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A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02305849
Collaborator
(none)
519
Enrollment
146
Locations
3
Arms
40.1
Actual Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study was to verify the efficacy of ASP015K versus placebo administrated in combination with methotrexate (MTX) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to MTX

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This study was a multi-center, randomized, placebo-controlled, double-blind, parallel-group, confirmatory study to evaluate the efficacy and safety of ASP015K (100 and 150 mg/day) administered in combination with MTX in participants with RA who had an inadequate response to MTX.

Participants orally received ASP015K 100 mg, ASP015K 150 mg or placebo once daily (QD) in combination with MTX after breakfast for 52 weeks.

At Week 12, inadequate responders in the placebo group, as determined by a < 20% improvement from baseline (i.e., treatment initiation day) in tender or painful joint count (TJC) and swollen joint count (SJC), were switched to either ASP015K 100 mg or ASP015K 150 mg, and the dosage was maintained until the end of treatment (EOT). In addition, participants who received placebo at Week 28 were switched to either ASP015K 100 mg or ASP015K 150 mg, and the dosage was maintained until the EOT.

The ASP015K dose that was started for placebo group participants at Week 12 or Week 28 was randomly chosen at baseline. The dose was switched under the blinded condition.

Participants who completed this study were eligible for participation in the open-label extension study (015K-CL-RAJ2). Participants made a follow-up visit after the week 52 visit if they did not enroll into the extension study on the day of the week 52 visit.

Study Design

Study Type:
Interventional
Actual Enrollment :
519 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX
Actual Study Start Date :
Jul 25, 2014
Actual Primary Completion Date :
Jun 20, 2017
Actual Study Completion Date :
Nov 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peficitinib 100 mg

Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.

Drug: Peficitinib
oral tablet
Other Names:
  • ASP015K

    • Drug: Methotrexate
    Oral tablet/capsule
    Experimental: Peficitinib 150 mg

    Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.

    Drug: Peficitinib
    oral tablet
    Other Names:
  • ASP015K

    • Drug: Methotrexate
    Oral tablet/capsule
    Placebo Comparator: Placebo

    Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.

    Drug: Placebo
    oral tablet

    Drug: Methotrexate
    Oral tablet/capsule

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 [Baseline and week 12/Early termination (ET)]

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

    2. Change From Baseline in mTSS at Week 28 [Baseline and week 28/ET]

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

    Secondary Outcome Measures

    1. Percentage of Participants With an ACR20-CRP Response Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    2. Percentage of Participants With an ACR50-CRP Response at Week 12 [Baseline and week 12/ET]

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

    3. Percentage of Participants With an ACR50-CRP Response Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    4. Percentage of Participants With an ACR70-CRP Response at Week 12 [Baseline and week 12/ET]

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

    5. Percentage of Participants With an ACR70-CRP Response Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    6. Change From Baseline in mTSS at Week 52 [Baseline and week 52/ET]

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

    7. Change From Baseline in JSN Score at Week 28 and Week 52 [Baseline and weeks 28/ET and 52/ET]

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

    8. Change From Baseline in Erosion Score at Week 28 and Week 52 [Baseline and weeks 28/ET and 52/ET]

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

    9. Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 [Baseline and week 28/ET and 52/ET]

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

    10. Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 [Baseline and week 12/ET]

      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.

    11. Change From Baseline in DAS28-CRP Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    12. Change From Baseline in DAS28-ESR at Week 12 [Baseline and week 12/ET]

      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.

    13. Change From Baseline in DAS28-ESR Score Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    14. Change From Baseline in TJC (68 Joints) at Week 12 [Baseline and week 12/ET]

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

    15. Change From Baseline in TJC (68 Joints) Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    16. Change From Baseline in SJC (66 Joints) at Week 12 [Baseline and week 12/ET]

      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.

    17. Change From Baseline in SJC (66 Joints) Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    18. Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12 [Week 12/ET]

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

    19. Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    20. Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12 [Week 12/ET]

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

    21. Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    22. Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12 [Week 12/ET]

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

    23. Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    24. Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12 [Week 12/ET]

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

    25. Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    26. Change From Baseline in CRP at Week 12 [Baseline and week 12/ET]

      Higher CRP indicates greater disease activity.

    27. Change From Baseline in CRP Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      Higher CRP indicates greater disease activity.

    28. Change From Baseline in ESR at Week 12 [Baseline and week 12/ET]

      Higher ESR indicates greater disease activity.

    29. Change From Baseline in ESR Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      Higher ESR indicates greater disease activity.

    30. Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 [Week 12/ET]

      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.

    31. Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    32. Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 [Week 12/ET]

      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.

    33. Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    34. Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12 [Week 12/ET]

      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.

    35. Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    36. Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12 [Week 12/ET]

      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.

    37. Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    38. Percentage of Participants Achieving ACR / EULAR Remission at Week 12 [Week 12/ET]

      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).

    39. Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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).

    40. Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12 [Week 12/ET]

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

    41. Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

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

    42. Change From Baseline in SDAI Score at Week 12 [Baseline and week 12/ET]

      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.

    43. Change From Baseline in SDAI Score Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    44. Change From Baseline in PGA at Week 12 [Baseline and week 12/ET]

      The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.

    45. Change From Baseline in PGA Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.

    46. Change From Baseline in SGA at Week 12 [Baseline and week 12/ET]

      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.

    47. Change From Baseline in SGA Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    48. Change From Baseline in SGAP at Week 12 [Baseline and week 12/ET]

      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.

    49. Change From Baseline in SGAP Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    50. Number of Participants Who Withdrew Due to Lack of Efficacy [Up to week 52]

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

    51. Change From Baseline in HAQ-DI at Week 12 [Baseline and week 12/ET]

      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.

    52. Change From Baseline in HAQ-DI Through Week 52 [Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT]

      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.

    53. Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 [Baseline and week 12/ET]

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

    54. Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.

    55. Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 [Baseline and week 12/ET]

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

    56. Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.

    57. Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 [Baseline and week 12/ET]

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

    58. Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.

    59. Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 [Baseline and week 12/ET]

      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.

    60. Change From Baseline in WPAI Percent Work Time Missed Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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.

    61. Change From Baseline in WPAI Percent Impairment While Working at Week 12 [Baseline and week 12/ET]

      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.

    62. Change From Baseline in WPAI Percent Impairment While Working Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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 calculates as Q5/10. Negative values indicate improvement from baseline.

    63. Change From Baseline in Percent Overall Work Impairment at Week 12 [Baseline and week 12/ET]

      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.

    64. Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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.

    65. Change From Baseline in WPAI Percent Activity Impairment at Week 12 [Baseline and week 12/ET]

      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.

    66. Change From Baseline in WPAI Percent Activity Impairment Through Week 52 [Baseline, weeks 4, 8, 12, 28, 52 and 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.

    67. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks [Week 0 to week 12]

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

    68. Number of Participants With TEAEs From Week 12 to Week 28 [Week 12 to week 28]

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

    69. Number of Participants With TEAEs From Week 28 to Week 52 [Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study]

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

    Eligibility Criteria

    Criteria

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

    • Subject has RA of < 10 years duration at baseline that was diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria

    • Subject who did not receive the following drugs, or received the drugs with stable dosage for at least 28 days prior to the baseline (start of treatment) for RA treatment:

    • Non-steroidal anti-inflammatory drugs (NSAIDs; excluding topical formulations with a local action), oral morphine or equivalent opioid analgesics (≤ 30 mg/day), acetaminophen, or oral corticosteroids (≤ 10 mg/day in prednisolone equivalent)

    • At screening subject has active RA as evidenced by both of the following:

    • ≥ 6 tender/painful joints (using 68-joint assessment)

    • ≥ 6 swollen joints (using 66-joint assessment)

    • CRP (latex agglutination test) of ≥ 1.00 mg/dL at screening.

    • Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening

    • Inadequate responders to MTX which was continuously administered for at least 90 days prior to screening and MTX ≥ 8 mg/week for at least 28 days prior to baseline. However, inadequate responder to MTX < 8 mg/week is eligible if intolerance precludes dose increase and defined as MTX-IR

    • Subject is able to continue stable dose of MTX (a maximum of 16 mg/week) from at least 28 days prior to screening until the end of treatment

    • Subject has bone erosion at the joint (as evidenced by x-rays of hands and feet) assessed in mTSS and any of the following apply at screening. Bone erosion may be evidenced by x-rays within 90 days prior to baseline.

    • Positive anti-CCP antibody: ≥ 4.5 U/mL

    • Positive rheumatoid factor: > 15 IU/mL

    Exclusion Criteria:

    • Subject has received a biologic DMARD within the specified period

    • Inadequate responders to biologic DMARD as determined by investigator/sub-investigator

    • Subject has received intra-articular, intravenous, intramuscular or endorectal (excluding suppositories for anal diseases) corticosteroid within 28 days prior to baseline

    • Subject has participated in any study of ASP015K and has received ASP015K or placebo

    • Subject has received other investigational drugs within 90 days or within 5 half-lives, whichever is longer, prior to baseline

    • Subject has received plasma exchange therapy within 60 days prior to baseline

    • Subject has undergone joint drainage, has received local anesthesia and nerve block, or has received articular cartilage protectant at the assessed joint within 28 days prior to baseline

    • Subject has undergone surgery and has residual effects in the assessed joints at the discretion of investigator/sub-investigator, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints at the discretion of investigator/sub-investigator

    • A diagnosis of inflammatory arthritis (psoriatic arthritis, ankylosing spondylitis, SLE, sarcoidosis, etc.) other than RA

    • Any of the following laboratory values at screening:

    • Hemoglobin < 9.0 g/dL

    • Absolute neutrophil count < 1000/μL

    • Absolute lymphocyte count < 800/μL

    • Platelet count < 75000/μL

    • ALT ≥ 2 ×ULN

    • AST ≥ 2 × ULN

    • Total bilirubin (TBL) ≥ 1.5 × ULN

    • Estimated GFR ≤ 40 mL/min as measured by the MDRD method

    • β-D-glucan ≥ 11 pg/mL

    • Positive HBs antigen, HBc antibody, HBs antibody or HBV-DNA quantitation (However, subject with negative HBs antigen and HBV-DNA quantitation, and positive HBc antibody and/or HBs antibody is eligible if HBV-DNA is monitored by HBV-DNA quantitation at every scheduled visit after initiation of study drug administration.)

    • Positive HCV antibody

    • Subject has a history of or concurrent active tuberculosis (TB)

    • Subject has a history of or concurrent interstitial pneumonia and investigator/sub-investigator judges that it is inappropriate for the subject to participate in this study

    • Subject has a history of or concurrent malignant tumor (except for successfully treated basal cell carcinoma)

    • Subject has received live or live attenuated virus vaccination within 56 days prior to baseline. (Inactivated vaccines including influenza and pneumococcal vaccines are allowed.)

    • Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA (excluding Sjogren's syndrome and chronic thyroiditis), or any ongoing illness which would make the subject unsuitable for the study as determined by the investigator/sub-investigator

    • Subject has a history of clinically significant allergy. (Clinically significant allergy includes allergies such as systemic urticaria induced by specific antigens and drugs, anaphylaxis, and allergy associated with shock necessitating hospitalized treatment.)

