20.5	13.5	36.1	38.9	45.7	44.1	43.6
Placebo / Peficitinib 150 mg at Week 12	0.0	0.0	0.0	2.7	2.7	16.7	38.9	44.4	42.9	38.2	36.4	42.4	48.5	42.1
Placebo / Peficitinib 150 mg at Week 28	0.0	0.0	2.9	2.9	2.9	2.9	8.8	20.6	33.3	33.3	39.4	39.4	48.5	50.0

Change From Baseline in CDAI Score at Week 12

"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Units on a Scale (Mean)
Placebo	-7.25
Peficitinib 100 mg	-14.91
Peficitinib 150 mg	-19.20
Etanercept	-20.74

Change From Baseline in CRP at Week 12

Higher CRP indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	mg/dL (Mean)
Placebo	0.022
Peficitinib 100 mg	-1.056
Peficitinib 150 mg	-1.734
Etanercept	-1.207

Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below 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." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Units on a Scale (Mean)
Placebo	-0.62
Peficitinib 100 mg	-1.60
Peficitinib 150 mg	-2.24
Etanercept	-2.51

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 below 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." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Units on a Scale (Mean)
Placebo	-0.64
Peficitinib 100 mg	-1.62
Peficitinib 150 mg	-2.17
Etanercept	-2.42

Change From Baseline in ESR at Week 12

Higher ESR indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	mm/hour (Mean)
Placebo	-1.96
Peficitinib 100 mg	-12.96
Peficitinib 150 mg	-23.92
Etanercept	-20.92

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12

The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Units on a Scale (Mean)
Placebo	0.03
Peficitinib 100 mg	-0.28
Peficitinib 150 mg	-0.37
Etanercept	-0.39

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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percent iImpairment (Mean)
Placebo	3.62
Peficitinib 100 mg	-12.20
Peficitinib 150 mg	-18.68
Etanercept	-24.68

Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12

Intervention	Units on a Scale (Mean)
Placebo	-13.94
Peficitinib 100 mg	-27.69
Peficitinib 150 mg	-34.65
Etanercept	-37.40

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 below description.~SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Units on a Scale (Mean)
Placebo	-7.22
Peficitinib 100 mg	-16.08
Peficitinib 150 mg	-20.93
Etanercept	-21.94

Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12

Intervention	Units on a Scale (Mean)
Placebo	0.00
Peficitinib 100 mg	2.70
Peficitinib 150 mg	3.69
Etanercept	3.23

Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12

Intervention	Units on a Scale (Mean)
Placebo	0.17
Peficitinib 100 mg	1.24
Peficitinib 150 mg	7.04
Etanercept	7.16

Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12

Intervention	Units on a Scale (Mean)
Placebo	1.95
Peficitinib 100 m	8.36
Peficitinib 150 mg	8.81
Etanercept	8.53

Change From Baseline in Subject's Assessment of Pain at Week 12

The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Units on a Scale (Mean)
Placebo	-6.64
Peficitinib 100 mg	-23.78
Peficitinib 150 mg	-30.65
Etanercept	-30.82

Change From Baseline in Subject's SGA at Week 12

Intervention	Units on a Scale (Mean)
Placebo	-7.87
Peficitinib 100 mg	-23.74
Peficitinib 150 mg	-31.59
Etanercept	-32.43

Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12

"The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.~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)." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Tender Joints (Mean)
Placebo	-3.2
Peficitinib 100 mg	-6.0
Peficitinib 150 mg	-8.4
Etanercept	-8.3

Change From Baseline in TJC (68 Joints) at Week 12

"The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.~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)." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Tender Joints (Mean)
Placebo	-4.3
Peficitinib 100 mg	-8.2
Peficitinib 150 mg	-9.9
Etanercept	-10.7

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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percent Work Time (Mean)
Placebo	6.78
Peficitinib 100 mg	-2.14
Peficitinib 150 mg	-6.80
Etanercept	-5.60

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 indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percent Impairment (Mean)
Placebo	-4.65
Peficitinib 100 mg	-19.61
Peficitinib 150 mg	-24.65
Etanercept	-26.40

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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percent Impairment (Mean)
Placebo	4.13
Peficitinib 100 mg	-13.04
Peficitinib 150 mg	-16.12
Etanercept	-24.43

Number of Participants Who Withdrew Due to Lack of Efficacy

The number of participants who withdrew due to lack of efficacy up to week 12 was calculated. (NCT02308163)
Timeframe: Up to week 12

Intervention	Participants (Count of Participants)
Placebo	7
Peficitinib 100 mg	1
Peficitinib 150 mg	1
Etanercept	1

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 subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	2.0
Peficitinib 100 mg	5.9
Peficitinib 150 mg	5.9
Etanercept	13.5

Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12

"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	0.0
Peficitinib 100 mg	8.7
Peficitinib 150 mg	9.9
Etanercept	19.0

Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below 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." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	5.0
Peficitinib 100 mg	24.5
Peficitinib 150 mg	34.7
Etanercept	45.5

Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below 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." (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	11.0
Peficitinib 100 mg	40.2
Peficitinib 150 mg	53.5
Etanercept	68.0

Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below 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." (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	1.0
Peficitinib 100 mg	11.7
Peficitinib 150 mg	17.8
Etanercept	31.7

Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below 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." (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	7.0
Peficitinib 100 mg	19.4
Peficitinib 150 mg	37.6
Etanercept	49.7

Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12

"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	0.0
Peficitinib 100 mg	8.8
Peficitinib 150 mg	8.9
Etanercept	18.5

Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12

Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	9.1
Peficitinib 100 mg	38.6
Peficitinib 150 mg	51.5
Etanercept	65.5

Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12

Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	5.1
Peficitinib 100 mg	18.6
Peficitinib 150 mg	36.6
Etanercept	49.0

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12

Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	41.4
Peficitinib 100 mg	75.2
Peficitinib 150 mg	92.1
Etanercept	92.5

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12

Intervention	Percentage of Participants (Number)
Placebo	37.8
Peficitinib 100 mg	69.6
Peficitinib 150 mg	88.1
Etanercept	90.9

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12

"The ACR20 response required that all criteria from (1) to (3) below be met.~Tender joint count (TJC) : ≥ 20% reduction compared with baseline.~Swollen joint count (SJC) : ≥ 20% reduction compared with baseline.~≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline~(3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP)." (NCT02308163)
Timeframe: Baseline and Week 12/early termination (ET)

Intervention	Percentage of Participants (Number)
Placebo	30.7
Peficitinib 100 mg	57.7
Peficitinib 150 mg	74.5
Etanercept	83.5

Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12

"The ACR50 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 50% reduction compared with baseline.~SJC : ≥ 50% reduction compared with baseline.~≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	8.9
Peficitinib 100 mg	30.8
Peficitinib 150 mg	42.2
Etanercept	52.5

Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12

"The ACR70 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 70% reduction compared with baseline.~SJC : ≥ 70% reduction compared with baseline.~≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Week 12/ET

Intervention	Percentage of Participants (Number)
Placebo	1.0
Peficitinib 100 mg	13.5
Peficitinib 150 mg	27.5
Etanercept	30.5

Change From Baseline DAS28-CRP Through Week 52

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below 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. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-1.89	-2.27	-2.49	-2.61	-2.73	-2.79	-2.90	-2.94	-2.91	-2.99	-2.97	-3.03	-3.04	-2.80
Peficitinib 100 mg	-1.11	-1.48	-1.66	-1.96	-2.01	-2.06	-2.12	-2.26	-2.31	-2.31	-2.34	-2.26	-2.28	-2.01
Peficitinib 150 mg	-1.29	-1.92	-2.27	-2.40	-2.57	-2.68	-2.80	-2.77	-2.87	-2.88	-2.86	-2.98	-2.99	-2.75
Placebo / Peficitinib 100 mg	-0.49	-0.70	-0.70	-1.60	-1.58	-1.60	-1.90	-1.98	-2.21	-2.17	-2.39	-2.58	-2.51	-2.11
Placebo / Peficitinib 150 mg	-0.56	-0.65	-0.82	-1.92	-2.15	-2.28	-2.35	-2.22	-2.26	-2.47	-2.47	-2.73	-2.73	-2.50

Change From Baseline in CDAI Score Through Week 52

,,,,

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-15.73	-19.31	-21.21	-22.08	-22.92	-23.30	-24.09	-24.25	-24.30	-24.87	-24.54	-24.96	-25.17	-23.52
Peficitinib 100 mg	-11.01	-13.74	-15.55	-18.17	-18.51	-18.92	-18.97	-20.52	-20.03	-20.41	-20.34	-20.11	-20.05	-17.82
Peficitinib 150 mg	-11.42	-17.06	-19.81	-20.06	-21.55	-22.28	-23.38	-23.30	-23.58	-23.76	-23.84	-24.50	-24.93	-23.12
Placebo / Peficitinib 100 mg	-5.61	-7.29	-7.52	-14.40	-15.08	-15.71	-16.74	-16.46	-19.48	-19.00	-21.34	-21.58	-21.44	-17.96
Placebo / Peficitinib 150 mg	-7.28	-8.35	-10.04	-17.72	-19.31	-20.93	-21.48	-20.17	-20.83	-21.86	-22.00	-23.20	-23.67	-21.39

