Page last updated: 2024-10-19

niacinamide and Shingles

niacinamide has been researched along with Shingles in 11 studies

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

Research Excerpts

ExcerptRelevanceReference
" Incidence rates per 100 patient-years of adverse events of special interest were calculated, and Cox proportional hazard analysis was conducted."3.11Impact of age on the efficacy and safety of peficitinib (ASP015K) for the treatment of rheumatoid arthritis. ( Fukuda, M; Kaneko, Y; Kato, D; Miyatake, D; Takeuchi, T; Tanaka, Y, 2022)
" Treatment-emergent adverse events (TEAEs) were reported in 757/843 (89."2.94Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan. ( Chen, YH; Izutsu, H; Kaneko, Y; Kawakami, A; Nakashima, Y; Rokuda, M; Shiomi, T; Song, YW; Takeuchi, T; Tanaka, S; Tanaka, Y; Ushijima, S; Yamada, E, 2020)
" 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."2.90Efficacy 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)
"The treatment of rheumatoid arthritis has changed dramatically over the last two decades since the development of biological disease-modifying anti-rheumatic drugs (bDMARDs)."2.66JAK inhibitors for the treatment of rheumatoid arthritis. ( Morinobu, A, 2020)

Research

Studies (11)

TimeframeStudies, this research(%)All Research%
pre-19902 (18.18)18.7374
1990's0 (0.00)18.2507
2000's1 (9.09)29.6817
2010's3 (27.27)24.3611
2020's5 (45.45)2.80

Authors

AuthorsStudies
Tanaka, Y5
Takeuchi, T5
Kato, D2
Kaneko, Y6
Fukuda, M2
Miyatake, D1
Izutsu, H4
Rokuda, M4
Tanaka, S3
Kawakami, A3
Song, YW2
Chen, YH2
Ushijima, S3
Nakashima, Y1
Shiomi, T3
Yamada, E3
Morinobu, A1
Iwasaki, M2
Katayama, K1
van der Heijde, D1
Wei, JC1
Lee, SH1
Akazawa, R1
Aunhachoke, K1
Bussaratid, V1
Chirachanakul, P1
Chua-Intra, B1
Dhitavat, J1
Jaisathaporn, K1
Kaewkungwal, J1
Kampirapap, K1
Khuhaprema, T1
Pairayayutakul, K1
Pitisuttithum, P1
Sindhvananda, J1
Thaipisuttikul, Y1
NICKEL, G1
WALTHER, H1
KOST, W1
Medhurst, SJ1
Collins, SD1
Billinton, A1
Bingham, S1
Dalziel, RG1
Brass, A1
Roberts, JC1
Medhurst, AD1
Chessell, IP1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K[NCT01638013]Phase 3843 participants (Actual)Interventional2012-06-13Completed
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 3519 participants (Actual)Interventional2014-07-25Completed
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 3509 participants (Actual)Interventional2014-08-08Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants Who Withdrew Due to Lack of Efficacy

Participants who discontinued due to lack of efficacy have been reported. (NCT01638013)
Timeframe: Baseline up to week 372

Interventionpercentage of participants (Number)
Participants Who Completed 015K-CL-RAJ119.4
Participants Who Completed 015K-CL-RAJ34.9
Participants Who Completed 015K-CL-RAJ43.4

Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ4-2.83-2.90-2.99-3.07-3.13-3.11-3.22-3.20-3.21-3.31-3.26-3.33-3.30-3.32-3.18-3.38-3.11-4.29-3.11-2.13
Participants Who Completed 015K-CL-RAJ3-2.70-2.68-2.71-2.85-2.82-2.78-2.91-2.81-2.84-2.92-3.05-2.98-3.00-3.14-3.13-3.08-3.25-3.04-2.69-2.00

Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-0.70-1.03-1.11-1.43-1.66-1.83-1.88-1.96-2.05-2.03-2.14-2.18-2.28-2.28-2.32-2.39-2.45-2.59-2.64-2.54-2.67-2.76-2.67-2.68-2.64-2.73-2.79-2.73-2.80-2.83-2.83-2.75-2.84-2.77-2.76-2.77-2.84-2.62-2.52-3.07-5.13-2.14-1.58

Change From Baseline of Preceding Study CDAI Score Through Week 372

CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-22.70-22.39-22.62-23.41-23.32-23.01-23.45-23.20-23.81-23.81-24.84-24.86-25.06-26.95-25.34-24.54-22.87-25.35-22.24-17.97
Participants Who Completed 015K-CL-RAJ4-23.22-23.21-23.93-24.42-24.66-24.66-25.29-25.16-25.54-26.22-25.74-25.77-25.23-25.64-25.13-26.81-25.93-35.05-24.74-18.78

Change From Baseline of Preceding Study CDAI Score Through Week 372

CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-7.07-9.38-10.19-13.30-15.11-16.35-16.87-17.37-18.06-17.36-18.29-18.90-19.60-19.80-19.79-20.19-20.40-20.92-21.17-20.68-21.46-21.97-21.77-22.06-21.90-22.24-22.95-22.62-22.73-23.11-22.98-22.86-23.58-23.13-23.02-23.26-23.89-22.23-21.08-25.05-50.85-18.05-13.84

Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372

Higher CRP indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionmg/dL (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-1.590-1.528-1.507-1.552-1.604-1.534-1.726-1.501-1.561-1.565-1.730-1.519-1.474-1.731-1.418-2.088-1.501-1.570-1.386-1.262
Participants Who Completed 015K-CL-RAJ4-1.932-1.932-1.991-2.031-2.088-2.063-2.019-1.991-1.983-2.066-1.964-2.058-2.120-2.432-2.211-2.230-2.060-0.950-1.845-1.270

Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372

Higher CRP indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionmg/dL (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-0.334-0.752-0.745-1.032-1.034-1.176-1.242-1.237-1.376-1.296-1.330-1.361-1.361-1.367-1.310-1.456-1.418-1.485-1.562-1.507-1.443-1.609-1.423-1.576-1.170-1.506-1.477-1.374-1.449-1.440-1.488-1.498-1.647-1.580-1.537-1.263-1.565-1.452-1.365-2.179-2.330-1.072-0.967

Change From Baseline of Preceding Study in DAS28-CRP Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOSEOT
Participants Who Completed 015K-CL-RAJ3-2.67-2.64-2.66-2.79-2.77-2.71-2.88-2.77-2.82-2.88-3.02-2.98-2.96-3.15-3.06-3.14-3.14-3.52-2.67-2.01
Participants Who Completed 015K-CL-RAJ4-2.79-2.82-2.93-3.01-3.08-3.06-3.13-3.12-3.16-3.22-3.17-3.19-3.12-3.25-3.16-3.34-3.14-4.01-3.05-2.13

Change From Baseline of Preceding Study in DAS28-CRP Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOSEOT
Participants Who Completed 015K-CL-RAJ1-0.71-1.04-1.09-1.41-1.61-1.76-1.85-1.92-2.03-1.97-2.08-2.12-2.24-2.22-2.25-2.35-2.41-2.49-2.57-2.51-2.58-2.67-2.59-2.61-2.57-2.70-2.76-2.70-2.75-2.77-2.75-2.75-2.86-2.81-2.81-2.79-2.89-2.65-2.53-3.28-4.63-2.14-1.59

Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372

Higher ESR indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionmm/h (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-22.66-22.43-22.91-22.51-23.63-23.34-24.70-22.58-21.71-22.46-24.36-22.13-21.48-23.14-24.95-23.52-38.63-11.00-20.04-14.48
Participants Who Completed 015K-CL-RAJ4-27.02-27.72-28.54-29.41-30.31-30.06-30.06-29.23-29.70-29.97-29.46-30.35-31.44-30.77-29.68-33.46-26.50-57.00-26.36-17.26

Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372

Higher ESR indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionmm/h (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-2.46-6.65-6.93-10.54-11.93-13.39-14.07-14.45-15.15-16.20-16.26-16.27-15.60-16.09-16.71-16.78-16.89-18.81-19.24-19.48-19.43-22.19-20.62-20.58-16.28-18.86-19.05-17.85-20.09-19.24-20.78-19.11-20.21-17.57-19.51-16.81-17.28-17.51-16.53-20.63-28.00-12.52-8.90

Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108

FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108EOTEOS
Participants Who Completed 015K-CL-RAJ11.714.503.294.154.855.915.865.995.955.915.916.066.056.347.185.876.116.10-6.05.953.67

Change From Baseline of Preceding Study in HAQ-DI Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-0.43-0.44-0.43-0.43-0.42-0.43-0.44-0.45-0.42-0.40-0.48-0.49-0.49-0.52-0.41-0.29-0.25-0.75-0.37-0.17
Participants Who Completed 015K-CL-RAJ4-0.49-0.48-0.52-0.52-0.55-0.55-0.56-0.56-0.59-0.60-0.60-0.60-0.58-0.58-0.51-0.52-0.44-0.75-0.51-0.28

Change From Baseline of Preceding Study in HAQ-DI Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-0.03-0.07-0.08-0.13-0.17-0.21-0.22-0.25-0.27-0.27-0.25-0.25-0.26-0.27-0.28-0.29-0.29-0.29-0.30-0.30-0.31-0.33-0.33-0.31-0.32-0.32-0.32-0.35-0.34-0.31-0.35-0.32-0.36-0.34-0.35-0.37-0.35-0.31-0.29-0.41-0.88-0.22-0.08

Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372

"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly." (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-41.57-40.22-40.65-41.60-41.92-41.84-42.48-41.31-43.26-43.55-45.11-45.51-45.70-48.04-45.54-44.62-33.75-30.00-39.86-30.01
Participants Who Completed 015K-CL-RAJ4-43.09-42.77-43.81-44.81-45.71-45.20-47.05-46.42-47.35-48.04-46.99-47.50-45.85-46.65-45.07-46.01-44.50-53.50-45.04-36.11

Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372

"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly." (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-10.77-13.48-16.78-20.59-24.33-26.64-27.12-27.56-29.22-27.80-29.94-31.58-31.60-33.04-32.82-33.68-33.39-34.12-35.70-35.14-37.24-39.11-37.72-39.55-37.34-39.13-40.46-40.80-40.08-41.67-41.55-41.13-42.46-42.21-41.40-42.18-42.73-39.55-38.71-40.25-47.00-30.72-20.31

Change From Baseline of Preceding Study in SDAI Score Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-24.30-23.93-24.13-25.00-24.93-24.54-25.17-24.70-25.37-25.38-26.57-26.38-26.53-28.68-26.75-26.63-24.37-26.92-23.68-19.25
Participants Who Completed 015K-CL-RAJ4-25.12-25.15-25.93-26.45-26.75-26.73-27.31-27.15-27.52-28.28-27.71-27.83-27.38-28.07-27.34-29.04-27.99-36.00-26.58-20.05

Change From Baseline of Preceding Study in SDAI Score Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-7.41-10.13-10.93-14.33-16.14-17.53-18.11-18.61-19.43-18.66-19.62-20.26-20.96-21.17-21.10-21.65-21.82-22.40-22.73-22.18-22.90-23.58-23.19-23.64-23.07-23.75-24.42-24.00-24.18-24.55-24.47-24.36-25.23-24.71-24.56-24.52-25.45-23.68-22.45-27.23-53.18-19.12-14.81

Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

,
Interventionunits on a scale (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ32.942.021.742.872.102.401.562.412.231.54
Participants Who Completed 015K-CL-RAJ42.692.612.892.802.221.621.652.042.312.16

Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

Interventionunits on a scale (Mean)
Week 0Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 192Week 216Week 240Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOT
Participants Who Completed 015K-CL-RAJ13.003.883.854.724.614.976.015.385.135.185.705.795.525.275.285.585.423.894.64-2.524.382.174.093.562.953.454.036.203.7211.124.627.833.782.805.15-3.243.63

Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

,
Interventionunits on a scale (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ35.215.065.065.654.304.555.180.50-0.973.92
Participants Who Completed 015K-CL-RAJ45.455.565.806.375.805.925.434.112.174.74

Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

Interventionunits on a scale (Mean)
Week 0Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 192Week 216Week 240Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOT
Participants Who Completed 015K-CL-RAJ1-0.520.291.301.702.842.331.592.683.751.662.421.932.853.052.560.812.67-1.622.97-5.252.645.752.882.753.503.462.651.823.9912.343.8715.793.54-1.111.64-8.612.06

Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

,
Interventionunits on a scale (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ311.6212.5512.3112.3512.1512.5912.469.6410.4210.29
Participants Who Completed 015K-CL-RAJ411.6013.2313.5213.4814.2014.5914.3813.9412.6012.62

Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

Interventionunits on a scale (Mean)
Week 0Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 192Week 216Week 240Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOT
Participants Who Completed 015K-CL-RAJ1-0.550.301.532.524.103.723.563.974.143.634.274.494.515.894.945.595.020.275.01-7.236.94-31.606.466.436.736.135.97-22.646.214.736.1321.104.33-5.216.920.163.44

Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-37.24-36.80-37.13-37.33-36.12-36.18-36.86-35.33-35.75-35.54-38.88-38.66-38.99-39.62-38.36-38.41-49.90-83.50-33.53-27.86
Participants Who Completed 015K-CL-RAJ4-35.60-34.81-36.25-37.57-37.40-37.46-38.42-38.26-38.50-39.69-39.56-37.79-37.44-38.45-38.89-38.41-42.09-57.00-36.57-22.79

Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-6.82-11.31-13.42-17.89-20.60-23.45-24.35-24.78-27.29-27.78-27.45-29.23-29.01-29.80-30.39-31.18-29.73-32.65-31.75-31.87-32.61-33.67-34.15-33.59-33.56-34.94-35.65-33.69-34.81-35.14-34.84-34.57-36.39-35.51-36.97-37.52-35.50-33.11-28.87-40.29-71.50-26.04-18.67

Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionunits on a scale (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-36.09-35.75-36.38-36.68-35.88-35.77-36.54-35.14-34.55-35.52-38.32-38.30-39.02-40.11-38.27-42.90-50.81-82.50-33.82-29.87
Participants Who Completed 015K-CL-RAJ4-34.79-34.27-36.17-37.30-37.16-36.93-37.36-37.58-37.83-38.72-38.34-36.66-36.34-37.08-36.96-37.85-40.86-58.00-35.84-21.54

Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionunits on a scale (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-7.37-11.21-13.10-17.70-20.54-23.12-24.00-24.41-26.74-27.41-26.73-28.62-29.08-30.08-30.88-30.47-29.41-31.59-31.16-31.92-32.42-33.53-33.61-34.24-33.40-34.50-35.88-33.21-34.44-34.98-34.88-34.81-36.12-34.63-35.73-35.42-33.43-32.56-25.96-35.59-58.60-26.57-19.77

Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionswollen joint count (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-9.6-9.5-9.9-10.3-10.4-10.3-10.3-10.2-10.6-10.7-11.1-11.2-11.2-12.4-11.4-10.6-9.0-6.0-9.7-8.2
Participants Who Completed 015K-CL-RAJ4-10.5-10.4-10.8-11.1-11.0-11.1-11.3-11.2-11.3-11.5-11.4-11.5-11.3-11.4-11.7-11.9-11.3-17.0-11.1-9.3

Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionswollen joint count (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-3.8-4.6-4.8-6.1-6.7-7.1-7.4-7.6-7.6-7.5-7.9-8.1-8.6-8.7-8.4-8.6-8.7-8.8-9.0-8.7-9.0-9.1-8.9-9.2-9.2-9.1-9.5-9.2-9.4-9.7-9.6-9.7-9.9-9.5-9.7-9.4-9.5-9.4-9.4-11.0-18.0-7.8-6.3

Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372

The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventiontender joint count (Mean)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ3-11.7-11.8-11.9-12.4-11.9-11.9-11.9-11.9-12.3-12.3-12.7-12.8-12.9-14.1-11.8-12.2-11.8-8.0-11.5-9.1
Participants Who Completed 015K-CL-RAJ4-11.5-11.8-12.1-12.3-12.3-12.4-12.8-12.9-13.1-13.8-13.5-13.8-13.3-13.3-13.2-14.2-13.2-17.0-12.6-9.4

Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372

The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventiontender joint count (Mean)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ1-4.3-5.3-5.7-7.7-8.7-9.4-9.5-9.8-10.0-9.5-10.0-10.4-10.9-10.7-10.8-10.4-10.7-10.8-10.7-10.6-10.8-11.1-11.2-11.3-11.3-11.4-11.8-11.7-11.7-11.7-11.8-11.7-12.0-11.5-11.5-11.9-12.0-11.5-11.2-13.8-23.0-10.2-8.6

Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

,
Interventionpercent work time missed (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ3-5.36-4.81-4.52-4.73-4.74-5.15-3.21-8.650.00-2.76
Participants Who Completed 015K-CL-RAJ4-2.20-3.29-3.30-3.17-3.13-4.49-1.26-5.19-2.29-1.96

Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

,
Interventionpercent activity impairment (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ3-28.16-27.38-27.81-28.09-27.92-29.26-26.39-20.81-20.00-25.55
Participants Who Completed 015K-CL-RAJ4-25.39-29.31-28.85-31.59-30.69-33.07-31.11-26.53-23.18-27.87

Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

,
Interventionpercent work impairment (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ3-21.05-21.94-20.70-21.06-20.11-24.40-18.08-17.06-15.00-21.49
Participants Who Completed 015K-CL-RAJ4-22.18-24.79-25.17-27.12-28.54-30.00-27.16-23.24-28.00-24.13

Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

,
Interventionpercent overall work impairment (Mean)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ3-22.24-22.45-20.80-21.59-20.58-24.71-18.29-19.03-15.00-20.75
Participants Who Completed 015K-CL-RAJ4-22.20-25.78-25.32-27.41-28.93-31.40-26.76-24.76-28.06-24.63

Number of Participants With Adverse Events

AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug. (NCT01638013)
Timeframe: Baseline up to end of study (EOS) (up to week 376)

,,
InterventionParticipants (Count of Participants)
Adverse Events (AE)Drug related AE (DAE)DeathsSerious AE (SAE)Drug Related serious AE (DSAE)Grade 3 or higher in severity AEAE leading to permanent discontinuation of studyDAE leading to permanent discontinuation of drugSAE leading to permanent discontinuation of drugDSAE leading to permanent discontinuation of drugAE leading to dose reduction of study drugDAE leading to dose reduction of study drugAE leading to temporary discontinuation of drugDAE leading to temporary discontinuation of drug
Participants Who Completed 015K-CL-RAJ1193175059227550302311448167
Participants Who Completed 015K-CL-RAJ3208160156377334182012888676
Participants Who Completed 015K-CL-RAJ4395321184541185644322766191158

Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372

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). (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ318.316.920.229.125.924.129.530.026.628.729.129.330.927.135.123.825.0100.025.77.7
Participants Who Completed 015K-CL-RAJ422.423.026.928.332.728.930.734.033.230.026.331.428.931.131.634.831.8100.031.312.4

Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372

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). (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ11.54.05.04.54.07.17.47.59.210.611.08.311.011.010.811.314.317.518.016.920.618.317.621.621.121.623.425.024.524.225.624.419.825.024.724.123.424.515.025.00.015.910.9

Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission, DAS28-CRP <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ458.260.362.265.469.266.671.170.771.372.776.174.374.872.672.482.668.2100.069.444.9
Participants Who Completed 015K-CL-RAJ355.453.956.358.356.357.163.960.663.662.866.965.566.071.462.266.787.5100.057.235.4

Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission, DAS28-CRP <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ18.013.016.115.120.223.027.426.229.929.130.836.939.939.343.946.751.454.751.157.755.660.059.761.258.864.065.463.561.265.366.762.270.963.167.965.871.960.465.081.30.045.322.8

Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ373.773.172.175.275.675.979.879.480.378.085.184.582.580.078.481.087.5100.071.647.7
Participants Who Completed 015K-CL-RAJ472.774.078.479.382.083.184.583.786.087.686.987.486.785.886.889.190.9100.084.060.7

Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ118.524.525.133.238.942.346.849.751.650.856.459.560.161.364.364.768.675.277.474.677.081.778.276.775.476.683.275.082.780.077.882.286.083.382.783.584.477.480.0100.0100.061.740.6

Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission, DAS28-ESR <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ330.936.135.337.439.136.147.341.039.547.646.647.848.548.654.138.137.50.042.920.0
Participants Who Completed 015K-CL-RAJ438.039.743.345.848.045.451.650.048.752.149.854.355.653.347.455.645.5100.049.820.2

Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission, DAS28-ESR <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ14.54.57.07.612.113.312.713.918.016.918.617.320.920.922.928.726.634.632.331.534.935.032.836.233.639.135.535.943.937.940.032.638.441.735.838.039.132.127.531.30.027.414.9

Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ356.553.054.158.358.457.659.957.956.464.066.267.063.967.164.957.162.5100.054.535.4
Participants Who Completed 015K-CL-RAJ455.759.662.364.765.967.369.969.871.270.871.472.671.167.669.775.668.2100.067.540.4

Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372

DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ18.513.514.614.222.722.423.828.329.531.532.030.438.740.540.143.343.953.751.948.555.658.355.556.057.555.560.754.459.260.060.056.262.857.160.557.060.952.852.550.0100.042.823.8

Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ359.261.559.955.858.259.759.663.357.256.762.857.861.970.062.247.650.0100.055.444.6
Participants Who Completed 015K-CL-RAJ467.065.768.371.470.671.969.969.573.973.873.274.975.076.469.771.759.1100.068.956.2

Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ135.037.040.741.748.051.049.550.354.350.048.348.850.950.354.154.053.651.854.952.353.255.853.853.457.055.051.455.852.050.554.450.054.747.654.351.951.650.947.562.5100.046.844.6

Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372

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. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ361.262.164.962.858.962.867.265.663.062.269.670.771.168.673.071.487.5100.062.340.0
Participants Who Completed 015K-CL-RAJ462.163.065.564.365.467.168.869.269.167.468.168.069.967.068.473.959.10.063.648.3

Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372

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. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ137.038.538.739.742.946.947.448.750.550.051.252.455.254.055.460.062.962.062.463.166.766.765.567.268.467.667.372.170.468.468.967.872.170.269.167.170.362.360.056.3100.052.735.6

Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

,
Interventionpercentage of participants (Number)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ339.937.233.239.333.537.230.932.437.535.8
Participants Who Completed 015K-CL-RAJ437.437.639.235.838.433.828.734.231.834.6

Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

Interventionpercentage of participants (Number)
Week 0Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 192Week 216Week 240Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOT
Participants Who Completed 015K-CL-RAJ143.042.747.243.445.445.351.947.848.347.749.449.151.548.653.757.149.650.045.4047.5041.439.637.542.143.310041.710043.033.337.722.243.8039.8

Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

,
Interventionpercentage of participants (Number)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ37070.573.068.371.768.266.070.362.561.0
Participants Who Completed 015K-CL-RAJ471.174.174.773.975.979.382.477.677.3306

Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

Interventionpercentage of participants (Number)
Week 0Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 192Week 216Week 240Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOT
Participants Who Completed 015K-CL-RAJ134.033.740.239.443.440.044.442.944.445.347.047.245.447.847.750.643.850.044.6053.3050.052.351.953.752.2048.8048.166.743.411.156.3041.8

Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

,
Interventionpercentage of participants (Number)
Week 0Week 24Week 48Week 72Week 96Week 120Week 144Week 168Week 192EOT
Participants Who Completed 015K-CL-RAJ344.847.846.447.542.845.351.535.125.043.1
Participants Who Completed 015K-CL-RAJ448.548.047.146.748.249.348.540.831.844.7

Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT

Interventionpercentage of participants (Number)
Week 0Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 192Week 216Week 240Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOT
Participants Who Completed 015K-CL-RAJ126.027.635.739.939.838.436.439.140.033.138.738.740.539.938.929.938.7039.2038.310039.738.740.041.137.8042.9100.045.683.339.622.231.30.039.8

Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372

CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ323.724.229.330.633.528.336.633.937.637.239.944.042.341.451.433.325.00.034.512.3
Participants Who Completed 015K-CL-RAJ430.630.636.039.142.240.742.442.642.740.439.042.344.940.643.443.545.5100.042.525.8

Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372

CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ13.04.04.56.05.67.78.911.814.116.815.113.715.319.614.018.720.023.426.323.125.425.019.328.428.130.629.933.733.734.730.031.131.438.130.931.634.426.420.031.30.024.914.9

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ494.694.996.296.997.396.196.396.497.798.196.797.796.398.198.797.895.5100.095.483.1
Participants Who Completed 015K-CL-RAJ394.292.795.295.194.993.795.195.094.293.998.094.090.797.194.695.287.5100.089.280.0

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ148.560.565.875.479.881.684.284.588.088.391.392.993.392.094.992.792.194.295.593.192.195.094.194.093.995.596.394.293.994.793.391.195.394.093.894.998.498.192.5100.0100.078.672.3

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ389.791.392.392.294.492.191.292.794.291.593.989.687.695.786.590.587.5100.087.180.0
Participants Who Completed 015K-CL-RAJ493.492.295.495.595.194.996.095.997.197.496.297.797.096.296.193.395.5100.093.782.0

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ141.554.559.370.175.878.185.284.087.484.891.389.393.392.693.090.789.992.692.591.592.193.394.192.293.894.595.393.292.992.692.292.194.292.995.194.996.994.392.5100.0100.076.667.3

Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ371.070.370.272.373.171.776.575.077.575.683.880.280.475.775.776.287.5100.069.443.1
Participants Who Completed 015K-CL-RAJ471.072.377.278.280.182.384.082.084.085.885.485.785.284.986.884.886.4100.083.358.4

Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ111.518.019.627.134.836.243.744.447.846.449.453.053.456.458.059.363.672.372.970.873.878.374.873.371.974.877.673.179.678.976.780.081.478.680.281.079.771.775.0100.0100.058.738.6

Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ354.750.752.754.956.355.558.254.554.761.664.264.360.865.764.957.162.5100.052.235.4
Participants Who Completed 015K-CL-RAJ454.558.161.663.765.166.568.568.669.668.969.571.468.967.668.473.363.6100.065.840.4

Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372

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. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ17.011.513.113.721.721.923.327.329.030.930.828.636.838.039.542.743.951.550.446.254.056.753.855.256.654.559.852.458.256.857.856.260.554.858.054.459.450.952.550.0100.041.320.8

Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372

SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ324.627.428.431.632.530.437.735.637.639.640.541.441.242.951.442.925.00.036.013.8
Participants Who Completed 015K-CL-RAJ432.631.437.140.942.841.643.342.342.042.738.044.045.242.544.745.750.0100.043.424.7

Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372

SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ14.05.06.05.56.18.710.013.415.216.216.912.516.618.414.021.321.424.125.624.628.627.524.428.427.233.330.833.737.837.931.135.632.638.133.332.934.428.322.531.30.023.913.9

Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372

ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ380.380.784.582.482.781.784.280.083.279.383.180.284.590.073.081.062.5100.074.667.7
Participants Who Completed 015K-CL-RAJ485.785.388.891.188.888.590.389.690.290.690.690.991.991.590.893.595.5100.087.468.5

Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372

ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ128.537.042.245.752.061.263.263.665.263.166.367.970.674.273.276.774.377.475.276.977.881.777.377.680.780.282.278.880.676.877.874.479.173.875.378.579.775.565.081.3100.064.253.5

Percentage of Participants With an ACR50-CRP Response Through Week 372

ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ362.860.163.865.967.364.466.163.964.264.667.672.468.075.770.371.462.5100.059.841.5
Participants Who Completed 015K-CL-RAJ467.567.473.174.575.777.579.175.177.577.976.178.377.274.578.976.177.3100.073.847.2

Percentage of Participants With an ACR50-CRP Response Through Week 372

ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ18.59.514.123.128.330.134.736.940.838.041.342.946.648.549.055.352.154.756.456.259.563.362.264.761.463.168.261.564.361.162.263.365.161.963.059.562.560.450.068.8100.045.831.7

Percentage of Participants With an ACR50-ESR Response Through Week 372

ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of Participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ358.358.360.964.462.262.865.061.761.863.464.971.666.070.067.661.962.5100.058.938.5
Participants Who Completed 015K-CL-RAJ465.366.471.172.274.174.776.873.774.675.375.675.477.272.676.373.972.7100.072.346.1

Percentage of Participants With an ACR50-ESR Response Through Week 372

ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of Participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ18.09.013.121.624.229.131.133.238.634.638.441.144.845.445.951.349.354.754.955.458.760.861.363.857.960.463.658.763.356.857.855.659.358.360.555.754.756.645.062.5100.045.828.7

Percentage of Participants With an ACR70-CRP Response Through Week 372

ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ342.240.440.642.441.345.542.644.443.947.648.648.348.548.648.647.650.0100.039.724.6
Participants Who Completed 015K-CL-RAJ445.946.151.550.954.853.756.755.356.057.352.655.452.948.152.658.759.1100.053.433.7

Percentage of Participants With an ACR70-CRP Response Through Week 372

ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ13.54.56.09.012.112.213.217.118.517.922.722.623.925.224.226.729.329.935.335.436.536.739.539.742.144.146.741.343.944.246.743.344.241.740.746.850.041.527.550.00.029.919.8

Percentage of Participants With an ACR70-ESR Response Through Week 372

ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ336.836.236.238.038.341.438.840.039.942.743.939.742.347.145.947.650.0100.038.420.0
Participants Who Completed 015K-CL-RAJ441.342.947.044.650.150.851.951.552.852.149.353.149.346.250.056.559.1100.050.732.6