    • Subject has concurrent cardiac failure, defined as NYHA classification Class III or higher, or a history of it

    • Subject has concurrent prolonged QT syndrome or a history of it. Subject has prolonged QT interval (defined as QTc ≥ 500 msec. Subject has QTc ≥ 500 msec at retest will be excluded) at screening

    • Subject has a history of positive HIV infection

    • Subject has congenital short QT syndrome or a history of it. Subject has shortened QT interval (defined as QTc < 330 msec. Subject has QTc < 330 msec at retest will be excluded) at screening.

    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 JP00108 Toyohashi Aichi Japan
    7 JP00170 Toyohashi Aichi Japan
    8 JP00156 Toyota Aichi Japan
    9 JP00068 Yatomi Aichi Japan
    10 JP00180 Asahi Chiba Japan
    11 JP00166 Funabashi Chiba Japan
    12 JP00115 Narashino Chiba Japan
    13 JP00138 Yotsukaido Chiba Japan
    14 JP00120 Iizuka Fukuoka Japan
    15 JP00110 Kasuga Fukuoka Japan
    16 JP00040 Kitakyushu Fukuoka Japan
    17 JP00119 Kitakyushu Fukuoka Japan
    18 JP00071 Kurume Fukuoka Japan
    19 JP00106 Kurume Fukuoka Japan
    20 JP00033 Takasaki Gunma Japan
    21 JP00163 Higashihiroshima Hiroshima Japan
    22 JP00124 Tomakomai Hokaido Japan
    23 JP00026 Asahikawa Hokkaido Japan
    24 JP00090 Hakodate Hokkaido Japan
    25 JP00172 Kitami Hokkaido Japan
    26 JP00125 Kushiro Hokkaido Japan
    27 JP00001 Sapporo Hokkaido Japan
    28 JP00002 Sapporo Hokkaido Japan
    29 JP00003 Sapporo Hokkaido Japan
    30 JP00038 Sapporo Hokkaido Japan
    31 JP00114 Sapporo Hokkaido Japan
    32 JP00056 Akashi Hyogo Japan
    33 JP00069 Himeji Hyogo Japan
    34 JP00136 Itami Hyogo Japan
    35 JP00113 Kakogawa Hyogo Japan
    36 JP00041 Kato Hyogo Japan
    37 JP00042 Kobe Hyogo Japan
    38 JP00092 Kobe Hyogo Japan
    39 JP00154 Kobe Hyogo Japan
    40 JP00171 Kobe Hyogo Japan
    41 JP00117 Nishinomiya Hyogo Japan
    42 JP00181 Hitachinaka Ibaraki Japan
    43 JP00107 Hitachi Ibaraki Japan
    44 JP00073 Koga Ibaraki Japan
    45 JP00054 Mito Ibaraki Japan
    46 JP00039 Tsukuba Ibaraki Japan
    47 JP00179 Komatsu Ishikawa Japan
    48 JP00049 Morioka Iwate Japan
    49 JP00088 Kida Kagawa Japan
    50 JP00084 Isehara Kanagawa Japan
    51 JP00048 Kawasaki Kanagawa Japan
    52 JP00058 Kawasaki Kanagawa Japan
    53 JP00141 Sagamihara Kanagawa Japan
    54 JP00096 Yokohama Kanagawa Japan
    55 JP00045 Zushi Kanagawa Japan
    56 JP00019 Koshi Kumamoto Japan
    57 JP00057 Tamana Kumamoto Japan
    58 JP00168 Yokkaichi Mie Japan
    59 JP00169 Osaki Miyagi Japan
    60 JP00004 Sendai Miyagi Japan
    61 JP00036 Sendai Miyagi Japan
    62 JP00105 Sendai Miyagi Japan
    63 JP00151 Sendai Miyagi Japan
    64 JP00050 Hyuga Miyazaki Japan
    65 JP00129 Matsumoto Nagano Japan
    66 JP00162 Isehaya Nagasaki Japan
    67 JP00101 Omura Nagasaki Japan
    68 JP00103 Omura Nagasaki Japan
    69 JP00153 Sasebo Nagasaki Japan
    70 JP00094 Kashihara Nara Japan
    71 JP00025 Nagaoka Niigata Japan
    72 JP00144 Shibata Niigata Japan
    73 JP00064 Beppu Oita Japan
    74 JP00051 Setouchi Okayama Japan
    75 JP00011 Hannan Osaka Japan
    76 JP00134 Higashiosaka Osaka Japan
    77 JP00178 Hirakata Osaka Japan
    78 JP00078 Kawachinagano Osaka Japan
    79 JP00137 Sakai Osaka Japan
    80 JP00070 Suita Osaka Japan
    81 JP00146 Suita Osaka Japan
    82 JP00061 Toyonaka Osaka Japan
    83 JP00075 Ureshino Saga Japan
    84 JP00126 Gyoda Saitama Japan
    85 JP00007 Hiki Saitama Japan
    86 JP00060 Kawagoe Saitama Japan
    87 JP00161 Kawagoe Saitama Japan
    88 JP00062 Kawaguchi Saitama Japan
    89 JP00052 Sayama Saitama Japan
    90 JP00008 Tokorozawa Saitama Japan
    91 JP00133 Kakegawa Shizuoka Japan
    92 JP00077 Kanuma Tochigi Japan
    93 JP00145 Shimotsuke Tochigi Japan
    94 JP00024 Bunkyo Tokyo Japan
    95 JP00143 Bunkyo Tokyo Japan
    96 JP00149 Bunkyo Tokyo Japan
    97 JP00152 Bunkyo Tokyo Japan
    98 JP00099 Chiyoda Tokyo Japan
    99 JP00142 Chuo Tokyo Japan
    100 JP00063 Hachioji Tokyo Japan
    101 JP00053 Kiyose Tokyo Japan
    102 JP00072 Meguro Tokyo Japan
    103 JP00148 Ota Tokyo Japan
    104 JP00081 Shibuya Tokyo Japan
    105 JP00010 Takaoka Toyama Japan
    106 JP00155 Nishimuro Wakayama Japan
    107 JP00104 Shimonoseki Yamaguchi Japan
    108 JP00047 Shunan Yamaguchi Japan
    109 JP00176 Fukui Japan
    110 JP00018 Fukuoka Japan
    111 JP00020 Fukuoka Japan
    112 JP00035 Fukuoka Japan
    113 JP00059 Fukuoka Japan
    114 JP00067 Fukuoka Japan
    115 JP00076 Fukuoka Japan
    116 JP00131 Fukuoka Japan
    117 JP00164 Fukuoka Japan
    118 JP00165 Fukushima Japan
    119 JP00013 Hiroshima Japan
    120 JP00014 Hiroshima Japan
    121 JP00016 Hiroshima Japan
    122 JP00055 Hiroshima Japan
    123 JP00074 Kagoshima Japan
    124 JP00167 Kagoshima Japan
    125 JP00093 Kochi Japan
    126 JP00022 Kumamoto Japan
    127 JP00046 Kumamoto Japan
    128 JP00085 Kyoto Japan
    129 JP00123 Kyoto Japan
    130 JP00160 Kyoto Japan
    131 JP00023 Miyagi Japan
    132 JP00122 Miyazaki Japan
    133 JP00080 Nagano Japan
    134 JP00174 Nagano Japan
    135 JP00098 Nagasaki Japan
    136 JP00112 Nagasaki Japan
    137 JP00147 Nagasaki Japan
    138 JP00017 Oita Japan
    139 JP00118 Okayama Japan
    140 JP00150 Osaka Japan
    141 JP00157 Osaka Japan
    142 JP00177 Osaka Japan
    143 JP00044 Shizuoka Japan
    144 JP00089 Shizuoka Japan
    145 JP00135 Shizuoka Japan
    146 JP00139 Toyama Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Medical Director, Astellas Pharma Inc

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT02305849
    Other Study ID Numbers:
    • 015K-CL-RAJ4
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Aug 3, 2020
    Last Verified:
    Jun 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
    ASP015K
    Rheumatoid Arthritis
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Methotrexate
    Peficitinib

    Study Results

    Participant Flow

    Recruitment Details Participants with rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) were enrolled in this study.
    Pre-assignment Detail Participants were randomized in a 1:1:1 ratio to peficitinib 100 milligram (mg), 150 mg or placebo groups in combination with MTX at baseline. At week 12 or 28, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg, which was determined in advance randomly.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg Placebo / Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
    Period Title: Overall Study
    STARTED 175 174 85 85
    COMPLETED 148 146 67 66
    NOT COMPLETED 27 28 18 19

    Baseline Characteristics

    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo Total
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Total of all reporting groups
    Overall Participants 174 174 170 518
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    58.5
    (10.8)
    56.2
    (11.6)
    55.3
    (12.1)
    56.7
    (11.6)
    Sex: Female, Male (Count of Participants)
    Female
    118
    67.8%
    125
    71.8%
    121
    71.2%
    364
    70.3%
    Male
    56
    32.2%
    49
    28.2%
    49
    28.8%
    154
    29.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    174
    100%
    174
    100%
    170
    100%
    518
    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/deciliter (mg/dL)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [milligram/deciliter (mg/dL)]
    2.432
    (2.076)
    2.524
    (2.183)
    2.622
    (2.146)
    2.525
    (2.132)
    Erosion Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    10.34
    (17.47)
    9.76
    (15.93)
    11.03
    (17.96)
    10.37
    (17.11)
    Erythrocyte Sedimentation Rate (ESR) (millimeter per hour (mm/h)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [millimeter per hour (mm/h)]
    50.4
    (26.2)
    51.5
    (26.8)
    53.8
    (26.9)
    51.9
    (26.6)
    Health Assessment Questionnaire - Disability Index (HAQ-DI) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.91
    (0.65)
    1.02
    (0.62)
    1.05
    (0.66)
    0.99
    (0.65)
    Joint Space Narrowing (JSN) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    14.89
    (19.47)
    15.23
    (18.33)
    17.37
    (20.13)
    15.82
    (19.31)
    Modified Total Sharp Score (mTSS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    25.23
    (35.5)
    25
    (32.38)
    28.4
    (36.28)
    26.19
    (34.71)
    Physician's Global Assessment of Arthritis (PGA) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    58.87
    (19.67)
    60.86
    (19.09)
    60.98
    (19.59)
    60.23
    (19.43)
    Subject's Global Assessment of Arthritis (SGA) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    51.7
    (25.25)
    55.44
    (24.49)
    58.18
    (23.9)
    55.07
    (24.65)
    Subject's Global Assessment of Arthritis Pain (SGAP) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    51.12
    (26.14)
    55.09
    (24.89)
    56.75
    (25.29)
    54.3
    (25.51)
    Swollen Joint Count (SJC) (66 Joints) (swollen joint count) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [swollen joint count]
    12.8
    (6.8)
    13.1
    (6.9)
    13.6
    (7)
    13.2
    (6.9)
    Tender Joint Count (TJC) (68 Joints) (tender joint count) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [tender joint count]
    14
    (8.6)
    14.5
    (7.8)
    15.4
    (9.4)
    14.6
    (8.6)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
    Description ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
    Time Frame Baseline and week 12/Early termination (ET)