Change From Baseline in CRP Through Week 52

Higher CRP indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	mg/dL (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-1.360	-1.337	-1.205	-1.383	-1.525	-1.473	-1.611	-1.593	-1.467	-1.594	-1.627	-1.611	-1.595	-1.326
Peficitinib 100 mg	-0.817	-0.967	-1.045	-1.083	-0.964	-1.225	-1.323	-1.200	-1.310	-1.199	-1.202	-0.964	-1.138	-0.949
Peficitinib 150 mg	-1.359	-1.664	-1.810	-1.849	-1.819	-1.824	-1.904	-1.979	-2.043	-2.019	-1.978	-1.833	-2.068	-1.832
Placebo / Peficitinib 100 mg	0.013	0.198	0.026	-0.802	-0.581	-0.434	-1.013	-1.239	-1.084	-1.325	-1.292	-1.610	-1.566	-0.797
Placebo / Peficitinib 150 mg	0.073	-0.076	-0.142	-1.180	-1.294	-1.318	-1.266	-0.975	-1.192	-1.232	-1.225	-1.407	-1.534	-0.987

Change From Baseline in DAS28-ESR Through Week 52

,,,,

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-1.90	-2.33	-2.58	-2.68	-2.76	-2.86	-2.97	-3.01	-3.00	-3.10	-3.05	-3.16	-3.10	-2.86
Peficitinib 100 mg	-1.13	-1.50	-1.65	-1.95	-2.06	-2.11	-2.14	-2.28	-2.38	-2.38	-2.40	-2.32	-2.35	-2.06
Peficitinib 150 mg	-1.26	-1.96	-2.35	-2.50	-2.65	-2.79	-2.87	-2.88	-3.00	-3.02	-3.02	-3.09	-3.06	-2.81
Placebo / Peficitinib 100 mg	-0.46	-0.68	-0.66	-1.53	-1.57	-1.60	-1.94	-1.98	-2.18	-2.12	-2.39	-2.67	-2.45	-2.06
Placebo / Peficitinib 150 mg	-0.63	-0.57	-0.80	-1.84	-2.15	-2.25	-2.31	-2.26	-2.28	-2.49	-2.55	-2.79	-2.67	-2.44

Change From Baseline in ESR Through Week 52

Higher ESR indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	mm/hour (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-19.20	-20.88	-21.74	-22.05	-21.91	-22.20	-23.52	-24.75	-24.66	-25.87	-25.73	-25.98	-24.23	-20.75
Peficitinib 100 mg	-9.98	-15.27	-13.49	-15.34	-16.77	-17.61	-16.47	-16.35	-18.67	-17.74	-17.77	-15.43	-16.77	-14.94
Peficitinib 150 mg	-14.99	-21.59	-25.26	-28.32	-27.34	-27.02	-27.21	-27.02	-29.50	-29.79	-29.07	-28.70	-28.59	-26.15
Placebo / Peficitinib 100 mg	-0.63	-0.95	-2.62	-11.76	-12.69	-13.18	-16.29	-19.54	-19.65	-19.45	-21.43	-23.40	-21.03	-15.37
Placebo / Peficitinib 150 mg	-3.87	-2.07	-4.43	-16.89	-20.62	-20.04	-18.02	-19.93	-21.99	-21.71	-22.31	-25.66	-23.24	-18.61

Change From Baseline in HAQ-DI Through Week 52

,,,,

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-0.24	-0.35	-0.39	-0.44	-0.46	-0.47	-0.47	-0.47	-0.47	-0.48	-0.49	-0.51	-0.51	-0.47
Peficitinib 100 mg	-0.10	-0.25	-0.30	-0.36	-0.34	-0.35	-0.35	-0.41	-0.40	-0.42	-0.39	-0.34	-0.36	-0.30
Peficitinib 150 mg	-0.19	-0.31	-0.38	-0.41	-0.46	-0.46	-0.49	-0.50	-0.50	-0.51	-0.51	-0.52	-0.54	-0.50
Placebo / Peficitinib 100 mg	-0.04	-0.07	-0.09	-0.21	-0.22	-0.33	-0.33	-0.36	-0.36	-0.35	-0.42	-0.40	-0.46	-0.37
Placebo / Peficitinib 150 mg	0.01	0.02	0.03	-0.12	-0.21	-0.26	-0.23	-0.29	-0.25	-0.28	-0.27	-0.31	-0.29	-0.24

Change From Baseline in PGA Through Week 52

,,,,

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-27.48	-33.80	-37.99	-39.20	-41.10	-41.18	-41.51	-41.95	-41.27	-42.93	-42.65	-43.71	-44.11	-41.07
Peficitinib 100 mg	-18.71	-25.92	-28.91	-34.84	-34.83	-36.67	-37.17	-39.14	-38.29	-39.95	-38.53	-38.29	-37.85	-34.09
Peficitinib 150 mg	-19.49	-30.55	-35.53	-34.68	-38.65	-38.50	-39.29	-40.49	-40.76	-41.88	-42.16	-43.41	-44.02	-40.56
Placebo / Peficitinib 100 mg	-8.77	-11.70	-14.85	-26.10	-28.43	-30.62	-31.69	-30.22	-35.44	-36.31	-38.01	-39.09	-39.43	-33.01
Placebo / Peficitinib 150 mg	-12.37	-16.04	-18.99	-31.35	-33.80	-37.43	-37.90	-37.27	-38.90	-38.83	-37.74	-41.99	-43.24	-39.28

