Page last updated: 2024-10-19

niacinamide and Nasopharyngitis

niacinamide has been researched along with Nasopharyngitis in 1 studies

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

Nasopharyngitis: Inflammation of the NASOPHARYNX, usually including its mucosa, related lymphoid structure, and glands.

Research Excerpts

Excerpt	Relevance	Reference
" 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)

Research

Studies (1)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	1 (100.00)	2.80

Authors

Authors	Studies
Takeuchi, T	1
Tanaka, Y	1
Tanaka, S	1
Kawakami, A	1
Song, YW	1
Chen, YH	1
Rokuda, M	1
Izutsu, H	1
Ushijima, S	1
Kaneko, Y	1
Nakashima, Y	1
Shiomi, T	1
Yamada, E	1

Clinical Trials (1)

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
[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

Trials

1 trial available for niacinamide and Nasopharyngitis

Article	Year
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