Page last updated: 2024-10-19

niacinamide and Rheumatoid Arthritis

niacinamide has been researched along with Rheumatoid Arthritis in 49 studies

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

Research Excerpts

Excerpt	Relevance	Reference
"Methotrexate is frequently used to treat rheumatoid arthritis."	9.34	Investigation of Potential Drug-Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis. ( Akinlade, B; Cao, Y; Chindalore, V; Moy, S; Sawamoto, T; Valluri, U; Zhang, W; Zhu, T, 2020)
"To evaluate the efficacy and safety of orally administered once-daily peficitinib in combination with methotrexate (MTX) in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to MTX."	9.24	Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate. ( Garg, JP; Genovese, MC; Gutierrez-Ureña, SR; Kivitz, AJ; Kristy, R; Poiley, J; Shay, K; Wang, X; Zubrzycka-Sienkiewicz, A, 2017)
"The relative efficacy and safety of tofacitinib and peficitinib were assessed in patients with rheumatoid arthritis (RA) with an inadequate response to disease-modifying antirheumatic drugs (DMARDs)."	9.05	Comparison of the efficacy and safety of tofacitinib and peficitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials. ( Lee, YH; Song, GG, 2020)
"Several clinical trials have attempted to evaluate the efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy in patients with active rheumatoid arthritis (RA), but their relative efficacy and safety as monotherapy remain unclear due to the lack of data from head-to-head comparison trials."	9.05	Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis. ( Gyu Song, G; Ho Lee, Y, 2020)
"The present study investigates synergistic effects of the TNF-alpha inhibitor thalidomide and the poly(ADP-ribose) polymerase (PARP)-inhibitor nicotinic acid amide (NAA) in male DBA/1 hybird mice suffering from type II collagen-induced arthritis."	7.69	Synergistic effects of thalidomide and poly (ADP-ribose) polymerase inhibition on type II collagen-induced arthritis in mice. ( Dietrich, A; Kröger, H; Miesel, R; Ockenfels, H; Ohde, M; Rajnavölgyi, E, 1996)
"The mean plasma total tryptophan concentration of 13 long-standing rheumatoid arthritis patients was found to be lower than that of seven nonrheumatoid control subjects, but the plasma nicotinic acid concentration was unchanged."	7.66	Metabolic abnormalities of tryptophan and nicotinic acid in patients with rheumatoid arthritis. ( Dickerson, JW; Labadarios, D; McKenzie, DY; Parke, DV, 1978)
"Methotrexate is frequently used to treat rheumatoid arthritis."	5.34	Investigation of Potential Drug-Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis. ( Akinlade, B; Cao, Y; Chindalore, V; Moy, S; Sawamoto, T; Valluri, U; Zhang, W; Zhu, T, 2020)
"To evaluate the efficacy and safety of orally administered once-daily peficitinib in combination with methotrexate (MTX) in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to MTX."	5.24	Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate. ( Garg, JP; Genovese, MC; Gutierrez-Ureña, SR; Kivitz, AJ; Kristy, R; Poiley, J; Shay, K; Wang, X; Zubrzycka-Sienkiewicz, A, 2017)
"The relative efficacy and safety of tofacitinib and peficitinib were assessed in patients with rheumatoid arthritis (RA) with an inadequate response to disease-modifying antirheumatic drugs (DMARDs)."	5.05	Comparison of the efficacy and safety of tofacitinib and peficitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials. ( Lee, YH; Song, GG, 2020)
"Several clinical trials have attempted to evaluate the efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy in patients with active rheumatoid arthritis (RA), but their relative efficacy and safety as monotherapy remain unclear due to the lack of data from head-to-head comparison trials."	5.05	Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis. ( Gyu Song, G; Ho Lee, Y, 2020)
"The present study investigates synergistic effects of the TNF-alpha inhibitor thalidomide and the poly(ADP-ribose) polymerase (PARP)-inhibitor nicotinic acid amide (NAA) in male DBA/1 hybird mice suffering from type II collagen-induced arthritis."	3.69	Synergistic effects of thalidomide and poly (ADP-ribose) polymerase inhibition on type II collagen-induced arthritis in mice. ( Dietrich, A; Kröger, H; Miesel, R; Ockenfels, H; Ohde, M; Rajnavölgyi, E, 1996)
"The mean plasma total tryptophan concentration of 13 long-standing rheumatoid arthritis patients was found to be lower than that of seven nonrheumatoid control subjects, but the plasma nicotinic acid concentration was unchanged."	3.66	Metabolic abnormalities of tryptophan and nicotinic acid in patients with rheumatoid arthritis. ( Dickerson, JW; Labadarios, D; McKenzie, DY; Parke, DV, 1978)
" Incidence rates per 100 patient-years of adverse events of special interest were calculated, and Cox proportional hazard analysis was conducted."	3.11	Impact 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)
" Samples for pharmacokinetic analysis were collected before dose and ≤72 hours after dose."	3.01	The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers. ( Kambayashi, A; Kaneko, Y; Kiyota, T; Nishimura, T; Oda, K; Shibata, M; Toyoshima, J, 2021)
" Incidence rates per 100 patient-years (PY) of adverse events (AEs) of special interest were calculated."	3.01	A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years. ( Fukuda, M; Izutsu, H; Kaneko, Y; Kato, D; Rokuda, M; Takeuchi, T; Tanaka, Y, 2021)
" Treatment-emergent adverse events (TEAEs) were reported in 757/843 (89."	2.94	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. ( 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."	2.90	Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). ( Akazawa, R; Chen, YH; Iwasaki, M; Izutsu, H; Kaneko, Y; Kawakami, A; Lee, SH; Rokuda, M; Shiomi, T; Song, YW; Takeuchi, T; Tanaka, S; Tanaka, Y; Ushijima, S; Wei, JC; Yamada, E, 2019)
"To evaluate the efficacy and safety of orally administered once-daily peficitinib in combination with limited conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with moderate-to-severe rheumatoid arthritis (RA)."	2.84	Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis. ( Cardiel, MH; Codding, C; Garg, JP; Genovese, MC; Greenwald, M; Kivitz, AJ; Shay, K; Wang, A; Wang, X; Zubrzycka-Sienkiewicz, A, 2017)
" The total incidence of treatment-emergent adverse events (TEAEs) was similar between the placebo (64."	2.82	Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study. ( Ishikura, H; Iwasaki, M; Kaneko, Y; Saeki, S; Takeuchi, T; Tanaka, Y, 2016)
" The difference in the number of patients with adverse events (AEs) among the intervention groups was not statistically significant."	2.66	Comparative Efficacy and Safety of Peficitinib 25, 50, 100, and 150 mg in Patients with Active Rheumatoid Arthritis: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. ( Lee, YH; Song, GG, 2020)
"The treatment of rheumatoid arthritis has changed dramatically over the last two decades since the development of biological disease-modifying anti-rheumatic drugs (bDMARDs)."	2.66	JAK inhibitors for the treatment of rheumatoid arthritis. ( Morinobu, A, 2020)
"All elevated bone formation and bone resorption markers were decreased with peficitinib but only partially decreased with etanercept."	1.72	Peficitinib improves bone fragility by recovering bone turnover imbalance in arthritic mice. ( Emori, T; Fujii, Y; Hanaoka, K; Nakamura, Y; Nakano, M; Sugahara, S; Suzuki, T; Takahashi, J; Takeshita, N, 2022)
" Therefore, we designed this updated network meta-analysis to further establish the optimal dosage of peficitinib in treating RA."	1.62	The optimal dosage of pefcitinib for the treatment of active rheumatoid arthritis: A protocol for an updated network meta-analysis. ( Chen, C; Sun, C; Zhou, Y, 2021)
" Peficitinib, an orally bioavailable inhibitor of the Janus kinase (JAK) receptor family, was approved in Japan in 2019 and Korea in 2020 for the treatment of RA."	1.56	Peficitinib for the treatment of rheumatoid arthritis: an overview from clinical trials. ( Izutsu, H; Tanaka, Y, 2020)
" Here, we describe the identification of the novel orally bioavailable JAK inhibitor 18, peficitinib (also known as ASP015K), which showed moderate selectivity for JAK3 over JAK1, JAK2, and TYK2 in enzyme assays."	1.48	Discovery and structural characterization of peficitinib (ASP015K) as a novel and potent JAK inhibitor. ( Amano, Y; Hamaguchi, H; Higashi, Y; Inoue, T; Ito, M; Moritomo, A; Nakai, K; Nakajima, Y; Nomura, N; Shirakami, S, 2018)
"Oral administration of ML120B inhibited paw swelling in a dose-dependent manner (median effective dosage 12 mg/kg twice daily) and offered significant protection against arthritis-induced weight loss as well as cartilage and bone erosion."	1.33	IKKbeta inhibition protects against bone and cartilage destruction in a rat model of rheumatoid arthritis. ( Anderson, K; Chandra, S; DuPont, M; Gangurde, P; Harriman, G; Hepperle, M; Jaffee, B; Kujawa, J; Lane, J; Morgan, J; Ocain, T; Savinainen, A; Schopf, L; Siebert, E; Silva, M; Wen, D; Xu, Y, 2006)

