A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01638013
• Collaborator: (none)
• Enrollment: 843
• Locations: 175
• Arms: 3
• Actual Duration (Months): 87.6
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: Peficitinib	Phase 3

Detailed Description

This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K [015K-CL-RAJ1 (hereinafter referred to as study RAJ1)], Phase III Study of ASP015K [015K-CL-RAJ3 (RAJ3)], or Phase III Study of ASP015K [015K-CL-RAJ4 (RAJ4)]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study".

Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy.

The duration of treatment with the study drug was differed depending upon the participants.

Study Design

• Study Type: Interventional
• Actual Enrollment: 843 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K
• Actual Study Start Date: Jun 13, 2012
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants who completed 015K-CL-RAJ1 Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Drug: Peficitinib; Oral Tablet; Other Names: ASP015K Smyraf
Experimental: Participants who completed 015K-CL-RAJ3 Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Drug: Peficitinib; Oral Tablet; Other Names: ASP015K Smyraf
Experimental: Participants who completed 015K-CL-RAJ4 Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Drug: Peficitinib; Oral Tablet; Other Names: ASP015K Smyraf

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [Baseline up to end of study (EOS) (up to week 376)]

   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.

Secondary Outcome Measures

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

   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.

2. Percentage of Participants With an ACR50-CRP Response Through Week 372 [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]

   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.

3. Percentage of Participants With an ACR70-CRP Response Through Week 372 [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]

   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.

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

   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.

5. Percentage of Participants With an ACR50-ESR Response Through Week 372 [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]

   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.

6. Percentage of Participants With an ACR70-ESR Response Through Week 372 [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]

   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.

7. Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 [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]

   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.

8. Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 [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]

   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.

9. Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 [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]

   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.

10. Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 [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]

    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.

11. Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 [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]

    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.

12. Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 [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]

    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.

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

    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.

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

    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.

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

    Higher CRP indicates greater disease activity.

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

    Higher ESR indicates greater disease activity.

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

    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).

18. Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 [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]

    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.

19. Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 [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]

    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.

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

    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.

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

    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.

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

    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.

23. Change From Baseline of Preceding Study in SDAI Score Through Week 372 [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]

    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.

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

    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.

25. Change From Baseline of Preceding Study CDAI Score Through Week 372 [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]

    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.

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

    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.

27. Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 [Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

    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.

28. Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 [Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

    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.

29. Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 [Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

    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.

30. Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 [Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

    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.

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

    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.

32. Change From Baseline of Preceding Study in HAQ-DI Through Week 372 [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]

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

43. Number of Participants Who Withdrew Due to Lack of Efficacy [Baseline up to week 372]

    Participants who discontinued due to lack of efficacy have been reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol

• The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

• There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected

• Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection

• Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it

• Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)

• Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	JP00037	Nagoya	Aichi	Japan
2	JP00109	Nagoya	Aichi	Japan
3	JP00130	Nagoya	Aichi	Japan
4	JP00175	Nagoya	Aichi	Japan
5	JP00066	Okazaki	Aichi	Japan
6	JP00140	Toyoake	Aichi	Japan
7	JP00108	Toyohashi	Aichi	Japan
8	JP00170	Toyohashi	Aichi	Japan
9	JP00156	Toyota	Aichi	Japan
10	JP00068	Yatomi	Aichi	Japan
11	JP00180	Asahi	Chiba	Japan
12	JP00166	Funabashi	Chiba	Japan
13	JP00102	Kamagaya	Chiba	Japan
14	JP00115	Narashino	Chiba	Japan
15	JP00138	Yotsukaido	Chiba	Japan
16	JP00120	Iizuka	Fukuoka	Japan
17	JP00040	Kitakyushu	Fukuoka	Japan
18	JP00119	Kitakyushu	Fukuoka	Japan
19	JP00071	Kurume	Fukuoka	Japan
20	JP00106	Kurume	Fukuoka	Japan
21	JP00033	Takasaki	Gunma	Japan
22	JP00163	Higashihiroshima	Hiroshima	Japan
23	JP00124	Tomakomai	Hokaido	Japan
24	JP00026	Asahikawa	Hokkaido	Japan
25	JP00090	Hakodate	Hokkaido	Japan
26	JP00172	Kitami	Hokkaido	Japan
27	JP00125	Kushiro	Hokkaido	Japan
28	JP00001	Sapporo	Hokkaido	Japan
29	JP00002	Sapporo	Hokkaido	Japan
30	JP00003	Sapporo	Hokkaido	Japan
31	JP00031	Sapporo	Hokkaido	Japan
32	JP00038	Sapporo	Hokkaido	Japan
33	JP00114	Sapporo	Hokkaido	Japan
34	JP00158	Sapporo	Hokkaido	Japan
35	JP00056	Akashi	Hyogo	Japan
36	JP00069	Himeji	Hyogo	Japan
37	JP00136	Itami	Hyogo	Japan
38	JP00041	Kato	Hyogo	Japan
39	JP00012	Kobe	Hyogo	Japan
40	JP00042	Kobe	Hyogo	Japan
41	JP00092	Kobe	Hyogo	Japan
42	JP00154	Kobe	Hyogo	Japan
43	JP00171	Kobe	Hyogo	Japan
44	JP00117	Nishinomiya	Hyogo	Japan
45	JP00181	Hitachinaka	Ibaraki	Japan
46	JP00107	Hitachi	Ibaraki	Japan
47	JP00073	Koga	Ibaraki	Japan
48	JP00054	Mito	Ibaraki	Japan
49	JP00039	Tsukuba	Ibaraki	Japan
50	JP00034	Komatsu	Ishikawa	Japan
51	JP00179	Komatsu	Ishikawa	Japan
52	JP00028	Morioka	Iwate	Japan
53	JP00049	Morioka	Iwate	Japan
54	JP00088	Kida-gun	Kagawa	Japan
55	JP00084	Isehara	Kanagawa	Japan
56	JP00058	Kawasaki	Kanagawa	Japan
57	JP00141	Sagamihara	Kanagawa	Japan
58	JP00096	Yokohama	Kanagawa	Japan
59	JP00045	Zushi	Kanagawa	Japan
60	JP00019	Koshi	Kumamoto	Japan
61	JP00057	Tamana	Kumamoto	Japan
62	JP00168	Yokkaichi	Mie	Japan
63	JP00023	Miyagi-gun	Miyagi	Japan
64	JP00169	Osaki	Miyagi	Japan
65	JP00004	Sendai	Miyagi	Japan
66	JP00027	Sendai	Miyagi	Japan
67	JP00036	Sendai	Miyagi	Japan
68	JP00105	Sendai	Miyagi	Japan
69	JP00151	Sendai	Miyagi	Japan
70	JP00050	Hyuga	Miyazaki	Japan
71	JP00129	Matsumoto	Nagano	Japan
72	JP00162	Isehaya	Nagasaki	Japan
73	JP00101	Omura	Nagasaki	Japan
74	JP00103	Omura	Nagasaki	Japan
75	JP00153	Sasebo	Nagasaki	Japan
76	JP00094	Kashihara	Nara	Japan
77	JP00025	Nagaoka	Niigata	Japan
78	JP00144	Shibata	Niigata	Japan
79	JP00064	Beppu	Oita	Japan
80	JP00051	Setouchi	Okayama	Japan
81	JP00011	Hannan	Osaka	Japan
82	JP00134	Higashiosaka	Osaka	Japan
83	JP00078	Kawachinagano	Osaka	Japan
84	JP00137	Sakai	Osaka	Japan
85	JP00070	Suita	Osaka	Japan
86	JP00086	Suita	Osaka	Japan
87	JP00146	Suita	Osaka	Japan
88	JP00061	Toyonaka	Osaka	Japan
89	JP00075	Ureshino	Saga	Japan
90	JP00126	Gyoda	Saitama	Japan
91	JP00007	Hiki-gun	Saitama	Japan
92	JP00060	Kawagoe	Saitama	Japan
93	JP00161	Kawagoe	Saitama	Japan
94	JP00062	Kawaguchi	Saitama	Japan
95	JP00052	Sayama	Saitama	Japan
96	JP00008	Tokorozawa	Saitama	Japan
97	JP00133	Kakegawa	Shizuoka	Japan
98	JP00077	Kanuma	Tochigi	Japan
99	JP00145	Shimotsuke	Tochigi	Japan
100	JP00024	Bunkyo-ku	Tokyo	Japan
101	JP00043	Bunkyo-ku	Tokyo	Japan
102	JP00143	Bunkyo-ku	Tokyo	Japan
103	JP00149	Bunkyo-ku	Tokyo	Japan
104	JP00152	Bunkyo-ku	Tokyo	Japan
105	JP00095	Chiyoda-ku	Tokyo	Japan
106	JP00099	Chiyoda-ku	Tokyo	Japan
107	JP00142	Chuo-ku	Tokyo	Japan
108	JP00063	Hachioji	Tokyo	Japan
109	JP00053	Kiyose	Tokyo	Japan
110	JP00072	Meguro-ku	Tokyo	Japan
111	JP00083	Meguro-ku	Tokyo	Japan
112	JP00148	Ota-ku	Tokyo	Japan
113	JP00100	Setagaya-ku	Tokyo	Japan
114	JP00081	Shibuya-ku	Tokyo	Japan
115	JP00032	Shinjuku-ku	Tokyo	Japan
116	JP00021	Sumida-ku	Tokyo	Japan
117	JP00010	Takaoka	Toyama	Japan
118	JP00155	Nishimuro-gun	Wakayama	Japan
119	JP00104	Shimonoseki	Yamaguchi	Japan
120	JP00047	Shunan	Yamaguchi	Japan
121	JP00176	Fukui		Japan
122	JP00018	Fukuoka		Japan
123	JP00020	Fukuoka		Japan
124	JP00035	Fukuoka		Japan
125	JP00059	Fukuoka		Japan
126	JP00076	Fukuoka		Japan
127	JP00131	Fukuoka		Japan
128	JP00164	Fukuoka		Japan
129	JP00165	Fukushima		Japan
130	JP00013	Hiroshima		Japan
131	JP00014	Hiroshima		Japan
132	JP00015	Hiroshima		Japan
133	JP00016	Hiroshima		Japan
134	JP00055	Hiroshima		Japan
135	JP00065	Kagoshima		Japan
136	JP00074	Kagoshima		Japan
137	JP00167	Kagoshima		Japan
138	JP00093	Kochi		Japan
139	JP00022	Kumamoto		Japan
140	JP00046	Kumamoto		Japan
141	JP00085	Kyoto		Japan
142	JP00123	Kyoto		Japan
143	JP00159	Kyoto		Japan
144	JP00122	Miyazaki		Japan
145	JP00080	Nagano		Japan
146	JP00174	Nagano		Japan
147	JP00098	Nagasaki		Japan
148	JP00112	Nagasaki		Japan
149	JP00147	Nagasaki		Japan
150	JP00006	Niigata		Japan
151	JP00017	Oita		Japan
152	JP00118	Okayama		Japan
153	JP00150	Osaka		Japan
154	JP00157	Osaka		Japan
155	JP00044	Shizuoka		Japan
156	JP00089	Shizuoka		Japan
157	JP00135	Shizuoka		Japan
158	JP00009	Toyama		Japan
159	JP00139	Toyama		Japan
160	KR00504	Daegu		Korea, Republic of
161	KR00505	Gwangju		Korea, Republic of
162	KR00506	Incheon		Korea, Republic of
163	KR00508	Jeonju		Korea, Republic of
164	KR00501	Seoul		Korea, Republic of
165	KR00502	Seoul		Korea, Republic of
166	KR00509	Seoul		Korea, Republic of
167	KR00511	Seoul		Korea, Republic of
168	KR00507	Suwon		Korea, Republic of
169	TW00709	Kaohsiung		Taiwan
170	TW00710	Taichung		Taiwan
171	TW00712	Tainan		Taiwan
172	TW00701	Taipei		Taiwan
173	TW00702	Taipei		Taiwan
174	TW00711	Taipei		Taiwan
175	TW00703	Taoyuan		Taiwan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Medical Director, Astellas Pharma Inc

Study Documents (Full-Text)

• Study Protocol - Mar 29, 2019
• Statistical Analysis Plan - Nov 12, 2019

More Information

Additional Information:

• Link to results on the Astellas Clinical Study Results website.

Publications

None provided.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT01638013
• Other Study ID Numbers: 015K-CL-RAJ2
• First Posted: Jul 11, 2012
• Last Update Posted: Oct 23, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Astellas Pharma Inc: Smyraf; Rheumatoid Arthritis; Peficitinib; ASP015K
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Peficitinib

Study Results

Participant Flow

Recruitment Details	Participants who completed 015K-CL-RAJ1 (NCT01649999), 015K-CL-RAJ3 (NCT02308163), 015K-CL-RAJ4 (NCT02305849) and met eligible criteria were enrolled in this study. Participants in the etanercept group in study 015K-CL-RAJ3 (NCT01649999) were not included in this study.
Pre-assignment Detail	For participants who were on 50mg at the time of peficitinib approval, dose was increased to 100mg. Participants whose dose increment was not possible were discontinued.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Period Title: Overall Study
STARTED	201	225	417
COMPLETED	70	147	296
NOT COMPLETED	131	78	121

Baseline Characteristics

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4	Total
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Total of all reporting groups
Overall Participants	201	224	412	837
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.7 (11.3)	55.2 (12.8)	57.2 (11.5)	55.6 (11.9)
Sex: Female, Male (Count of Participants)
Female	158 78.6%	163 72.8%	293 71.1%	614 73.4%
Male	43 21.4%	61 27.2%	119 28.9%	223 26.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	201 100%	224 100%	412 100%	837 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
C-Reactive Protein (CRP) (Milligram per deciliter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Milligram per deciliter]	2.214 (2.379)	2.167 (2.000)	2.476 (2.077)	2.331 (2.136)
Erythrocyte Sedimentation Rate (ESR) (Millimeter per hour (mm/h)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Millimeter per hour (mm/h)]	44.8 (22.2)	47.0 (25.9)	50.7 (26.2)	48.3 (25.3)
Health Assessment Questionnaire - Disability Index (HAQ-DI) (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	0.89 (0.63)	0.93 (0.67)	1.00 (0.65)	0.96 (0.65)
Physician's Global Assessment of Arthritis (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	55.68 (20.66)	58.52 (19.55)	59.47 (19.70)	58.3 (19.93)
Subject's Global Assessment of Arthritis (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	56.15 (25.10)	57.40 (25.24)	54.79 (24.94)	55.81 (25.06)
Subject's Global Assessment of Arthritis Pain (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	56.12 (24.71)	56.79 (25.44)	54.19 (25.63)	55.35 (25.36)
Swollen Joint Count (66 Joints) (Swollen joint count) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Swollen joint count]	12.0 (6.1)	12.4 (6.7)	13.1 (6.9)	12.7 (6.7)
Tender Joint Count (68 Joints) (Tender joint count) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Tender joint count]	15.1 (9.3)	15.0 (9.8)	14.9 (8.9)	15 (9.2)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	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.
Time Frame	Baseline up to end of study (EOS) (up to week 376)