    Outcome Measure Data

    Analysis Population Description
    FAS. Last observation carried forward (LOCF) was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 170 174 174
    Number [percentage of participants]
    21.8
    12.5%
    58.6
    33.7%
    64.4
    37.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Closed testing procedure was used for multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 36.9
    Confidence Interval (2-Sided) 95%
    26.7 to 47.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Closed testing procedure was used for multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 42.6
    Confidence Interval (2-Sided) 95%
    32.6 to 52.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution.
    2. Primary Outcome
    Title Change From Baseline in mTSS at Week 28
    Description mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
    Time Frame Baseline and week 28/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 153 164 164
    Mean (Standard Deviation) [units on a scale]
    3.37
    (5.46)
    1.62
    (4.23)
    1.03
    (2.86)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Closed testing procedure was used for multiplicity adjustment.
    Method RANCOVA
    Comments Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Closed testing procedure was used for multiplicity adjustment.
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
    3. Secondary Outcome
    Title Percentage of Participants With an ACR20-CRP Response Through Week 52
    Description ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52.
    Time Frame Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 174 174 37 38 39 34
    Week 4
    38.2
    22%
    48.2
    27.7%
    8.1
    4.8%
    2.7
    0.5%
    38.5
    NaN
    14.7
    NaN
    Week 8
    51.2
    29.4%
    62.0
    35.6%
    10.8
    6.4%
    0.0
    0%
    33.3
    NaN
    29.4
    NaN
    Week 12
    59.5
    34.2%
    66.3
    38.1%
    0.0
    0%
    0.0
    0%
    51.3
    NaN
    38.2
    NaN
    Week 16
    70.5
    40.5%
    77.0
    44.3%
    43.2
    25.4%
    51.4
    9.9%
    64.1
    NaN
    58.8
    NaN
    Week 20
    74.4
    42.8%
    79.8
    45.9%
    59.5
    35%
    67.6
    13.1%
    61.5
    NaN
    61.8
    NaN
    Week 24
    74.5
    42.8%
    85.0
    48.9%
    63.9
    37.6%
    80.6
    15.6%
    59.0
    NaN
    52.9
    NaN
    Week 28
    79.1
    45.5%
    83.0
    47.7%
    72.2
    42.5%
    83.3
    16.1%
    64.1
    NaN
    64.7
    NaN
    Week 32
    79.6
    45.7%
    85.2
    49%
    77.8
    45.8%
    86.1
    16.6%
    84.6
    NaN
    76.5
    NaN
    Week 36
    78.4
    45.1%
    86.5
    49.7%
    80.6
    47.4%
    85.7
    16.5%
    78.4
    NaN
    75.8
    NaN
    Week 40
    80.9
    46.5%
    86.9
    49.9%
    80.0
    47.1%
    88.2
    17%
    88.9
    NaN
    78.8
    NaN
    Week 44
    79.9
    45.9%
    86.9
    49.9%
    76.5
    45%
    90.9
    17.5%
    88.9
    NaN
    87.9
    NaN
    Week 48
    83.8
    48.2%
    89.4
    51.4%
    81.8
    48.1%
    90.9
    17.5%
    85.7
    NaN
    90.9
    NaN
    Week 52
    84.8
    48.7%
    87.1
    50.1%
    75.8
    44.6%
    90.9
    17.5%
    91.2
    NaN
    90.9
    NaN
    EOT
    76.4
    43.9%
    81.0
    46.6%
    73.0
    42.9%
    78.9
    15.2%
    92.3
    NaN
    91.2
    NaN
    4. Secondary Outcome
    Title Percentage of Participants With an ACR50-CRP Response at Week 12
    Description ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 170 174 174
    Number [percentage of participants]
    7.6
    4.4%
    29.9
    17.2%
    46.0
    27.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 22.2
    Confidence Interval (2-Sided) 95%
    13.8 to 30.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 38.3
    Confidence Interval (2-Sided) 95%
    29.3 to 47.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    5. Secondary Outcome
    Title Percentage of Participants With an ACR50-CRP Response Through Week 52
    Description ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
    Time Frame Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 174 174 37 38 39 34
    Week 4
    10.0
    5.7%
    15.9
    9.1%
    2.7
    1.6%
    0.0
    0%
    10.3
    NaN
    0.0
    NaN
    Week 8
    19.6
    11.3%
    33.1
    19%
    2.7
    1.6%
    0.0
    0%
    12.8
    NaN
    2.9
    NaN
    Week 12
    29.8
    17.1%
    48.2
    27.7%
    0.0
    0%
    0.0
    0%
    23.1
    NaN
    5.9
    NaN
    Week 16
    46.4
    26.7%
    53.9
    31%
    13.5
    7.9%
    21.6
    4.2%
    38.5
    NaN
    8.8
    NaN
    Week 20
    51.2
    29.4%
    54.6
    31.4%
    35.1
    20.6%
    37.8
    7.3%
    35.9
    NaN
    29.4
    NaN
    Week 24
    56.5
    32.5%
    60.6
    34.8%
    47.2
    27.8%
    52.8
    10.2%
    33.3
    NaN
    29.4
    NaN
    Week 28
    53.8
    30.9%
    63.5
    36.5%
    50.0
    29.4%
    69.4
    13.4%
    28.2
    NaN
    23.5
    NaN
    Week 32
    59.2
    34%
    65.8
    37.8%
    52.8
    31.1%
    61.1
    11.8%
    56.4
    NaN
    52.9
    NaN
    Week 36
    55.6
    32%
    67.7
    38.9%
    58.3
    34.3%
    71.4
    13.8%
    64.9
    NaN
    60.6
    NaN
    Week 40
    61.8
    35.5%
    68.0
    39.1%
    48.6
    28.6%
    67.6
    13.1%
    66.7
    NaN
    66.7
    NaN
    Week 44
    57.7
    33.2%
    71.2
    40.9%
    52.9
    31.1%
    72.7
    14%
    72.2
    NaN
    63.6
    NaN
    Week 48
    60.8
    34.9%
    64.9
    37.3%
    60.6
    35.6%
    69.7
    13.5%
    71.4
    NaN
    66.7
    NaN
    Week 52
    66.9
    38.4%
    68.0
    39.1%
    63.6
    37.4%
    63.6
    12.3%
    67.6
    NaN
    69.7
    NaN
    EOT
    60.3
    34.7%
    62.6
    36%
    62.2
    36.6%
    55.3
    10.7%
    69.2
    NaN
    70.6
    NaN
    6. Secondary Outcome
    Title Percentage of Participants With an ACR70-CRP Response at Week 12
    Description ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 170 174 174
    Number [percentage of participants]
    2.4
    1.4%
    12.1
    7%
    23.6
    13.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 9.7
    Confidence Interval (2-Sided) 95%
    3.8 to 15.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 21.2
    Confidence Interval (2-Sided) 95%
    13.9 to 28.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    7. Secondary Outcome
    Title Percentage of Participants With an ACR70-CRP Response Through Week 52
    Description ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
    Time Frame Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 174 174 37 38 39 34
    Week 4
    1.2
    0.7%
    4.1
    2.4%
    0.0
    0%
    0.0
    0%
    2.6
    NaN
    0.0
    NaN
    Week 8
    7.7
    4.4%
    13.9
    8%
    0.0
    0%
    0.0
    0%
    2.6
    NaN
    0.0
    NaN
    Week 12
    12.5
    7.2%
    24.7
    14.2%
    0.0
    0%
    0.0
    0%
    7.7
    NaN
    2.9
    NaN
    Week 16
    24.1
    13.9%
    32.1
    18.4%
    5.4
    3.2%
    2.7
    0.5%
    12.8
    NaN
    2.9
    NaN
    Week 20
    26.2
    15.1%
    35.0
    20.1%
    8.1
    4.8%
    2.7
    0.5%
    12.8
    NaN
    2.9
    NaN
    Week 24
    31.7
    18.2%
    36.0
    20.7%
    22.2
    13.1%
    16.7
    3.2%
    17.9
    NaN
    2.9
    NaN
    Week 28
    29.1
    16.7%
    42.8
    24.6%
    33.3
    19.6%
    38.9
    7.5%
    17.9
    NaN
    8.8
    NaN
    Week 32
    36.3
    20.9%
    43.9
    25.2%
    33.3
    19.6%
    44.4
    8.6%
    20.5
    NaN
    20.6
    NaN
    Week 36
    34.0
    19.5%
    47.1
    27.1%
    33.3
    19.6%
    42.9
    8.3%
    13.5
    NaN
    33.3
    NaN
    Week 40
    34.9
    20.1%
    41.8
    24%
    31.4
    18.5%
    38.2
    7.4%
    36.1
    NaN
    33.3
    NaN
    Week 44
    38.3
    22%
    48.4
    27.8%
    41.2
    24.2%
    36.4
    7%
    38.9
    NaN
    39.4
    NaN
    Week 48
    33.8
    19.4%
    49.0
    28.2%
    45.5
    26.8%
    42.4
    8.2%
    45.7
    NaN
    39.4
    NaN
    Week 52
    39.3
    22.6%
    52.4
    30.1%
    42.4
    24.9%
    48.5
    9.4%
    44.1
    NaN
    48.5
    NaN
    EOT
    35.1
    20.2%
    48.3
    27.8%
    40.5
    23.8%
    42.1
    8.1%
    43.6
    NaN
    50.0
    NaN
    8. Secondary Outcome
    Title Change From Baseline in mTSS at Week 52
    Description mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
    Time Frame Baseline and week 52/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 153 164 164
    Mean (Standard Deviation) [units on a scale]
    6.27
    (10.18)
    2.12
    (5.83)
    1.54
    (4.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
    Method RANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
    Method RANCOVA
    Comments
    9. Secondary Outcome
    Title Change From Baseline in JSN Score at Week 28 and Week 52
    Description JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity.
    Time Frame Baseline and weeks 28/ET and 52/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 153 164 164
    Week 28/ET
    1.90
    (3.76)
    0.99
    (2.86)
    0.82
    (2.39)
    Week 52/ET
    3.55
    (7.01)
    1.30
    (3.37)
    1.19
    (3.03)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Week 28/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Week 28/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Week 52/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.039
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Week 52/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.
    10. Secondary Outcome
    Title Change From Baseline in Erosion Score at Week 28 and Week 52
    Description The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.
    Time Frame Baseline and weeks 28/ET and 52/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 153 164 164
    Week 28/ET
    1.35
    (3.01)
    0.63
    (2.03)
    0.18
    (1.10)
    Week 52/ET
    2.52
    (5.58)
    0.82
    (3.14)
    0.32
    (1.87)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Week 28/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.036
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Week 28/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Week 52/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Week 52/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method RANCOVA
    Comments Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
    11. Secondary Outcome
    Title Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52
    Description mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
    Time Frame Baseline and week 28/ET and 52/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 153 164 164
    Week 28/ET
    45.8
    26.3%
    67.1
    38.6%
    72.6
    42.7%
    Week 52/ET
    42.5
    24.4%
    64.0
    36.8%
    68.9
    40.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Week 28/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 21.3
    Confidence Interval (2-Sided) 95%
    10.0 to 32.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Week 28/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 26.8
    Confidence Interval (2-Sided) 95%
    15.7 to 37.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Week 52/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 21.5
    Confidence Interval (2-Sided) 95%
    10.2 to 32.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Week 52/ET: Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 26.4