Research

Studies (49)

Timeframe	Studies, this research(%)	All Research%
pre-1990	10 (20.41)	18.7374
1990's	1 (2.04)	18.2507
2000's	2 (4.08)	29.6817
2010's	14 (28.57)	24.3611
2020's	22 (44.90)	2.80

Authors

Authors	Studies
Tanaka, Y	11
Takeuchi, T	9
Kato, D	4
Kaneko, Y	11
Fukuda, M	4
Miyatake, D	1
Izutsu, H	8
Rokuda, M	6
Sugahara, S	2
Hanaoka, K	1
Emori, T	2
Takeshita, N	1
Fujii, Y	4
Nakano, M	1
Suzuki, T	1
Takahashi, J	1
Nakamura, Y	1
Ishikawa, G	1
Kwon, C	1
Perez-Sanchez, C	1
Escudero-Contreras, A	1
Cerdó, T	1
Sánchez-Mendoza, LM	1
Llamas-Urbano, A	1
la Rosa, IA	1
Pérez-Rodriguez, M	1
Muñoz-Barrera, L	1
Del Carmen Abalos-Aguilera, M	1
Barbarroja, N	1
Calvo, J	1
Ortega-Castro, R	1
Ruiz-Vilchez, D	1
Moreno, JA	1
Burón, MI	1
González-Reyes, JA	1
Collantes-Estevez, E	1
Lopez-Pedrera, C	1
Villalba, JM	1
Lee, YH	2
Song, GG	2
Kim, J	1
Kang, SC	1
Yoon, NE	1
Kim, Y	1
Choi, J	1
Park, N	1
Jung, H	1
Jung, BH	1
Ju, JH	1
Kitanaga, Y	1
Imamura, E	1
Nakahara, Y	1
Fukahori, H	1
Kubo, S	1
Nakayamada, S	1
Tanaka, S	3
Kawakami, A	3
Song, YW	2
Chen, YH	2
Ushijima, S	3
Nakashima, Y	1
Shiomi, T	3
Yamada, E	3
Ho Lee, Y	1
Gyu Song, G	1
Morinobu, A	1
Kasahara, M	1
Hashimoto, M	1
Ito, H	1
Narumiya, S	1
Higashi, Y	2
Zhu, T	1
Moy, S	1
Valluri, U	1
Cao, Y	1
Zhang, W	1
Sawamoto, T	1
Chindalore, V	1
Akinlade, B	1
Shibata, M	2
Toyoshima, J	2
Oda, K	1
Kiyota, T	1
Kambayashi, A	1
Nishimura, T	2
Gutiérrez-Ureña, SR	2
Amaya-Cabrera, EL	1
Uribe-Martínez, JF	1
Ventura-Valenzuela, ME	1
Rosal-Arteaga, C	1
Martínez-Bonilla, GE	1
González-Díaz, V	1
Almengor-Montenegro, O	1
Cerpa-Cruz, S	1
Nash, P	1
Kerschbaumer, A	1
Dörner, T	1
Dougados, M	1
Fleischmann, RM	1
Geissler, K	1
McInnes, I	1
Pope, JE	1
van der Heijde, D	2
Stoffer-Marx, M	1
Trauner, M	1
Winthrop, KL	1
de Wit, M	1
Aletaha, D	1
Baraliakos, X	1
Boehncke, WH	1
Emery, P	1
Isaacs, JD	1
Kremer, J	1
Lee, EB	1
Maksymowych, WP	1
Voshaar, M	1
Tam, LS	1
van den Bosch, F	1
Westhovens, R	2
Xavier, R	1
Smolen, JS	1
Zhou, Y	1
Sun, C	1
Chen, C	1
Kaibara, A	1
Schultz, NM	1
Hamaguchi, H	1
Amano, Y	1
Moritomo, A	1
Shirakami, S	1
Nakajima, Y	1
Nakai, K	1
Nomura, N	1
Ito, M	1
Inoue, T	1
Diller, M	1
Hasseli, R	1
Hülser, ML	1
Aykara, I	1
Frommer, K	1
Rehart, S	1
Müller-Ladner, U	1
Neumann, E	1
Qiu, Q	1
Feng, Q	1
Tan, X	1
Guo, M	1
Markham, A	1
Keam, SJ	1
Iwasaki, M	3
Katayama, K	1
Wei, JC	1
Lee, SH	1
Akazawa, R	1
Ishikura, H	1
Saeki, S	1
Smolenska, Z	1
Smolenski, RT	1
Zdrojewski, Z	1
Kivitz, AJ	2
Poiley, J	1
Genovese, MC	2
Kristy, R	1
Shay, K	2
Wang, X	2
Garg, JP	2
Zubrzycka-Sienkiewicz, A	2
Greenwald, M	1
Codding, C	1
Wang, A	1
Cardiel, MH	1
Grabiec, AM	1
Krausz, S	1
de Jager, W	1
Burakowski, T	1
Groot, D	1
Sanders, ME	1
Prakken, BJ	1
Maslinski, W	1
Eldering, E	1
Tak, PP	1
Reedquist, KA	1
Kats-Ugurlu, G	1
Maass, C	1
van Herpen, C	1
de Waal, R	1
Oosterwijk, E	1
Mulders, P	1
Hulsbergen-van de Kaa, C	1
Leenders, W	1
REINCKE, A	1
HART, FD	1
BOARDMAN, PL	1
SZIRMAI, E	1
ROSSI, A	1
Schopf, L	2
Savinainen, A	1
Anderson, K	1
Kujawa, J	1
DuPont, M	1
Silva, M	1
Siebert, E	1
Chandra, S	1
Morgan, J	1
Gangurde, P	1
Wen, D	1
Lane, J	1
Xu, Y	2
Hepperle, M	2
Harriman, G	2
Ocain, T	2
Jaffee, B	2
Izmailova, ES	1
Paz, N	1
Alencar, H	1
Chun, M	1
Lane, JH	1
Weissleder, R	1
Mahmood, U	1
Healy, AM	1
Kröger, H	1
Miesel, R	1
Dietrich, A	1
Ohde, M	1
Rajnavölgyi, E	1
Ockenfels, H	1
Knoell, KH	1
Labadarios, D	1
McKenzie, DY	1
Dickerson, JW	1
Parke, DV	1
Seidel, K	1
Eckstein, M	1
Fanelli, V	1
Thompson, GR	1
Duff, IF	1
Hvidberg, EF	1
Barthwell, JC	1
Houpt, JB	1
Ogryzlo, MA	1
Hunt, M	1