Outcome Measure Data

Analysis Population Description

Safety Population: All participants who received at least 1 dose of the study drug.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	225	417
Adverse Events (AE)	193 96%	208 92.9%	395 95.9%
Drug related AE (DAE)	175 87.1%	160 71.4%	321 77.9%
Deaths	0 0%	1 0.4%	1 0.2%
Serious AE (SAE)	59 29.4%	56 25%	84 20.4%
Drug Related serious AE (DSAE)	22 10.9%	37 16.5%	54 13.1%
Grade 3 or higher in severity AE	75 37.3%	73 32.6%	118 28.6%
AE leading to permanent discontinuation of study	50 24.9%	34 15.2%	56 13.6%
DAE leading to permanent discontinuation of drug	30 14.9%	18 8%	44 10.7%
SAE leading to permanent discontinuation of drug	23 11.4%	20 8.9%	32 7.8%
DSAE leading to permanent discontinuation of drug	11 5.5%	12 5.4%	27 6.6%
AE leading to dose reduction of study drug	4 2%	8 3.6%	6 1.5%
DAE leading to dose reduction of study drug	4 2%	8 3.6%	6 1.5%
AE leading to temporary discontinuation of drug	81 40.3%	86 38.4%	191 46.4%
DAE leading to temporary discontinuation of drug	67 33.3%	76 33.9%	158 38.3%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	29.5 14.7%	82.5 36.8%	86.2 20.9%
Week 2	37.0 18.4%
Week 4	42.2 21%
Week 8	47.2 23.5%
Week 12	55.1 27.4%	81.2 36.3%	85.0 20.6%
Week 16	59.7 29.7%
Week 20	63.7 31.7%
Week 24	63.6 31.6%	85.5 38.2%	89.1 21.6%
Week 28	65.2 32.4%
Week 32	62.6 31.1%
Week 36	68.0 33.8%	83.9 37.5%	91.9 22.3%
Week 40	70.2 34.9%
Week 44	73.0 36.3%
Week 48	76.1 37.9%	83.7 37.4%	90.2 21.9%
Week 60	73.2 36.4%	81.7 36.5%	89.0 21.6%
Week 72	77.3 38.5%	86.3 38.5%	90.0 21.8%
Week 84	76.4 38%	80.6 36%	89.9 21.8%
Week 96	78.1 38.9%	85.0 37.9%	90.6 22%
Week 108	77.4 38.5%	79.3 35.4%	91.0 22.1%
Week 120	78.5 39.1%	84.5 37.7%	91.1 22.1%
Week 132	79.4 39.5%	81.0 36.2%	91.4 22.2%
Week 144	83.3 41.4%	85.6 38.2%	91.9 22.3%
Week 156	79.0 39.3%	90.0 40.2%	93.4 22.7%
Week 168	77.6 38.6%	75.7 33.8%	93.4 22.7%
Week 180	79.8 39.7%	81.0 36.2%	93.5 22.7%
Week 192	82.9 41.2%	62.5 27.9%	95.5 23.2%
Week 204	83.2 41.4%	100.0 44.6%	100.0 24.3%
Week 216	80.8 40.2%
Week 228	80.6 40.1%
Week 240	78.9 39.3%
Week 252	78.9 39.3%
Week 264	75.6 37.6%
Week 276	81.4 40.5%
Week 288	76.2 37.9%
Week 300	76.5 38.1%
Week 312	81.0 40.3%
Week 324	82.8 41.2%
Week 336	75.5 37.6%
Week 348	70.0 34.8%
Week 360	87.5 43.5%
Week 372	100.0 49.8%
EOT	64.7 32.2%	74.6 33.3%	87.9 21.3%
EOS	52.5 26.1%	69.2 30.9%	68.5 16.6%

3. Secondary Outcome

Title	Percentage of Participants With an ACR50-CRP Response Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	8.5 4.2%	62.8 28%	67.5 16.4%
Week 2	9.5 4.7%
Week 4	14.1 7%
Week 8	23.1 11.5%
Week 12	28.3 14.1%	60.1 26.8%	67.4 16.4%
Week 16	30.1 15%
Week 20	34.7 17.3%
Week 24	36.9 18.4%	63.8 28.5%	73.1 17.7%
Week 28	40.8 20.3%
Week 32	38.0 18.9%
Week 36	41.3 20.5%	65.9 29.4%	74.5 18.1%
Week 40	42.9 21.3%
Week 44	46.6 23.2%
Week 48	48.5 24.1%	67.3 30%	75.7 18.4%
Week 60	49.0 24.4%	64.4 28.8%	77.5 18.8%
Week 72	55.3 27.5%	66.1 29.5%	79.1 19.2%
Week 84	52.1 25.9%	63.9 28.5%	75.1 18.2%
Week 96	54.7 27.2%	64.2 28.7%	77.5 18.8%
Week 108	56.4 28.1%	64.6 28.8%	77.9 18.9%
Week 120	56.2 28%	67.6 30.2%	76.1 18.5%
Week 132	59.5 29.6%	72.4 32.3%	78.3 19%
Week 144	63.3 31.5%	68.0 30.4%	77.2 18.7%
Week 156	62.2 30.9%	75.7 33.8%	74.5 18.1%
Week 168	64.7 32.2%	70.3 31.4%	78.9 19.2%
Week 180	61.4 30.5%	71.4 31.9%	76.1 18.5%
Week 192	63.1 31.4%	62.5 27.9%	77.3 18.8%
Week 204	68.2 33.9%	100.0 44.6%	100.0 24.3%
Week 216	61.5 30.6%
Week 228	64.3 32%
Week 240	61.1 30.4%
Week 252	62.2 30.9%
Week 264	63.3 31.5%
Week 276	65.1 32.4%
Week 288	61.9 30.8%
Week 300	63.0 31.3%
Week 312	59.5 29.6%
Week 324	62.5 31.1%
Week 336	60.4 30%
Week 348	50.0 24.9%
Week 360	68.8 34.2%
Week 372	100.0 49.8%
EOT	45.8 22.8%	59.8 26.7%	73.8 17.9%
EOS	31.7 15.8%	41.5 18.5%	47.2 11.5%

4. Secondary Outcome

Title	Percentage of Participants With an ACR70-CRP Response Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	3.5 1.7%	42.2 18.8%	45.9 11.1%
Week 2	4.5 2.2%
Week 4	6.0 3%
Week 8	9.0 4.5%
Week 12	12.1 6%	40.4 18%	46.1 11.2%
Week 16	12.2 6.1%
Week 20	13.2 6.6%
Week 24	17.1 8.5%	40.6 18.1%	51.5 12.5%
Week 28	18.5 9.2%
Week 32	17.9 8.9%
Week 36	22.7 11.3%	42.4 18.9%	50.9 12.4%
Week 40	22.6 11.2%
Week 44	23.9 11.9%
Week 48	25.2 12.5%	41.3 18.4%	54.8 13.3%
Week 60	24.2 12%	45.5 20.3%	53.7 13%
Week 72	26.7 13.3%	42.6 19%	56.7 13.8%
Week 84	29.3 14.6%	44.4 19.8%	55.3 13.4%
Week 96	29.9 14.9%	43.9 19.6%	56.0 13.6%
Week 108	35.3 17.6%	47.6 21.3%	57.3 13.9%
Week 120	35.4 17.6%	48.6 21.7%	52.6 12.8%
Week 132	36.5 18.2%	48.3 21.6%	55.4 13.4%
Week 144	36.7 18.3%	48.5 21.7%	52.9 12.8%
Week 156	39.5 19.7%	48.6 21.7%	48.1 11.7%
Week 168	39.7 19.8%	48.6 21.7%	52.6 12.8%
Week 180	42.1 20.9%	47.6 21.3%	58.7 14.2%
Week 192	44.1 21.9%	50.0 22.3%	59.1 14.3%
Week 204	46.7 23.2%	100.0 44.6%	100.0 24.3%
Week 216	41.3 20.5%
Week 228	43.9 21.8%
Week 240	44.2 22%
Week 252	46.7 23.2%
Week 264	43.3 21.5%
Week 276	44.2 22%
Week 288	41.7 20.7%
Week 300	40.7 20.2%
Week 312	46.8 23.3%
Week 324	50.0 24.9%
Week 336	41.5 20.6%
Week 348	27.5 13.7%
Week 360	50.0 24.9%
Week 372	0.0 0%
EOT	29.9 14.9%	39.7 17.7%	53.4 13%
EOS	19.8 9.9%	24.6 11%	33.7 8.2%

5. Secondary Outcome

Title	Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	28.5 14.2%	80.3 35.8%	85.7 20.8%
Week 2	37.0 18.4%
Week 4	42.2 21%
Week 8	45.7 22.7%
Week 12	52.0 25.9%	80.7 36%	85.3 20.7%
Week 16	61.2 30.4%
Week 20	63.2 31.4%
Week 24	63.6 31.6%	84.5 37.7%	88.8 21.6%
Week 28	65.2 32.4%
Week 32	63.1 31.4%
Week 36	66.3 33%	82.4 36.8%	91.1 22.1%
Week 40	67.9 33.8%
Week 44	70.6 35.1%
Week 48	74.2 36.9%	82.7 36.9%	88.8 21.6%
Week 60	73.2 36.4%	81.7 36.5%	88.5 21.5%
Week 72	76.7 38.2%	84.2 37.6%	90.3 21.9%
Week 84	74.3 37%	80.0 35.7%	89.6 21.7%
Week 96	77.4 38.5%	83.2 37.1%	90.2 21.9%
Week 108	75.2 37.4%	79.3 35.4%	90.6 22%
Week 120	76.9 38.3%	83.1 37.1%	90.6 22%
Week 132	77.8 38.7%	80.2 35.8%	90.9 22.1%
Week 144	81.7 40.6%	84.5 37.7%	91.9 22.3%
Week 156	77.3 38.5%	90.0 40.2%	91.5 22.2%
Week 168	77.6 38.6%	73.0 32.6%	90.8 22%
Week 180	80.7 40.1%	81.0 36.2%	93.5 22.7%
Week 192	80.2 39.9%	62.5 27.9%	95.5 23.2%
Week 204	82.2 40.9%	100.0 44.6%	100.0 24.3%
Week 216	78.8 39.2%
Week 228	80.6 40.1%
Week 240	76.8 38.2%
Week 252	77.8 38.7%
Week 264	74.4 37%
Week 276	79.1 39.4%
Week 288	73.8 36.7%
Week 300	75.3 37.5%
Week 312	78.5 39.1%
Week 324	79.7 39.7%
Week 336	75.5 37.6%
Week 348	65.0 32.3%
Week 360	81.3 40.4%
Week 372	100.0 49.8%
EOT	64.2 31.9%	74.6 33.3%	87.4 21.2%
EOS	53.5 26.6%	67.7 30.2%	68.5 16.6%

6. Secondary Outcome

Title	Percentage of Participants With an ACR50-ESR Response Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	8.0 4%	58.3 26%	65.3 15.8%
Week 2	9.0 4.5%
Week 4	13.1 6.5%
Week 8	21.6 10.7%
Week 12	24.2 12%	58.3 26%	66.4 16.1%
Week 16	29.1 14.5%
Week 20	31.1 15.5%
Week 24	33.2 16.5%	60.9 27.2%	71.1 17.3%
Week 28	38.6 19.2%
Week 32	34.6 17.2%
Week 36	38.4 19.1%	64.4 28.8%	72.2 17.5%
Week 40	41.1 20.4%
Week 44	44.8 22.3%
Week 48	45.4 22.6%	62.2 27.8%	74.1 18%
Week 60	45.9 22.8%	62.8 28%	74.7 18.1%
Week 72	51.3 25.5%	65.0 29%	76.8 18.6%
Week 84	49.3 24.5%	61.7 27.5%	73.7 17.9%
Week 96	54.7 27.2%	61.8 27.6%	74.6 18.1%
Week 108	54.9 27.3%	63.4 28.3%	75.3 18.3%
Week 120	55.4 27.6%	64.9 29%	75.6 18.3%
Week 132	58.7 29.2%	71.6 32%	75.4 18.3%
Week 144	60.8 30.2%	66.0 29.5%	77.2 18.7%
Week 156	61.3 30.5%	70.0 31.3%	72.6 17.6%
Week 168	63.8 31.7%	67.6 30.2%	76.3 18.5%
Week 180	57.9 28.8%	61.9 27.6%	73.9 17.9%
Week 192	60.4 30%	62.5 27.9%	72.7 17.6%
Week 204	63.6 31.6%	100.0 44.6%	100.0 24.3%
Week 216	58.7 29.2%
Week 228	63.3 31.5%
Week 240	56.8 28.3%
Week 252	57.8 28.8%
Week 264	55.6 27.7%
Week 276	59.3 29.5%
Week 288	58.3 29%
Week 300	60.5 30.1%
Week 312	55.7 27.7%
Week 324	54.7 27.2%
Week 336	56.6 28.2%
Week 348	45.0 22.4%
Week 360	62.5 31.1%
Week 372	100.0 49.8%
EOT	45.8 22.8%	58.9 26.3%	72.3 17.5%
EOS	28.7 14.3%	38.5 17.2%	46.1 11.2%

7. Secondary Outcome

Title	Percentage of Participants With an ACR70-ESR Response Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	2.5 1.2%	36.8 16.4%	41.3 10%
Week 2	4.0 2%
Week 4	5.5 2.7%
Week 8	7.0 3.5%
Week 12	10.1 5%	36.2 16.2%	42.9 10.4%
Week 16	9.7 4.8%
Week 20	11.1 5.5%
Week 24	12.8 6.4%	36.2 16.2%	47.0 11.4%
Week 28	16.3 8.1%
Week 32	17.3 8.6%
Week 36	22.1 11%	38.0 17%	44.6 10.8%
Week 40	20.2 10%
Week 44	19.6 9.8%
Week 48	22.1 11%	38.3 17.1%	50.1 12.2%
Week 60	21.0 10.4%	41.4 18.5%	50.8 12.3%
Week 72	25.3 12.6%	38.8 17.3%	51.9 12.6%
Week 84	27.1 13.5%	40.0 17.9%	51.5 12.5%
Week 96	28.5 14.2%	39.9 17.8%	52.8 12.8%
Week 108	34.6 17.2%	42.7 19.1%	52.1 12.6%
Week 120	32.3 16.1%	43.9 19.6%	49.3 12%
Week 132	34.1 17%	39.7 17.7%	53.1 12.9%
Week 144	34.2 17%	42.3 18.9%	49.3 12%
Week 156	37.8 18.8%	47.1 21%	46.2 11.2%
Week 168	37.1 18.5%	45.9 20.5%	50.0 12.1%
Week 180	36.8 18.3%	47.6 21.3%	56.5 13.7%
Week 192	42.3 21%	50.0 22.3%	59.1 14.3%
Week 204	44.9 22.3%	100.0 44.6%	100.0 24.3%
Week 216	42.3 21%
Week 228	43.9 21.8%
Week 240	41.1 20.4%
Week 252	42.2 21%
Week 264	40.0 19.9%
Week 276	38.4 19.1%
Week 288	39.3 19.6%
Week 300	35.8 17.8%
Week 312	43.0 21.4%
Week 324	43.8 21.8%
Week 336	35.8 17.8%
Week 348	27.5 13.7%
Week 360	37.5 18.7%
Week 372	0.0 0%
EOT	28.4 14.1%	38.4 17.1%	50.7 12.3%
EOS	17.8 8.9%	20.0 8.9%	32.6 7.9%