Change From Baseline in SDAI Score Through Week 52

,,,,

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-17.09	-20.64	-22.54	-23.46	-24.44	-24.78	-25.70	-25.84	-25.77	-26.46	-26.17	-26.57	-26.77	-24.85
Peficitinib 100 mg	-11.83	-14.71	-16.59	-19.25	-19.47	-20.14	-20.29	-21.72	-21.34	-21.55	-21.54	-21.11	-21.19	-18.92
Peficitinib 150 mg	-12.78	-18.66	-21.62	-21.90	-23.37	-24.40	-25.29	-25.28	-25.62	-25.78	-25.82	-26.33	-26.99	-24.95
Placebo / Peficitinib 100 mg	-5.57	-7.07	-7.48	-15.20	-15.67	-16.13	-17.75	-17.71	-20.57	-20.34	-22.65	-23.21	-23.04	-18.76
Placebo / Peficitinib 150 mg	-7.21	-8.43	-10.18	-18.90	-20.61	-22.25	-22.74	-21.14	-22.02	-23.09	-23.23	-24.61	-25.20	-22.38

Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	2.85	3.56	3.63	3.80	3.79
Peficitinib 100 mg	1.53	2.91	2.38	2.95	4.23
Peficitinib 150 mg	1.72	3.55	4.01	3.52	4.39

Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	6.10	7.35	8.40	10.28	11.18
Peficitinib 100 mg	3.82	6.43	9.93	10.85	13.07
Peficitinib 150 mg	3.20	6.78	9.63	10.95	9.88

Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	4.06	6.51	7.49	7.31	8.36
Peficitinib 100 mg	0.40	3.80	1.68	4.18	3.88
Peficitinib 150 mg	4.27	5.96	7.82	8.78	9.15

Change From Baseline in SGA Through Week 52

,,,,

Intervention	units on a scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-24.38	-29.31	-33.14	-34.88	-36.10	-37.12	-37.75	-38.02	-37.54	-38.42	-39.01	-39.47	-40.36	-37.09
Peficitinib 100 mg	-14.66	-21.29	-25.09	-29.98	-29.82	-30.09	-31.19	-34.49	-32.11	-34.66	-34.87	-35.53	-35.61	-28.52
Peficitinib 150 mg	-18.30	-29.55	-32.75	-34.37	-36.21	-37.51	-37.91	-38.71	-39.08	-40.85	-39.51	-41.60	-41.54	-38.84
Placebo / Peficitinib 100 mg	-1.83	-5.71	-6.93	-21.29	-17.76	-25.96	-25.66	-27.97	-31.56	-30.76	-36.01	-34.09	-32.06	-26.80
Placebo / Peficitinib 150 mg	-6.59	-8.78	-8.85	-21.98	-24.53	-25.42	-26.01	-26.17	-26.64	-28.80	-28.19	-31.05	-32.91	-28.71

Change From Baseline in SJC (66 Joints) Through Week 52

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Intervention	Swollen Joints (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-6.3	-7.6	-8.3	-8.7	-9.2	-9.1	-9.7	-9.8	-9.8	-10.0	-9.9	-9.9	-10.2	-9.7
Lacebo / Peficitinib 150 mg	-2.2	-3.4	-3.9	-6.3	-7.8	-8.2	-8.7	-8.2	-8.5	-9.1	-9.3	-9.1	-9.4	-8.6
Peficitinib 100 mg	-4.5	-5.6	-6.4	-7.7	-7.6	-7.9	-8.2	-8.2	-8.4	-8.4	-8.8	-8.6	-8.7	-7.7
Peficitinib 150 mg	-4.7	-7.1	-8.7	-8.7	-9.1	-9.7	-10.4	-10.4	-10.4	-10.4	-10.5	-10.8	-11.0	-10.0
Placebo / Peficitinib 100 mg	-2.5	-2.8	-3.3	-6.4	-6.6	-6.5	-6.7	-5.9	-7.6	-7.6	-8.0	-8.0	-8.2	-6.7