    Confidence Interval (2-Sided) 95%
    15.2 to 37.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    12. Secondary Outcome
    Title Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    -0.51
    (1.10)
    -1.70
    (1.20)
    -2.09
    (1.33)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -1.21
    Confidence Interval (2-Sided) 95%
    -1.46 to -0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -1.59
    Confidence Interval (2-Sided) 95%
    -1.85 to -1.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in DAS28-CRP Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 172 171 37 37 39 34
    Week 4
    -1.11
    (0.81)
    -1.39
    (0.98)
    -0.28
    (0.67)
    -0.30
    (0.56)
    -0.82
    (1.09)
    -0.74
    (0.62)
    Week 8
    -1.48
    (1.00)
    -1.87
    (1.16)
    -0.21
    (0.86)
    -0.10
    (0.63)
    -0.94
    (0.97)
    -0.90
    (0.65)
    Week 12
    -1.72
    (1.19)
    -2.15
    (1.29)
    0.24
    (0.75)
    0.27
    (0.60)
    -1.34
    (1.00)
    -1.20
    (0.66)
    Week 16
    -2.01
    (1.18)
    -2.40
    (1.30)
    -1.11
    (1.15)
    -1.37
    (1.18)
    -1.37
    (1.35)
    -1.31
    (0.74)
    Week 20
    -2.21
    (1.24)
    -2.53
    (1.29)
    -1.69
    (1.22)
    -1.76
    (1.24)
    -1.38
    (1.19)
    -1.48
    (0.78)
    Week 24
    -2.40
    (1.21)
    -2.71
    (1.18)
    -2.01
    (1.26)
    -2.26
    (1.07)
    -1.41
    (1.32)
    -1.64
    (0.92)
    Week 28
    -2.42
    (1.21)
    -2.70
    (1.25)
    -2.24
    (1.11)
    -2.51
    (1.13)
    -1.53
    (1.39)
    -1.71
    (0.97)
    Week 32
    -2.50
    (1.18)
    -2.77
    (1.19)
    -2.49
    (1.24)
    -2.72
    (1.27)
    -2.18
    (1.27)
    -2.47
    (0.89)
    Week 36
    -2.55
    (1.12)
    -2.83
    (1.20)
    -2.49
    (1.14)
    -2.70
    (1.22)
    -2.22
    (1.23)
    -2.57
    (0.89)
    Week 40
    -2.66
    (1.16)
    -2.86
    (1.14)
    -2.66
    (1.24)
    -2.72
    (1.13)
    -2.62
    (1.05)
    -2.73
    (0.93)
    Week 44
    -2.65
    (1.13)
    -2.88
    (1.15)
    -2.68
    (1.23)
    -2.72
    (1.19)
    -2.63
    (1.35)
    -2.87
    (0.89)
    Week 48
    -2.62
    (1.15)
    -2.92
    (1.14)
    -2.86
    (1.26)
    -2.90
    (1.18)
    -2.66
    (1.49)
    -2.96
    (0.97)
    Week 52
    -2.67
    (1.19)
    -2.96
    (1.24)
    -2.80
    (1.46)
    -2.74
    (1.13)
    -2.70
    (1.32)
    -2.89
    (0.92)
    EOT
    -2.43
    (1.37)
    -2.76
    (1.40)
    -2.61
    (1.62)
    -2.52
    (1.25)
    -2.72
    (1.26)
    -2.87
    (0.92)
    14. Secondary Outcome
    Title Change From Baseline in DAS28-ESR at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 170
    Mean (Standard Deviation) [units on a scale]
    -0.51
    (1.11)
    -1.66
    (1.22)
    -2.12
    (1.36)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -1.19
    Confidence Interval (2-Sided) 95%
    -1.44 to -0.94
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -1.63
    Confidence Interval (2-Sided) 95%
    -1.89 to -1.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.13
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline in DAS28-ESR Score Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 172 170 37 37 39 34
    Week 4
    -1.07
    (0.83)
    -1.37
    (1.02)
    -0.26
    (0.66)
    -0.26
    (0.59)
    -0.87
    (1.08)
    -0.67
    (0.64)
    Week 8
    -1.47
    (1.06)
    -1.88
    (1.18)
    -0.24
    (0.88)
    -0.12
    (0.64)
    -1.00
    (0.93)
    -0.85
    (0.76)
    Week 12
    -1.68
    (1.21)
    -2.18
    (1.32)
    0.24
    (0.76)
    0.25
    (0.59)
    -1.40
    (0.99)
    -1.10
    (0.76)
    Week 16
    -1.98
    (1.22)
    -2.46
    (1.32)
    -1.01
    (1.14)
    -1.38
    (1.21)
    -1.47
    (1.39)
    -1.21
    (0.82)
    Week 20
    -2.23
    (1.27)
    -2.60
    (1.35)
    -1.61
    (1.23)
    -1.78
    (1.26)
    -1.45
    (1.19)
    -1.37
    (0.81)
    Week 24
    -2.43
    (1.28)
    -2.78
    (1.25)
    -1.94
    (1.24)
    -2.24
    (1.16)
    -1.47
    (1.31)
    -1.56
    (0.99)
    Week 28
    -2.47
    (1.31)
    -2.79
    (1.29)
    -2.11
    (1.16)
    -2.48
    (1.15)
    -1.63
    (1.41)
    -1.62
    (1.07)
    Week 32
    -2.56
    (1.31)
    -2.87
    (1.27)
    -2.39
    (1.26)
    -2.68
    (1.30)
    -2.27
    (1.34)
    -2.37
    (1.05)
    Week 36
    -2.59
    (1.23)
    -2.91
    (1.25)
    -2.45
    (1.20)
    -2.71
    (1.20)
    -2.38
    (1.29)
    -2.54
    (1.02)
    Week 40
    -2.70
    (1.22)
    -2.96
    (1.20)
    -2.60
    (1.34)
    -2.78
    (1.11)
    -2.71
    (1.16)
    -2.68
    (0.96)
    Week 44
    -2.71
    (1.19)
    -3.00
    (1.25)
    -2.63
    (1.25)
    -2.76
    (1.25)
    -2.74
    (1.43)
    -2.78
    (1.04)
    Week 48
    -2.64
    (1.20)
    -3.01
    (1.22)
    -2.80
    (1.36)
    -2.88
    (1.23)
    -2.72
    (1.58)
    -2.93
    (1.06)
    Week 52
    -2.70
    (1.27)
    -3.07
    (1.28)
    -2.77
    (1.54)
    -2.78
    (1.24)
    -2.79
    (1.33)
    -2.85
    (1.08)
    EOT
    -2.47
    (1.43)
    -2.86
    (1.44)
    -2.60
    (1.69)
    -2.56
    (1.34)
    -2.80
    (1.27)
    -2.82
    (1.08)
    16. Secondary Outcome
    Title Change From Baseline in TJC (68 Joints) at Week 12
    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), 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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [tender joint count]
    -2.1
    (8.2)
    -6.9
    (8.6)
    -9.1
    (8.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -5.2
    Confidence Interval () 95%
    -6.9 to -3.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.9
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -7.2
    Confidence Interval (2-Sided) 95%
    -8.9 to -5.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.8
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in TJC (68 Joints) Through Week 52
    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), 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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -5.1
    (5.8)
    -6.3
    (6.9)
    Week 8
    -6.8
    (7.2)
    -8.3
    (7.3)
    Week 12
    -7.1
    (8.6)
    -9.3
    (7.7)
    Week 16
    -8.1
    (7.8)
    -10.5
    (7.4)
    Week 20
    -9.1
    (7.9)
    -10.8
    (8.0)
    Week 24
    -9.9
    (7.5)
    -11.3
    (7.6)
    Week 28
    -9.6
    (7.4)
    -11.4
    (7.8)
    Week 32
    -9.7
    (7.2)
    -12.1
    (7.6)
    Week 36
    -10.4
    (7.6)
    -11.8
    (7.7)
    Week 40
    -10.8
    (7.2)
    -11.9
    (8.2)
    Week 44
    -10.6
    (7.4)
    -12.1
    (7.8)
    Week 48
    -10.5
    (7.1)
    -12.1
    (7.7)
    Week 52
    -10.8
    (7.4)
    -11.9
    (8.6)
    EOT
    -9.8
    (7.8)
    -11.2
    (8.8)
    18. Secondary Outcome
    Title Change From Baseline in SJC (66 Joints) at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [swollen joint count]
    -2.2
    (6.6)
    -5.9
    (6.7)
    -7.6
    (6.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -3.9
    Confidence Interval (2-Sided) 95%
    -5.3 to -2.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.7
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -6.9 to -4.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    19. Secondary Outcome
    Title Change From Baseline in SJC (66 Joints) Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -4.3
    (4.5)
    -5.3
    (5.6)
    Week 8
    -5.6
    (5.5)
    -7.1
    (5.5)
    Week 12
    -6.0
    (6.7)
    -7.8
    (5.9)
    Week 16
    -7.5
    (6.2)
    -8.9
    (6.0)
    Week 20
    -8.1
    (6.1)
    -9.2
    (5.7)
    Week 24
    -8.8
    (6.4)
    -9.9
    (5.6)
    Week 28
    -8.8
    (6.2)
    -9.8
    (5.7)
    Week 32
    -9.0
    (6.2)
    -10.3
    (5.8)
    Week 36
    -9.0
    (6.1)
    -10.5
    (5.9)
    Week 40
    -9.4
    (6.1)
    -10.7
    (6.1)
    Week 44
    -9.4
    (6.1)
    -10.8
    (6.4)
    Week 48
    -9.2
    (6.2)
    -11.0
    (6.3)
    Week 52
    -9.6
    (6.2)
    -11.0
    (6.1)
    EOT
    -8.8
    (6.6)
    -10.3
    (6.4)
    20. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12
    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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
    Time Frame Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    7.7
    4.4%
    31.4
    18%
    35.1
    20.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 23.7
    Confidence Interval (2-Sided) 95%
    15.1 to 32.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 27.4
    Confidence Interval (2-Sided) 95%
    18.6 to 36.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    21. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52
    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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
    Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 172 171 37 38 39 34
    Week 4
    11.2
    6.4%
    14.7
    8.4%
    0.0
    0%
    0.0
    0%
    15.4
    NaN
    5.9
    NaN
    Week 8
    19.0
    10.9%
    21.7
    12.5%
    0.0
    0%
    0.0
    0%
    10.3
    NaN
    11.8
    NaN
    Week 12
    31.0
    17.8%
    36.1
    20.7%
    0.0
    0%
    0.0
    0%
    20.5
    NaN
    11.8
    NaN
    Week 16
    39.2
    22.5%
    43.0
    24.7%
    8.1
    4.8%
    13.5
    2.6%
    20.5
    NaN
    8.8
    NaN
    Week 20
    45.7
    26.3%
    52.1
    29.9%
    21.6
    12.7%
    16.2
    3.1%
    17.9
    NaN
    29.4
    NaN
    Week 24
    51.6
    29.7%
    56.9
    32.7%
    27.8
    16.4%
    33.3
    6.4%
    20.5
    NaN
    32.4
    NaN
    Week 28
    51.9
    29.8%
    52.8
    30.3%
    30.6
    18%
    38.9
    7.5%
    25.6
    NaN
    26.5
    NaN
    Week 32
    54.1
    31.1%
    52.9
    30.4%
    44.4
    26.1%
    50.0
    9.7%
    30.8
    NaN
    44.1
    NaN
    Week 36
    53.6
    30.8%
    53.5
    30.7%
    50.0
    29.4%
    48.6
    9.4%
    35.1
    NaN
    54.5
    NaN
    Week 40
    59.9
    34.4%
    58.8
    33.8%
    42.9
    25.2%
    50.0
    9.7%
    61.1
    NaN
    54.5
    NaN
    Week 44
    57.0
    32.8%
    55.6
    32%
    50.0
    29.4%
    42.4
    8.2%
    55.6
    NaN
    57.6
    NaN
    Week 48
    56.1
    32.2%
    60.3
    34.7%
    54.5
    32.1%
    54.5
    10.5%
    62.9
    NaN
    66.7
    NaN
    Week 52
    60.0
    34.5%
    62.6
    36%
    54.5
    32.1%
    39.4
    7.6%
    55.9
    NaN
    63.6
    NaN
    EOT
    56.4
    32.4%
    57.9
    33.3%
    54.1
    31.8%
    34.2
    6.6%
    56.4
    NaN
    64.7
    NaN
    22. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12
    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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
    Time Frame Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    2.4
    1.4%
    12.8
    7.4%
    19.3
    11.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 10.4
    Confidence Interval (2-Sided) 95%
    4.3 to 16.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected)
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 16.9
    Confidence Interval (2-Sided) 95%
    10.0 to 23.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected)
    23. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52
    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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
    Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 172 171 37 38 39 34
    Week 4
    4.1
    2.4%
    5.9
    3.4%
    0.0
    0%
    0.0
    0%
    2.6
    NaN
    0.0
    NaN
    Week 8