8. Secondary Outcome

Title	Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-0.71 (1.10)	-2.67 (1.32)	-2.79 (1.23)
Week 2	-1.04 (1.10)
Week 4	-1.09 (1.15)
Week 8	-1.41 (1.13)
Week 12	-1.61 (1.17)	-2.64 (1.34)	-2.82 (1.26)
Week 16	-1.76 (1.16)
Week 20	-1.85 (1.19)
Week 24	-1.92 (1.18)	-2.66 (1.34)	-2.93 (1.20)
Week 28	-2.03 (1.16)
Week 32	-1.97 (1.21)
Week 36	-2.08 (1.10)	-2.79 (1.34)	-3.01 (1.16)
Week 40	-2.12 (1.15)
Week 44	-2.24 (1.16)
Week 48	-2.22 (1.19)	-2.77 (1.31)	-3.08 (1.17)
Week 60	-2.25 (1.19)	-2.71 (1.37)	-3.06 (1.16)
Week 72	-2.35 (1.32)	-2.88 (1.34)	-3.13 (1.16)
Week 84	-2.41 (1.28)	-2.77 (1.37)	-3.12 (1.18)
Week 96	-2.49 (1.24)	-2.82 (1.35)	-3.16 (1.11)
Week 108	-2.57 (1.28)	-2.88 (1.41)	-3.22 (1.13)
Week 120	-2.51 (1.33)	-3.02 (1.33)	-3.17 (1.18)
Week 132	-2.58 (1.39)	-2.98 (1.48)	-3.19 (1.14)
Week 144	-2.67 (1.25)	-2.96 (1.49)	-3.12 (1.28)
Week 156	-2.59 (1.28)	-3.15 (1.40)	-3.25 (1.25)
Week 168	-2.61 (1.27)	-3.06 (1.58)	-3.16 (1.25)
Week 180	-2.57 (1.37)	-3.14 (1.52)	-3.34 (1.21)
Week 192	-2.70 (1.32)	-3.14 (1.51)	-3.14 (1.27)
Week 204	-2.76 (1.17)	-3.52 (NA)	-4.01 (NA)
Week 216	-2.70 (1.38)
Week 228	-2.75 (1.35)
Week 240	-2.77 (1.36)
Week 252	-2.75 (1.42)
Week 264	-2.75 (1.41)
Week 276	-2.86 (1.29)
Week 288	-2.81 (1.39)
Week 300	-2.81 (1.42)
Week 312	-2.79 (1.36)
Week 324	-2.89 (1.29)
Week 336	-2.65 (1.23)
Week 348	-2.53 (1.25)
Week 360	-3.28 (1.06)
Week 372	-4.63 (NA)
EOS	-2.14 (1.57)	-2.67 (1.50)	-3.05 (1.30)
EOT	-1.59 (1.38)	-2.01 (1.41)	-2.13 (1.45)

9. Secondary Outcome

Title	Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-0.70 (1.09)	-2.70 (1.40)	-2.83 (1.30)
Week 2	-1.03 (1.12)
Week 4	-1.11 (1.21)
Week 8	-1.43 (1.12)
Week 12	-1.66 (1.19)	-2.68 (1.41)	-2.90 (1.33)
Week 16	-1.83 (1.21)
Week 20	-1.88 (1.19)
Week 24	-1.96 (1.17)	-2.71 (1.40)	-2.99 (1.29)
Week 28	-2.05 (1.15)
Week 32	-2.03 (1.24)
Week 36	-2.14 (1.16)	-2.85 (1.44)	-3.07 (1.24)
Week 40	-2.18 (1.19)
Week 44	-2.28 (1.18)
Week 48	-2.28 (1.22)	-2.82 (1.42)	-3.13 (1.27)
Week 60	-2.32 (1.26)	-2.78 (1.46)	-3.11 (1.24)
Week 72	-2.39 (1.37)	-2.91 (1.44)	-3.22 (1.28)
Week 84	-2.45 (1.33)	-2.81 (1.46)	-3.20 (1.28)
Week 96	-2.59 (1.32)	-2.84 (1.45)	-3.21 (1.18)
Week 108	-2.64 (1.35)	-2.92 (1.52)	-3.31 (1.25)
Week 120	-2.54 (1.39)	-3.05 (1.48)	-3.26 (1.24)
Week 132	-2.67 (1.44)	-2.98 (1.58)	-3.33 (1.24)
Week 144	-2.76 (1.30)	-3.00 (1.59)	-3.30 (1.36)
Week 156	-2.67 (1.34)	-3.14 (1.52)	-3.32 (1.40)
Week 168	-2.68 (1.32)	-3.13 (1.69)	-3.18 (1.27)
Week 180	-2.64 (1.40)	-3.08 (1.80)	-3.38 (1.31)
Week 192	-2.73 (1.35)	-3.25 (1.52)	-3.11 (1.32)
Week 204	-2.79 (1.20)	-3.04 (NA)	-4.29 (NA)
Week 216	-2.73 (1.32)
Week 228	-2.80 (1.35)
Week 240	-2.83 (1.37)
Week 252	-2.83 (1.38)
Week 264	-2.75 (1.39)
Week 276	-2.84 (1.27)
Week 288	-2.77 (1.35)
Week 300	-2.76 (1.34)
Week 312	-2.77 (1.32)
Week 324	-2.84 (1.25)
Week 336	-2.62 (1.29)
Week 348	-2.52 (1.33)
Week 360	-3.07 (1.17)
Week 372	-5.13 (NA)
EOT	-2.14 (1.61)	-2.69 (1.62)	-3.11 (1.37)
EOS	-1.58 (1.43)	-2.00 (1.37)	-2.13 (1.41)

10. Secondary Outcome

Title	Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	8.0 4%	55.4 24.7%	58.2 14.1%
Week 2	13.0 6.5%
Week 4	16.1 8%
Week 8	15.1 7.5%
Week 12	20.2 10%	53.9 24.1%	60.3 14.6%
Week 16	23.0 11.4%
Week 20	27.4 13.6%
Week 24	26.2 13%	56.3 25.1%	62.2 15.1%
Week 28	29.9 14.9%
Week 32	29.1 14.5%
Week 36	30.8 15.3%	58.3 26%	65.4 15.9%
Week 40	36.9 18.4%
Week 44	39.9 19.9%
Week 48	39.3 19.6%	56.3 25.1%	69.2 16.8%
Week 60	43.9 21.8%	57.1 25.5%	66.6 16.2%
Week 72	46.7 23.2%	63.9 28.5%	71.1 17.3%
Week 84	51.4 25.6%	60.6 27.1%	70.7 17.2%
Week 96	54.7 27.2%	63.6 28.4%	71.3 17.3%
Week 108	51.1 25.4%	62.8 28%	72.7 17.6%
Week 120	57.7 28.7%	66.9 29.9%	76.1 18.5%
Week 132	55.6 27.7%	65.5 29.2%	74.3 18%
Week 144	60.0 29.9%	66.0 29.5%	74.8 18.2%
Week 156	59.7 29.7%	71.4 31.9%	72.6 17.6%
Week 168	61.2 30.4%	62.2 27.8%	72.4 17.6%
Week 180	58.8 29.3%	66.7 29.8%	82.6 20%
Week 192	64.0 31.8%	87.5 39.1%	68.2 16.6%
Week 204	65.4 32.5%	100.0 44.6%	100.0 24.3%
Week 216	63.5 31.6%
Week 228	61.2 30.4%
Week 240	65.3 32.5%
Week 252	66.7 33.2%
Week 264	62.2 30.9%
Week 276	70.9 35.3%
Week 288	63.1 31.4%
Week 300	67.9 33.8%
Week 312	65.8 32.7%
Week 324	71.9 35.8%
Week 336	60.4 30%
Week 348	65.0 32.3%
Week 360	81.3 40.4%
Week 372	0.0 0%
EOT	45.3 22.5%	57.2 25.5%	69.4 16.8%
EOS	22.8 11.3%	35.4 15.8%	44.9 10.9%

11. Secondary Outcome

Title	Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	4.5 2.2%	30.9 13.8%	38.0 9.2%
Week 2	4.5 2.2%
Week 4	7.0 3.5%
Week 8	7.6 3.8%
Week 12	12.1 6%	36.1 16.1%	39.7 9.6%
Week 16	13.3 6.6%
Week 20	12.7 6.3%
Week 24	13.9 6.9%	35.3 15.8%	43.3 10.5%
Week 28	18.0 9%
Week 32	16.9 8.4%
Week 36	18.6 9.3%	37.4 16.7%	45.8 11.1%
Week 40	17.3 8.6%
Week 44	20.9 10.4%
Week 48	20.9 10.4%	39.1 17.5%	48.0 11.7%
Week 60	22.9 11.4%	36.1 16.1%	45.4 11%
Week 72	28.7 14.3%	47.3 21.1%	51.6 12.5%
Week 84	26.6 13.2%	41.0 18.3%	50.0 12.1%
Week 96	34.6 17.2%	39.5 17.6%	48.7 11.8%
Week 108	32.3 16.1%	47.6 21.3%	52.1 12.6%
Week 120	31.5 15.7%	46.6 20.8%	49.8 12.1%
Week 132	34.9 17.4%	47.8 21.3%	54.3 13.2%
Week 144	35.0 17.4%	48.5 21.7%	55.6 13.5%
Week 156	32.8 16.3%	48.6 21.7%	53.3 12.9%
Week 168	36.2 18%	54.1 24.2%	47.4 11.5%
Week 180	33.6 16.7%	38.1 17%	55.6 13.5%
Week 192	39.1 19.5%	37.5 16.7%	45.5 11%
Week 204	35.5 17.7%	0.0 0%	100.0 24.3%
Week 216	35.9 17.9%
Week 228	43.9 21.8%
Week 240	37.9 18.9%
Week 252	40.0 19.9%
Week 264	32.6 16.2%
Week 276	38.4 19.1%
Week 288	41.7 20.7%
Week 300	35.8 17.8%
Week 312	38.0 18.9%
Week 324	39.1 19.5%
Week 336	32.1 16%
Week 348	27.5 13.7%
Week 360	31.3 15.6%
Week 372	0.0 0%
EOT	27.4 13.6%	42.9 19.2%	49.8 12.1%
EOS	14.9 7.4%	20.0 8.9%	20.2 4.9%

12. Secondary Outcome

Title	Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	18.5 9.2%	73.7 32.9%	72.7 17.6%
Week 2	24.5 12.2%
Week 4	25.1 12.5%
Week 8	33.2 16.5%
Week 12	38.9 19.4%	73.1 32.6%	74.0 18%
Week 16	42.3 21%
Week 20	46.8 23.3%
Week 24	49.7 24.7%	72.1 32.2%	78.4 19%
Week 28	51.6 25.7%
Week 32	50.8 25.3%
Week 36	56.4 28.1%	75.2 33.6%	79.3 19.2%
Week 40	59.5 29.6%
Week 44	60.1 29.9%
Week 48	61.3 30.5%	75.6 33.8%	82.0 19.9%
Week 60	64.3 32%	75.9 33.9%	83.1 20.2%
Week 72	64.7 32.2%	79.8 35.6%	84.5 20.5%
Week 84	68.6 34.1%	79.4 35.4%	83.7 20.3%
Week 96	75.2 37.4%	80.3 35.8%	86.0 20.9%
Week 108	77.4 38.5%	78.0 34.8%	87.6 21.3%
Week 120	74.6 37.1%	85.1 38%	86.9 21.1%
Week 132	77.0 38.3%	84.5 37.7%	87.4 21.2%
Week 144	81.7 40.6%	82.5 36.8%	86.7 21%
Week 156	78.2 38.9%	80.0 35.7%	85.8 20.8%
Week 168	76.7 38.2%	78.4 35%	86.8 21.1%
Week 180	75.4 37.5%	81.0 36.2%	89.1 21.6%
Week 192	76.6 38.1%	87.5 39.1%	90.9 22.1%
Week 204	83.2 41.4%	100.0 44.6%	100.0 24.3%
Week 216	75.0 37.3%
Week 228	82.7 41.1%
Week 240	80.0 39.8%
Week 252	77.8 38.7%
Week 264	82.2 40.9%
Week 276	86.0 42.8%
Week 288	83.3 41.4%
Week 300	82.7 41.1%
Week 312	83.5 41.5%
Week 324	84.4 42%
Week 336	77.4 38.5%
Week 348	80.0 39.8%
Week 360	100.0 49.8%
Week 372	100.0 49.8%
EOT	61.7 30.7%	71.6 32%	84.0 20.4%
EOS	40.6 20.2%	47.7 21.3%	60.7 14.7%

13. Secondary Outcome

Title	Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	8.5 4.2%	56.5 25.2%	55.7 13.5%
Week 2	13.5 6.7%
Week 4	14.6 7.3%
Week 8	14.2 7.1%
Week 12	22.7 11.3%	53.0 23.7%	59.6 14.5%
Week 16	22.4 11.1%
Week 20	23.8 11.8%
Week 24	28.3 14.1%	54.1 24.2%	62.3 15.1%
Week 28	29.5 14.7%
Week 32	31.5 15.7%
Week 36	32.0 15.9%	58.3 26%	64.7 15.7%
Week 40	30.4 15.1%
Week 44	38.7 19.3%
Week 48	40.5 20.1%	58.4 26.1%	65.9 16%
Week 60	40.1 20%	57.6 25.7%	67.3 16.3%
Week 72	43.3 21.5%	59.9 26.7%	69.9 17%
Week 84	43.9 21.8%	57.9 25.8%	69.8 16.9%
Week 96	53.7 26.7%	56.4 25.2%	71.2 17.3%
Week 108	51.9 25.8%	64.0 28.6%	70.8 17.2%
Week 120	48.5 24.1%	66.2 29.6%	71.4 17.3%
Week 132	55.6 27.7%	67.0 29.9%	72.6 17.6%
Week 144	58.3 29%	63.9 28.5%	71.1 17.3%
Week 156	55.5 27.6%	67.1 30%	67.6 16.4%
Week 168	56.0 27.9%	64.9 29%	69.7 16.9%
Week 180	57.5 28.6%	57.1 25.5%	75.6 18.3%
Week 192	55.5 27.6%	62.5 27.9%	68.2 16.6%
Week 204	60.7 30.2%	100.0 44.6%	100.0 24.3%
Week 216	54.4 27.1%
Week 228	59.2 29.5%
Week 240	60.0 29.9%
Week 252	60.0 29.9%
Week 264	56.2 28%
Week 276	62.8 31.2%
Week 288	57.1 28.4%
Week 300	60.5 30.1%
Week 312	57.0 28.4%
Week 324	60.9 30.3%
Week 336	52.8 26.3%
Week 348	52.5 26.1%
Week 360	50.0 24.9%
Week 372	100.0 49.8%
EOT	42.8 21.3%	54.5 24.3%	67.5 16.4%
EOS	23.8 11.8%	35.4 15.8%	40.4 9.8%