Percentage of Participants With an ACR70-ESR Response Through Week 372

ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ12.54.05.57.010.19.711.112.816.317.322.120.219.622.121.025.327.128.534.632.334.134.237.837.136.842.344.942.343.941.142.240.038.439.335.843.043.835.827.537.50.028.417.8

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372

"ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.~EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT." (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

,
Interventionpercentage of participants (Number)
Week 0Week 12Week 24Week 36Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204EOTEOS
Participants Who Completed 015K-CL-RAJ382.581.285.583.983.781.786.380.685.079.384.581.085.690.075.781.062.5100.074.669.2
Participants Who Completed 015K-CL-RAJ486.285.089.191.990.289.090.089.990.691.091.191.491.993.493.493.595.5100.087.968.5

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372

"ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.~EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT." (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS

Interventionpercentage of participants (Number)
Week 0Week 2Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 60Week 72Week 84Week 96Week 108Week 120Week 132Week 144Week 156Week 168Week 180Week 192Week 204Week 216Week 228Week 240Week 252Week 264Week 276Week 288Week 300Week 312Week 324Week 336Week 348Week 360Week 372EOTEOS
Participants Who Completed 015K-CL-RAJ129.537.042.247.255.159.763.763.665.262.668.070.273.076.173.277.376.478.177.478.579.483.379.077.679.882.983.280.880.678.978.975.681.476.276.581.082.875.570.087.5100.064.752.5

Change From Baseline in CRP at Week 12

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

Interventionmg/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

Interventionunits 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

Interventionunits 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

Interventionmm/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

Interventionunits on a scale (Mean)
Placebo0.01
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

Interventionunits on a scale (Mean)
Placebo3.37
Peficitinib 100 mg1.62
Peficitinib 150 mg1.03

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

Interventionunits on a scale (Mean)
Placebo6.27
Peficitinib 100 mg2.12
Peficitinib 150 mg1.54

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

Interventionpercent 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

Interventionunits 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

Interventionunits 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

Interventionunits on a scale (Mean)
Placebo1.07
Peficitinib 100 mg3.28
Peficitinib 150 mg2.50

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline and week 12/ET

Interventionunits on a scale (Mean)
Placebo-0.09
Peficitinib 100 mg2.30
Peficitinib 150 mg3.90

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

Interventionunits 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

Interventionunits 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

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

Interventionunits on a scale (Mean)
Placebo0.57
Peficitinib 100 mg6.60
Peficitinib 150 mg9.02

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

Interventionswollen 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

Interventiontender 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

Interventionpercent work time missed (Mean)
Placebo-0.82
Peficitinib 100 mg0.36
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

Interventionpercent 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

Interventionpercent 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

InterventionParticipants (Count of Participants)
Peficitinib 100 mg10
Peficitinib 150 mg6
Placebo / Peficitinib 100 mg3
Placebo / Peficitinib 150 mg9

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

Interventionpercentage of participants (Number)
Placebo0.6
Peficitinib 100 mg5.8
Peficitinib 150 mg9.9

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

Interventionpercentage of participants (Number)
Placebo7.7
Peficitinib 100 mg31.4
Peficitinib 150 mg35.1

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

Interventionpercentage of participants (Number)
Placebo12.4
Peficitinib 100 mg47.1
Peficitinib 150 mg57.9

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

Interventionpercentage of participants (Number)
Placebo2.4
Peficitinib 100 mg12.8
Peficitinib 150 mg19.3

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

Interventionpercentage of participants (Number)
Placebo4.7
Peficitinib 100 mg25.0
Peficitinib 150 mg36.3

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

Interventionpercentage of participants (Number)
Placebo0.6
Peficitinib 100 mg7.0
Peficitinib 150 mg14.0

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

Interventionpercentage of participants (Number)
Placebo32.0
Peficitinib 100 mg74.4
Peficitinib 150 mg78.9

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

Interventionpercentage of participants (Number)
Placebo4.1
Peficitinib 100 mg23.8
Peficitinib 150 mg34.5

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

Interventionpercentage of participants (Number)
Placebo10.1
Peficitinib 100 mg43.0
Peficitinib 150 mg55.6

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

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Week 12/ET

Interventionpercentage of participants (Number)
Placebo35.5
Peficitinib 100 mg77.9
Peficitinib 150 mg84.8

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

Interventionpercentage of participants (Number)
Placebo7.6
Peficitinib 100 mg29.9
Peficitinib 150 mg46.0

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

Interventionpercentage of participants (Number)
Placebo2.4
Peficitinib 100 mg12.1
Peficitinib 150 mg23.6

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)

Interventionpercentage of participants (Number)
Placebo21.8
Peficitinib 100 mg58.6
Peficitinib 150 mg64.4

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

,
Interventionmg/dL (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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 12-0.28-0.210.24-1.11-1.69-2.01-2.24-2.49-2.49-2.66-2.68-2.86-2.80-2.61
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 12-0.30-0.100.27-1.37-1.76-2.26-2.51-2.72-2.70-2.72-2.72-2.90-2.74-2.52
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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 12-0.26-0.240.24-1.01-1.61-1.94-2.11-2.39-2.45-2.60-2.63-2.80-2.77-2.60
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 12-0.26-0.120.25-1.38-1.78-2.24-2.48-2.68-2.71-2.78-2.76-2.88-2.78-2.56
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

,,
Interventionunits on a scale (Mean)
Week 28/ETWeek 52/ET
Peficitinib 100 mg0.630.82
Peficitinib 150 mg0.180.32
Placebo1.352.52

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

,
Interventionmm/h (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

,,
Interventionunits on a scale (Mean)
Week 28/ETWeek 52/ET
Peficitinib 100 mg0.991.30
Peficitinib 150 mg0.821.19
Placebo1.903.55

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

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 28, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
Peficitinib 100 mg1.452.723.443.062.622.21
Peficitinib 150 mg1.332.442.673.121.851.67

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
Peficitinib 100 mg3.844.926.689.8911.279.92
Peficitinib 150 mg5.777.919.3212.4412.4511.51

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
Peficitinib 100 mg1.412.502.324.064.303.49
Peficitinib 150 mg1.703.303.924.817.175.88

Change From Baseline in SGA Through Week 52

The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionswollen joint count (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventiontender joint count (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

,
Interventionpercent activity impairment (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
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

,
Interventionpercent work impairment (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
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

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, weeks 4, 8, 12, 28, 52 and EOT

,
Interventionpercent overall work impairment (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
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

,
Interventionpercent work time missed (Mean)
Week 4Week 8Week 12Week 28Week 52EOT
Peficitinib 100 mg-0.90-1.48-0.70-0.58-1.93-1.76
Peficitinib 150 mg0.02-1.73-1.97-3.49-1.66-1.66

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

,,,,
InterventionParticipants (Count of Participants)
TEAEsDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEs≥ Grade 3 TEAEsTEAEs leading to permanent discontinuationDrug-Related TEAE leading to permanent dicont.
Peficitinib 100 mg9563053743
Peficitinib 150 mg10472031611
Placebo5027022543
Placebo / Peficitinib 100 mg at Week 122116000100
Placebo / Peficitinib 150 mg at Week 122511000100