    8.9
    5.1%
    12.7
    7.3%
    0.0
    0%
    0.0
    0%
    2.6
    NaN
    2.9
    NaN
    Week 12
    13.1
    7.5%
    19.9
    11.4%
    0.0
    0%
    0.0
    0%
    5.1
    NaN
    5.9
    NaN
    Week 16
    18.1
    10.4%
    24.2
    13.9%
    0.0
    0%
    10.8
    2.1%
    10.3
    NaN
    2.9
    NaN
    Week 20
    22.6
    13%
    33.1
    19%
    5.4
    3.2%
    10.8
    2.1%
    7.7
    NaN
    5.9
    NaN
    Week 24
    28.0
    16.1%
    31.3
    18%
    5.6
    3.3%
    27.8
    5.4%
    12.8
    NaN
    5.9
    NaN
    Week 28
    30.4
    17.5%
    32.1
    18.4%
    11.1
    6.5%
    22.2
    4.3%
    12.8
    NaN
    8.8
    NaN
    Week 32
    33.8
    19.4%
    41.3
    23.7%
    22.2
    13.1%
    30.6
    5.9%
    15.4
    NaN
    26.5
    NaN
    Week 36
    32.7
    18.8%
    40.0
    23%
    13.9
    8.2%
    37.1
    7.2%
    13.5
    NaN
    24.2
    NaN
    Week 40
    37.1
    21.3%
    36.2
    20.8%
    20.0
    11.8%
    35.3
    6.8%
    22.2
    NaN
    30.3
    NaN
    Week 44
    34.0
    19.5%
    37.3
    21.4%
    17.6
    10.4%
    24.2
    4.7%
    25.0
    NaN
    30.3
    NaN
    Week 48
    33.3
    19.1%
    40.4
    23.2%
    21.2
    12.5%
    39.4
    7.6%
    34.3
    NaN
    36.4
    NaN
    Week 52
    38.6
    22.2%
    42.9
    24.7%
    27.3
    16.1%
    36.4
    7%
    26.5
    NaN
    39.4
    NaN
    EOT
    34.9
    20.1%
    38.6
    22.2%
    24.3
    14.3%
    31.6
    6.1%
    25.6
    NaN
    41.2
    NaN
    24. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12
    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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
    Time Frame Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    12.4
    7.1%
    47.1
    27.1%
    57.9
    34.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 34.7
    Confidence Interval (2-Sided) 95%
    25.1 to 44.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 45.5
    Confidence Interval (2-Sided) 95%
    36.0 to 55.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    25. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52
    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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
    Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    22.4
    12.9%
    24.1
    13.9%
    Week 8
    36.3
    20.9%
    44.0
    25.3%
    Week 12
    47.0
    27%
    59.6
    34.3%
    Week 16
    55.4
    31.8%
    63.6
    36.6%
    Week 20
    62.2
    35.7%
    69.9
    40.2%
    Week 24
    67.1
    38.6%
    71.9
    41.3%
    Week 28
    67.7
    38.9%
    76.7
    44.1%
    Week 32
    65.6
    37.7%
    70.3
    40.4%
    Week 36
    69.3
    39.8%
    73.5
    42.2%
    Week 40
    76.3
    43.9%
    80.4
    46.2%
    Week 44
    70.5
    40.5%
    82.4
    47.4%
    Week 48
    73.6
    42.3%
    78.8
    45.3%
    Week 52
    71.7
    41.2%
    77.6
    44.6%
    EOT
    66.9
    38.4%
    71.3
    41%
    26. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12
    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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
    Time Frame Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    4.7
    2.7%
    25.0
    14.4%
    36.3
    21.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 20.3
    Confidence Interval (2-Sided) 95%
    12.5 to 28.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 31.5
    Confidence Interval (2-Sided) 95%
    23.1 to 40.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments C.I. was based on normal approximation to the binomial distribution (continuity corrected).
    27. Secondary Outcome
    Title Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52
    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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
    Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    10.6
    6.1%
    12.9
    7.4%
    Week 8
    17.9
    10.3%
    29.5
    17%
    Week 12
    25.6
    14.7%
    37.3
    21.4%
    Week 16
    34.9
    20.1%
    44.2
    25.4%
    Week 20
    44.5
    25.6%
    48.5
    27.9%
    Week 24
    52.2
    30%
    57.5
    33%
    Week 28
    49.4
    28.4%
    56.0
    32.2%
    Week 32
    52.2
    30%
    56.1
    32.2%
    Week 36
    53.6
    30.8%
    56.8
    32.6%
    Week 40
    58.3
    33.5%
    60.5
    34.8%
    Week 44
    53.7
    30.9%
    60.8
    34.9%
    Week 48
    55.8
    32.1%
    62.9
    36.1%
    Week 52
    55.2
    31.7%
    60.5
    34.8%
    EOT
    50.6
    29.1%
    57.3
    32.9%
    28. Secondary Outcome
    Title Change From Baseline in CRP at Week 12
    Description Higher CRP indicates greater disease activity.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [mg/dL]
    -0.001
    (2.038)
    -1.499
    (1.855)
    -1.421
    (2.182)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.597
    Confidence Interval (2-Sided) 95%
    -1.948 to -1.247
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.178
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.458
    Confidence Interval (2-Sided) 95%
    -1.852 to -1.065
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.200
    Estimation Comments
    29. Secondary Outcome
    Title Change From Baseline in CRP Through Week 52
    Description Higher CRP indicates greater disease activity.
    Time Frame Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -1.055
    (1.539)
    -1.411
    (1.652)
    Week 8
    -1.207
    (1.839)
    -1.569
    (1.769)
    Week 12
    -1.532
    (1.849)
    -1.458
    (2.170)
    Week 16
    -1.666
    (1.828)
    -1.513
    (2.083)
    Week 20
    -1.660
    (2.050)
    -1.660
    (2.179)
    Week 24
    -1.774
    (2.022)
    -1.721
    (2.055)
    Week 28
    -1.803
    (2.150)
    -1.721
    (2.151)
    Week 32
    -1.844
    (2.214)
    -1.640
    (2.411)
    Week 36
    -1.832
    (2.005)
    -1.696
    (2.500)
    Week 40
    -1.833
    (2.156)
    -1.716
    (2.329)
    Week 44
    -1.815
    (1.948)
    -1.725
    (2.324)
    Week 48
    -1.771
    (2.189)
    -1.751
    (2.338)
    Week 52
    -1.841
    (2.102)
    -1.912
    (1.992)
    EOT
    -1.545
    (2.315)
    -1.629
    (2.386)
    30. Secondary Outcome
    Title Change From Baseline in ESR at Week 12
    Description Higher ESR indicates greater disease activity.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [mm/h]
    -2.42
    (19.71)
    -18.90
    (19.85)
    -22.17
    (22.79)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -17.89
    Confidence Interval (2-Sided) 95%
    -21.61 to -14.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.89
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -20.61
    Confidence Interval (2-Sided) 95%
    -24.67 to -16.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.06
    Estimation Comments
    31. Secondary Outcome
    Title Change From Baseline in ESR Through Week 52
    Description Higher ESR indicates greater disease activity.
    Time Frame Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 170
    Week 4
    -11.09
    (14.34)
    -16.59
    (16.68)
    Week 8
    -14.96
    (18.73)
    -21.10
    (20.37)
    Week 12
    -19.14
    (19.81)
    -22.92
    (22.66)
    Week 16
    -21.42
    (19.70)
    -24.29
    (23.14)
    Week 20
    -23.22
    (20.78)
    -26.20
    (24.12)
    Week 24
    -25.35
    (22.48)
    -27.36
    (23.23)
    Week 28
    -26.03
    (23.70)
    -27.88
    (24.27)
    Week 32
    -26.92
    (23.85)
    -27.21
    (24.92)
    Week 36
    -25.95
    (22.68)
    -27.25
    (25.10)
    Week 40
    -25.86
    (24.41)
    -27.74
    (24.86)
    Week 44
    -27.13
    (22.73)
    -27.99
    (23.93)
    Week 48
    -25.63
    (24.72)
    -27.83
    (23.29)
    Week 52
    -26.86
    (23.60)
    -29.12
    (23.28)
    EOT
    -24.00
    (24.49)
    -26.11
    (25.22)
    32. Secondary Outcome
    Title Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
    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 Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    10.1
    5.8%
    43.0
    24.7%
    55.6
    32.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 33.0
    Confidence Interval (2-Sided) 95%
    23.7 to 42.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 45.5
    Confidence Interval (2-Sided) 95%
    36.2 to 54.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    33. Secondary Outcome
    Title Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
    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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    19.4
    11.1%
    21.8
    12.5%
    Week 8
    30.4
    17.5%
    41.0
    23.6%
    Week 12
    42.9
    24.7%
    57.2
    32.9%
    Week 16
    51.8
    29.8%
    60.0
    34.5%
    Week 20
    59.1
    34%
    68.1
    39.1%
    Week 24
    65.2
    37.5%
    70.0
    40.2%
    Week 28
    63.3
    36.4%
    74.2
    42.6%
    Week 32
    63.1
    36.3%
    69.0
    39.7%
    Week 36
    67.3
    38.7%
    72.9
    41.9%
    Week 40
    73.7
    42.4%
    79.1
    45.5%
    Week 44
    65.8
    37.8%
    81.0
    46.6%
    Week 48
    71.6
    41.1%
    78.1
    44.9%
    Week 52
    69.0
    39.7%
    76.9
    44.2%
    EOT
    64.5
    37.1%
    70.8
    40.7%
    34. Secondary Outcome
    Title Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
    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 Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    35.5
    20.4%
    77.9
    44.8%
    84.8
    49.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 42.4
    Confidence Interval (2-Sided) 95%
    32.3 to 52.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 49.3
    Confidence Interval (2-Sided) 95%
    39.7 to 58.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected
    35. Secondary Outcome
    Title Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
    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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    67.1
    38.6%
    77.1
    44.3%
    Week 8
    73.8
    42.4%
    80.1
    46%
    Week 12
    78.6
    45.2%
    85.5
    49.1%
    Week 16
    84.3
    48.4%
    89.1
    51.2%
    Week 20
    86.6
    49.8%
    91.4
    52.5%
    Week 24
    89.4
    51.4%
    95.6
    54.9%
    Week 28
    91.1
    52.4%
    93.7
    53.9%
    Week 32
    93.0
    53.4%
    94.2
    54.1%
    Week 36
    94.8
    54.5%
    95.5
    54.9%
    Week 40
    92.8
    53.3%
    96.1
    55.2%
    Week 44
    95.3
    54.8%
    94.1
    54.1%
    Week 48
    95.3
    54.8%
    97.4
    56%
    Week 52
    95.2
    54.7%
    94.6
    54.4%
    EOT
    88.4
    50.8%
    92.4
    53.1%
    36. Secondary Outcome
    Title Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12
    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 Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    4.1
    2.4%
    23.8
    13.7%
    34.5
    20.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments No multiplicity adjustment.
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 19.7
    Confidence Interval (2-Sided) 95%
    12.1 to 27.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 30.4
    Confidence Interval (2-Sided) 95%
    22.0 to 38.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    37. Secondary Outcome
    Title Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52
    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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    7.6