14. Secondary Outcome

Title	Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-4.3 (8.2)	-11.7 (8.8)	-11.5 (8.4)
Week 2	-5.3 (7.9)
Week 4	-5.7 (8.6)
Week 8	-7.7 (8.8)
Week 12	-8.7 (8.5)	-11.8 (8.9)	-11.8 (8.1)
Week 16	-9.4 (8.3)
Week 20	-9.5 (8.4)
Week 24	-9.8 (9.0)	-11.9 (8.8)	-12.1 (8.0)
Week 28	-10.0 (8.7)
Week 32	-9.5 (8.2)
Week 36	-10.0 (8.0)	-12.4 (8.8)	-12.3 (7.9)
Week 40	-10.4 (8.1)
Week 44	-10.9 (8.2)
Week 48	-10.7 (8.3)	-11.9 (8.8)	-12.3 (8.2)
Week 60	-10.8 (8.3)	-11.9 (9.2)	-12.4 (8.3)
Week 72	-10.4 (8.8)	-11.9 (9.4)	-12.8 (8.5)
Week 84	-10.7 (8.7)	-11.9 (9.0)	-12.9 (8.3)
Week 96	-10.8 (7.9)	-12.3 (9.5)	-13.1 (8.4)
Week 108	-10.7 (8.2)	-12.3 (9.3)	-13.8 (8.9)
Week 120	-10.6 (8.4)	-12.7 (9.5)	-13.5 (9.2)
Week 132	-10.8 (8.3)	-12.8 (9.9)	-13.8 (9.0)
Week 144	-11.1 (9.0)	-12.9 (9.5)	-13.3 (9.3)
Week 156	-11.2 (8.4)	-14.1 (10.4)	-13.3 (9.7)
Week 168	-11.3 (8.7)	-11.8 (10.0)	-13.2 (9.1)
Week 180	-11.3 (8.5)	-12.2 (7.5)	-14.2 (9.9)
Week 192	-11.4 (8.7)	-11.8 (5.6)	-13.2 (10.8)
Week 204	-11.8 (7.8)	-8.0 (NA)	-17.0 (NA)
Week 216	-11.7 (8.1)
Week 228	-11.7 (7.9)
Week 240	-11.7 (8.0)
Week 252	-11.8 (8.3)
Week 264	-11.7 (8.4)
Week 276	-12.0 (8.4)
Week 288	-11.5 (8.5)
Week 300	-11.5 (8.6)
Week 312	-11.9 (8.6)
Week 324	-12.0 (8.2)
Week 336	-11.5 (6.6)
Week 348	-11.2 (5.8)
Week 360	-13.8 (5.6)
Week 372	-23.0 (NA)
EOT	-10.2 (9.6)	-11.5 (9.4)	-12.6 (8.6)
EOS	-8.6 (9.8)	-9.1 (7.6)	-9.4 (9.9)

15. Secondary Outcome

Title	Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-3.8 (5.5)	-9.6 (6.9)	-10.5 (6.4)
Week 2	-4.6 (5.8)
Week 4	-4.8 (6.2)
Week 8	-6.1 (6.3)
Week 12	-6.7 (6.1)	-9.5 (6.6)	-10.4 (6.4)
Week 16	-7.1 (5.8)
Week 20	-7.4 (6.1)
Week 24	-7.6 (5.9)	-9.9 (6.4)	-10.8 (6.4)
Week 28	-7.6 (6.0)
Week 32	-7.5 (5.7)
Week 36	-7.9 (5.5)	-10.3 (6.6)	-11.1 (6.5)
Week 40	-8.1 (5.5)
Week 44	-8.6 (5.4)
Week 48	-8.7 (5.6)	-10.4 (6.4)	-11.0 (6.7)
Week 60	-8.4 (6.1)	-10.3 (6.8)	-11.1 (6.6)
Week 72	-8.6 (5.8)	-10.3 (6.6)	-11.3 (6.7)
Week 84	-8.7 (5.6)	-10.2 (6.7)	-11.2 (6.6)
Week 96	-8.8 (5.2)	-10.6 (7.0)	-11.3 (6.5)
Week 108	-9.0 (5.3)	-10.7 (7.5)	-11.5 (6.9)
Week 120	-8.7 (5.8)	-11.1 (7.3)	-11.4 (6.6)
Week 132	-9.0 (5.7)	-11.2 (7.3)	-11.5 (6.8)
Week 144	-9.1 (5.6)	-11.2 (7.8)	-11.3 (6.7)
Week 156	-8.9 (5.7)	-12.4 (8.1)	-11.4 (7.0)
Week 168	-9.2 (5.9)	-11.4 (7.0)	-11.7 (6.8)
Week 180	-9.2 (5.4)	-10.6 (6.2)	-11.9 (7.3)
Week 192	-9.1 (5.7)	-9.0 (7.3)	-11.3 (7.5)
Week 204	-9.5 (5.5)	-6.0 (NA)	-17.0 (NA)
Week 216	-9.2 (6.0)
Week 228	-9.4 (5.4)
Week 240	-9.7 (5.8)
Week 252	-9.6 (5.7)
Week 264	-9.7 (5.5)
Week 276	-9.9 (5.5)
Week 288	-9.5 (5.7)
Week 300	-9.7 (5.7)
Week 312	-9.4 (5.8)
Week 324	-9.5 (5.7)
Week 336	-9.4 (5.3)
Week 348	-9.4 (5.1)
Week 360	-11.0 (5.8)
Week 372	-18.0 (NA)
EOT	-7.8 (6.6)	-9.7 (7.1)	-11.1 (6.8)
EOS	-6.3 (7.2)	-8.2 (7.4)	-9.3 (7.6)

16. Secondary Outcome

Title	Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Description	Higher CRP indicates greater disease activity.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-0.334 (1.691)	-1.590 (2.106)	-1.932 (2.014)
Week 2	-0.752 (1.724)
Week 4	-0.745 (1.897)
Week 8	-1.032 (1.932)
Week 12	-1.034 (2.225)	-1.528 (2.121)	-1.932 (2.037)
Week 16	-1.176 (2.203)
Week 20	-1.242 (2.221)
Week 24	-1.237 (2.168)	-1.507 (2.129)	-1.991 (2.125)
Week 28	-1.376 (2.039)
Week 32	-1.296 (2.040)
Week 36	-1.330 (2.073)	-1.552 (2.087)	-2.031 (2.116)
Week 40	-1.361 (2.217)
Week 44	-1.361 (2.260)
Week 48	-1.367 (2.070)	-1.604 (2.096)	-2.088 (2.034)
Week 60	-1.310 (2.011)	-1.534 (2.163)	-2.063 (2.062)
Week 72	-1.456 (2.165)	-1.726 (2.008)	-2.019 (2.023)
Week 84	-1.418 (2.159)	-1.501 (2.337)	-1.991 (2.092)
Week 96	-1.485 (2.113)	-1.561 (2.101)	-1.983 (2.606)
Week 108	-1.562 (2.060)	-1.565 (2.444)	-2.066 (1.990)
Week 120	-1.507 (2.199)	-1.730 (2.163)	-1.964 (2.108)
Week 132	-1.443 (2.602)	-1.519 (2.231)	-2.058 (2.178)
Week 144	-1.609 (2.297)	-1.474 (2.155)	-2.120 (2.329)
Week 156	-1.423 (2.489)	-1.731 (1.892)	-2.432 (2.277)
Week 168	-1.576 (2.213)	-1.418 (2.153)	-2.211 (2.227)
Week 180	-1.170 (2.340)	-2.088 (1.984)	-2.230 (2.053)
Week 192	-1.506 (1.976)	-1.501 (1.575)	-2.060 (2.014)
Week 204	-1.477 (2.154)	-1.570 (NA)	-0.950 (NA)
Week 216	-1.374 (2.209)
Week 228	-1.449 (2.232)
Week 240	-1.440 (2.340)
Week 252	-1.488 (2.263)
Week 264	-1.498 (2.379)
Week 276	-1.647 (2.264)
Week 288	-1.580 (2.404)
Week 300	-1.537 (2.470)
Week 312	-1.263 (2.319)
Week 324	-1.565 (2.238)
Week 336	-1.452 (2.189)
Week 348	-1.365 (2.015)
Week 360	-2.179 (2.117)
Week 372	-2.330 (NA)
EOT	-1.072 (2.470)	-1.386 (2.340)	-1.845 (2.438)
EOS	-0.967 (2.251)	-1.262 (2.930)	-1.270 (2.818)

17. Secondary Outcome

Title	Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Description	Higher ESR indicates greater disease activity.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-2.46 (17.83)	-22.66 (25.31)	-27.02 (23.11)
Week 2	-6.65 (18.03)
Week 4	-6.93 (18.01)
Week 8	-10.54 (17.93)
Week 12	-11.93 (18.44)	-22.43 (26.18)	-27.72 (23.47)
Week 16	-13.39 (19.30)
Week 20	-14.07 (17.92)
Week 24	-14.45 (18.12)	-22.91 (25.13)	-28.54 (24.45)
Week 28	-15.15 (17.28)
Week 32	-16.20 (17.74)
Week 36	-16.26 (19.70)	-22.51 (26.62)	-29.41 (23.34)
Week 40	-16.27 (19.89)
Week 44	-15.60 (20.47)
Week 48	-16.09 (19.14)	-23.63 (25.51)	-30.31 (23.67)
Week 60	-16.71 (19.07)	-23.34 (24.86)	-30.06 (23.69)
Week 72	-16.78 (21.18)	-24.70 (24.16)	-30.06 (23.85)
Week 84	-16.89 (20.87)	-22.58 (26.95)	-29.23 (24.23)
Week 96	-18.81 (21.28)	-21.71 (25.55)	-29.70 (25.14)
Week 108	-19.24 (20.02)	-22.46 (25.87)	-29.97 (25.60)
Week 120	-19.48 (21.41)	-24.36 (25.63)	-29.46 (25.87)
Week 132	-19.43 (23.78)	-22.13 (26.42)	-30.35 (24.34)
Week 144	-22.19 (22.29)	-21.48 (22.87)	-31.44 (24.17)
Week 156	-20.62 (23.11)	-23.14 (23.91)	-30.77 (25.02)
Week 168	-20.58 (22.98)	-24.95 (22.89)	-29.68 (22.86)
Week 180	-16.28 (23.48)	-23.52 (28.44)	-33.46 (24.70)
Week 192	-18.86 (20.85)	-38.63 (35.76)	-26.50 (27.72)
Week 204	-19.05 (21.63)	-11.00 (NA)	-57.00 (NA)
Week 216	-17.85 (23.11)
Week 228	-20.09 (22.96)
Week 240	-19.24 (22.01)
Week 252	-20.78 (21.72)
Week 264	-19.11 (24.20)
Week 276	-20.21 (21.14)
Week 288	-17.57 (25.36)
Week 300	-19.51 (20.15)
Week 312	-16.81 (21.06)
Week 324	-17.28 (22.08)
Week 336	-17.51 (21.38)
Week 348	-16.53 (21.63)
Week 360	-20.63 (22.81)
Week 372	-28.00 (NA)
EOT	-12.52 (21.92)	-20.04 (26.47)	-26.36 (27.00)
EOS	-8.90 (24.70)	-14.48 (25.73)	-17.26 (27.20)

18. Secondary Outcome

Title	Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Description	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).
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	1.5 0.7%	18.3 8.2%	22.4 5.4%
Week 2	4.0 2%
Week 4	5.0 2.5%
Week 8	4.5 2.2%
Week 12	4.0 2%	16.9 7.5%	23.0 5.6%
Week 16	7.1 3.5%
Week 20	7.4 3.7%
Week 24	7.5 3.7%	20.2 9%	26.9 6.5%
Week 28	9.2 4.6%
Week 32	10.6 5.3%
Week 36	11.0 5.5%	29.1 13%	28.3 6.9%
Week 40	8.3 4.1%
Week 44	11.0 5.5%
Week 48	11.0 5.5%	25.9 11.6%	32.7 7.9%
Week 60	10.8 5.4%	24.1 10.8%	28.9 7%
Week 72	11.3 5.6%	29.5 13.2%	30.7 7.5%
Week 84	14.3 7.1%	30.0 13.4%	34.0 8.3%
Week 96	17.5 8.7%	26.6 11.9%	33.2 8.1%
Week 108	18.0 9%	28.7 12.8%	30.0 7.3%
Week 120	16.9 8.4%	29.1 13%	26.3 6.4%
Week 132	20.6 10.2%	29.3 13.1%	31.4 7.6%
Week 144	18.3 9.1%	30.9 13.8%	28.9 7%
Week 156	17.6 8.8%	27.1 12.1%	31.1 7.5%
Week 168	21.6 10.7%	35.1 15.7%	31.6 7.7%
Week 180	21.1 10.5%	23.8 10.6%	34.8 8.4%
Week 192	21.6 10.7%	25.0 11.2%	31.8 7.7%
Week 204	23.4 11.6%	100.0 44.6%	100.0 24.3%
Week 216	25.0 12.4%
Week 228	24.5 12.2%
Week 240	24.2 12%
Week 252	25.6 12.7%
Week 264	24.4 12.1%
Week 276	19.8 9.9%
Week 288	25.0 12.4%
Week 300	24.7 12.3%
Week 312	24.1 12%
Week 324	23.4 11.6%
Week 336	24.5 12.2%
Week 348	15.0 7.5%
Week 360	25.0 12.4%
Week 372	0.0 0%
EOT	15.9 7.9%	25.7 11.5%	31.3 7.6%
EOS	10.9 5.4%	7.7 3.4%	12.4 3%

19. Secondary Outcome

Title	Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	11.5 5.7%	71.0 31.7%	71.0 17.2%
Week 2	18.0 9%
Week 4	19.6 9.8%
Week 8	27.1 13.5%
Week 12	34.8 17.3%	70.3 31.4%	72.3 17.5%
Week 16	36.2 18%
Week 20	43.7 21.7%
Week 24	44.4 22.1%	70.2 31.3%	77.2 18.7%
Week 28	47.8 23.8%
Week 32	46.4 23.1%
Week 36	49.4 24.6%	72.3 32.3%	78.2 19%
Week 40	53.0 26.4%
Week 44	53.4 26.6%
Week 48	56.4 28.1%	73.1 32.6%	80.1 19.4%
Week 60	58.0 28.9%	71.7 32%	82.3 20%
Week 72	59.3 29.5%	76.5 34.2%	84.0 20.4%
Week 84	63.6 31.6%	75.0 33.5%	82.0 19.9%
Week 96	72.3 36%	77.5 34.6%	84.0 20.4%
Week 108	72.9 36.3%	75.6 33.8%	85.8 20.8%
Week 120	70.8 35.2%	83.8 37.4%	85.4 20.7%
Week 132	73.8 36.7%	80.2 35.8%	85.7 20.8%
Week 144	78.3 39%	80.4 35.9%	85.2 20.7%
Week 156	74.8 37.2%	75.7 33.8%	84.9 20.6%
Week 168	73.3 36.5%	75.7 33.8%	86.8 21.1%
Week 180	71.9 35.8%	76.2 34%	84.8 20.6%
Week 192	74.8 37.2%	87.5 39.1%	86.4 21%
Week 204	77.6 38.6%	100.0 44.6%	100.0 24.3%
Week 216	73.1 36.4%
Week 228	79.6 39.6%
Week 240	78.9 39.3%
Week 252	76.7 38.2%
Week 264	80.0 39.8%
Week 276	81.4 40.5%
Week 288	78.6 39.1%
Week 300	80.2 39.9%
Week 312	81.0 40.3%
Week 324	79.7 39.7%
Week 336	71.7 35.7%
Week 348	75.0 37.3%
Week 360	100.0 49.8%
Week 372	100.0 49.8%
EOT	58.7 29.2%	69.4 31%	83.3 20.2%
EOS	38.6 19.2%	43.1 19.2%	58.4 14.2%