Clinical Trials (8)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K[NCT01638013]	Phase 3	843 participants (Actual)	Interventional	2012-06-13	Completed
A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis[NCT01754805]	Phase 1	15 participants (Actual)	Interventional	2010-01-22	Completed
ASP015K Pharmacokinetic Study - Bioequivalence Evaluation of a Small and Current Tablet of ASP015K[NCT02531191]	Phase 1	40 participants (Actual)	Interventional	2015-06-21	Completed
Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients[NCT01649999]	Phase 2	281 participants (Actual)	Interventional	2012-03-01	Completed
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX[NCT02305849]	Phase 3	519 participants (Actual)	Interventional	2014-07-25	Completed
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs[NCT02308163]	Phase 3	509 participants (Actual)	Interventional	2014-08-08	Completed
A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotr[NCT01554696]	Phase 2	379 participants (Actual)	Interventional	2012-07-06	Completed
A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Patients[NCT01565655]	Phase 2	289 participants (Actual)	Interventional	2012-06-19	Completed
[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

Intervention	percentage of participants (Number)
Participants Who Completed 015K-CL-RAJ1	19.4
Participants Who Completed 015K-CL-RAJ3	4.9
Participants Who Completed 015K-CL-RAJ4	3.4

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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	mg/dL (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	mg/dL (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOS	EOT
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOS	EOT
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

Intervention	mm/h (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	mm/h (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	1.71	4.50	3.29	4.15	4.85	5.91	5.86	5.99	5.95	5.91	5.91	6.06	6.05	6.34	7.18	5.87	6.11	6.10	-6.0	5.95	3.67

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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	2.94	2.02	1.74	2.87	2.10	2.40	1.56	2.41	2.23	1.54
Participants Who Completed 015K-CL-RAJ4	2.69	2.61	2.89	2.80	2.22	1.62	1.65	2.04	2.31	2.16

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

Intervention	units on a scale (Mean)
	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 192	Week 216	Week 240	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT
Participants Who Completed 015K-CL-RAJ1	3.00	3.88	3.85	4.72	4.61	4.97	6.01	5.38	5.13	5.18	5.70	5.79	5.52	5.27	5.28	5.58	5.42	3.89	4.64	-2.52	4.38	2.17	4.09	3.56	2.95	3.45	4.03	6.20	3.72	11.12	4.62	7.83	3.78	2.80	5.15	-3.24	3.63

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

Intervention	units on a scale (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	5.21	5.06	5.06	5.65	4.30	4.55	5.18	0.50	-0.97	3.92
Participants Who Completed 015K-CL-RAJ4	5.45	5.56	5.80	6.37	5.80	5.92	5.43	4.11	2.17	4.74

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

Intervention	units on a scale (Mean)
	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 192	Week 216	Week 240	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT
Participants Who Completed 015K-CL-RAJ1	-0.52	0.29	1.30	1.70	2.84	2.33	1.59	2.68	3.75	1.66	2.42	1.93	2.85	3.05	2.56	0.81	2.67	-1.62	2.97	-5.25	2.64	5.75	2.88	2.75	3.50	3.46	2.65	1.82	3.99	12.34	3.87	15.79	3.54	-1.11	1.64	-8.61	2.06

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

Intervention	units on a scale (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	11.62	12.55	12.31	12.35	12.15	12.59	12.46	9.64	10.42	10.29
Participants Who Completed 015K-CL-RAJ4	11.60	13.23	13.52	13.48	14.20	14.59	14.38	13.94	12.60	12.62

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

Intervention	units on a scale (Mean)
	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 192	Week 216	Week 240	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT
Participants Who Completed 015K-CL-RAJ1	-0.55	0.30	1.53	2.52	4.10	3.72	3.56	3.97	4.14	3.63	4.27	4.49	4.51	5.89	4.94	5.59	5.02	0.27	5.01	-7.23	6.94	-31.60	6.46	6.43	6.73	6.13	5.97	-22.64	6.21	4.73	6.13	21.10	4.33	-5.21	6.92	0.16	3.44

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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	units on a scale (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	swollen joint count (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	swollen joint count (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	tender joint count (Mean)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
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

Intervention	tender joint count (Mean)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
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

Intervention	percent work time missed (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	-5.36	-4.81	-4.52	-4.73	-4.74	-5.15	-3.21	-8.65	0.00	-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

Intervention	percent activity impairment (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
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

Intervention	percent work impairment (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
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

Intervention	percent overall work impairment (Mean)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
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)

Intervention	Participants (Count of Participants)
	Adverse Events (AE)	Drug related AE (DAE)	Deaths	Serious AE (SAE)	Drug Related serious AE (DSAE)	Grade 3 or higher in severity AE	AE leading to permanent discontinuation of study	DAE leading to permanent discontinuation of drug	SAE leading to permanent discontinuation of drug	DSAE leading to permanent discontinuation of drug	AE leading to dose reduction of study drug	DAE leading to dose reduction of study drug	AE leading to temporary discontinuation of drug	DAE leading to temporary discontinuation of drug
Participants Who Completed 015K-CL-RAJ1	193	175	0	59	22	75	50	30	23	11	4	4	81	67
Participants Who Completed 015K-CL-RAJ3	208	160	1	56	37	73	34	18	20	12	8	8	86	76
Participants Who Completed 015K-CL-RAJ4	395	321	1	84	54	118	56	44	32	27	6	6	191	158

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	18.3	16.9	20.2	29.1	25.9	24.1	29.5	30.0	26.6	28.7	29.1	29.3	30.9	27.1	35.1	23.8	25.0	100.0	25.7	7.7
Participants Who Completed 015K-CL-RAJ4	22.4	23.0	26.9	28.3	32.7	28.9	30.7	34.0	33.2	30.0	26.3	31.4	28.9	31.1	31.6	34.8	31.8	100.0	31.3	12.4

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	1.5	4.0	5.0	4.5	4.0	7.1	7.4	7.5	9.2	10.6	11.0	8.3	11.0	11.0	10.8	11.3	14.3	17.5	18.0	16.9	20.6	18.3	17.6	21.6	21.1	21.6	23.4	25.0	24.5	24.2	25.6	24.4	19.8	25.0	24.7	24.1	23.4	24.5	15.0	25.0	0.0	15.9	10.9

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ4	58.2	60.3	62.2	65.4	69.2	66.6	71.1	70.7	71.3	72.7	76.1	74.3	74.8	72.6	72.4	82.6	68.2	100.0	69.4	44.9
Participants Who Completed 015K-CL-RAJ3	55.4	53.9	56.3	58.3	56.3	57.1	63.9	60.6	63.6	62.8	66.9	65.5	66.0	71.4	62.2	66.7	87.5	100.0	57.2	35.4