    4.4%
    12.4
    7.1%
    Week 8
    16.1
    9.3%
    28.3
    16.3%
    Week 12
    24.4
    14%
    35.5
    20.4%
    Week 16
    34.3
    19.7%
    43.6
    25.1%
    Week 20
    43.3
    24.9%
    46.0
    26.4%
    Week 24
    51.6
    29.7%
    55.6
    32%
    Week 28
    48.1
    27.6%
    54.1
    31.1%
    Week 32
    51.0
    29.3%
    54.8
    31.5%
    Week 36
    53.6
    30.8%
    54.8
    31.5%
    Week 40
    57.6
    33.1%
    58.6
    33.7%
    Week 44
    52.4
    30.1%
    59.5
    34.2%
    Week 48
    53.7
    30.9%
    60.9
    35%
    Week 52
    53.8
    30.9%
    59.2
    34%
    EOT
    49.4
    28.4%
    56.1
    32.2%
    38. Secondary Outcome
    Title Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12
    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 Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks
    Measure Participants 169 172 171
    Number [percentage of participants]
    32.0
    18.4%
    74.4
    42.8%
    78.9
    46.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 42.5
    Confidence Interval (2-Sided) 95%
    32.3 to 52.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 47.0
    Confidence Interval (2-Sided) 95%
    37.1 to 56.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    39. Secondary Outcome
    Title Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52
    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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    55.9
    32.1%
    68.2
    39.2%
    Week 8
    72.0
    41.4%
    76.5
    44%
    Week 12
    75.0
    43.1%
    80.1
    46%
    Week 16
    80.7
    46.4%
    87.9
    50.5%
    Week 20
    82.3
    47.3%
    92.0
    52.9%
    Week 24
    87.6
    50.3%
    91.9
    52.8%
    Week 28
    88.0
    50.6%
    91.2
    52.4%
    Week 32
    90.4
    52%
    92.9
    53.4%
    Week 36
    94.1
    54.1%
    94.8
    54.5%
    Week 40
    92.7
    53.3%
    94.1
    54.1%
    Week 44
    96.6
    55.5%
    94.1
    54.1%
    Week 48
    94.6
    54.4%
    95.4
    54.8%
    Week 52
    93.8
    53.9%
    94.6
    54.4%
    EOT
    86.0
    49.4%
    90.6
    52.1%
    40. Secondary Outcome
    Title Percentage of Participants Achieving ACR / EULAR Remission at Week 12
    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 Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    0.6
    0.3%
    5.8
    3.3%
    9.9
    5.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 5.2
    Confidence Interval (2-Sided) 95%
    1.0 to 9.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 9.3
    Confidence Interval (2-Sided) 95%
    4.1 to 14.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    41. Secondary Outcome
    Title Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
    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 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    1.2
    0.7%
    1.2
    0.7%
    Week 8
    1.2
    0.7%
    3.6
    2.1%
    Week 12
    6.0
    3.4%
    10.2
    5.9%
    Week 16
    9.0
    5.2%
    12.1
    7%
    Week 20
    11.0
    6.3%
    14.1
    8.1%
    Week 24
    11.8
    6.8%
    18.1
    10.4%
    Week 28
    14.6
    8.4%
    20.1
    11.6%
    Week 32
    17.2
    9.9%
    25.8
    14.8%
    Week 36
    17.0
    9.8%
    27.7
    15.9%
    Week 40
    19.1
    11%
    20.9
    12%
    Week 44
    16.1
    9.3%
    20.3
    11.7%
    Week 48
    17.6
    10.1%
    21.2
    12.2%
    Week 52
    21.4
    12.3%
    26.5
    15.2%
    EOT
    19.2
    11%
    23.4
    13.4%
    42. Secondary Outcome
    Title Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12
    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. SDAI Remission was defined as SDAI score ≤ 3.3.
    Time Frame Week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 169 172 171
    Number [percentage of participants]
    0.6
    0.3%
    7.0
    4%
    14.0
    8.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments No multiplicity adjustment.
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 6.4
    Confidence Interval (2-Sided) 95%
    1.8 to 11.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent Difference
    Estimated Value 13.4
    Confidence Interval (2-Sided) 95%
    7.5 to 19.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments CI was based on normal approximation to the binomial distribution (continuity corrected).
    43. Secondary Outcome
    Title Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52
    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. SDAI Remission was defined as SDAI score ≤ 3.3.
    Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    1.2
    0.7%
    2.4
    1.4%
    Week 8
    3.0
    1.7%
    8.4
    4.8%
    Week 12
    7.1
    4.1%
    14.5
    8.3%
    Week 16
    14.5
    8.3%
    18.2
    10.5%
    Week 20
    18.3
    10.5%
    20.9
    12%
    Week 24
    20.5
    11.8%
    22.5
    12.9%
    Week 28
    22.2
    12.8%
    23.3
    13.4%
    Week 32
    25.5
    14.7%
    28.4
    16.3%
    Week 36
    24.2
    13.9%
    32.9
    18.9%
    Week 40
    31.6
    18.2%
    28.8
    16.6%
    Week 44
    27.5
    15.8%
    30.1
    17.3%
    Week 48
    25.7
    14.8%
    32.5
    18.7%
    Week 52
    30.3
    17.4%
    39.5
    22.7%
    EOT
    28.5
    16.4%
    35.1
    20.2%
    44. Secondary Outcome
    Title Change From Baseline in SDAI Score at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    -4.90
    (12.32)
    -15.66
    (12.69)
    -19.57
    (13.53)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -11.22
    Confidence Interval (2-Sided) 95%
    -13.84 to -8.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.33
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -14.67
    Confidence Interval (2-Sided) 95%
    -17.35 to -11.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.36
    Estimation Comments
    45. Secondary Outcome
    Title Change From Baseline in SDAI Score Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -11.02
    (8.23)
    -13.79
    (10.43)
    Week 8
    -14.60
    (10.40)
    -18.36
    (11.76)
    Week 12
    -15.94
    (12.59)
    -20.08
    (13.08)
    Week 16
    -18.75
    (11.58)
    -22.21
    (12.56)
    Week 20
    -20.24
    (11.89)
    -23.03
    (13.26)
    Week 24
    -21.62
    (11.64)
    -24.68
    (11.52)
    Week 28
    -21.89
    (11.54)
    -24.57
    (12.17)
    Week 32
    -22.61
    (11.15)
    -25.38
    (11.91)
    Week 36
    -22.89
    (11.10)
    -25.55
    (11.74)
    Week 40
    -23.55
    (11.20)
    -26.14
    (11.93)
    Week 44
    -23.55
    (11.17)
    -26.44
    (12.15)
    Week 48
    -23.23
    (11.30)
    -26.50
    (12.12)
    Week 52
    -23.67
    (11.91)
    -26.63
    (12.82)
    EOT
    -21.48
    (13.42)
    -24.72
    (14.13)
    46. Secondary Outcome
    Title Change From Baseline in PGA at Week 12
    Description The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    -11.88
    (21.46)
    -28.83
    (22.21)
    -35.96
    (25.00)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -17.67
    Confidence Interval (2-Sided) 95%
    -22.11 to -13.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.26
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -24.09
    Confidence Interval () 95%
    -28.66 to -19.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.33
    Estimation Comments
    47. Secondary Outcome
    Title Change From Baseline in PGA Through Week 52
    Description The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
    Time Frame Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -18.36
    (17.10)
    -22.94
    (19.32)
    Week 8
    -25.79
    (19.59)
    -31.54
    (22.43)
    Week 12
    -29.07
    (22.22)
    -36.55
    (24.64)
    Week 16
    -33.60
    (21.27)
    -38.86
    (23.83)
    Week 20
    -36.18
    (21.87)
    -41.44
    (22.71)
    Week 24
    -37.13
    (21.71)
    -43.67
    (21.39)
    Week 28
    -38.72
    (22.45)
    -42.43
    (21.27)
    Week 32
    -40.04
    (20.82)
    -43.96
    (21.78)
    Week 36
    -39.35
    (21.25)
    -44.37
    (21.77)
    Week 40
    -41.04
    (22.33)
    -44.32
    (21.54)
    Week 44
    -41.47
    (22.73)
    -46.00
    (21.60)
    Week 48
    -41.55
    (23.23)
    -45.84
    (21.83)
    Week 52
    -41.49
    (23.75)
    -45.46
    (23.75)
    EOT
    -38.41
    (25.07)
    -43.33
    (24.31)
    48. Secondary Outcome
    Title Change From Baseline in SGA at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    -7.11
    (23.05)
    -21.09
    (23.63)
    -26.57
    (25.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -16.64
    Confidence Interval (2-Sided) 95%
    -21.09 to -12.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.26
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -20.34
    Confidence Interval (2-Sided) 95%
    -25.07 to -15.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.40
    Estimation Comments
    49. Secondary Outcome
    Title Change From Baseline in SGA Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -13.80
    (19.47)
    -17.59
    (20.25)
    Week 8
    -19.11
    (23.22)
    -24.97
    (22.65)
    Week 12
    -21.59
    (23.43)
    -27.40
    (24.84)
    Week 16
    -25.20
    (24.41)
    -30.14
    (24.29)
    Week 20
    -26.94
    (25.49)
    -31.20
    (25.39)
    Week 24
    -29.00
    (25.51)
    -32.79
    (25.68)
    Week 28
    -30.04
    (24.96)
    -34.25
    (25.01)
    Week 32
    -31.92
    (24.99)
    -33.46
    (24.28)
    Week 36
    -32.38
    (25.34)
    -34.01
    (23.83)
    Week 40
    -32.80
    (25.85)
    -34.24
    (23.85)
    Week 44
    -33.49
    (25.86)
    -35.31
    (25.23)
    Week 48
    -33.69
    (26.18)
    -35.33
    (23.77)
    Week 52
    -33.18
    (27.83)
    -36.16
    (25.27)
    EOT
    -29.34
    (28.78)
    -34.05
    (26.60)
    50. Secondary Outcome
    Title Change From Baseline in SGAP at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    -6.64
    (25.22)
    -21.09
    (27.04)
    -26.87
    (26.65)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -17.19
    Confidence Interval (2-Sided) 95%
    -22.00 to -12.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.44
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).
    Method of Estimation Estimation Parameter LS Mean difference
    Estimated Value -20.89
    Confidence Interval (2-Sided) 95%
    -25.80 to -15.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.50
    Estimation Comments
    51. Secondary Outcome
    Title Change From Baseline in SGAP Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -12.94
    (20.75)
    -16.18
    (22.06)
    Week 8
    -19.10
    (25.81)
    -24.98
    (23.68)
    Week 12
    -21.27
    (27.03)
    -27.81
    (26.13)
    Week 16
    -24.03
    (26.09)
    -28.42
    (26.88)
    Week 20
    -25.57
    (28.52)
    -30.63
    (26.68)
    Week 24
    -27.34
    (27.54)
    -32.72
    (26.04)
    Week 28
    -28.54
    (27.24)
    -34.18
    (25.89)
    Week 32
    -31.32
    (25.76)
    -33.74
    (25.44)
    Week 36
    -31.95
    (26.17)
    -32.66
    (26.25)
    Week 40
    -32.17
    (26.81)
    -34.07
    (25.22)
    Week 44
    -32.73
    (26.67)
    -34.88
    (25.27)
    Week 48
    -33.60
    (25.87)
    -35.07
    (25.05)
    Week 52
    -33.34
    (26.98)
    -35.00
    (27.37)
    EOT
    -28.94
    (28.63)
    -32.68
    (28.48)
    52. 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 Up to week 52