20. Secondary Outcome

Title	Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	7.0 3.5%	54.7 24.4%	54.5 13.2%
Week 2	11.5 5.7%
Week 4	13.1 6.5%
Week 8	13.7 6.8%
Week 12	21.7 10.8%	50.7 22.6%	58.1 14.1%
Week 16	21.9 10.9%
Week 20	23.3 11.6%
Week 24	27.3 13.6%	52.7 23.5%	61.6 15%
Week 28	29.0 14.4%
Week 32	30.9 15.4%
Week 36	30.8 15.3%	54.9 24.5%	63.7 15.5%
Week 40	28.6 14.2%
Week 44	36.8 18.3%
Week 48	38.0 18.9%	56.3 25.1%	65.1 15.8%
Week 60	39.5 19.7%	55.5 24.8%	66.5 16.1%
Week 72	42.7 21.2%	58.2 26%	68.5 16.6%
Week 84	43.9 21.8%	54.5 24.3%	68.6 16.7%
Week 96	51.5 25.6%	54.7 24.4%	69.6 16.9%
Week 108	50.4 25.1%	61.6 27.5%	68.9 16.7%
Week 120	46.2 23%	64.2 28.7%	69.5 16.9%
Week 132	54.0 26.9%	64.3 28.7%	71.4 17.3%
Week 144	56.7 28.2%	60.8 27.1%	68.9 16.7%
Week 156	53.8 26.8%	65.7 29.3%	67.6 16.4%
Week 168	55.2 27.5%	64.9 29%	68.4 16.6%
Week 180	56.6 28.2%	57.1 25.5%	73.3 17.8%
Week 192	54.5 27.1%	62.5 27.9%	63.6 15.4%
Week 204	59.8 29.8%	100.0 44.6%	100.0 24.3%
Week 216	52.4 26.1%
Week 228	58.2 29%
Week 240	56.8 28.3%
Week 252	57.8 28.8%
Week 264	56.2 28%
Week 276	60.5 30.1%
Week 288	54.8 27.3%
Week 300	58.0 28.9%
Week 312	54.4 27.1%
Week 324	59.4 29.6%
Week 336	50.9 25.3%
Week 348	52.5 26.1%
Week 360	50.0 24.9%
Week 372	100.0 49.8%
EOT	41.3 20.5%	52.2 23.3%	65.8 16%
EOS	20.8 10.3%	35.4 15.8%	40.4 9.8%

21. Secondary Outcome

Title	Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	41.5 20.6%	89.7 40%	93.4 22.7%
Week 2	54.5 27.1%
Week 4	59.3 29.5%
Week 8	70.1 34.9%
Week 12	75.8 37.7%	91.3 40.8%	92.2 22.4%
Week 16	78.1 38.9%
Week 20	85.2 42.4%
Week 24	84.0 41.8%	92.3 41.2%	95.4 23.2%
Week 28	87.4 43.5%
Week 32	84.8 42.2%
Week 36	91.3 45.4%	92.2 41.2%	95.5 23.2%
Week 40	89.3 44.4%
Week 44	93.3 46.4%
Week 48	92.6 46.1%	94.4 42.1%	95.1 23.1%
Week 60	93.0 46.3%	92.1 41.1%	94.9 23%
Week 72	90.7 45.1%	91.2 40.7%	96.0 23.3%
Week 84	89.9 44.7%	92.7 41.4%	95.9 23.3%
Week 96	92.6 46.1%	94.2 42.1%	97.1 23.6%
Week 108	92.5 46%	91.5 40.8%	97.4 23.6%
Week 120	91.5 45.5%	93.9 41.9%	96.2 23.3%
Week 132	92.1 45.8%	89.6 40%	97.7 23.7%
Week 144	93.3 46.4%	87.6 39.1%	97.0 23.5%
Week 156	94.1 46.8%	95.7 42.7%	96.2 23.3%
Week 168	92.2 45.9%	86.5 38.6%	96.1 23.3%
Week 180	93.8 46.7%	90.5 40.4%	93.3 22.6%
Week 192	94.5 47%	87.5 39.1%	95.5 23.2%
Week 204	95.3 47.4%	100.0 44.6%	100.0 24.3%
Week 216	93.2 46.4%
Week 228	92.9 46.2%
Week 240	92.6 46.1%
Week 252	92.2 45.9%
Week 264	92.1 45.8%
Week 276	94.2 46.9%
Week 288	92.9 46.2%
Week 300	95.1 47.3%
Week 312	94.9 47.2%
Week 324	96.9 48.2%
Week 336	94.3 46.9%
Week 348	92.5 46%
Week 360	100.0 49.8%
Week 372	100.0 49.8%
EOT	76.6 38.1%	87.1 38.9%	93.7 22.7%
EOS	67.3 33.5%	80.0 35.7%	82.0 19.9%

22. Secondary Outcome

Title	Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	48.5 24.1%	94.2 42.1%	94.6 23%
Week 2	60.5 30.1%
Week 4	65.8 32.7%
Week 8	75.4 37.5%
Week 12	79.8 39.7%	92.7 41.4%	94.9 23%
Week 16	81.6 40.6%
Week 20	84.2 41.9%
Week 24	84.5 42%	95.2 42.5%	96.2 23.3%
Week 28	88.0 43.8%
Week 32	88.3 43.9%
Week 36	91.3 45.4%	95.1 42.5%	96.9 23.5%
Week 40	92.9 46.2%
Week 44	93.3 46.4%
Week 48	92.0 45.8%	94.9 42.4%	97.3 23.6%
Week 60	94.9 47.2%	93.7 41.8%	96.1 23.3%
Week 72	92.7 46.1%	95.1 42.5%	96.3 23.4%
Week 84	92.1 45.8%	95.0 42.4%	96.4 23.4%
Week 96	94.2 46.9%	94.2 42.1%	97.7 23.7%
Week 108	95.5 47.5%	93.9 41.9%	98.1 23.8%
Week 120	93.1 46.3%	98.0 43.8%	96.7 23.5%
Week 132	92.1 45.8%	94.0 42%	97.7 23.7%
Week 144	95.0 47.3%	90.7 40.5%	96.3 23.4%
Week 156	94.1 46.8%	97.1 43.3%	98.1 23.8%
Week 168	94.0 46.8%	94.6 42.2%	98.7 24%
Week 180	93.9 46.7%	95.2 42.5%	97.8 23.7%
Week 192	95.5 47.5%	87.5 39.1%	95.5 23.2%
Week 204	96.3 47.9%	100.0 44.6%	100.0 24.3%
Week 216	94.2 46.9%
Week 228	93.9 46.7%
Week 240	94.7 47.1%
Week 252	93.3 46.4%
Week 264	91.1 45.3%
Week 276	95.3 47.4%
Week 288	94.0 46.8%
Week 300	93.8 46.7%
Week 312	94.9 47.2%
Week 324	98.4 49%
Week 336	98.1 48.8%
Week 348	92.5 46%
Week 360	100.0 49.8%
Week 372	100.0 49.8%
EOT	78.6 39.1%	89.2 39.8%	95.4 23.2%
EOS	72.3 36%	80.0 35.7%	83.1 20.2%

23. Secondary Outcome

Title	Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	4.0 2%	24.6 11%	32.6 7.9%
Week 2	5.0 2.5%
Week 4	6.0 3%
Week 8	5.5 2.7%
Week 12	6.1 3%	27.4 12.2%	31.4 7.6%
Week 16	8.7 4.3%
Week 20	10.0 5%
Week 24	13.4 6.7%	28.4 12.7%	37.1 9%
Week 28	15.2 7.6%
Week 32	16.2 8.1%
Week 36	16.9 8.4%	31.6 14.1%	40.9 9.9%
Week 40	12.5 6.2%
Week 44	16.6 8.3%
Week 48	18.4 9.2%	32.5 14.5%	42.8 10.4%
Week 60	14.0 7%	30.4 13.6%	41.6 10.1%
Week 72	21.3 10.6%	37.7 16.8%	43.3 10.5%
Week 84	21.4 10.6%	35.6 15.9%	42.3 10.3%
Week 96	24.1 12%	37.6 16.8%	42.0 10.2%
Week 108	25.6 12.7%	39.6 17.7%	42.7 10.4%
Week 120	24.6 12.2%	40.5 18.1%	38.0 9.2%
Week 132	28.6 14.2%	41.4 18.5%	44.0 10.7%
Week 144	27.5 13.7%	41.2 18.4%	45.2 11%
Week 156	24.4 12.1%	42.9 19.2%	42.5 10.3%
Week 168	28.4 14.1%	51.4 22.9%	44.7 10.8%
Week 180	27.2 13.5%	42.9 19.2%	45.7 11.1%
Week 192	33.3 16.6%	25.0 11.2%	50.0 12.1%
Week 204	30.8 15.3%	0.0 0%	100.0 24.3%
Week 216	33.7 16.8%
Week 228	37.8 18.8%
Week 240	37.9 18.9%
Week 252	31.1 15.5%
Week 264	35.6 17.7%
Week 276	32.6 16.2%
Week 288	38.1 19%
Week 300	33.3 16.6%
Week 312	32.9 16.4%
Week 324	34.4 17.1%
Week 336	28.3 14.1%
Week 348	22.5 11.2%
Week 360	31.3 15.6%
Week 372	0.0 0%
EOT	23.9 11.9%	36.0 16.1%	43.4 10.5%
EOS	13.9 6.9%	13.8 6.2%	24.7 6%

24. Secondary Outcome

Title	Change From Baseline of Preceding Study in SDAI Score Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-7.41 (11.53)	-24.30 (13.03)	-25.12 (12.32)
Week 2	-10.13 (11.06)
Week 4	-10.93 (12.01)
Week 8	-14.33 (12.03)
Week 12	-16.14 (12.02)	-23.93 (13.02)	-25.15 (12.17)
Week 16	-17.53 (11.95)
Week 20	-18.11 (12.16)
Week 24	-18.61 (11.99)	-24.13 (12.84)	-25.93 (11.90)
Week 28	-19.43 (12.07)
Week 32	-18.66 (12.25)
Week 36	-19.62 (11.23)	-25.00 (13.12)	-26.45 (11.70)
Week 40	-20.26 (11.40)
Week 44	-20.96 (11.46)
Week 48	-21.17 (11.97)	-24.93 (12.56)	-26.75 (11.98)
Week 60	-21.10 (12.21)	-24.54 (13.27)	-26.73 (12.04)
Week 72	-21.65 (13.09)	-25.17 (13.02)	-27.31 (12.04)
Week 84	-21.82 (12.90)	-24.70 (13.34)	-27.15 (12.02)
Week 96	-22.40 (12.25)	-25.37 (13.36)	-27.52 (11.72)
Week 108	-22.73 (12.74)	-25.38 (13.68)	-28.28 (12.38)
Week 120	-22.18 (13.61)	-26.57 (13.40)	-27.71 (12.37)
Week 132	-22.90 (13.51)	-26.38 (14.24)	-27.83 (12.16)
Week 144	-23.58 (12.96)	-26.53 (14.75)	-27.38 (13.05)
Week 156	-23.19 (13.04)	-28.68 (15.05)	-28.07 (13.27)
Week 168	-23.64 (13.12)	-26.75 (15.71)	-27.34 (13.31)
Week 180	-23.07 (13.37)	-26.63 (15.13)	-29.04 (13.67)
Week 192	-23.75 (13.34)	-24.37 (15.48)	-27.99 (13.04)
Week 204	-24.42 (12.08)	-26.92 (NA)	-36.00 (NA)
Week 216	-24.00 (12.81)
Week 228	-24.18 (12.64)
Week 240	-24.55 (12.88)
Week 252	-24.47 (13.18)
Week 264	-24.36 (13.22)
Week 276	-25.23 (12.77)
Week 288	-24.71 (13.15)
Week 300	-24.56 (13.46)
Week 312	-24.52 (13.38)
Week 324	-25.45 (12.83)
Week 336	-23.68 (12.34)
Week 348	-22.45 (11.80)
Week 360	-27.23 (11.15)
Week 372	-53.18 (NA)
EOT	-19.12 (15.01)	-23.68 (14.37)	-26.58 (13.07)
EOS	-14.81 (13.90)	-19.25 (14.64)	-20.05 (14.05)

25. Secondary Outcome

Title	Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	3.0 1.5%	23.7 10.6%	30.6 7.4%
Week 2	4.0 2%
Week 4	4.5 2.2%
Week 8	6.0 3%
Week 12	5.6 2.8%	24.2 10.8%	30.6 7.4%
Week 16	7.7 3.8%
Week 20	8.9 4.4%
Week 24	11.8 5.9%	29.3 13.1%	36.0 8.7%
Week 28	14.1 7%
Week 32	16.8 8.4%
Week 36	15.1 7.5%	30.6 13.7%	39.1 9.5%
Week 40	13.7 6.8%
Week 44	15.3 7.6%
Week 48	19.6 9.8%	33.5 15%	42.2 10.2%
Week 60	14.0 7%	28.3 12.6%	40.7 9.9%
Week 72	18.7 9.3%	36.6 16.3%	42.4 10.3%
Week 84	20.0 10%	33.9 15.1%	42.6 10.3%
Week 96	23.4 11.6%	37.6 16.8%	42.7 10.4%
Week 108	26.3 13.1%	37.2 16.6%	40.4 9.8%
Week 120	23.1 11.5%	39.9 17.8%	39.0 9.5%
Week 132	25.4 12.6%	44.0 19.6%	42.3 10.3%
Week 144	25.0 12.4%	42.3 18.9%	44.9 10.9%
Week 156	19.3 9.6%	41.4 18.5%	40.6 9.9%
Week 168	28.4 14.1%	51.4 22.9%	43.4 10.5%
Week 180	28.1 14%	33.3 14.9%	43.5 10.6%
Week 192	30.6 15.2%	25.0 11.2%	45.5 11%
Week 204	29.9 14.9%	0.0 0%	100.0 24.3%
Week 216	33.7 16.8%
Week 228	33.7 16.8%
Week 240	34.7 17.3%
Week 252	30.0 14.9%
Week 264	31.1 15.5%
Week 276	31.4 15.6%
Week 288	38.1 19%
Week 300	30.9 15.4%
Week 312	31.6 15.7%
Week 324	34.4 17.1%
Week 336	26.4 13.1%
Week 348	20.0 10%
Week 360	31.3 15.6%
Week 372	0.0 0%
EOT	24.9 12.4%	34.5 15.4%	42.5 10.3%
EOS	14.9 7.4%	12.3 5.5%	25.8 6.3%