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	8.0	13.0	16.1	15.1	20.2	23.0	27.4	26.2	29.9	29.1	30.8	36.9	39.9	39.3	43.9	46.7	51.4	54.7	51.1	57.7	55.6	60.0	59.7	61.2	58.8	64.0	65.4	63.5	61.2	65.3	66.7	62.2	70.9	63.1	67.9	65.8	71.9	60.4	65.0	81.3	0.0	45.3	22.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	73.7	73.1	72.1	75.2	75.6	75.9	79.8	79.4	80.3	78.0	85.1	84.5	82.5	80.0	78.4	81.0	87.5	100.0	71.6	47.7
Participants Who Completed 015K-CL-RAJ4	72.7	74.0	78.4	79.3	82.0	83.1	84.5	83.7	86.0	87.6	86.9	87.4	86.7	85.8	86.8	89.1	90.9	100.0	84.0	60.7

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	18.5	24.5	25.1	33.2	38.9	42.3	46.8	49.7	51.6	50.8	56.4	59.5	60.1	61.3	64.3	64.7	68.6	75.2	77.4	74.6	77.0	81.7	78.2	76.7	75.4	76.6	83.2	75.0	82.7	80.0	77.8	82.2	86.0	83.3	82.7	83.5	84.4	77.4	80.0	100.0	100.0	61.7	40.6

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	30.9	36.1	35.3	37.4	39.1	36.1	47.3	41.0	39.5	47.6	46.6	47.8	48.5	48.6	54.1	38.1	37.5	0.0	42.9	20.0
Participants Who Completed 015K-CL-RAJ4	38.0	39.7	43.3	45.8	48.0	45.4	51.6	50.0	48.7	52.1	49.8	54.3	55.6	53.3	47.4	55.6	45.5	100.0	49.8	20.2

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	4.5	4.5	7.0	7.6	12.1	13.3	12.7	13.9	18.0	16.9	18.6	17.3	20.9	20.9	22.9	28.7	26.6	34.6	32.3	31.5	34.9	35.0	32.8	36.2	33.6	39.1	35.5	35.9	43.9	37.9	40.0	32.6	38.4	41.7	35.8	38.0	39.1	32.1	27.5	31.3	0.0	27.4	14.9

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	56.5	53.0	54.1	58.3	58.4	57.6	59.9	57.9	56.4	64.0	66.2	67.0	63.9	67.1	64.9	57.1	62.5	100.0	54.5	35.4
Participants Who Completed 015K-CL-RAJ4	55.7	59.6	62.3	64.7	65.9	67.3	69.9	69.8	71.2	70.8	71.4	72.6	71.1	67.6	69.7	75.6	68.2	100.0	67.5	40.4

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	8.5	13.5	14.6	14.2	22.7	22.4	23.8	28.3	29.5	31.5	32.0	30.4	38.7	40.5	40.1	43.3	43.9	53.7	51.9	48.5	55.6	58.3	55.5	56.0	57.5	55.5	60.7	54.4	59.2	60.0	60.0	56.2	62.8	57.1	60.5	57.0	60.9	52.8	52.5	50.0	100.0	42.8	23.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	59.2	61.5	59.9	55.8	58.2	59.7	59.6	63.3	57.2	56.7	62.8	57.8	61.9	70.0	62.2	47.6	50.0	100.0	55.4	44.6
Participants Who Completed 015K-CL-RAJ4	67.0	65.7	68.3	71.4	70.6	71.9	69.9	69.5	73.9	73.8	73.2	74.9	75.0	76.4	69.7	71.7	59.1	100.0	68.9	56.2

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	35.0	37.0	40.7	41.7	48.0	51.0	49.5	50.3	54.3	50.0	48.3	48.8	50.9	50.3	54.1	54.0	53.6	51.8	54.9	52.3	53.2	55.8	53.8	53.4	57.0	55.0	51.4	55.8	52.0	50.5	54.4	50.0	54.7	47.6	54.3	51.9	51.6	50.9	47.5	62.5	100.0	46.8	44.6

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	61.2	62.1	64.9	62.8	58.9	62.8	67.2	65.6	63.0	62.2	69.6	70.7	71.1	68.6	73.0	71.4	87.5	100.0	62.3	40.0
Participants Who Completed 015K-CL-RAJ4	62.1	63.0	65.5	64.3	65.4	67.1	68.8	69.2	69.1	67.4	68.1	68.0	69.9	67.0	68.4	73.9	59.1	0.0	63.6	48.3

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	37.0	38.5	38.7	39.7	42.9	46.9	47.4	48.7	50.5	50.0	51.2	52.4	55.2	54.0	55.4	60.0	62.9	62.0	62.4	63.1	66.7	66.7	65.5	67.2	68.4	67.6	67.3	72.1	70.4	68.4	68.9	67.8	72.1	70.2	69.1	67.1	70.3	62.3	60.0	56.3	100.0	52.7	35.6

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

Intervention	percentage of participants (Number)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	39.9	37.2	33.2	39.3	33.5	37.2	30.9	32.4	37.5	35.8
Participants Who Completed 015K-CL-RAJ4	37.4	37.6	39.2	35.8	38.4	33.8	28.7	34.2	31.8	34.6

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

Intervention	percentage of participants (Number)
	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 192	Week 216	Week 240	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT
Participants Who Completed 015K-CL-RAJ1	43.0	42.7	47.2	43.4	45.4	45.3	51.9	47.8	48.3	47.7	49.4	49.1	51.5	48.6	53.7	57.1	49.6	50.0	45.4	0	47.5	0	41.4	39.6	37.5	42.1	43.3	100	41.7	100	43.0	33.3	37.7	22.2	43.8	0	39.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	70	70.5	73.0	68.3	71.7	68.2	66.0	70.3	62.5	61.0
Participants Who Completed 015K-CL-RAJ4	71.1	74.1	74.7	73.9	75.9	79.3	82.4	77.6	77.3	306

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

Intervention	percentage of participants (Number)
	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 192	Week 216	Week 240	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT
Participants Who Completed 015K-CL-RAJ1	34.0	33.7	40.2	39.4	43.4	40.0	44.4	42.9	44.4	45.3	47.0	47.2	45.4	47.8	47.7	50.6	43.8	50.0	44.6	0	53.3	0	50.0	52.3	51.9	53.7	52.2	0	48.8	0	48.1	66.7	43.4	11.1	56.3	0	41.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 24	Week 48	Week 72	Week 96	Week 120	Week 144	Week 168	Week 192	EOT
Participants Who Completed 015K-CL-RAJ3	44.8	47.8	46.4	47.5	42.8	45.3	51.5	35.1	25.0	43.1
Participants Who Completed 015K-CL-RAJ4	48.5	48.0	47.1	46.7	48.2	49.3	48.5	40.8	31.8	44.7