Change From Baseline in Subject's Assessment of Pain Through Week 52

,,,,

Intervention	Units on a Scale (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-22.24	-27.43	-31.37	-32.48	-34.76	-35.45	-36.23	-37.20	-36.31	-36.45	-36.24	-37.03	-38.47	-35.47
Peficitinib 100 mg	-14.80	-22.45	-25.02	-28.58	-29.68	-29.78	-31.66	-34.15	-32.44	-35.06	-34.59	-34.87	-33.24	-28.49
Peficitinib 150 mg	-18.36	-29.58	-31.83	-34.41	-35.83	-37.78	-36.48	-37.65	-38.48	-40.67	-38.76	-40.27	-42.01	-38.03
Placebo / Peficitinib 100 mg	-2.00	-4.11	-5.40	-20.93	-16.21	-22.64	-22.63	-25.53	-28.38	-26.65	-32.32	-31.57	-29.57	-24.18
Placebo / Peficitinib 150 mg	-8.23	-9.17	-9.15	-21.20	-24.63	-26.51	-24.93	-27.09	-26.79	-29.48	-28.55	-30.73	-32.11	-28.51

Change From Baseline in TJC (68 Joints) Through Week 52

,,,,

Intervention	Tender Joints (Mean)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	-8.3	-10.3	-11.0	-11.5	-12.0	-12.2	-12.6	-12.4	-12.6	-12.9	-12.8	-12.8	-12.8	-11.9
Peficitinib 100 mg	-5.9	-7.8	-8.6	-9.2	-9.8	-9.4	-9.7	-10.4	-10.2	-10.5	-10.6	-10.1	-10.1	-9.1
Peficitinib 150 mg	-5.4	-8.6	-10.3	-10.3	-11.3	-11.3	-12.0	-12.2	-11.7	-11.8	-12.0	-12.4	-12.8	-11.5
Placebo / Peficitinib 100 mg	-3.9	-4.4	-5.0	-7.7	-8.1	-7.6	-8.4	-9.2	-10.1	-9.9	-10.7	-11.3	-11.4	-9.6
Placebo / Peficitinib 150 mg	-4.3	-3.9	-5.5	-9.6	-10.3	-11.7	-11.5	-11.1	-11.5	-12.2	-12.5	-13.2	-12.9	-11.9

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 indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

Intervention	percent impairment (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	-17.90	-25.33	-27.33	-30.34	-31.79
Peficitinib 100 mg	-10.92	-20.10	-21.47	-25.18	-28.17
Peficitinib 150 mg	-11.30	-23.64	-26.74	-30.00	-34.07

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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

Intervention	percent impairment (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	-18.33	-20.52	-24.11	-29.53	-31.36
Peficitinib 100 mg	-6.42	-14.31	-13.33	-17.35	-20.79
Peficitinib 150 mg	-6.46	-15.42	-19.77	-25.85	-23.89

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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

Intervention	Percent Impairment (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	-18.20	-20.94	-25.35	-30.12	-32.18
Peficitinib 100 mg	-5.72	-14.16	-13.16	-17.48	-21.53
Peficitinib 150 mg	-8.67	-17.44	-22.84	-28.68	-24.75

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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

Intervention	Percent Work Time (Mean)
	Week 4	Week 8	Week 12	Week 28	Week 52
Etanercept	-3.71	-4.33	-4.73	-5.03	-4.52
Peficitinib 100 mg	-0.56	-2.38	-1.38	-3.14	-6.76
Peficitinib 150 mg	-6.35	-6.10	-6.69	-6.46	-6.35

Number of Participants With Adverse Events During the First 12 Weeks

Treatment-emergent adverse events (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) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02308163)
Timeframe: Week 0 to Week 12

,,,

Intervention	Participants (Count of Participants)
	TEAEs	Drug-related TEAEs	TEAEs leading to death	Serious TEAEs	Drug-related serious TEAEs	≥ Grade 3 TEAEs	TEAEs leading to discontinuation	Drug-related TEAEs leading to discontinuation	Serious TEAEs leading to discontinuation	Drug-related serious TEAEs leading to discont.
Etanercept	119	75	0	4	4	6	5	5	2	2
Peficitinib 100 mg	49	33	0	3	2	6	6	4	2	1
Peficitinib 150 mg	55	38	0	2	1	3	3	2	2	1
Placebo	54	29	0	4	3	8	4	1	2	1

Number of Participants With Adverse Events From Week 12

Treatment-emergent adverse events (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) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02308163)
Timeframe: Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

,,,,

Intervention	Participants (Count of Participants)
	TEAEs	Drug-related TEAEs	TEAEs leading to death	Serious TEAEs	Drug-related serious TEAEs	≥ Grade 3 TEAEs	TEAEs leading to discontinuation	Drug-related TEAEs leading to discontinuation	Serious TEAEs leading to discontinuation	Drug-related serious TEAEs leading to discont.
Etanercept	156	93	0	14	5	23	8	6	3	2
Peficitinib 100 mg	78	50	0	5	2	9	7	3	4	2
Peficitinib 150 mg	79	47	0	6	2	16	3	2	0	0
Placebo / Peficitinib 100 mg	41	27	0	4	2	2	2	2	1	1
Placebo / Peficitinib 150 mg	37	26	0	5	2	12	4	4	2	2