26. Secondary Outcome

Title	Change From Baseline of Preceding Study CDAI Score Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-7.07 (10.78)	-22.70 (12.24)	-23.22 (11.73)
Week 2	-9.38 (10.44)
Week 4	-10.19 (11.36)
Week 8	-13.30 (11.28)
Week 12	-15.11 (11.10)	-22.39 (12.28)	-23.21 (11.54)
Week 16	-16.35 (10.88)
Week 20	-16.87 (11.15)
Week 24	-17.37 (11.35)	-22.62 (12.17)	-23.93 (11.24)
Week 28	-18.06 (11.39)
Week 32	-17.36 (11.37)
Week 36	-18.29 (10.42)	-23.41 (12.39)	-24.42 (11.13)
Week 40	-18.90 (10.50)
Week 44	-19.60 (10.58)
Week 48	-19.80 (11.03)	-23.32 (11.98)	-24.66 (11.45)
Week 60	-19.79 (11.41)	-23.01 (12.53)	-24.66 (11.53)
Week 72	-20.19 (12.16)	-23.45 (12.39)	-25.29 (11.55)
Week 84	-20.40 (12.11)	-23.20 (12.61)	-25.16 (11.54)
Week 96	-20.92 (11.41)	-23.81 (12.62)	-25.54 (11.27)
Week 108	-21.17 (11.87)	-23.81 (12.76)	-26.22 (11.82)
Week 120	-20.68 (12.79)	-24.84 (12.73)	-25.74 (11.66)
Week 132	-21.46 (12.30)	-24.86 (13.57)	-25.77 (11.56)
Week 144	-21.97 (11.87)	-25.06 (14.11)	-25.23 (12.10)
Week 156	-21.77 (11.89)	-26.95 (14.59)	-25.64 (12.50)
Week 168	-22.06 (12.12)	-25.34 (14.99)	-25.13 (12.55)
Week 180	-21.90 (12.27)	-24.54 (14.26)	-26.81 (13.07)
Week 192	-22.24 (12.55)	-22.87 (14.41)	-25.93 (12.65)
Week 204	-22.95 (11.32)	-25.35 (NA)	-35.05 (NA)
Week 216	-22.62 (11.84)
Week 228	-22.73 (11.89)
Week 240	-23.11 (11.88)
Week 252	-22.98 (12.28)
Week 264	-22.86 (12.21)
Week 276	-23.58 (11.91)
Week 288	-23.13 (12.18)
Week 300	-23.02 (12.27)
Week 312	-23.26 (12.34)
Week 324	-23.89 (11.85)
Week 336	-22.23 (11.56)
Week 348	-21.08 (11.11)
Week 360	-25.05 (10.77)
Week 372	-50.85 (NA)
EOT	-18.05 (13.98)	-22.24 (13.54)	-24.74 (12.26)
EOS	-13.84 (13.08)	-17.97 (12.75)	-18.78 (12.87)

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point. Only 015K-CL-RAJ1 arm was analyzed for this outcome as planned.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201
Week 0	1.71 (8.52)
Week 2	4.50 (3.54)
Week 4	3.29 (8.08)
Week 8	4.15 (8.66)
Week 12	4.85 (8.79)
Week 16	5.91 (8.50)
Week 20	5.86 (9.26)
Week 24	5.99 (8.93)
Week 28	5.95 (8.96)
Week 32	5.91 (8.49)
Week 36	5.91 (8.72)
Week 40	6.06 (8.87)
Week 44	6.05 (8.40)
Week 48	6.34 (8.44)
Week 60	7.18 (9.03)
Week 72	5.87 (8.90)
Week 84	6.11 (8.15)
Week 96	6.10 (8.22)
Week 108	-6.0 (NA)
EOT	5.95 (9.24)
EOS	3.67 (9.77)

28. Secondary Outcome

Title	Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Description	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.
Time Frame	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	116	211
Week 0	-5.36 (16.76)	-2.20 (18.46)
Week 24	-4.81 (17.40)	-3.29 (14.30)
Week 48	-4.52 (19.86)	-3.30 (17.16)
Week 72	-4.73 (18.43)	-3.17 (15.47)
Week 96	-4.74 (19.00)	-3.13 (14.38)
Week 120	-5.15 (20.38)	-4.49 (17.14)
Week 144	-3.21 (14.26)	-1.26 (20.09)
Week 168	-8.65 (21.30)	-5.19 (19.82)
Week 192	0.00 (0.00)	-2.29 (6.62)
EOT	-2.76 (20.13)	-1.96 (17.64)

29. Secondary Outcome

Title	Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Description	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.
Time Frame	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	114	208
Week 0	-21.05 (33.06)	-22.18 (28.64)
Week 24	-21.94 (32.60)	-24.79 (26.64)
Week 48	-20.70 (31.82)	-25.17 (27.33)
Week 72	-21.06 (31.47)	-27.12 (27.72)
Week 96	-20.11 (31.39)	-28.54 (26.94)
Week 120	-24.40 (30.15)	-30.00 (29.38)
Week 144	-18.08 (30.62)	-27.16 (31.37)
Week 168	-17.06 (34.96)	-23.24 (31.79)
Week 192	-15.00 (21.21)	-28.00 (35.53)
EOT	-21.49 (33.56)	-24.13 (29.46)

30. Secondary Outcome

Title	Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Description	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.
Time Frame	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	114	208
Week 0	-22.24 (33.23)	-22.20 (30.83)
Week 24	-22.45 (32.86)	-25.78 (27.99)
Week 48	-20.80 (32.72)	-25.32 (30.00)
Week 72	-21.59 (32.40)	-27.41 (28.98)
Week 96	-20.58 (32.29)	-28.93 (28.34)
Week 120	-24.71 (30.92)	-31.40 (30.13)
Week 144	-18.29 (31.64)	-26.76 (33.82)
Week 168	-19.03 (36.72)	-24.76 (32.39)
Week 192	-15.00 (21.21)	-28.06 (36.25)
EOT	-20.75 (33.46)	-24.63 (31.29)

31. Secondary Outcome

Title	Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Description	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.
Time Frame	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	223	410
Week 0	-28.16 (29.69)	-25.39 (29.77)
Week 24	-27.38 (30.15)	-29.31 (28.92)
Week 48	-27.81 (30.76)	-28.85 (29.34)
Week 72	-28.09 (31.12)	-31.59 (30.71)
Week 96	-27.92 (30.69)	-30.69 (29.30)
Week 120	-29.26 (31.56)	-33.07 (30.69)
Week 144	-26.39 (32.57)	-31.11 (30.68)
Week 168	-20.81 (26.71)	-26.53 (31.64)
Week 192	-20.00 (30.24)	-23.18 (32.13)
EOT	-25.55 (32.04)	-27.87 (32.40)

32. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	37.0 18.4%	61.2 27.3%	62.1 15.1%
Week 2	38.5 19.2%
Week 4	38.7 19.3%
Week 8	39.7 19.8%
Week 12	42.9 21.3%	62.1 27.7%	63.0 15.3%
Week 16	46.9 23.3%
Week 20	47.4 23.6%
Week 24	48.7 24.2%	64.9 29%	65.5 15.9%
Week 28	50.5 25.1%
Week 32	50.0 24.9%
Week 36	51.2 25.5%	62.8 28%	64.3 15.6%
Week 40	52.4 26.1%
Week 44	55.2 27.5%
Week 48	54.0 26.9%	58.9 26.3%	65.4 15.9%
Week 60	55.4 27.6%	62.8 28%	67.1 16.3%
Week 72	60.0 29.9%	67.2 30%	68.8 16.7%
Week 84	62.9 31.3%	65.6 29.3%	69.2 16.8%
Week 96	62.0 30.8%	63.0 28.1%	69.1 16.8%
Week 108	62.4 31%	62.2 27.8%	67.4 16.4%
Week 120	63.1 31.4%	69.6 31.1%	68.1 16.5%
Week 132	66.7 33.2%	70.7 31.6%	68.0 16.5%
Week 144	66.7 33.2%	71.1 31.7%	69.9 17%
Week 156	65.5 32.6%	68.6 30.6%	67.0 16.3%
Week 168	67.2 33.4%	73.0 32.6%	68.4 16.6%
Week 180	68.4 34%	71.4 31.9%	73.9 17.9%
Week 192	67.6 33.6%	87.5 39.1%	59.1 14.3%
Week 204	67.3 33.5%	100.0 44.6%	0.0 0%
Week 216	72.1 35.9%
Week 228	70.4 35%
Week 240	68.4 34%
Week 252	68.9 34.3%
Week 264	67.8 33.7%
Week 276	72.1 35.9%
Week 288	70.2 34.9%
Week 300	69.1 34.4%
Week 312	67.1 33.4%
Week 324	70.3 35%
Week 336	62.3 31%
Week 348	60.0 29.9%
Week 360	56.3 28%
Week 372	100.0 49.8%
EOT	52.7 26.2%	62.3 27.8%	63.6 15.4%
EOS	35.6 17.7%	40.0 17.9%	48.3 11.7%

33. Secondary Outcome

Title	Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-0.03 (0.47)	-0.43 (0.57)	-0.49 (0.55)
Week 2	-0.07 (0.44)
Week 4	-0.08 (0.44)
Week 8	-0.13 (0.47)
Week 12	-0.17 (0.45)	-0.44 (0.57)	-0.48 (0.59)
Week 16	-0.21 (0.45)
Week 20	-0.22 (0.46)
Week 24	-0.25 (0.46)	-0.43 (0.60)	-0.52 (0.59)
Week 28	-0.27 (0.46)
Week 32	-0.27 (0.48)
Week 36	-0.25 (0.48)	-0.43 (0.60)	-0.52 (0.56)
Week 40	-0.25 (0.48)
Week 44	-0.26 (0.48)
Week 48	-0.27 (0.48)	-0.42 (0.57)	-0.55 (0.55)
Week 60	-0.28 (0.50)	-0.43 (0.59)	-0.55 (0.56)
Week 72	-0.29 (0.51)	-0.44 (0.59)	-0.56 (0.58)
Week 84	-0.29 (0.51)	-0.45 (0.59)	-0.56 (0.57)
Week 96	-0.29 (0.50)	-0.42 (0.61)	-0.59 (0.58)
Week 108	-0.30 (0.48)	-0.40 (0.62)	-0.60 (0.60)
Week 120	-0.30 (0.49)	-0.48 (0.59)	-0.60 (0.58)
Week 132	-0.31 (0.50)	-0.49 (0.59)	-0.60 (0.57)
Week 144	-0.33 (0.51)	-0.49 (0.60)	-0.58 (0.53)
Week 156	-0.33 (0.53)	-0.52 (0.60)	-0.58 (0.55)
Week 168	-0.31 (0.53)	-0.41 (0.62)	-0.51 (0.50)
Week 180	-0.32 (0.56)	-0.29 (0.69)	-0.52 (0.48)
Week 192	-0.32 (0.53)	-0.25 (0.68)	-0.44 (0.58)
Week 204	-0.32 (0.53)	-0.75 (NA)	-0.75 (NA)
Week 216	-0.35 (0.57)
Week 228	-0.34 (0.58)
Week 240	-0.31 (0.61)
Week 252	-0.35 (0.55)
Week 264	-0.32 (0.57)
Week 276	-0.36 (0.56)
Week 288	-0.34 (0.59)
Week 300	-0.35 (0.59)
Week 312	-0.37 (0.59)
Week 324	-0.35 (0.54)
Week 336	-0.31 (0.60)
Week 348	-0.29 (0.62)
Week 360	-0.41 (0.58)
Week 372	-0.88 (NA)
EOT	-0.22 (0.62)	-0.37 (0.63)	-0.51 (0.62)
EOS	-0.08 (0.63)	-0.17 (0.62)	-0.28 (0.73)

34. Secondary Outcome

Title	Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	35.0 17.4%	59.2 26.4%	67.0 16.3%
Week 2	37.0 18.4%
Week 4	40.7 20.2%
Week 8	41.7 20.7%
Week 12	48.0 23.9%	61.5 27.5%	65.7 15.9%
Week 16	51.0 25.4%
Week 20	49.5 24.6%
Week 24	50.3 25%	59.9 26.7%	68.3 16.6%
Week 28	54.3 27%
Week 32	50.0 24.9%
Week 36	48.3 24%	55.8 24.9%	71.4 17.3%
Week 40	48.8 24.3%
Week 44	50.9 25.3%
Week 48	50.3 25%	58.2 26%	70.6 17.1%
Week 60	54.1 26.9%	59.7 26.7%	71.9 17.5%
Week 72	54.0 26.9%	59.6 26.6%	69.9 17%
Week 84	53.6 26.7%	63.3 28.3%	69.5 16.9%
Week 96	51.8 25.8%	57.2 25.5%	73.9 17.9%
Week 108	54.9 27.3%	56.7 25.3%	73.8 17.9%
Week 120	52.3 26%	62.8 28%	73.2 17.8%
Week 132	53.2 26.5%	57.8 25.8%	74.9 18.2%
Week 144	55.8 27.8%	61.9 27.6%	75.0 18.2%
Week 156	53.8 26.8%	70.0 31.3%	76.4 18.5%
Week 168	53.4 26.6%	62.2 27.8%	69.7 16.9%
Week 180	57.0 28.4%	47.6 21.3%	71.7 17.4%
Week 192	55.0 27.4%	50.0 22.3%	59.1 14.3%
Week 204	51.4 25.6%	100.0 44.6%	100.0 24.3%
Week 216	55.8 27.8%
Week 228	52.0 25.9%
Week 240	50.5 25.1%
Week 252	54.4 27.1%
Week 264	50.0 24.9%
Week 276	54.7 27.2%
Week 288	47.6 23.7%
Week 300	54.3 27%
Week 312	51.9 25.8%
Week 324	51.6 25.7%
Week 336	50.9 25.3%
Week 348	47.5 23.6%
Week 360	62.5 31.1%
Week 372	100.0 49.8%
EOT	46.8 23.3%	55.4 24.7%	68.9 16.7%
EOS	44.6 22.2%	44.6 19.9%	56.2 13.6%

35. Secondary Outcome

Title	Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-10.77 (21.64)	-41.57 (22.92)	-43.09 (23.21)
Week 2	-13.48 (20.82)
Week 4	-16.78 (21.81)
Week 8	-20.59 (23.69)
Week 12	-24.33 (23.00)	-40.22 (23.50)	-42.77 (23.09)
Week 16	-26.64 (22.86)
Week 20	-27.12 (23.28)
Week 24	-27.56 (23.81)	-40.65 (24.02)	-43.81 (23.23)
Week 28	-29.22 (24.18)
Week 32	-27.80 (24.05)
Week 36	-29.94 (22.82)	-41.60 (24.88)	-44.81 (21.41)
Week 40	-31.58 (21.55)
Week 44	-31.60 (22.50)
Week 48	-33.04 (23.41)	-41.92 (23.36)	-45.71 (21.52)
Week 60	-32.82 (24.00)	-41.84 (23.31)	-45.20 (22.00)
Week 72	-33.68 (24.19)	-42.48 (22.83)	-47.05 (21.35)
Week 84	-33.39 (25.87)	-41.31 (25.12)	-46.42 (22.33)
Week 96	-34.12 (23.79)	-43.26 (24.46)	-47.35 (21.98)
Week 108	-35.70 (24.63)	-43.55 (23.34)	-48.04 (22.43)
Week 120	-35.14 (25.13)	-45.11 (23.65)	-46.99 (22.76)
Week 132	-37.24 (25.90)	-45.51 (24.94)	-47.50 (20.77)
Week 144	-39.11 (24.31)	-45.70 (27.19)	-45.85 (22.35)
Week 156	-37.72 (24.91)	-48.04 (25.43)	-46.65 (21.24)
Week 168	-39.55 (24.87)	-45.54 (24.77)	-45.07 (22.38)
Week 180	-37.34 (25.47)	-44.62 (29.00)	-46.01 (20.30)
Week 192	-39.13 (24.79)	-33.75 (36.86)	-44.50 (19.39)
Week 204	-40.46 (22.73)	-30.00 (NA)	-53.50 (NA)
Week 216	-40.80 (23.52)
Week 228	-40.08 (23.25)
Week 240	-41.67 (24.00)
Week 252	-41.55 (23.74)
Week 264	-41.13 (24.71)
Week 276	-42.46 (22.75)
Week 288	-42.21 (25.60)
Week 300	-41.40 (22.39)
Week 312	-42.18 (22.71)
Week 324	-42.73 (22.93)
Week 336	-39.55 (25.31)
Week 348	-38.71 (24.27)
Week 360	-40.25 (18.36)
Week 372	-47.00 (NA)
EOT	-30.72 (27.55)	-39.86 (26.19)	-45.04 (24.76)
EOS	-20.31 (26.25)	-30.01 (25.67)	-36.11 (27.05)