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

Intervention	percentage of participants (Number)
	Week 0	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 192	Week 216	Week 240	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT
Participants Who Completed 015K-CL-RAJ1	26.0	27.6	35.7	39.9	39.8	38.4	36.4	39.1	40.0	33.1	38.7	38.7	40.5	39.9	38.9	29.9	38.7	0	39.2	0	38.3	100	39.7	38.7	40.0	41.1	37.8	0	42.9	100.0	45.6	83.3	39.6	22.2	31.3	0.0	39.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	23.7	24.2	29.3	30.6	33.5	28.3	36.6	33.9	37.6	37.2	39.9	44.0	42.3	41.4	51.4	33.3	25.0	0.0	34.5	12.3
Participants Who Completed 015K-CL-RAJ4	30.6	30.6	36.0	39.1	42.2	40.7	42.4	42.6	42.7	40.4	39.0	42.3	44.9	40.6	43.4	43.5	45.5	100.0	42.5	25.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	3.0	4.0	4.5	6.0	5.6	7.7	8.9	11.8	14.1	16.8	15.1	13.7	15.3	19.6	14.0	18.7	20.0	23.4	26.3	23.1	25.4	25.0	19.3	28.4	28.1	30.6	29.9	33.7	33.7	34.7	30.0	31.1	31.4	38.1	30.9	31.6	34.4	26.4	20.0	31.3	0.0	24.9	14.9

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ4	94.6	94.9	96.2	96.9	97.3	96.1	96.3	96.4	97.7	98.1	96.7	97.7	96.3	98.1	98.7	97.8	95.5	100.0	95.4	83.1
Participants Who Completed 015K-CL-RAJ3	94.2	92.7	95.2	95.1	94.9	93.7	95.1	95.0	94.2	93.9	98.0	94.0	90.7	97.1	94.6	95.2	87.5	100.0	89.2	80.0

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	48.5	60.5	65.8	75.4	79.8	81.6	84.2	84.5	88.0	88.3	91.3	92.9	93.3	92.0	94.9	92.7	92.1	94.2	95.5	93.1	92.1	95.0	94.1	94.0	93.9	95.5	96.3	94.2	93.9	94.7	93.3	91.1	95.3	94.0	93.8	94.9	98.4	98.1	92.5	100.0	100.0	78.6	72.3

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	89.7	91.3	92.3	92.2	94.4	92.1	91.2	92.7	94.2	91.5	93.9	89.6	87.6	95.7	86.5	90.5	87.5	100.0	87.1	80.0
Participants Who Completed 015K-CL-RAJ4	93.4	92.2	95.4	95.5	95.1	94.9	96.0	95.9	97.1	97.4	96.2	97.7	97.0	96.2	96.1	93.3	95.5	100.0	93.7	82.0

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	41.5	54.5	59.3	70.1	75.8	78.1	85.2	84.0	87.4	84.8	91.3	89.3	93.3	92.6	93.0	90.7	89.9	92.6	92.5	91.5	92.1	93.3	94.1	92.2	93.8	94.5	95.3	93.2	92.9	92.6	92.2	92.1	94.2	92.9	95.1	94.9	96.9	94.3	92.5	100.0	100.0	76.6	67.3

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	71.0	70.3	70.2	72.3	73.1	71.7	76.5	75.0	77.5	75.6	83.8	80.2	80.4	75.7	75.7	76.2	87.5	100.0	69.4	43.1
Participants Who Completed 015K-CL-RAJ4	71.0	72.3	77.2	78.2	80.1	82.3	84.0	82.0	84.0	85.8	85.4	85.7	85.2	84.9	86.8	84.8	86.4	100.0	83.3	58.4

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	11.5	18.0	19.6	27.1	34.8	36.2	43.7	44.4	47.8	46.4	49.4	53.0	53.4	56.4	58.0	59.3	63.6	72.3	72.9	70.8	73.8	78.3	74.8	73.3	71.9	74.8	77.6	73.1	79.6	78.9	76.7	80.0	81.4	78.6	80.2	81.0	79.7	71.7	75.0	100.0	100.0	58.7	38.6

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	54.7	50.7	52.7	54.9	56.3	55.5	58.2	54.5	54.7	61.6	64.2	64.3	60.8	65.7	64.9	57.1	62.5	100.0	52.2	35.4
Participants Who Completed 015K-CL-RAJ4	54.5	58.1	61.6	63.7	65.1	66.5	68.5	68.6	69.6	68.9	69.5	71.4	68.9	67.6	68.4	73.3	63.6	100.0	65.8	40.4

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	7.0	11.5	13.1	13.7	21.7	21.9	23.3	27.3	29.0	30.9	30.8	28.6	36.8	38.0	39.5	42.7	43.9	51.5	50.4	46.2	54.0	56.7	53.8	55.2	56.6	54.5	59.8	52.4	58.2	56.8	57.8	56.2	60.5	54.8	58.0	54.4	59.4	50.9	52.5	50.0	100.0	41.3	20.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	24.6	27.4	28.4	31.6	32.5	30.4	37.7	35.6	37.6	39.6	40.5	41.4	41.2	42.9	51.4	42.9	25.0	0.0	36.0	13.8
Participants Who Completed 015K-CL-RAJ4	32.6	31.4	37.1	40.9	42.8	41.6	43.3	42.3	42.0	42.7	38.0	44.0	45.2	42.5	44.7	45.7	50.0	100.0	43.4	24.7

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	4.0	5.0	6.0	5.5	6.1	8.7	10.0	13.4	15.2	16.2	16.9	12.5	16.6	18.4	14.0	21.3	21.4	24.1	25.6	24.6	28.6	27.5	24.4	28.4	27.2	33.3	30.8	33.7	37.8	37.9	31.1	35.6	32.6	38.1	33.3	32.9	34.4	28.3	22.5	31.3	0.0	23.9	13.9

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	80.3	80.7	84.5	82.4	82.7	81.7	84.2	80.0	83.2	79.3	83.1	80.2	84.5	90.0	73.0	81.0	62.5	100.0	74.6	67.7
Participants Who Completed 015K-CL-RAJ4	85.7	85.3	88.8	91.1	88.8	88.5	90.3	89.6	90.2	90.6	90.6	90.9	91.9	91.5	90.8	93.5	95.5	100.0	87.4	68.5

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	28.5	37.0	42.2	45.7	52.0	61.2	63.2	63.6	65.2	63.1	66.3	67.9	70.6	74.2	73.2	76.7	74.3	77.4	75.2	76.9	77.8	81.7	77.3	77.6	80.7	80.2	82.2	78.8	80.6	76.8	77.8	74.4	79.1	73.8	75.3	78.5	79.7	75.5	65.0	81.3	100.0	64.2	53.5

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	62.8	60.1	63.8	65.9	67.3	64.4	66.1	63.9	64.2	64.6	67.6	72.4	68.0	75.7	70.3	71.4	62.5	100.0	59.8	41.5
Participants Who Completed 015K-CL-RAJ4	67.5	67.4	73.1	74.5	75.7	77.5	79.1	75.1	77.5	77.9	76.1	78.3	77.2	74.5	78.9	76.1	77.3	100.0	73.8	47.2

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	8.5	9.5	14.1	23.1	28.3	30.1	34.7	36.9	40.8	38.0	41.3	42.9	46.6	48.5	49.0	55.3	52.1	54.7	56.4	56.2	59.5	63.3	62.2	64.7	61.4	63.1	68.2	61.5	64.3	61.1	62.2	63.3	65.1	61.9	63.0	59.5	62.5	60.4	50.0	68.8	100.0	45.8	31.7