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

,,,,,
InterventionParticipants (Count of Participants)
TEAEsDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEs≥ Grade 3 TEAEsTEAEs leading to permanent discontinuation
Peficitinib 100 mg114720104154
Peficitinib 150 mg11274085156
Placebo / Peficitinib 100 mg at Week 12221402223
Placebo / Peficitinib 100 mg at Week 28251711022
Placebo / Peficitinib 150 mg at Week 12271801122
Placebo / Peficitinib 150 mg at Week 28261701120

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

,,
InterventionParticipants (Count of Participants)
TEAEsDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEs≥ Grade 3 TEAEsTEAEs leading to permanent discontinuationDrug-Related AE leading to permanent discont.
Peficitinib 100 mg8957053953
Peficitinib 150 mg104800331655
Placebo8447042876

Percentage of Participants Achieving ACR / EULAR Remission Through Week 52

ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg1.21.26.09.011.011.814.617.217.019.116.117.621.419.2
Peficitinib 150 mg1.23.610.212.114.118.120.125.827.720.920.321.226.523.4

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

,,
Interventionpercentage of participants (Number)
Week 28/ETWeek 52/ET
Peficitinib 100 mg67.164.0
Peficitinib 150 mg72.668.9
Placebo45.842.5

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

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg11.219.031.039.245.751.651.954.153.659.957.056.160.056.4
Peficitinib 150 mg14.721.736.143.052.156.952.852.953.558.855.660.362.657.9
Placebo / Peficitinib 100 mg at Week 120.00.00.08.121.627.830.644.450.042.950.054.554.554.1
Placebo / Peficitinib 100 mg at Week 2815.410.320.520.517.920.525.630.835.161.155.662.955.956.4
Placebo / Peficitinib 150 mg at Week 120.00.00.013.516.233.338.950.048.650.042.454.539.434.2
Placebo / Peficitinib 150 mg at Week 285.911.811.88.829.432.426.544.154.554.557.666.763.664.7

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

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg22.436.347.055.462.267.167.765.669.376.370.573.671.766.9
Peficitinib 150 mg24.144.059.663.669.971.976.770.373.580.482.478.877.671.3

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

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg4.18.913.118.122.628.030.433.832.737.134.033.338.634.9
Peficitinib 150 mg5.912.719.924.233.131.332.141.340.036.237.340.442.938.6
Placebo / Peficitinib 100 mg at Week 120.00.00.00.05.45.611.122.213.920.017.621.227.324.3
Placebo / Peficitinib 100 mg at Week 282.62.65.110.37.712.812.815.413.522.225.034.326.525.6
Placebo / Peficitinib 150 mg at Week 120.00.00.010.810.827.822.230.637.135.324.239.436.431.6
Placebo / Peficitinib 150 mg at Week 280.02.95.92.95.95.98.826.524.230.330.336.439.441.2

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

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg10.617.925.634.944.552.249.452.253.658.353.755.855.250.6
Peficitinib 150 mg12.929.537.344.248.557.556.056.156.860.560.862.960.557.3

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

SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg1.23.07.114.518.320.522.225.524.231.627.525.730.328.5
Peficitinib 150 mg2.48.414.518.220.922.523.328.432.928.830.132.539.535.1

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

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg55.972.075.080.782.387.688.090.494.192.796.694.693.886.0
Peficitinib 150 mg68.276.580.187.992.091.991.292.994.894.194.195.494.690.6

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

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg19.430.442.951.859.165.263.363.167.373.765.871.669.064.5
Peficitinib 150 mg21.841.057.260.068.170.074.269.072.979.181.078.176.970.8

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

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg7.616.124.434.343.351.648.151.053.657.652.453.753.849.4
Peficitinib 150 mg12.428.335.543.646.055.654.154.854.858.659.560.959.256.1

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

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg67.173.878.684.386.689.491.193.094.892.895.395.395.288.4
Peficitinib 150 mg77.180.185.589.191.495.693.794.295.596.194.197.494.692.4

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

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg38.251.259.570.574.474.579.179.678.480.979.983.884.876.4
Peficitinib 150 mg48.262.066.377.079.885.083.085.286.586.986.989.487.181.0
Placebo / Peficitinib 100 mg at Week 128.110.80.043.259.563.972.277.880.680.076.581.875.873.0
Placebo / Peficitinib 100 mg at Week 2838.533.351.364.161.559.064.184.678.488.988.985.791.292.3
Placebo / Peficitinib 150 mg at Week 122.70.00.051.467.680.683.386.185.788.290.990.990.978.9
Placebo / Peficitinib 150 mg at Week 2814.729.438.258.861.852.964.776.575.878.887.990.990.991.2

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

ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg10.019.629.846.451.256.553.859.255.661.857.760.866.960.3
Peficitinib 150 mg15.933.148.253.954.660.663.565.867.768.071.264.968.062.6
Placebo / Peficitinib 100 mg at Week 122.72.70.013.535.147.250.052.858.348.652.960.663.662.2
Placebo / Peficitinib 100 mg at Week 2810.312.823.138.535.933.328.256.464.966.772.271.467.669.2
Placebo / Peficitinib 150 mg at Week 120.00.00.021.637.852.869.461.171.467.672.769.763.655.3
Placebo / Peficitinib 150 mg at Week 280.02.95.98.829.429.423.552.960.666.763.666.769.770.6

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

ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Peficitinib 100 mg1.27.712.524.126.231.729.136.334.034.938.333.839.335.1
Peficitinib 150 mg4.113.924.732.135.036.042.843.947.141.848.449.052.448.3
Placebo / Peficitinib 100 mg at Week 120.00.00.05.48.122.233.333.333.331.441.245.542.440.5
Placebo / Peficitinib 100 mg at Week 282.62.67.712.812.817.917.920.513.536.138.945.744.143.6
Placebo / Peficitinib 150 mg at Week 120.00.00.02.72.716.738.944.442.938.236.442.448.542.1
Placebo / Peficitinib 150 mg at Week 280.00.02.92.92.92.98.820.633.333.339.439.448.550.0

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

InterventionUnits 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

Interventionmg/dL (Mean)
Placebo0.022
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

InterventionUnits 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

InterventionUnits 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

Interventionmm/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

InterventionUnits on a Scale (Mean)
Placebo0.03
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

InterventionPercent iImpairment (Mean)
Placebo3.62
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

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

InterventionUnits 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

InterventionUnits 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

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

InterventionUnits on a Scale (Mean)
Placebo0.00
Peficitinib 100 mg2.70
Peficitinib 150 mg3.69
Etanercept3.23

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 12/ET

InterventionUnits on a Scale (Mean)
Placebo0.17
Peficitinib 100 mg1.24
Peficitinib 150 mg7.04
Etanercept7.16

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 12/ET

InterventionUnits on a Scale (Mean)
Placebo1.95
Peficitinib 100 m8.36
Peficitinib 150 mg8.81
Etanercept8.53

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

InterventionUnits 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

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

InterventionUnits 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

InterventionTender 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

InterventionTender 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

InterventionPercent Work Time (Mean)
Placebo6.78
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

InterventionPercent 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

InterventionPercent Impairment (Mean)
Placebo4.13
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

InterventionParticipants (Count of Participants)
Placebo7
Peficitinib 100 mg1
Peficitinib 150 mg1
Etanercept1

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

InterventionPercentage of Participants (Number)
Placebo2.0
Peficitinib 100 mg5.9
Peficitinib 150 mg5.9
Etanercept13.5

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

InterventionPercentage of Participants (Number)
Placebo0.0
Peficitinib 100 mg8.7
Peficitinib 150 mg9.9
Etanercept19.0