36. Secondary Outcome

Title	Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-6.82 (25.41)	-37.24 (29.85)	-35.60 (26.98)
Week 2	-11.31 (24.37)
Week 4	-13.42 (25.21)
Week 8	-17.89 (27.08)
Week 12	-20.60 (26.15)	-36.80 (30.55)	-34.81 (27.68)
Week 16	-23.45 (27.01)
Week 20	-24.35 (27.63)
Week 24	-24.78 (26.98)	-37.13 (30.97)	-36.25 (27.07)
Week 28	-27.29 (27.34)
Week 32	-27.78 (28.04)
Week 36	-27.45 (27.10)	-37.33 (30.74)	-37.57 (25.19)
Week 40	-29.23 (27.43)
Week 44	-29.01 (27.10)
Week 48	-29.80 (27.43)	-36.12 (29.92)	-37.40 (26.38)
Week 60	-30.39 (28.54)	-36.18 (30.34)	-37.46 (26.55)
Week 72	-31.18 (28.44)	-36.86 (29.67)	-38.42 (25.49)
Week 84	-29.73 (30.45)	-35.33 (31.10)	-38.26 (25.81)
Week 96	-32.65 (30.12)	-35.75 (30.98)	-38.50 (27.57)
Week 108	-31.75 (30.27)	-35.54 (31.35)	-39.69 (26.38)
Week 120	-31.87 (29.95)	-38.88 (29.82)	-39.56 (27.28)
Week 132	-32.61 (31.77)	-38.66 (30.54)	-37.79 (27.53)
Week 144	-33.67 (29.23)	-38.99 (31.62)	-37.44 (27.31)
Week 156	-34.15 (30.71)	-39.62 (29.17)	-38.45 (26.52)
Week 168	-33.59 (30.34)	-38.36 (28.96)	-38.89 (26.37)
Week 180	-33.56 (30.55)	-38.41 (32.82)	-38.41 (25.29)
Week 192	-34.94 (29.42)	-49.90 (33.93)	-42.09 (25.39)
Week 204	-35.65 (29.79)	-83.50 (NA)	-57.00 (NA)
Week 216	-33.69 (32.20)
Week 228	-34.81 (32.30)
Week 240	-35.14 (31.35)
Week 252	-34.84 (31.90)
Week 264	-34.57 (33.12)
Week 276	-36.39 (30.81)
Week 288	-35.51 (32.04)
Week 300	-36.97 (33.07)
Week 312	-37.52 (30.54)
Week 324	-35.50 (30.28)
Week 336	-33.11 (29.66)
Week 348	-28.87 (31.14)
Week 360	-40.29 (28.74)
Week 372	-71.50 (NA)
EOT	-26.04 (31.99)	-33.53 (32.73)	-36.57 (28.95)
EOS	-18.67 (29.38)	-27.86 (33.15)	-22.79 (30.38)

37. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Week 0	-7.37 (25.85)	-36.09 (30.09)	-34.79 (26.98)
Week 2	-11.21 (23.60)
Week 4	-13.10 (24.45)
Week 8	-17.70 (26.93)
Week 12	-20.54 (25.98)	-35.75 (30.36)	-34.27 (28.19)
Week 16	-23.12 (26.94)
Week 20	-24.00 (27.30)
Week 24	-24.41 (26.68)	-36.38 (30.17)	-36.17 (27.15)
Week 28	-26.74 (27.81)
Week 32	-27.41 (28.35)
Week 36	-26.73 (28.04)	-36.68 (30.38)	-37.30 (26.59)
Week 40	-28.62 (28.43)
Week 44	-29.08 (27.27)
Week 48	-30.08 (27.09)	-35.88 (30.24)	-37.16 (26.89)
Week 60	-30.88 (28.64)	-35.77 (30.45)	-36.93 (27.51)
Week 72	-30.47 (28.23)	-36.54 (29.83)	-37.36 (26.86)
Week 84	-29.41 (31.51)	-35.14 (30.67)	-37.58 (27.07)
Week 96	-31.59 (31.98)	-34.55 (30.47)	-37.83 (27.59)
Week 108	-31.16 (31.19)	-35.52 (30.77)	-38.72 (26.97)
Week 120	-31.92 (30.85)	-38.32 (29.85)	-38.34 (27.88)
Week 132	-32.42 (31.62)	-38.30 (29.75)	-36.66 (26.60)
Week 144	-33.53 (31.99)	-39.02 (29.85)	-36.34 (25.75)
Week 156	-33.61 (31.76)	-40.11 (29.13)	-37.08 (26.55)
Week 168	-34.24 (32.17)	-38.27 (28.57)	-36.96 (26.23)
Week 180	-33.40 (32.56)	-42.90 (30.70)	-37.85 (25.95)
Week 192	-34.50 (30.26)	-50.81 (36.83)	-40.86 (28.24)
Week 204	-35.88 (30.63)	-82.50 (NA)	-58.00 (NA)
Week 216	-33.21 (33.60)
Week 228	-34.44 (33.92)
Week 240	-34.98 (32.39)
Week 252	-34.88 (33.20)
Week 264	-34.81 (34.02)
Week 276	-36.12 (32.40)
Week 288	-34.63 (33.46)
Week 300	-35.73 (34.47)
Week 312	-35.42 (33.21)
Week 324	-33.43 (34.58)
Week 336	-32.56 (32.27)
Week 348	-25.96 (33.18)
Week 360	-35.59 (26.94)
Week 372	-58.60 (NA)
EOT	-26.57 (32.59)	-33.82 (32.32)	-35.84 (30.02)
EOS	-19.77 (28.17)	-29.87 (31.05)	-21.54 (30.66)

38. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	223	412
Week 0	-0.55 (13.12)	11.62 (12.80)	11.60 (12.48)
Week 4	0.30 (13.81)
Week 8	1.53 (12.85)
Week 12	2.52 (13.47)
Week 16	4.10 (13.36)
Week 20	3.72 (14.22)
Week 24	3.56 (13.69)	12.55 (13.84)	13.23 (12.43)
Week 28	3.97 (14.13)
Week 32	4.14 (13.35)
Week 36	3.63 (14.08)
Week 40	4.27 (13.92)
Week 44	4.49 (13.26)
Week 48	4.51 (13.42)	12.31 (13.60)	13.52 (12.11)
Week 60	5.89 (13.46)
Week 72	4.94 (14.02)	12.35 (14.10)	13.48 (13.23)
Week 84	5.59 (13.30)
Week 96	5.02 (14.20)	12.15 (14.95)	14.20 (13.16)
Week 108	0.27 (14.50)
Week 120	5.01 (14.34)	12.59 (15.29)	14.59 (13.37)
Week 132	-7.23 (NA)
Week 144	6.94 (14.43)	12.46 (14.20)	14.38 (13.42)
Week 156	-31.60 (NA)
Week 168	6.46 (15.80)	9.64 (12.16)	13.94 (13.97)
Week 192	6.43 (14.75)	10.42 (16.12)	12.60 (12.95)
Week 216	6.73 (15.24)
Week 240	6.13 (16.19)
Week 264	5.97 (17.28)
Week 276	-22.64 (NA)
Week 288	6.21 (16.43)
Week 300	4.73 (NA)
Week 312	6.13 (16.23)
Week 324	21.10 (23.80)
Week 336	4.33 (15.78)
Week 348	-5.21 (13.68)
Week 360	6.92 (9.75)
Week 372	0.16 (NA)
EOT	3.44 (NA)	10.29 (15.46)	12.62 (13.23)

39. Secondary Outcome

Title	Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	223	412
Week 0	3.00 (8.40)	2.94 (8.52)	2.69 (8.67)
Week 4	3.88 (8.86)
Week 8	3.85 (9.51)
Week 12	4.72 (9.08)
Week 16	4.61 (9.25)
Week 20	4.97 (9.18)
Week 24	6.01 (9.13)	2.02 (9.15)	2.61 (9.04)
Week 28	5.38 (9.74)
Week 32	5.13 (9.20)
Week 36	5.18 (9.05)
Week 40	5.70 (9.27)
Week 44	5.79 (9.33)
Week 48	5.52 (9.24)	1.74 (8.78)	2.89 (8.76)
Week 60	5.27 (9.15)
Week 72	5.28 (8.83)	2.87 (9.31)	2.80 (8.94)
Week 84	5.58 (9.06)
Week 96	5.42 (9.17)	2.10 (8.98)	2.22 (9.52)
Week 108	3.89 (7.29)
Week 120	4.64 (8.73)	2.40 (8.67)	1.62 (9.24)
Week 132	-2.52 (NA)
Week 144	4.38 (9.16)	1.56 (9.22)	1.65 (8.15)
Week 156	2.17 (NA)
Week 168	4.09 (9.41)	2.41 (8.92)	2.04 (8.41)
Week 192	3.56 (8.52)	2.23 (3.58)	2.31 (6.81)
Week 216	2.95 (9.70)
Week 240	3.45 (9.60)
Week 264	4.03 (9.69)
Week 276	6.20 (NA)
Week 288	3.72 (9.09)
Week 300	11.12 (NA)
Week 312	4.62 (10.58)
Week 324	7.83 (10.42)
Week 336	3.78 (8.57)
Week 348	2.80 (6.90)
Week 360	5.15 (9.50)
Week 372	-3.24 (NA)
EOT	3.63 (9.97)	1.54 (9.91)	2.16 (9.29)

40. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	223	412
Week 0	-0.52 (12.29)	5.21 (13.96)	5.45 (15.40)
Week 4	0.29 (11.16)
Week 8	1.30 (12.39)
Week 12	1.70 (12.00)
Week 16	2.84 (11.58)
Week 20	2.33 (12.73)
Week 24	1.59 (11.27)	5.06 (13.55)	5.56 (15.36)
Week 28	2.68 (11.73)
Week 32	3.75 (11.55)
Week 36	1.66 (12.08)
Week 40	2.42 (12.57)
Week 44	1.93 (12.08)
Week 48	2.85 (11.64)	5.06 (14.54)	5.80 (15.27)
Week 60	3.05 (12.65)
Week 72	2.56 (12.84)	5.65 (13.93)	6.37 (15.33)
Week 84	0.81 (12.75)
Week 96	2.67 (12.51)	4.30 (13.56)	5.80 (15.61)
Week 108	-1.62 (1.64)
Week 120	2.97 (12.90)	4.55 (14.28)	5.92 (16.32)
Week 132	-5.25 (NA)
Week 144	2.64 (12.95)	5.18 (14.52)	5.43 (15.59)
Week 156	5.75 (NA)
Week 168	2.88 (12.83)	0.50 (12.86)	4.11 (14.33)
Week 192	2.75 (12.81)	-0.97 (12.36)	2.17 (15.20)
Week 216	3.50 (13.80)
Week 240	3.46 (13.20)
Week 264	2.65 (13.28)
Week 276	1.82 (NA)
Week 288	3.99 (12.95)
Week 300	12.34 (NA)
Week 312	3.87 (14.89)
Week 324	15.79 (12.43)
Week 336	3.54 (13.56)
Week 348	-1.11 (12.48)
Week 360	1.64 (12.72)
Week 372	-8.61 (NA)
EOT	2.06 (14.35)	3.92 (13.85)	4.74 (16.31)

41. Secondary Outcome

Title	Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	223	412
Week 0	34.0 16.9%	70 31.3%	71.1 17.3%
Week 4	33.7 16.8%
Week 8	40.2 20%
Week 12	39.4 19.6%
Week 16	43.4 21.6%
Week 20	40.0 19.9%
Week 24	44.4 22.1%	70.5 31.5%	74.1 18%
Week 28	42.9 21.3%
Week 32	44.4 22.1%
Week 36	45.3 22.5%
Week 40	47.0 23.4%
Week 44	47.2 23.5%
Week 48	45.4 22.6%	73.0 32.6%	74.7 18.1%
Week 60	47.8 23.8%
Week 72	47.7 23.7%	68.3 30.5%	73.9 17.9%
Week 84	50.6 25.2%
Week 96	43.8 21.8%	71.7 32%	75.9 18.4%
Week 108	50.0 24.9%
Week 120	44.6 22.2%	68.2 30.4%	79.3 19.2%
Week 132	0 0%
Week 144	53.3 26.5%	66.0 29.5%	82.4 20%
Week 156	0 0%
Week 168	50.0 24.9%	70.3 31.4%	77.6 18.8%
Week 192	52.3 26%	62.5 27.9%	77.3 18.8%
Week 216	51.9 25.8%
Week 240	53.7 26.7%
Week 264	52.2 26%
Week 276	0 0%
Week 288	48.8 24.3%
Week 300	0 0%
Week 312	48.1 23.9%
Week 324	66.7 33.2%
Week 336	43.4 21.6%
Week 348	11.1 5.5%
Week 360	56.3 28%
Week 372	0 0%
EOT	41.8 20.8%	61.0 27.2%	306 74.3%

42. Secondary Outcome

Title	Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	223	412
Week 0	43.0 21.4%	39.9 17.8%	37.4 9.1%
Week 4	42.7 21.2%
Week 8	47.2 23.5%
Week 12	43.4 21.6%
Week 16	45.4 22.6%
Week 20	45.3 22.5%
Week 24	51.9 25.8%	37.2 16.6%	37.6 9.1%
Week 28	47.8 23.8%
Week 32	48.3 24%
Week 36	47.7 23.7%
Week 40	49.4 24.6%
Week 44	49.1 24.4%
Week 48	51.5 25.6%	33.2 14.8%	39.2 9.5%
Week 60	48.6 24.2%
Week 72	53.7 26.7%	39.3 17.5%	35.8 8.7%
Week 84	57.1 28.4%
Week 96	49.6 24.7%	33.5 15%	38.4 9.3%
Week 108	50.0 24.9%
Week 120	45.4 22.6%	37.2 16.6%	33.8 8.2%
Week 132	0 0%
Week 144	47.5 23.6%	30.9 13.8%	28.7 7%
Week 156	0 0%
Week 168	41.4 20.6%	32.4 14.5%	34.2 8.3%
Week 192	39.6 19.7%	37.5 16.7%	31.8 7.7%
Week 216	37.5 18.7%
Week 240	42.1 20.9%
Week 264	43.3 21.5%
Week 276	100 49.8%
Week 288	41.7 20.7%
Week 300	100 49.8%
Week 312	43.0 21.4%
Week 324	33.3 16.6%
Week 336	37.7 18.8%
Week 348	22.2 11%
Week 360	43.8 21.8%
Week 372	0 0%
EOT	39.8 19.8%	35.8 16%	34.6 8.4%

43. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population with available data at each time point.