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

Intervention	percentage of Participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	58.3	58.3	60.9	64.4	62.2	62.8	65.0	61.7	61.8	63.4	64.9	71.6	66.0	70.0	67.6	61.9	62.5	100.0	58.9	38.5
Participants Who Completed 015K-CL-RAJ4	65.3	66.4	71.1	72.2	74.1	74.7	76.8	73.7	74.6	75.3	75.6	75.4	77.2	72.6	76.3	73.9	72.7	100.0	72.3	46.1

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

Intervention	percentage of Participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	8.0	9.0	13.1	21.6	24.2	29.1	31.1	33.2	38.6	34.6	38.4	41.1	44.8	45.4	45.9	51.3	49.3	54.7	54.9	55.4	58.7	60.8	61.3	63.8	57.9	60.4	63.6	58.7	63.3	56.8	57.8	55.6	59.3	58.3	60.5	55.7	54.7	56.6	45.0	62.5	100.0	45.8	28.7

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	42.2	40.4	40.6	42.4	41.3	45.5	42.6	44.4	43.9	47.6	48.6	48.3	48.5	48.6	48.6	47.6	50.0	100.0	39.7	24.6
Participants Who Completed 015K-CL-RAJ4	45.9	46.1	51.5	50.9	54.8	53.7	56.7	55.3	56.0	57.3	52.6	55.4	52.9	48.1	52.6	58.7	59.1	100.0	53.4	33.7

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	3.5	4.5	6.0	9.0	12.1	12.2	13.2	17.1	18.5	17.9	22.7	22.6	23.9	25.2	24.2	26.7	29.3	29.9	35.3	35.4	36.5	36.7	39.5	39.7	42.1	44.1	46.7	41.3	43.9	44.2	46.7	43.3	44.2	41.7	40.7	46.8	50.0	41.5	27.5	50.0	0.0	29.9	19.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	36.8	36.2	36.2	38.0	38.3	41.4	38.8	40.0	39.9	42.7	43.9	39.7	42.3	47.1	45.9	47.6	50.0	100.0	38.4	20.0
Participants Who Completed 015K-CL-RAJ4	41.3	42.9	47.0	44.6	50.1	50.8	51.9	51.5	52.8	52.1	49.3	53.1	49.3	46.2	50.0	56.5	59.1	100.0	50.7	32.6

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	2.5	4.0	5.5	7.0	10.1	9.7	11.1	12.8	16.3	17.3	22.1	20.2	19.6	22.1	21.0	25.3	27.1	28.5	34.6	32.3	34.1	34.2	37.8	37.1	36.8	42.3	44.9	42.3	43.9	41.1	42.2	40.0	38.4	39.3	35.8	43.0	43.8	35.8	27.5	37.5	0.0	28.4	17.8

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

Intervention	percentage of participants (Number)
	Week 0	Week 12	Week 24	Week 36	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	EOT	EOS
Participants Who Completed 015K-CL-RAJ3	82.5	81.2	85.5	83.9	83.7	81.7	86.3	80.6	85.0	79.3	84.5	81.0	85.6	90.0	75.7	81.0	62.5	100.0	74.6	69.2
Participants Who Completed 015K-CL-RAJ4	86.2	85.0	89.1	91.9	90.2	89.0	90.0	89.9	90.6	91.0	91.1	91.4	91.9	93.4	93.4	93.5	95.5	100.0	87.9	68.5

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

Intervention	percentage of participants (Number)
	Week 0	Week 2	Week 4	Week 8	Week 12	Week 16	Week 20	Week 24	Week 28	Week 32	Week 36	Week 40	Week 44	Week 48	Week 60	Week 72	Week 84	Week 96	Week 108	Week 120	Week 132	Week 144	Week 156	Week 168	Week 180	Week 192	Week 204	Week 216	Week 228	Week 240	Week 252	Week 264	Week 276	Week 288	Week 300	Week 312	Week 324	Week 336	Week 348	Week 360	Week 372	EOT	EOS
Participants Who Completed 015K-CL-RAJ1	29.5	37.0	42.2	47.2	55.1	59.7	63.7	63.6	65.2	62.6	68.0	70.2	73.0	76.1	73.2	77.3	76.4	78.1	77.4	78.5	79.4	83.3	79.0	77.6	79.8	82.9	83.2	80.8	80.6	78.9	78.9	75.6	81.4	76.2	76.5	81.0	82.8	75.5	70.0	87.5	100.0	64.7	52.5

Change From Baseline in CRP at Week 12

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

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

Change From Baseline in DAS28-ESR at Week 12

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

Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12

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

Change From Baseline in ESR at Week 12

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

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

Change From Baseline in HAQ-DI at Week 12

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

Change From Baseline in mTSS at Week 28

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 28/ET

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

Change From Baseline in mTSS at Week 52

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 52/ET

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

Change From Baseline in Percent Overall Work Impairment at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Change From Baseline in PGA at Week 12

The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Change From Baseline in SDAI Score at Week 12

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

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

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

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

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

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

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

Change From Baseline in SGA at Week 12

The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Change From Baseline in SGAP at Week 12

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

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

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

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

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

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

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

The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12

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

Change From Baseline in WPAI Percent Activity Impairment at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Change From Baseline in WPAI Percent Impairment While Working at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Number of Participants Who Withdrew Due to Lack of Efficacy

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

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

Percentage of Participants Achieving ACR / EULAR Remission at Week 12

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

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

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

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

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

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

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

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

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

Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12

SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT02305849)
Timeframe: Week 12/ET

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

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

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

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

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

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

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

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

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

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

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

Percentage of Participants With an ACR50-CRP Response at Week 12

ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

Percentage of Participants With an ACR70-CRP Response at Week 12

ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/ET

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

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

ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/Early termination (ET)

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

Change From Baseline in CRP Through Week 52

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

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

Change From Baseline in DAS28-CRP Through Week 52

,,,,,

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

Change From Baseline in DAS28-ESR Score Through Week 52

,,,,,

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

Change From Baseline in Erosion Score at Week 28 and Week 52

The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET

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

Change From Baseline in ESR Through Week 52

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

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

Change From Baseline in HAQ-DI Through Week 52

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

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

Change From Baseline in JSN Score at Week 28 and Week 52

JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET

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

Change From Baseline in PGA Through Week 52

The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

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

Change From Baseline in SDAI Score Through Week 52

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline in SGA Through Week 52

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

Change From Baseline in SGAP Through Week 52

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

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

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

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

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

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

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

Change From Baseline in WPAI Percent Activity Impairment Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

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

Change From Baseline in WPAI Percent Impairment While Working Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculates as Q5/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

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

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

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

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

Change From Baseline in WPAI Percent Work Time Missed Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

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

Number of Participants With TEAEs From Week 12 to Week 28

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE (NCT02305849)
Timeframe: Week 12 to week 28

,,,,

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

Number of Participants With TEAEs From Week 28 to Week 52

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02305849)
Timeframe: Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

,,,,,

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02305849)
Timeframe: Week 0 to week 12

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

Percentage of Participants Achieving ACR / EULAR Remission Through Week 52

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

Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 28/ET and 52/ET

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

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

,,,,,

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

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

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

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

,,,,,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

,,,,,

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

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

,,,,,

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

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

,,,,,

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

Change From Baseline in CDAI Score at Week 12

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

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

Change From Baseline in CRP at Week 12

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

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

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

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

Change From Baseline in ESR at Week 12

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

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

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

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

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

Change From Baseline in Percent Overall Work Impairment at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

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

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

Change From Baseline in SDAI Score at Week 12

"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

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

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline in Subject's SGA at Week 12