    Outcome Measure Data

    Analysis Population Description
    FAS.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg Placebo / Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
    Measure Participants 175 174 85 85
    Count of Participants [Participants]
    10
    5.7%
    6
    3.4%
    3
    1.8%
    9
    1.7%
    53. Secondary Outcome
    Title Change From Baseline in HAQ-DI at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    0.01
    (0.47)
    -0.22
    (0.44)
    -0.37
    (0.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.27
    Confidence Interval (2-Sided) 95%
    -0.36 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.05
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -0.48 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.05
    Estimation Comments
    54. Secondary Outcome
    Title Change From Baseline in HAQ-DI Through Week 52
    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, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    -0.08
    (0.30)
    -0.21
    (0.36)
    Week 8
    -0.18
    (0.41)
    -0.32
    (0.42)
    Week 12
    -0.23
    (0.44)
    -0.38
    (0.47)
    Week 16
    -0.30
    (0.46)
    -0.41
    (0.51)
    Week 20
    -0.33
    (0.48)
    -0.47
    (0.53)
    Week 24
    -0.36
    (0.50)
    -0.48
    (0.52)
    Week 28
    -0.36
    (0.51)
    -0.51
    (0.52)
    Week 32
    -0.37
    (0.51)
    -0.53
    (0.54)
    Week 36
    -0.39
    (0.50)
    -0.53
    (0.52)
    Week 40
    -0.42
    (0.50)
    -0.56
    (0.52)
    Week 44
    -0.45
    (0.50)
    -0.54
    (0.53)
    Week 48
    -0.44
    (0.49)
    -0.56
    (0.53)
    Week 52
    -0.43
    (0.51)
    -0.56
    (0.54)
    EOT
    -0.36
    (0.55)
    -0.51
    (0.56)
    55. Secondary Outcome
    Title Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12
    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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    0.57
    (12.08)
    6.60
    (11.06)
    9.02
    (11.54)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 6.41
    Confidence Interval (2-Sided) 95%
    4.09 to 8.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.18
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 8.61
    Confidence Interval (2-Sided) 95%
    6.36 to 10.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.14
    Estimation Comments
    56. Secondary Outcome
    Title Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
    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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
    Time Frame Baseline, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    3.84
    (8.91)
    5.77
    (11.05)
    Week 8
    4.92
    (10.82)
    7.91
    (11.88)
    Week 12
    6.68
    (11.08)
    9.32
    (11.55)
    Week 28
    9.89
    (11.86)
    12.44
    (11.88)
    Week 52
    11.27
    (12.05)
    12.45
    (12.45)
    EOT
    9.92
    (12.81)
    11.51
    (12.77)
    57. Secondary Outcome
    Title Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12
    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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    1.07
    (8.27)
    3.28
    (7.47)
    2.50
    (8.44)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.70
    Confidence Interval (2-Sided) 95%
    1.21 to 4.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.036
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.65
    Confidence Interval (2-Sided) 95%
    0.11 to 3.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    58. Secondary Outcome
    Title Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
    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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
    Time Frame Baseline, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    1.45
    (7.02)
    1.33
    (7.93)
    Week 8
    2.72
    (7.39)
    2.44
    (8.47)
    Week 12
    3.44
    (7.47)
    2.67
    (8.23)
    Week 28
    3.06
    (8.55)
    3.12
    (8.20)
    Week 52
    2.62
    (9.10)
    1.85
    (8.71)
    EOT
    2.21
    (8.89)
    1.67
    (8.90)
    59. Secondary Outcome
    Title Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12
    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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
    Time Frame Baseline and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 172 171
    Mean (Standard Deviation) [units on a scale]
    -0.09
    (16.69)
    2.30
    (13.92)
    3.90
    (13.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.099
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.29
    Confidence Interval (2-Sided) 95%
    -0.44 to 5.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.39
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.22
    Confidence Interval (2-Sided) 95%
    1.53 to 6.91
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.37
    Estimation Comments
    60. Secondary Outcome
    Title Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
    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 Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
    Time Frame Baseline, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 172 171
    Week 4
    1.41
    (11.51)
    1.70
    (11.44)
    Week 8
    2.50
    (13.79)
    3.30
    (13.43)
    Week 12
    2.32
    (14.05)
    3.92
    (13.31)
    Week 28
    4.06
    (14.92)
    4.81
    (13.83)
    Week 52
    4.30
    (15.31)
    7.17
    (14.05)
    EOT
    3.49
    (14.85)
    5.88
    (14.31)
    61. Secondary Outcome
    Title Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 98 82 95
    Mean (Standard Deviation) [percent work time missed]
    -0.82
    (17.77)
    0.36
    (18.15)
    -1.46
    (15.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.879
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.37
    Confidence Interval (2-Sided) 95%
    -5.16 to 4.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.43
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.377
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.81
    Confidence Interval (2-Sided) 95%
    -5.86 to 2.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.05
    Estimation Comments
    62. Secondary Outcome
    Title Change From Baseline in WPAI Percent Work Time Missed Through Week 52
    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, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 82 95
    Week 4
    -0.90
    (16.50)
    0.02
    (16.53)
    Week 8
    -1.48
    (15.72)
    -1.73
    (16.59)
    Week 12
    -0.70
    (14.69)
    -1.97
    (12.14)
    Week 28
    -0.58
    (19.15)
    -3.49
    (13.77)
    Week 52
    -1.93
    (12.14)
    -1.66
    (18.74)
    EOT
    -1.76
    (14.68)
    -1.66
    (20.31)
    63. Secondary Outcome
    Title Change From Baseline in WPAI Percent Impairment While Working at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 95 82 94
    Mean (Standard Deviation) [percent work impairment]
    -2.42
    (27.78)
    -11.71
    (25.62)
    -15.96
    (28.30)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.63
    Confidence Interval (2-Sided) 95%
    -16.54 to -2.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.50
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -14.17
    Confidence Interval (2-Sided) 95%
    -21.24 to -7.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.58
    Estimation Comments
    64. Secondary Outcome
    Title Change From Baseline in WPAI Percent Impairment While Working Through Week 52
    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 calculates as Q5/10. Negative values indicate improvement from baseline.
    Time Frame Baseline, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 83 94
    Week 4
    -10.00
    (22.39)
    -6.56
    (29.31)
    Week 8
    -12.50
    (24.93)
    -13.98
    (26.37)
    Week 12
    -11.97
    (26.33)
    -16.29
    (27.77)
    Week 28
    -20.00
    (25.27)
    -21.40
    (25.21)
    Week 52
    -22.97
    (29.90)
    -22.41
    (28.16)
    EOT
    -17.35
    (29.10)
    -20.43
    (28.85)
    65. Secondary Outcome
    Title Change From Baseline in Percent Overall Work Impairment at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 95 81 94
    Mean (Standard Deviation) [percent overall work impairment]
    -2.75
    (28.56)
    -11.58
    (26.22)
    -16.91
    (29.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.43
    Confidence Interval (2-Sided) 95%
    -16.60 to -2.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.63
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -14.61
    Confidence Interval (2-Sided) 95%
    -21.92 to -7.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.70
    Estimation Comments
    66. Secondary Outcome
    Title Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
    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, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 82 94
    Week 4
    -10.61
    (22.36)
    -7.51
    (30.12)
    Week 8
    -13.13
    (25.07)
    -14.67
    (26.94)
    Week 12
    -12.15
    (26.81)
    -17.15
    (28.94)
    Week 28
    -20.76
    (25.78)
    -22.49
    (26.69)
    Week 52
    -22.48
    (30.96)
    -23.40
    (29.54)
    EOT
    -17.43
    (30.01)
    -21.59
    (29.88)
    67. Secondary Outcome
    Title Change From Baseline in WPAI Percent Activity Impairment at Week 12
    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 and week 12/ET