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	223	412
Week 0	26.0 12.9%	44.8 20%	48.5 11.8%
Week 4	27.6 13.7%
Week 8	35.7 17.8%
Week 12	39.9 19.9%
Week 16	39.8 19.8%
Week 20	38.4 19.1%
Week 24	36.4 18.1%	47.8 21.3%	48.0 11.7%
Week 28	39.1 19.5%
Week 32	40.0 19.9%
Week 36	33.1 16.5%
Week 40	38.7 19.3%
Week 44	38.7 19.3%
Week 48	40.5 20.1%	46.4 20.7%	47.1 11.4%
Week 60	39.9 19.9%
Week 72	38.9 19.4%	47.5 21.2%	46.7 11.3%
Week 84	29.9 14.9%
Week 96	38.7 19.3%	42.8 19.1%	48.2 11.7%
Week 108	0 0%
Week 120	39.2 19.5%	45.3 20.2%	49.3 12%
Week 132	0 0%
Week 144	38.3 19.1%	51.5 23%	48.5 11.8%
Week 156	100 49.8%
Week 168	39.7 19.8%	35.1 15.7%	40.8 9.9%
Week 192	38.7 19.3%	25.0 11.2%	31.8 7.7%
Week 216	40.0 19.9%
Week 240	41.1 20.4%
Week 264	37.8 18.8%
Week 276	0 0%
Week 288	42.9 21.3%
Week 300	100.0 49.8%
Week 312	45.6 22.7%
Week 324	83.3 41.4%
Week 336	39.6 19.7%
Week 348	22.2 11%
Week 360	31.3 15.6%
Week 372	0.0 0%
EOT	39.8 19.8%	43.1 19.2%	44.7 10.8%

44. Secondary Outcome

Title	Number of Participants Who Withdrew Due to Lack of Efficacy
Description	Participants who discontinued due to lack of efficacy have been reported.
Time Frame	Baseline up to week 372

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Participants Who Completed 015K-CL-RAJ1	Participants Who Completed 015K-CL-RAJ3	Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.	Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Measure Participants	201	224	412
Number [percentage of participants]	19.4 9.7%	4.9 2.2%	3.4 0.8%

Adverse Events

Time Frame	Baseline up to EOS (Up to 376 weeks)
Adverse Event Reporting Description	Safety Population
Arm/Group Title	Participants Who Completed 015K-CL-RAJ1		Participants Who Completed 015K-CL-RAJ3		Participants Who Completed 015K-CL-RAJ4
Arm/Group Description	Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.		Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.		Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR >= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
All Cause Mortality
	Participants Who Completed 015K-CL-RAJ1		Participants Who Completed 015K-CL-RAJ3		Participants Who Completed 015K-CL-RAJ4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/201 (0%)		1/225 (0.4%)		1/417 (0.2%)
Serious Adverse Events
	Participants Who Completed 015K-CL-RAJ1		Participants Who Completed 015K-CL-RAJ3		Participants Who Completed 015K-CL-RAJ4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/201 (29.4%)		56/225 (24.9%)		84/417 (20.1%)
Cardiac disorders
Acute myocardial infarction	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Angina pectoris	1/201 (0.5%)	1	0/225 (0%)	0	1/417 (0.2%)	1
Aortic valve incompetence	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Atrial fibrillation	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Cardiac failure	1/201 (0.5%)	1	1/225 (0.4%)	1	0/417 (0%)	0
Coronary artery stenosis	1/201 (0.5%)	1	1/225 (0.4%)	1	0/417 (0%)	0
Ventricular tachycardia	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Congenital, familial and genetic disorders
Ankyloglossia congenital	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Odontogenic cyst	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Urachal abnormality	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Ear and labyrinth disorders
Vertigo	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Vertigo positional	1/201 (0.5%)	1	0/225 (0%)	0	1/417 (0.2%)	1
Endocrine disorders
Hyperparathyroidism	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Steroid withdrawal syndrome	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Eye disorders
Cataract	0/201 (0%)	0	1/225 (0.4%)	1	2/417 (0.5%)	2
Glaucoma	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Maculopathy	1/201 (0.5%)	1	0/225 (0%)	0	1/417 (0.2%)	1
Pterygium	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Gastrointestinal disorders
Colitis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Colonic polyp	0/201 (0%)	0	0/225 (0%)	0	2/417 (0.5%)	2
Crohn's disease	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Dental caries	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Duodenal perforation	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Gastric ulcer haemorrhage	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Gastrointestinal perforation	1/201 (0.5%)	1	0/225 (0%)	0	1/417 (0.2%)	1
Haemorrhoids	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Large intestine perforation	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Pancreatitis acute	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Periodontitis	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Peritonitis	0/201 (0%)	0	0/225 (0%)	0	3/417 (0.7%)	3
Tooth impacted	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Upper gastrointestinal haemorrhage	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
General disorders
Chest pain	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Gait disturbance	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Impaired healing	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Pyrexia	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Hepatobiliary disorders
Bile duct stone	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Cholecystitis acute	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Cholelithiasis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Hepatic function abnormal	0/201 (0%)	0	1/225 (0.4%)	1	3/417 (0.7%)	3
Hepatic steatosis	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Immune system disorders
Anaphylactic shock	0/201 (0%)	0	1/225 (0.4%)	1	2/417 (0.5%)	2
Infections and infestations
Arthritis bacterial	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Bacteraemia	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Campylobacter gastroenteritis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Cellulitis	2/201 (1%)	2	0/225 (0%)	0	1/417 (0.2%)	1
Chronic tonsillitis	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Dacryocystitis	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Diverticulitis	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Empyema	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Enterocolitis bacterial	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Epiglottitis	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Erysipelas	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Hepatitis B	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Herpes zoster	1/201 (0.5%)	1	4/225 (1.8%)	4	9/417 (2.2%)	9
Herpes zoster disseminated	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Herpes zoster oticus	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Infective spondylitis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Keratitis herpetic	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Liver abscess	0/201 (0%)	0	0/225 (0%)	0	2/417 (0.5%)	2
Lung infection	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Meningitis bacterial	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Osteomyelitis	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Pharyngitis	0/201 (0%)	0	1/225 (0.4%)	1	1/417 (0.2%)	1
Pilonidal cyst	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Pneumonia	2/201 (1%)	2	6/225 (2.7%)	6	1/417 (0.2%)	1
Pneumonia bacterial	0/201 (0%)	0	1/225 (0.4%)	1	1/417 (0.2%)	1
Pneumonia cryptococcal	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Pneumonia pneumococcal	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Psoas abscess	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Pyelonephritis	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Pyelonephritis acute	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Pyoderma	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Sepsis	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Sinusitis	0/201 (0%)	0	2/225 (0.9%)	2	0/417 (0%)	0
Subdiaphragmatic abscess	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Urinary tract infection	0/201 (0%)	0	2/225 (0.9%)	3	1/417 (0.2%)	1
Urosepsis	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Viral infection	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Injury, poisoning and procedural complications
Ankle fracture	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Cerebral haemorrhage traumatic	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Clavicle fracture	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Compression fracture	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Contusion	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Dislocation of vertebra	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Femoral neck fracture	2/201 (1%)	2	0/225 (0%)	0	0/417 (0%)	0
Femur fracture	0/201 (0%)	0	0/225 (0%)	0	2/417 (0.5%)	2
Foot fracture	1/201 (0.5%)	1	0/225 (0%)	0	1/417 (0.2%)	1
Fractured ischium	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Fractured sacrum	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Humerus fracture	1/201 (0.5%)	1	1/225 (0.4%)	1	2/417 (0.5%)	2
Ligament injury	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Lower limb fracture	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Rib fracture	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Spinal compression fracture	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Spinal fracture	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Tendon rupture	4/201 (2%)	5	1/225 (0.4%)	1	4/417 (1%)	4
Thoracic vertebral fracture	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Tibia fracture	2/201 (1%)	2	0/225 (0%)	0	0/417 (0%)	0
Ulna fracture	0/201 (0%)	0	1/225 (0.4%)	1	1/417 (0.2%)	2
Investigations
Bronchoscopy	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Endoscopy large bowel	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Liver function test abnormal	0/201 (0%)	0	0/225 (0%)	0	2/417 (0.5%)	2
Prostatic specific antigen increased	0/201 (0%)	0	0/225 (0%)	0	2/417 (0.5%)	2
Weight increased	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Metabolism and nutrition disorders
Feeding disorder	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Hyponatraemia	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Intervertebral disc protrusion	3/201 (1.5%)	3	1/225 (0.4%)	2	0/417 (0%)	0
Jaw disorder	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Osteoarthritis	1/201 (0.5%)	1	1/225 (0.4%)	1	0/417 (0%)	0
Rheumatoid arthritis	1/201 (0.5%)	1	2/225 (0.9%)	2	1/417 (0.2%)	1
Spondylolisthesis	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Bile duct cancer	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Bladder cancer	1/201 (0.5%)	1	1/225 (0.4%)	1	0/417 (0%)	0
Bone neoplasm	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Bowen's disease	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Breast cancer	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Carcinoma in situ	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Colon cancer	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Colon cancer stage 0	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Diffuse large B-cell lymphoma	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Extraskeletal chondrosarcoma	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Gastric cancer	2/201 (1%)	2	2/225 (0.9%)	2	2/417 (0.5%)	2
Large intestine carcinoma	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Liposarcoma	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Lung adenocarcinoma	0/201 (0%)	0	0/225 (0%)	0	3/417 (0.7%)	3
Lung neoplasm malignant	0/201 (0%)	0	1/225 (0.4%)	1	1/417 (0.2%)	1
Lymphoma	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Metastases to bone	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Metastases to liver	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Oesophageal carcinoma	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Ovarian adenoma	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Ovarian germ cell teratoma benign	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Ovarian neoplasm	0/201 (0%)	0	2/225 (0.9%)	2	0/417 (0%)	0
Renal cancer	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Retroperitoneal neoplasm	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Small cell lung cancer stage unspecified	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Thyroid cancer	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Uterine leiomyoma	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Nervous system disorders
Cerebral haemorrhage	0/201 (0%)	0	1/225 (0.4%)	1	1/417 (0.2%)	1
Cerebral infarction	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Facial palsy	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Lacunar infarction	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Subarachnoid haemorrhage	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Thrombotic cerebral infarction	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Psychiatric disorders
Depression	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Suicide attempt	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Renal and urinary disorders
Calculus ureteric	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Calculus urinary	0/201 (0%)	0	3/225 (1.3%)	3	0/417 (0%)	0
Hypertonic bladder	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Nephrolithiasis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Reproductive system and breast disorders
Cervical dysplasia	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Uterine polyp	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	2/201 (1%)	2	0/225 (0%)	0	0/417 (0%)	0
Haemothorax	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Hyperventilation	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Interstitial lung disease	0/201 (0%)	0	1/225 (0.4%)	1	1/417 (0.2%)	1
Pulmonary artery thrombosis	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Sleep apnoea syndrome	1/201 (0.5%)	1	0/225 (0%)	0	2/417 (0.5%)	2
Skin and subcutaneous tissue disorders
Skin ulcer	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Surgical and medical procedures
Ankle operation	0/201 (0%)	0	1/225 (0.4%)	1	0/417 (0%)	0
Cataract operation	0/201 (0%)	0	0/225 (0%)	0	2/417 (0.5%)	2
Intestinal polypectomy	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Jaw operation	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Peripheral nerve neurostimulation	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Vascular disorders
Aortic aneurysm rupture	1/201 (0.5%)	1	0/225 (0%)	0	0/417 (0%)	0
Lymphoedema	0/201 (0%)	0	0/225 (0%)	0	1/417 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Participants Who Completed 015K-CL-RAJ1		Participants Who Completed 015K-CL-RAJ3		Participants Who Completed 015K-CL-RAJ4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	181/201 (90%)		174/225 (77.3%)		358/417 (85.9%)
Eye disorders
Dry eye	12/201 (6%)	13	3/225 (1.3%)	3	5/417 (1.2%)	5
Gastrointestinal disorders
Constipation	21/201 (10.4%)	23	14/225 (6.2%)	15	25/417 (6%)	27
Dental caries	19/201 (9.5%)	24	13/225 (5.8%)	16	29/417 (7%)	38
Diarrhoea	16/201 (8%)	18	9/225 (4%)	16	12/417 (2.9%)	14
Gastritis	12/201 (6%)	12	8/225 (3.6%)	8	7/417 (1.7%)	7
Nausea	12/201 (6%)	13	11/225 (4.9%)	11	18/417 (4.3%)	22
Periodontitis	13/201 (6.5%)	16	9/225 (4%)	9	13/417 (3.1%)	14
Hepatobiliary disorders
Hepatic function abnormal	7/201 (3.5%)	8	7/225 (3.1%)	8	27/417 (6.5%)	27
Infections and infestations
Bronchitis	29/201 (14.4%)	76	22/225 (9.8%)	30	28/417 (6.7%)	32
Cystitis	17/201 (8.5%)	35	17/225 (7.6%)	25	27/417 (6.5%)	50
Gastroenteritis	24/201 (11.9%)	30	16/225 (7.1%)	17	22/417 (5.3%)	30
Herpes zoster	35/201 (17.4%)	36	35/225 (15.6%)	36	63/417 (15.1%)	68
Influenza	35/201 (17.4%)	41	22/225 (9.8%)	23	44/417 (10.6%)	51
Nasopharyngitis	110/201 (54.7%)	368	91/225 (40.4%)	211	195/417 (46.8%)	423
Pharyngitis	22/201 (10.9%)	65	14/225 (6.2%)	33	33/417 (7.9%)	57
Upper respiratory tract infection	23/201 (11.4%)	76	15/225 (6.7%)	26	26/417 (6.2%)	38
Injury, poisoning and procedural complications
Contusion	22/201 (10.9%)	26	17/225 (7.6%)	19	35/417 (8.4%)	39
Investigations
Blood creatine phosphokinase increased	29/201 (14.4%)	47	23/225 (10.2%)	35	45/417 (10.8%)	55
Lymphocyte count decreased	8/201 (4%)	8	7/225 (3.1%)	9	28/417 (6.7%)	49
Musculoskeletal and connective tissue disorders
Back pain	19/201 (9.5%)	26	12/225 (5.3%)	15	28/417 (6.7%)	30
Rheumatoid arthritis	50/201 (24.9%)	78	27/225 (12%)	35	55/417 (13.2%)	61
Nervous system disorders
Headache	16/201 (8%)	27	9/225 (4%)	12	19/417 (4.6%)	95
Respiratory, thoracic and mediastinal disorders
Cough	20/201 (10%)	28	12/225 (5.3%)	13	20/417 (4.8%)	23
Oropharyngeal pain	14/201 (7%)	24	3/225 (1.3%)	3	8/417 (1.9%)	8
Upper respiratory tract inflammation	17/201 (8.5%)	22	9/225 (4%)	13	12/417 (2.9%)	19
Skin and subcutaneous tissue disorders
Eczema	19/201 (9.5%)	26	10/225 (4.4%)	12	13/417 (3.1%)	17
Hyperkeratosis	13/201 (6.5%)	16	4/225 (1.8%)	5	6/417 (1.4%)	6
Rash	12/201 (6%)	17	4/225 (1.8%)	4	13/417 (3.1%)	14
Vascular disorders
Hypertension	30/201 (14.9%)	30	14/225 (6.2%)	14	28/417 (6.7%)	29

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.