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

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

"The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)." (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

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

"The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)." (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

Change From Baseline in WPAI Percent Activity Impairment at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

Change From Baseline in WPAI Percent Impairment While Working at Week 12

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

Number of Participants Who Withdrew Due to Lack of Efficacy

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

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

Percentage of Participants Achieving ACR / EULAR Remission at Week 12

"ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET

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

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

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

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

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

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Baseline and Week 12/ET

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

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

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Week 12/ET

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

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

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Week 12/ET

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

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

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Week 12/ET

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline DAS28-CRP Through Week 52

DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

,,,,

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

Change From Baseline in CDAI Score Through Week 52

,,,,

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

Change From Baseline in CRP Through Week 52

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

,,,,

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

Change From Baseline in DAS28-ESR Through Week 52

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

Change From Baseline in ESR Through Week 52

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

,,,,

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

Change From Baseline in HAQ-DI Through Week 52

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

Change From Baseline in PGA Through Week 52

,,,,

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

Change From Baseline in SDAI Score Through Week 52

,,,,

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

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

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

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

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

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

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

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

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

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

Change From Baseline in SGA Through Week 52

,,,,

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

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

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

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

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

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

,,,,

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

Change From Baseline in WPAI Percent Activity Impairment Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

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

Change From Baseline in WPAI Percent Impairment While Working Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

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

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

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

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

Change From Baseline in WPAI Percent Work Time Missed Through Week 52

WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52

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

Number of Participants With Adverse Events During the First 12 Weeks

Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02308163)
Timeframe: Week 0 to Week 12

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

Number of Participants With Adverse Events From Week 12

Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02308163)
Timeframe: Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

,,,,

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

Percentage of Participants Achieving ACR / EULAR Remission Through Week 52

ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm). (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

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

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

,,,,

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

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

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

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

"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

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

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

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

"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

Percentage of Participants Achieving SDAI Remission Through Week 52

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

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

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

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

,,,,

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

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

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

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

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

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

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

,,,,

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

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

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

,,,,

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

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

,,,,

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

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

,,,,

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

Reviews

10 reviews available for niacinamide and Rheumatoid Arthritis

Article	Year
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
Comparative Efficacy and Safety of Peficitinib 25, 50, 100, and 150 mg in Patients with Active Rheumatoid Arthritis: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Clinical drug investigation, 2020, Volume: 40, Issue:1 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Bayes Theorem; Dose-Response Relationship,	2020
Comparison of the efficacy and safety of tofacitinib and peficitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials. International journal of rheumatic diseases, 2020, Volume: 23, Issue:7 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Bayes Theorem; Drug Therapy, Combination; H	2020
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis. Journal of clinical pharmacy and therapeutics, 2020, Volume: 45, Issue:4 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Azetidines; Bayes Theorem; Heterocyclic Com	2020
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
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement. Annals of the rheumatic diseases, 2021, Volume: 80, Issue:1 Topics: Adamantane; Advisory Committees; Antirheumatic Agents; Arthritis, Psoriatic; Arthritis, Rheumatoid;	2021
Clinical efficacy of new JAK inhibitors under development. Just more of the same? Rheumatology (Oxford, England), 2019, 02-01, Volume: 58, Issue:Suppl 1 Topics: Adamantane; Arthritis, Rheumatoid; Azetidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compound	2019
JAK3-selective inhibitor peficitinib for the treatment of rheumatoid arthritis. Expert review of clinical pharmacology, 2019, Volume: 12, Issue:6 Topics: Adamantane; Adult; Antirheumatic Agents; Arthritis, Rheumatoid; Cell Proliferation; Humans; Janus Ki	2019
Peficitinib: First Global Approval. Drugs, 2019, Volume: 79, Issue:8 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Drug Approval; Humans; Janus Kinases; Niaci	2019

Trials

13 trials available for niacinamide and Rheumatoid Arthritis

Article	Year
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
Investigation of Potential Drug-Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis. Clinical drug investigation, 2020, Volume: 40, Issue:9 Topics: Adamantane; Adult; Antirheumatic Agents; Area Under Curve; Arthritis, Rheumatoid; Drug Interactions;	2020
The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers. Clinical pharmacology in drug development, 2021, Volume: 10, Issue:3 Topics: Adamantane; Administration, Oral; Adult; Area Under Curve; Arthritis, Rheumatoid; Biological Availab	2021
A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years. Modern rheumatology, 2021, Volume: 31, Issue:3 Topics: Adamantane; Adult; Antirheumatic Agents; Arthritis, Rheumatoid; Asian People; Drug Tolerance; Female	2021
Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis. Arthritis research & therapy, 2021, 08-24, Volume: 23, Issue:1 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Humans; Methotrexate;	2021
Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis. Arthritis research & therapy, 2021, 08-24, Volume: 23, Issue:1 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Humans; Methotrexate;	2021
Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis. Arthritis research & therapy, 2021, 08-24, Volume: 23, Issue:1 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Humans; Methotrexate;	2021
Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis. Arthritis research & therapy, 2021, 08-24, Volume: 23, Issue:1 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Humans; Methotrexate;	2021
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
Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study. Annals of the rheumatic diseases, 2016, Volume: 75, Issue:6 Topics: Adamantane; Adult; Antirheumatic Agents; Arthritis, Rheumatoid; Dose-Response Relationship, Drug; Do	2016
Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate. Arthritis & rheumatology (Hoboken, N.J.), 2017, Volume: 69, Issue:4 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Female; Humans; Janus	2017
Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis. Arthritis & rheumatology (Hoboken, N.J.), 2017, Volume: 69, Issue:5 Topics: Adamantane; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Arthritis, R	2017
[Results of a clinical study on nicopyrone]. Die Medizinische Welt, 1976, Nov-05, Volume: 27, Issue:45 Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Antipyrine; Arthritis, Rheumatoid; Clinical Trials a	1976
A controlled study of niacinamide therapy. Michigan medicine, 1970, Volume: 69, Issue:17 Topics: Arthritis, Rheumatoid; Clinical Trials as Topic; Humans; Niacinamide	1970