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 subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm). (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	7.0	11.8	14.1	18.6	20.9	28.0	24.3	25.0	22.3	24.3	25.1	27.4	30.2	25.0
Peficitinib 100 mg	1.0	2.1	6.3	11.8	12.0	13.8	12.0	13.6	16.5	16.0	16.0	17.6	18.3	14.7
Peficitinib 150 mg	0.0	1.0	6.5	8.6	13.0	10.1	18.0	20.9	18.6	19.8	24.7	25.0	18.5	15.8
Placebo / Peficitinib 100 mg	0.0	2.3	0.0	4.8	4.8	5.0	9.8	10.8	8.1	7.9	20.0	25.7	22.9	20.9
Placebo / Peficitinib 150 mg	0.0	0.0	4.3	2.1	6.5	8.9	10.9	11.1	7.0	14.3	7.7	15.4	10.5	8.5

Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52

"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	9.0	14.4	19.9	23.9	28.0	31.9	31.6	32.4	30.3	31.8	33.3	36.3	38.3	32.5
Peficitinib 100 mg	1.0	4.2	9.4	14.0	18.5	16.1	20.5	17.3	19.0	22.4	21.3	23.0	21.1	18.4
Peficitinib 150 mg	2.0	6.1	10.9	16.1	17.4	15.6	27.0	27.9	26.7	29.1	36.5	34.5	27.2	23.8
Placebo / Peficitinib 100 mg	0.0	0.0	0.0	2.4	2.4	7.5	14.6	16.2	18.9	13.2	25.7	28.6	22.9	20.9
Placebo / Peficitinib 150 mg	0.0	0.0	0.0	6.4	10.9	15.6	17.4	13.3	7.0	21.4	15.4	23.1	18.4	17.0

Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below 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." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	26.0	37.4	47.6	53.2	59.3	59.9	61.6	68.2	61.7	68.8	69.6	70.8	67.9	61.5
Peficitinib 100 mg	10.2	19.8	25.0	35.5	37.0	37.9	36.1	38.3	49.4	45.3	46.7	43.2	43.7	39.2
Peficitinib 150 mg	5.0	23.5	37.0	39.8	51.1	51.7	55.1	55.8	54.7	53.5	57.6	61.9	66.7	59.4
Placebo / Peficitinib 100 mg	0.0	9.3	7.1	21.4	16.7	25.0	34.1	37.8	43.2	36.8	48.6	51.4	45.7	41.9
Placebo / Peficitinib 150 mg	2.1	2.1	4.3	23.4	32.6	33.3	41.3	37.8	39.5	45.2	41.0	56.4	55.3	51.1

Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below 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." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	47.0	59.5	70.2	73.4	75.8	77.5	81.9	83.0	83.4	85.0	83.0	86.3	89.5	81.5
Peficitinib 100 mg	18.4	32.3	41.7	52.7	55.4	50.6	55.4	58.0	63.3	62.7	61.3	64.9	63.4	54.9
Peficitinib 150 mg	21.0	40.8	55.4	64.5	67.4	74.2	76.4	70.9	75.6	76.7	75.3	81.0	84.0	77.2
Placebo / Peficitinib 100 mg	4.7	11.6	14.3	33.3	45.2	35.0	41.5	51.4	56.8	57.9	57.1	60.0	54.3	48.8
Placebo / Peficitinib 150 mg	4.3	12.8	10.6	44.7	47.8	62.2	63.0	55.6	67.4	71.4	74.4	79.5	81.6	76.6

Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below 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." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	14.5	27.7	33.2	35.1	38.1	41.4	39.8	43.4	40.0	43.9	43.3	47.6	43.2	39.5
Peficitinib 100 mg	2.0	8.4	11.5	18.3	22.0	23.0	27.7	22.2	25.3	28.9	32.0	24.3	25.4	23.3
Peficitinib 150 mg	4.0	13.3	19.6	26.1	28.6	34.1	34.8	30.2	41.2	44.2	48.2	39.3	34.6	28.7
Placebo / Peficitinib 100 mg	0.0	0.0	2.4	11.9	14.6	15.4	26.8	19.4	25.0	32.4	35.3	37.1	29.4	26.2
Placebo / Peficitinib 150 mg	2.1	0.0	0.0	14.9	19.6	17.8	21.7	24.4	18.6	28.6	28.2	38.5	28.9	27.7

Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below 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." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	33.0	42.6	51.1	53.7	56.9	58.6	60.8	65.7	62.3	67.1	64.3	72.6	62.3	58.0
Peficitinib 100 mg	9.2	20.0	19.8	32.3	36.3	37.9	36.1	42.0	48.1	51.3	48.0	45.9	45.1	38.8
Peficitinib 150 mg	10.0	24.5	39.1	42.4	51.6	50.0	59.6	54.7	61.2	59.3	60.0	61.9	69.1	61.4
Placebo / Peficitinib 100 mg	0.0	9.3	7.1	21.4	19.5	23.1	36.6	38.9	41.7	43.2	50.0	54.3	41.2	38.1
Placebo / Peficitinib 150 mg	4.3	2.2	8.5	25.5	34.8	37.8	41.3	40.0	37.2	47.6	46.2	53.8	52.6	46.8