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

InterventionPercentage of Participants (Number)
Placebo5.0
Peficitinib 100 mg24.5
Peficitinib 150 mg34.7
Etanercept45.5

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

InterventionPercentage of Participants (Number)
Placebo11.0
Peficitinib 100 mg40.2
Peficitinib 150 mg53.5
Etanercept68.0

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

InterventionPercentage of Participants (Number)
Placebo1.0
Peficitinib 100 mg11.7
Peficitinib 150 mg17.8
Etanercept31.7

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

InterventionPercentage of Participants (Number)
Placebo7.0
Peficitinib 100 mg19.4
Peficitinib 150 mg37.6
Etanercept49.7

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

InterventionPercentage of Participants (Number)
Placebo0.0
Peficitinib 100 mg8.8
Peficitinib 150 mg8.9
Etanercept18.5

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

InterventionPercentage of Participants (Number)
Placebo9.1
Peficitinib 100 mg38.6
Peficitinib 150 mg51.5
Etanercept65.5

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

InterventionPercentage of Participants (Number)
Placebo5.1
Peficitinib 100 mg18.6
Peficitinib 150 mg36.6
Etanercept49.0

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

InterventionPercentage of Participants (Number)
Placebo41.4
Peficitinib 100 mg75.2
Peficitinib 150 mg92.1
Etanercept92.5

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

InterventionPercentage of Participants (Number)
Placebo37.8
Peficitinib 100 mg69.6
Peficitinib 150 mg88.1
Etanercept90.9

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)

InterventionPercentage of Participants (Number)
Placebo30.7
Peficitinib 100 mg57.7
Peficitinib 150 mg74.5
Etanercept83.5

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

InterventionPercentage of Participants (Number)
Placebo8.9
Peficitinib 100 mg30.8
Peficitinib 150 mg42.2
Etanercept52.5

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

InterventionPercentage of Participants (Number)
Placebo1.0
Peficitinib 100 mg13.5
Peficitinib 150 mg27.5
Etanercept30.5

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

,,,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

,,,,
Interventionmg/dL (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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 mg0.0130.1980.026-0.802-0.581-0.434-1.013-1.239-1.084-1.325-1.292-1.610-1.566-0.797
Placebo / Peficitinib 150 mg0.073-0.076-0.142-1.180-1.294-1.318-1.266-0.975-1.192-1.232-1.225-1.407-1.534-0.987

Change From Baseline in DAS28-ESR Through Week 52

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

,,,,
Interventionmm/hour (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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 mg0.010.020.03-0.12-0.21-0.26-0.23-0.29-0.25-0.28-0.27-0.31-0.29-0.24

Change From Baseline in PGA Through Week 52

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. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 28Week 52
Etanercept2.853.563.633.803.79
Peficitinib 100 mg1.532.912.382.954.23
Peficitinib 150 mg1.723.554.013.524.39

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 28Week 52
Etanercept6.107.358.4010.2811.18
Peficitinib 100 mg3.826.439.9310.8513.07
Peficitinib 150 mg3.206.789.6310.959.88

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

The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 28Week 52
Etanercept4.066.517.497.318.36
Peficitinib 100 mg0.403.801.684.183.88
Peficitinib 150 mg4.275.967.828.789.15

Change From Baseline in SGA Through Week 52

The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionSwollen Joints (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionUnits on a Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionTender Joints (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
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

,,
Interventionpercent impairment (Mean)
Week 4Week 8Week 12Week 28Week 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

,,
Interventionpercent impairment (Mean)
Week 4Week 8Week 12Week 28Week 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

,,
InterventionPercent Impairment (Mean)
Week 4Week 8Week 12Week 28Week 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

,,
InterventionPercent Work Time (Mean)
Week 4Week 8Week 12Week 28Week 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

,,,
InterventionParticipants (Count of Participants)
TEAEsDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEs≥ Grade 3 TEAEsTEAEs leading to discontinuationDrug-related TEAEs leading to discontinuationSerious TEAEs leading to discontinuationDrug-related serious TEAEs leading to discont.
Etanercept1197504465522
Peficitinib 100 mg493303266421
Peficitinib 150 mg553802133221
Placebo542904384121

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

,,,,
InterventionParticipants (Count of Participants)
TEAEsDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEs≥ Grade 3 TEAEsTEAEs leading to discontinuationDrug-related TEAEs leading to discontinuationSerious TEAEs leading to discontinuationDrug-related serious TEAEs leading to discont.
Etanercept156930145238632
Peficitinib 100 mg785005297342
Peficitinib 150 mg7947062163200
Placebo / Peficitinib 100 mg412704222211
Placebo / Peficitinib 150 mg3726052124422

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept7.011.814.118.620.928.024.325.022.324.325.127.430.225.0
Peficitinib 100 mg1.02.16.311.812.013.812.013.616.516.016.017.618.314.7
Peficitinib 150 mg0.01.06.58.613.010.118.020.918.619.824.725.018.515.8
Placebo / Peficitinib 100 mg0.02.30.04.84.85.09.810.88.17.920.025.722.920.9
Placebo / Peficitinib 150 mg0.00.04.32.16.58.910.911.17.014.37.715.410.58.5

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept9.014.419.923.928.031.931.632.430.331.833.336.338.332.5
Peficitinib 100 mg1.04.29.414.018.516.120.517.319.022.421.323.021.118.4
Peficitinib 150 mg2.06.110.916.117.415.627.027.926.729.136.534.527.223.8
Placebo / Peficitinib 100 mg0.00.00.02.42.47.514.616.218.913.225.728.622.920.9
Placebo / Peficitinib 150 mg0.00.00.06.410.915.617.413.37.021.415.423.118.417.0

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept26.037.447.653.259.359.961.668.261.768.869.670.867.961.5
Peficitinib 100 mg10.219.825.035.537.037.936.138.349.445.346.743.243.739.2
Peficitinib 150 mg5.023.537.039.851.151.755.155.854.753.557.661.966.759.4
Placebo / Peficitinib 100 mg0.09.37.121.416.725.034.137.843.236.848.651.445.741.9
Placebo / Peficitinib 150 mg2.12.14.323.432.633.341.337.839.545.241.056.455.351.1

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept47.059.570.273.475.877.581.983.083.485.083.086.389.581.5
Peficitinib 100 mg18.432.341.752.755.450.655.458.063.362.761.364.963.454.9
Peficitinib 150 mg21.040.855.464.567.474.276.470.975.676.775.381.084.077.2
Placebo / Peficitinib 100 mg4.711.614.333.345.235.041.551.456.857.957.160.054.348.8
Placebo / Peficitinib 150 mg4.312.810.644.747.862.263.055.667.471.474.479.581.676.6

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept14.527.733.235.138.141.439.843.440.043.943.347.643.239.5
Peficitinib 100 mg2.08.411.518.322.023.027.722.225.328.932.024.325.423.3
Peficitinib 150 mg4.013.319.626.128.634.134.830.241.244.248.239.334.628.7
Placebo / Peficitinib 100 mg0.00.02.411.914.615.426.819.425.032.435.337.129.426.2
Placebo / Peficitinib 150 mg2.10.00.014.919.617.821.724.418.628.628.238.528.927.7