Other Studies

26 other studies available for niacinamide and Rheumatoid Arthritis

Article	Year
Peficitinib improves bone fragility by recovering bone turnover imbalance in arthritic mice. Journal of pharmacological sciences, 2022, Volume: 148, Issue:1 Topics: Adamantane; Animals; Arthritis, Rheumatoid; Bone and Bones; Bone Density; Bone Remodeling; Bone Reso	2022
Peficitinib inhibits fibroblast-like synoviocyte activation and angiogenic vascular endothelial tube formation via inhibitory effects on PDGF and VEGF signaling in addition to JAK. Journal of pharmacological sciences, 2022, Volume: 150, Issue:2 Topics: Adamantane; Arthritis, Rheumatoid; Cells, Cultured; Fibroblasts; Human Umbilical Vein Endothelial Ce	2022
Preclinical Characterization of Pharmacologic NAD Arthritis & rheumatology (Hoboken, N.J.), 2023, Volume: 75, Issue:10 Topics: Arthritis, Rheumatoid; Humans; Leukocytes, Mononuclear; NAD; Niacinamide; Poly(ADP-ribose) Polymeras	2023
Metabolomic profiles of induced pluripotent stem cells derived from patients with rheumatoid arthritis and osteoarthritis. Stem cell research & therapy, 2019, 11-15, Volume: 10, Issue:1 Topics: Arthritis, Rheumatoid; Cell Proliferation; Chromatography, Liquid; Fibroblasts; Gene Expression Regu	2019
In vitro pharmacological effects of peficitinib on lymphocyte activation: a potential treatment for systemic sclerosis with JAK inhibitors. Rheumatology (Oxford, England), 2020, 08-01, Volume: 59, Issue:8 Topics: Adamantane; Arthritis, Rheumatoid; Female; Humans; Janus Kinase Inhibitors; Lymphocyte Activation; L	2020
Peficitinib for the treatment of rheumatoid arthritis: an overview from clinical trials. Expert opinion on pharmacotherapy, 2020, Volume: 21, Issue:9 Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Humans; Immunosuppressive Agents; Niacinami	2020
Role of JAK-STAT signaling in the pathogenic behavior of fibroblast-like synoviocytes in rheumatoid arthritis: Effect of the novel JAK inhibitor peficitinib. European journal of pharmacology, 2020, Sep-05, Volume: 882 Topics: Adamantane; Apoptosis; Arthritis, Rheumatoid; Azetidines; Cells, Cultured; Cytokines; Humans; Janus	2020
Peficitinib hydrobromide to treat rheumatoid arthritis. Drugs of today (Barcelona, Spain : 1998), 2020, Volume: 56, Issue:8 Topics: Adamantane; Arthritis, Rheumatoid; Clinical Trials as Topic; Humans; Janus Kinases; Niacinamide; Tre	2020
The optimal dosage of pefcitinib for the treatment of active rheumatoid arthritis: A protocol for an updated network meta-analysis. Medicine, 2021, Feb-19, Volume: 100, Issue:7 Topics: Adamantane; Arthritis, Rheumatoid; Humans; Immunosuppressive Agents; Network Meta-Analysis; Niacinam	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacology research & perspectives, 2021, Volume: 9, Issue:3 Topics: Adamantane; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive	2021
Discovery and structural characterization of peficitinib (ASP015K) as a novel and potent JAK inhibitor. Bioorganic & medicinal chemistry, 2018, 10-01, Volume: 26, Issue:18 Topics: Adamantane; Administration, Oral; Animals; Arthritis, Rheumatoid; Biological Availability; Drug Disc	2018
Targeting Activated Synovial Fibroblasts in Rheumatoid Arthritis by Peficitinib. Frontiers in immunology, 2019, Volume: 10 Topics: Adamantane; Arthritis, Rheumatoid; Azetidines; Cell Proliferation; Chemokine CCL2; Fibroblasts; Huma	2019
Plasma concentrations of amino acid and nicotinamide metabolites in rheumatoid arthritis--potential biomarkers of disease activity and drug treatment. Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals, 2016, Volume: 21, Issue:3 Topics: Adult; Aged; Aged, 80 and over; Amino Acids; Arthritis, Rheumatoid; Biomarkers; Chromatography, Liqu	2016
Histone deacetylase inhibitors suppress inflammatory activation of rheumatoid arthritis patient synovial macrophages and tissue. Journal of immunology (Baltimore, Md. : 1950), 2010, Mar-01, Volume: 184, Issue:5 Topics: Adult; Aged; Apoptosis; Arthritis, Rheumatoid; Blotting, Western; Cells, Cultured; Female; Flow Cyto	2010
Better effect of sorafenib on the rhabdoid component of a clear cell renal cell carcinoma owing to its higher level of vascular endothelial growth factor-A production. Histopathology, 2011, Volume: 59, Issue:3 Topics: Antineoplastic Agents; Arthritis, Rheumatoid; Benzenesulfonates; Carcinoma, Renal Cell; Clinical Tri	2011
[CLINICAL OBSERVATIONS ON THE EFFECT OF NICOPYRON AD INJECTIONEM ON DISORDERS OF THE RHEUMATIC SYMPTOM COMPLEX]. Medizinische Klinik, 1963, Aug-30, Volume: 58 Topics: Antipyrine; Arthritis; Arthritis, Rheumatoid; Humans; Niacinamide; Rheumatic Fever; Spondylitis; Spo	1963
TRIAL OF NIFENAZONE ("THYLIN"). British medical journal, 1964, Jun-13, Volume: 1, Issue:5397 Topics: Analgesics; Analgesics, Non-Narcotic; Antipyretics; Antipyrine; Arthritis; Arthritis, Rheumatoid; Ni	1964
[PHARMACOLOGICAL AND EXPERIMENTAL THERAPEUTIC STUDIES ON RAPOSTAN, A WATER-SOLUBLE NICOTINAMIDE DERIVATIVE]. Therapeutische Umschau. Revue therapeutique, 1964, Volume: 21 Topics: Antipyrine; Arthritis; Arthritis, Rheumatoid; Camphor; Drug Therapy; Niacinamide; Rats; Research; Wa	1964
[Phenyl-quinolincarbonic acid, associated with vitamin C and nicotinamide in the therapy of joint disease]. Il Policlinico. Sezione pratica, 1950, Apr-24, Volume: 57, Issue:17 Topics: Arthritis; Arthritis, Rheumatoid; Ascorbic Acid; Humans; Joint Diseases; Niacin; Niacinamide	1950
IKKbeta inhibition protects against bone and cartilage destruction in a rat model of rheumatoid arthritis. Arthritis and rheumatism, 2006, Volume: 54, Issue:10 Topics: Animals; Arthritis, Experimental; Arthritis, Rheumatoid; Bone and Bones; Carbolines; Cartilage; Dise	2006
Use of molecular imaging to quantify response to IKK-2 inhibitor treatment in murine arthritis. Arthritis and rheumatism, 2007, Volume: 56, Issue:1 Topics: Administration, Oral; Animals; Antirheumatic Agents; Arthritis, Experimental; Arthritis, Rheumatoid;	2007
Synergistic effects of thalidomide and poly (ADP-ribose) polymerase inhibition on type II collagen-induced arthritis in mice. Inflammation, 1996, Volume: 20, Issue:2 Topics: Animals; Arthritis; Arthritis, Rheumatoid; Cattle; Collagen; Disease Models, Animal; Drug Synergism;	1996
Metabolic abnormalities of tryptophan and nicotinic acid in patients with rheumatoid arthritis. Rheumatology and rehabilitation, 1978, Volume: 17, Issue:4 Topics: 3-Hydroxyanthranilic Acid; Arthritis, Rheumatoid; Feeding Behavior; Humans; Kynuramine; Niacinamide;	1978
[Testing of the antiphlogistic effect of antirheumatic drugs]. Munchener medizinische Wochenschrift (1950), 1966, Oct-14, Volume: 108, Issue:41 Topics: Antipyrine; Arthritis, Rheumatoid; Drug Synergism; Erythema; Humans; Injections, Intramuscular; Niac	1966
[Clinical observations on a new preparation with hepatoprotective action]. La Clinica terapeutica, 1967, Jan-31, Volume: 40, Issue:2 Topics: Adult; Aged; Amino Acids; Arthritis, Rheumatoid; Biliary Dyskinesia; Dyspepsia; Female; Folic Acid;	1967
Tryptophan metabolism in man (with special reference to rheumatoid arthritis and scleroderma). Seminars in arthritis and rheumatism, 1973, Volume: 2, Issue:4 Topics: Arthritis, Rheumatoid; Aspirin; Cystinuria; Drug Synergism; Edetic Acid; Humans; Kynurenic Acid; Kyn	1973