Percentage of Participants Achieving SDAI Remission Through Week 52

"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	10.0	16.9	19.4	23.9	29.7	34.1	33.9	35.2	30.9	33.5	34.5	39.3	39.5	33.5
Peficitinib 100 mg	1.0	4.2	9.4	12.9	17.4	18.4	19.3	16.0	21.5	24.0	22.7	18.9	21.1	17.6
Peficitinib 150 mg	1.0	6.1	9.8	15.1	18.5	18.0	29.2	27.9	27.9	36.0	38.8	38.1	29.6	25.7
Placebo / Peficitinib 100 mg	0.0	0.0	0.0	2.4	4.8	10.0	17.1	13.5	18.9	10.5	20.0	28.6	20.0	18.6
Placebo / Peficitinib 150 mg	0.0	0.0	0.0	8.5	15.2	17.8	17.4	13.3	4.7	19.0	15.4	25.6	21.1	17.0

Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52

Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	44.5	56.4	67.5	72.9	75.8	76.4	80.8	83.0	83.4	84.4	82.5	85.1	88.3	80.0
Peficitinib 100 mg	17.3	28.1	39.6	48.4	51.1	47.1	50.6	54.3	59.5	58.7	58.7	60.8	59.2	52.5
Peficitinib 150 mg	16.0	39.8	53.3	60.2	65.2	71.9	74.2	68.6	74.4	75.6	74.1	79.8	81.5	75.2
Placebo / Peficitinib 100 mg	4.8	11.9	12.2	34.1	46.3	33.3	40.0	50.0	55.6	54.1	55.9	55.9	52.9	47.6
Placebo / Peficitinib 150 mg	2.1	6.4	8.5	40.4	43.5	57.8	58.7	46.7	62.8	66.7	71.8	79.5	78.9	72.3

Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52

Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	31.7	41.2	50.0	52.7	56.4	56.4	59.7	63.4	62.3	67.1	63.7	72.6	61.7	57.3
Peficitinib 100 mg	8.2	16.8	18.8	31.2	34.1	35.6	32.5	39.5	44.3	47.4	45.3	41.9	43.7	38.2
Peficitinib 150 mg	10.0	24.5	38.0	40.2	51.6	50.0	59.6	54.7	60.0	59.3	60.0	61.9	69.1	61.4
Placebo / Peficitinib 100 mg	0.0	9.5	4.9	22.0	20.0	21.1	35.0	37.1	40.0	41.7	48.5	52.9	39.4	36.6
Placebo / Peficitinib 150 mg	2.2	0.0	6.5	21.7	31.1	34.1	37.8	36.4	33.3	43.9	43.6	52.6	48.6	43.5

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	87.5	92.3	94.2	96.8	95.6	97.3	99.4	98.3	97.7	100.0	99.4	98.2	98.8	95.5
Peficitinib 100 mg	63.3	76.0	77.1	81.7	79.3	85.1	89.2	91.4	87.3	89.3	93.3	90.5	91.5	78.2
Peficitinib 150 mg	72.0	86.7	94.6	92.5	96.7	96.6	95.5	96.5	96.5	96.5	94.1	97.6	98.8	93.1
Placebo / Peficitinib 100 mg	31.0	47.6	41.5	73.2	78.0	71.8	80.0	83.3	86.1	86.5	88.2	94.1	94.1	83.3
Placebo / Peficitinib 150 mg	40.4	40.4	48.9	85.1	91.3	91.1	87.0	82.2	86.0	85.7	87.2	89.7	92.1	85.1

Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	81.9	92.8	92.6	94.7	93.9	96.1	97.7	97.1	96.6	98.3	98.2	98.2	98.1	93.5
Peficitinib 100 mg	56.1	66.3	70.8	76.3	79.1	82.8	84.3	90.1	83.5	89.5	90.7	86.5	84.5	74.5
Peficitinib 150 mg	65.0	84.7	90.2	88.0	96.7	95.5	92.1	94.2	95.3	95.3	92.9	95.2	97.5	94.1
Placebo / Peficitinib 100 mg	31.0	45.2	39.0	73.2	72.5	73.7	77.5	77.1	85.7	83.3	84.8	88.2	84.8	75.6
Placebo / Peficitinib 150 mg	23.9	33.3	43.5	76.1	86.7	90.9	88.9	86.4	83.3	85.4	87.2	89.5	89.2	82.6