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept33.042.651.153.756.958.660.865.762.367.164.372.662.358.0
Peficitinib 100 mg9.220.019.832.336.337.936.142.048.151.348.045.945.138.8
Peficitinib 150 mg10.024.539.142.451.650.059.654.761.259.360.061.969.161.4
Placebo / Peficitinib 100 mg0.09.37.121.419.523.136.638.941.743.250.054.341.238.1
Placebo / Peficitinib 150 mg4.32.28.525.534.837.841.340.037.247.646.253.852.646.8

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept10.016.919.423.929.734.133.935.230.933.534.539.339.533.5
Peficitinib 100 mg1.04.29.412.917.418.419.316.021.524.022.718.921.117.6
Peficitinib 150 mg1.06.19.815.118.518.029.227.927.936.038.838.129.625.7
Placebo / Peficitinib 100 mg0.00.00.02.44.810.017.113.518.910.520.028.620.018.6
Placebo / Peficitinib 150 mg0.00.00.08.515.217.817.413.34.719.015.425.621.117.0

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept44.556.467.572.975.876.480.883.083.484.482.585.188.380.0
Peficitinib 100 mg17.328.139.648.451.147.150.654.359.558.758.760.859.252.5
Peficitinib 150 mg16.039.853.360.265.271.974.268.674.475.674.179.881.575.2
Placebo / Peficitinib 100 mg4.811.912.234.146.333.340.050.055.654.155.955.952.947.6
Placebo / Peficitinib 150 mg2.16.48.540.443.557.858.746.762.866.771.879.578.972.3

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept31.741.250.052.756.456.459.763.462.367.163.772.661.757.3
Peficitinib 100 mg8.216.818.831.234.135.632.539.544.347.445.341.943.738.2
Peficitinib 150 mg10.024.538.040.251.650.059.654.760.059.360.061.969.161.4
Placebo / Peficitinib 100 mg0.09.54.922.020.021.135.037.140.041.748.552.939.436.6
Placebo / Peficitinib 150 mg2.20.06.521.731.134.137.836.433.343.943.652.648.643.5

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

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: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept87.592.394.296.895.697.399.498.397.7100.099.498.298.895.5
Peficitinib 100 mg63.376.077.181.779.385.189.291.487.389.393.390.591.578.2
Peficitinib 150 mg72.086.794.692.596.796.695.596.596.596.594.197.698.893.1
Placebo / Peficitinib 100 mg31.047.641.573.278.071.880.083.386.186.588.294.194.183.3
Placebo / Peficitinib 150 mg40.440.448.985.191.391.187.082.286.085.787.289.792.185.1

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

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: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept81.992.892.694.793.996.197.797.196.698.398.298.298.193.5
Peficitinib 100 mg56.166.370.876.379.182.884.390.183.589.590.786.584.574.5
Peficitinib 150 mg65.084.790.288.096.795.592.194.295.395.392.995.297.594.1
Placebo / Peficitinib 100 mg31.045.239.073.272.573.777.577.185.783.384.888.284.875.6
Placebo / Peficitinib 150 mg23.933.343.576.186.790.988.986.483.385.487.289.589.282.6

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

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of Treatment (EOT)
Etanercept61.080.584.886.788.590.192.788.192.092.591.290.590.786.5
Peficitinib 100 mg43.951.059.464.564.163.272.376.572.273.774.774.373.265.4
Peficitinib 150 mg45.068.777.279.681.585.687.688.490.790.788.290.590.184.3
Placebo / Peficitinib 100 mg21.438.131.758.551.261.560.063.966.767.679.473.579.467.4
Placebo / Peficitinib 150 mg19.125.534.061.771.771.167.473.376.783.384.682.181.674.5

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

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept29.547.255.060.666.564.869.570.570.373.470.275.677.269.0
Peficitinib 100 mg8.225.032.343.041.343.744.650.653.247.450.748.649.343.3
Peficitinib 150 mg14.035.445.745.254.362.260.765.168.669.869.473.875.366.7
Placebo / Peficitinib 100 mg4.84.87.331.722.038.540.052.847.245.950.058.847.141.9
Placebo / Peficitinib 150 mg2.16.412.825.543.544.450.044.444.252.453.869.265.855.3

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

"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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,
InterventionPercentage of Participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52EOT
Etanercept14.520.531.937.841.844.548.047.744.649.752.054.256.248.0
Peficitinib 100 mg1.011.514.623.726.128.725.328.431.628.930.733.835.231.7
Peficitinib 150 mg2.014.129.328.030.440.038.239.543.047.749.451.248.142.2
Placebo / Peficitinib 100 mg0.00.00.07.37.315.420.025.027.827.041.232.438.234.9
Placebo / Peficitinib 150 mg0.02.12.18.519.622.217.424.418.635.728.238.542.134.0

Reviews

3 reviews available for niacinamide and Shingles

ArticleYear
A pooled analysis of serious infections and herpes zoster-related disease in Asian patients with rheumatoid arthritis treated with peficitinib (ASP015K) over a median of 3 years.
    Modern rheumatology, 2022, Jul-01, Volume: 32, Issue:4

    Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Herpes Zoster; Humans; Niacinamide; Prednis

2022
JAK inhibitors for the treatment of rheumatoid arthritis.
    Immunological medicine, 2020, Volume: 43, Issue:4

    Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Azetidines; Benzofurans; Cardiovascular Dis

2020
Efficacy and safety of peficitinib in rheumatoid arthritis.
    Modern rheumatology, 2020, Volume: 30, Issue:5

    Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Clinical Trials, Phase II as Topic; Herpes

2020

Trials

4 trials available for niacinamide and Shingles

ArticleYear
Impact of age on the efficacy and safety of peficitinib (ASP015K) for the treatment of rheumatoid arthritis.
    Modern rheumatology, 2022, Jul-01, Volume: 32, Issue:4

    Topics: Adamantane; Adult; Age Factors; Aged; Antirheumatic Agents; Arthritis, Rheumatoid; Herpes Zoster; Hu

2022
Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan.
    Arthritis research & therapy, 2020, 03-12, Volume: 22, Issue:1

    Topics: Adamantane; Adult; Aged; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive Protein; Female; He

2020
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

4 other studies available for niacinamide and Shingles

ArticleYear
Measuring herpes zoster, zoster-associated pain, post-herpetic neuralgia-associated loss of quality of life, and healthcare utilization and costs in Thailand.
    International journal of dermatology, 2011, Volume: 50, Issue:4

    Topics: Adult; Aged; Ambulatory Care; Cohort Studies; Female; Health Expenditures; Herpes Zoster; Humans; Im

2011
[1ST TRIALS WITH MEDIVITAN IN HERPES ZOSTER].
    Therapie der Gegenwart, 1963, Volume: 102

    Topics: Corrinoids; Folic Acid; Herpes Zoster; Humans; Niacin; Niacinamide; Pyridoxine; Vitamin B 12; Vitami

1963
[EXPERIENCES WITH THE PREPARATION "MEDIVITAN" IN HERPES ZOSTER IN GENERAL PRACTICE].
    Zeitschrift fur Haut- und Geschlechtskrankheiten, 1964, Oct-15, Volume: 37

    Topics: Corrinoids; Folic Acid; General Practice; Hematinics; Herpes Zoster; Humans; Niacin; Niacinamide; Vi

1964
Novel histamine H3 receptor antagonists GSK189254 and GSK334429 are efficacious in surgically-induced and virally-induced rat models of neuropathic pain.
    Pain, 2008, Aug-15, Volume: 138, Issue:1

    Topics: Animals; Azepines; Benzazepines; Disease Models, Animal; Herpes Zoster; Histamine H3 Antagonists; Hu

2008