Percentage of Participants With an ACR20-CRP Response Through Week 52

"The ACR20 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 20% reduction compared with baseline.~SJC : ≥ 20% reduction compared with baseline.~≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	End of Treatment (EOT)
Etanercept	61.0	80.5	84.8	86.7	88.5	90.1	92.7	88.1	92.0	92.5	91.2	90.5	90.7	86.5
Peficitinib 100 mg	43.9	51.0	59.4	64.5	64.1	63.2	72.3	76.5	72.2	73.7	74.7	74.3	73.2	65.4
Peficitinib 150 mg	45.0	68.7	77.2	79.6	81.5	85.6	87.6	88.4	90.7	90.7	88.2	90.5	90.1	84.3
Placebo / Peficitinib 100 mg	21.4	38.1	31.7	58.5	51.2	61.5	60.0	63.9	66.7	67.6	79.4	73.5	79.4	67.4
Placebo / Peficitinib 150 mg	19.1	25.5	34.0	61.7	71.7	71.1	67.4	73.3	76.7	83.3	84.6	82.1	81.6	74.5

Percentage of Participants With an ACR50-CRP Response Through Week 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	29.5	47.2	55.0	60.6	66.5	64.8	69.5	70.5	70.3	73.4	70.2	75.6	77.2	69.0
Peficitinib 100 mg	8.2	25.0	32.3	43.0	41.3	43.7	44.6	50.6	53.2	47.4	50.7	48.6	49.3	43.3
Peficitinib 150 mg	14.0	35.4	45.7	45.2	54.3	62.2	60.7	65.1	68.6	69.8	69.4	73.8	75.3	66.7
Placebo / Peficitinib 100 mg	4.8	4.8	7.3	31.7	22.0	38.5	40.0	52.8	47.2	45.9	50.0	58.8	47.1	41.9
Placebo / Peficitinib 150 mg	2.1	6.4	12.8	25.5	43.5	44.4	50.0	44.4	44.2	52.4	53.8	69.2	65.8	55.3

Percentage of Participants With an ACR70-CRP Response Through Week 52

,,,,

Intervention	Percentage of Participants (Number)
	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 52	EOT
Etanercept	14.5	20.5	31.9	37.8	41.8	44.5	48.0	47.7	44.6	49.7	52.0	54.2	56.2	48.0
Peficitinib 100 mg	1.0	11.5	14.6	23.7	26.1	28.7	25.3	28.4	31.6	28.9	30.7	33.8	35.2	31.7
Peficitinib 150 mg	2.0	14.1	29.3	28.0	30.4	40.0	38.2	39.5	43.0	47.7	49.4	51.2	48.1	42.2
Placebo / Peficitinib 100 mg	0.0	0.0	0.0	7.3	7.3	15.4	20.0	25.0	27.8	27.0	41.2	32.4	38.2	34.9
Placebo / Peficitinib 150 mg	0.0	2.1	2.1	8.5	19.6	22.2	17.4	24.4	18.6	35.7	28.2	38.5	42.1	34.0

Trials

2 trials available for niacinamide and Infections

Article	Year
Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan. Annals of the rheumatic diseases, 2019, Volume: 78, Issue:10 Topics: Adamantane; Adult; Aged; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Drug Subs	2019
Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). Annals of the rheumatic diseases, 2019, Volume: 78, Issue:10 Topics: Adamantane; Adult; Aged; Antirheumatic Agents; Arthritis, Rheumatoid; Blood Sedimentation; C-Reactiv	2019

Other Studies

5 other studies available for niacinamide and Infections

Article	Year
Pellagra: A clue as to why energy failure causes diseases? Medical hypotheses, 2007, Volume: 69, Issue:3 Topics: Animals; Biochemistry; Diet; Humans; Infections; Inflammation; Metabolism; Models, Biological; Model	2007
PET imaging of infection with a HYNIC-conjugated LTB4 antagonist labeled with F-18 via hydrazone formation. Nuclear medicine and biology, 2007, Volume: 34, Issue:6 Topics: Abscess; Animals; Escherichia coli Infections; Fluorine Radioisotopes; Hydrazines; Hydrazones; Indic	2007
A disorder of tryptophan metabolism in chronic granulomatous disease. Archives of disease in childhood, 1970, Volume: 45, Issue:242 Topics: Child; Child, Preschool; Chromatography, Paper; Chronic Disease; Granuloma; Humans; Infant, Newborn;	1970
[Problem in psychogeriatrics: quantitative and qualitative cerebral circulation insufficiencies in geriatric medicine]. Zeitschrift fur Alternsforschung, 1971, Volume: 24, Issue:1 Topics: Aged; Aging; Cerebrovascular Disorders; Dietary Proteins; Glucose; Hemodynamics; Humans; Infections;	1971
[Therapeutic value of an association of phospholipids and adrenal cortex in hepatology]. La Clinica terapeutica, 1971, Mar-31, Volume: 56, Issue:6 Topics: Adolescent; Adrenal Cortex Hormones; Adrenal Glands; Adult; Aged; Asthenia; Biliary Tract Diseases;	1971