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 168 171 170
    Mean (Standard Deviation) [percent activity impairment]
    -2.50
    (28.19)
    -13.98
    (27.17)
    -19.35
    (24.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 100 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -13.19
    Confidence Interval (2-Sided) 95%
    -18.23 to -8.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.56
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Peficitinib 150 mg
    Comments Treatment Difference vs Placebo
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No multiplicity adjustment.
    Method ANCOVA
    Comments Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -17.61
    Confidence Interval (2-Sided) 95%
    -22.57 to -12.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.52
    Estimation Comments
    68. Secondary Outcome
    Title Change From Baseline in WPAI Percent Activity Impairment Through Week 52
    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, weeks 4, 8, 12, 28, 52 and EOT

    Outcome Measure Data

    Analysis Population Description
    FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 171 170
    Week 4
    -9.23
    (22.81)
    -10.65
    (22.18)
    Week 8
    -13.07
    (26.12)
    -17.44
    (24.28)
    Week 12
    -13.71
    (27.30)
    -19.88
    (24.32)
    Week 28
    -22.17
    (27.25)
    -26.99
    (24.72)
    Week 52
    -24.10
    (31.72)
    -26.71
    (24.78)
    EOT
    -21.58
    (31.67)
    -23.47
    (25.96)
    69. Secondary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks
    Description TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
    Time Frame Week 0 to week 12

    Outcome Measure Data

    Analysis Population Description
    SAF.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
    Measure Participants 170 174 174
    TEAEs
    84
    48.3%
    89
    51.1%
    104
    61.2%
    Drug-related TEAEs
    47
    27%
    57
    32.8%
    80
    47.1%
    TEAEs leading to death
    0
    0%
    0
    0%
    0
    0%
    Serious TEAEs
    4
    2.3%
    5
    2.9%
    3
    1.8%
    Drug-related serious TEAEs
    2
    1.1%
    3
    1.7%
    3
    1.8%
    ≥ Grade 3 TEAEs
    8
    4.6%
    9
    5.2%
    16
    9.4%
    TEAEs leading to permanent discontinuation
    7
    4%
    5
    2.9%
    5
    2.9%
    Drug-Related AE leading to permanent discont.
    6
    3.4%
    3
    1.7%
    5
    2.9%
    70. Secondary Outcome
    Title Number of Participants With TEAEs From Week 12 to Week 28
    Description TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE
    Time Frame Week 12 to week 28

    Outcome Measure Data

    Analysis Population Description
    SAF. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Placebo Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12
    Arm/Group Description Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52. Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
    Measure Participants 82 167 165 37 38
    TEAEs
    50
    28.7%
    95
    54.6%
    104
    61.2%
    21
    4.1%
    25
    NaN
    Drug-related TEAEs
    27
    15.5%
    63
    36.2%
    72
    42.4%
    16
    3.1%
    11
    NaN
    TEAEs leading to death
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    Serious TEAEs
    2
    1.1%
    5
    2.9%
    3
    1.8%
    0
    0%
    0
    NaN
    Drug-related serious TEAEs
    2
    1.1%
    3
    1.7%
    1
    0.6%
    0
    0%
    0
    NaN
    ≥ Grade 3 TEAEs
    5
    2.9%
    7
    4%
    6
    3.5%
    1
    0.2%
    1
    NaN
    TEAEs leading to permanent discontinuation
    4
    2.3%
    4
    2.3%
    1
    0.6%
    0
    0%
    0
    NaN
    Drug-Related TEAE leading to permanent dicont.
    3
    1.7%
    3
    1.7%
    1
    0.6%
    0
    0%
    0
    NaN
    71. Secondary Outcome
    Title Number of Participants With TEAEs From Week 28 to Week 52
    Description TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
    Time Frame Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

    Outcome Measure Data

    Analysis Population Description
    SAF. Here, Number of participants analyzed signifies participants with available data.
    Arm/Group Title Peficitinib 100 mg Peficitinib 150 mg Placebo / Peficitinib 100 mg at Week 12 Placebo / Peficitinib 150 mg at Week 12 Placebo / Peficitinib 100 mg at Week 28 Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
    Measure Participants 158 158 36 36 39 34
    TEAEs
    114
    65.5%
    112
    64.4%
    22
    12.9%
    27
    5.2%
    25
    NaN
    26
    NaN
    Drug-related TEAEs
    72
    41.4%
    74
    42.5%
    14
    8.2%
    18
    3.5%
    17
    NaN
    17
    NaN
    TEAEs leading to death
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    NaN
    0
    NaN
    Serious TEAEs
    10
    5.7%
    8
    4.6%
    2
    1.2%
    1
    0.2%
    1
    NaN
    1
    NaN
    Drug-related serious TEAEs
    4
    2.3%
    5
    2.9%
    2
    1.2%
    1
    0.2%
    0
    NaN
    1
    NaN
    ≥ Grade 3 TEAEs
    15
    8.6%
    15
    8.6%
    2
    1.2%
    2
    0.4%
    2
    NaN
    2
    NaN
    TEAEs leading to permanent discontinuation
    4
    2.3%
    6
    3.4%
    3
    1.8%
    2
    0.4%
    2
    NaN
    0
    NaN

    Adverse Events

    Time Frame Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
    Adverse Event Reporting Description SAF.
    Arm/Group Title Week 0 to Week 12: Placebo Week 0 to Week 12: Peficitinib 100 mg Week 0 to Week 12: Peficitinib 150 mg Week 12 to Week 28: Placebo Week 12 to Week 28: Peficitinib 100 mg Week 12 to Week 28: Peficitinib 150 mg Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12 Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Peficitinib 100 mg Week 28 to Week 52: Peficitinib 150 mg Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28
    Arm/Group Description Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12. Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks. Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks. Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28. Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28. Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 28. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 28. Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52. Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 52. Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52. Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
    All Cause Mortality
    Week 0 to Week 12: Placebo Week 0 to Week 12: Peficitinib 100 mg Week 0 to Week 12: Peficitinib 150 mg Week 12 to Week 28: Placebo Week 12 to Week 28: Peficitinib 100 mg Week 12 to Week 28: Peficitinib 150 mg Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12 Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Peficitinib 100 mg Week 28 to Week 52: Peficitinib 150 mg Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/170 (0%) 0/174 (0%) 0/174 (0%) 0/82 (0%) 0/167 (0%) 0/165 (0%) 0/37 (0%) 0/38 (0%) 0/158 (0%) 0/158 (0%) 0/36 (0%) 0/36 (0%) 1/39 (2.6%) 0/34 (0%)
    Serious Adverse Events
    Week 0 to Week 12: Placebo Week 0 to Week 12: Peficitinib 100 mg Week 0 to Week 12: Peficitinib 150 mg Week 12 to Week 28: Placebo Week 12 to Week 28: Peficitinib 100 mg Week 12 to Week 28: Peficitinib 150 mg Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12 Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Peficitinib 100 mg Week 28 to Week 52: Peficitinib 150 mg Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/170 (2.4%) 5/174 (2.9%) 3/174 (1.7%) 2/82 (2.4%) 5/167 (3%) 3/165 (1.8%) 0/37 (0%) 0/38 (0%) 10/158 (6.3%) 8/158 (5.1%) 2/36 (5.6%) 1/36 (2.8%) 1/39 (2.6%) 1/34 (2.9%)
    Cardiac disorders
    Pericarditis 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Ear and labyrinth disorders
    Vertigo positional 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Eye disorders
    Retinal detachment 0/170 (0%) 0 1/174 (0.6%) 1 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Gastrointestinal disorders
    Colonic polyp 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Gastric ulcer 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 1/34 (2.9%) 1
    Hepatobiliary disorders
    Cholecystitis acute 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 1/167 (0.6%) 1 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Hepatic function abnormal 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 1/165 (0.6%) 1 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Infections and infestations
    Cellulitis 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 1/165 (0.6%) 1 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Gastroenteritis 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 1/36 (2.8%) 1 0/39 (0%) 0 0/34 (0%) 0
    Gastroenteritis viral 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 1/36 (2.8%) 1 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Herpes zoster 0/170 (0%) 0 1/174 (0.6%) 1 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Pneumocystis jiroveci pneumonia 0/170 (0%) 0 1/174 (0.6%) 1 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Pneumonia 0/170 (0%) 0 1/174 (0.6%) 1 0/174 (0%) 0 0/82 (0%) 0 1/167 (0.6%) 1 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 2/158 (1.3%) 2 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Pneumonia cryptococcal 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Pyelonephritis 0/170 (0%) 0 0/174 (0%) 0 1/174 (0.6%) 1 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Injury, poisoning and procedural complications
    Brachial plexus injury 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Spinal compression fracture 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 2/167 (1.2%) 2 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Investigations
    Investigation 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 1/167 (0.6%) 1 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 0/170 (0%) 0 1/174 (0.6%) 1 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Rheumatoid arthritis 1/170 (0.6%) 1 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Tendon disorder 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 1/165 (0.6%) 1 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Borderline ovarian tumour 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Small cell lung cancer stage unspecified 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Squamous cell carcinoma 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 1/82 (1.2%) 1 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Nervous system disorders
    Cerebellar haemorrhage 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Lacunar infarction 1/170 (0.6%) 1 0/174 (0%) 0 1/174 (0.6%) 1 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Psychiatric disorders
    Completed suicide 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 1/39 (2.6%) 1 0/34 (0%) 0
    Mania 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Renal and urinary disorders
    Nephrolithiasis 0/170 (0%) 0 0/174 (0%) 0 1/174 (0.6%) 1 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Alveolitis allergic 1/170 (0.6%) 1 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Interstitial lung disease 1/170 (0.6%) 1 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 1/167 (0.6%) 1 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Organising pneumonia 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 1/36 (2.8%) 1 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Pleural effusion 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 1/82 (1.2%) 1 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Status asthmaticus 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Skin and subcutaneous tissue disorders
    Drug eruption 0/170 (0%) 0 0/174 (0%) 0 1/174 (0.6%) 1 0/82 (0%) 0 0/167 (0%) 0 0/165 (0%) 0 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Other (Not Including Serious) Adverse Events
    Week 0 to Week 12: Placebo Week 0 to Week 12: Peficitinib 100 mg Week 0 to Week 12: Peficitinib 150 mg Week 12 to Week 28: Placebo Week 12 to Week 28: Peficitinib 100 mg Week 12 to Week 28: Peficitinib 150 mg Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12 Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Peficitinib 100 mg Week 28 to Week 52: Peficitinib 150 mg Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12 Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28 Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 42/170 (24.7%) 54/174 (31%) 61/174 (35.1%) 26/82 (31.7%) 56/167 (33.5%) 60/165 (36.4%) 14/37 (37.8%) 11/38 (28.9%) 63/158 (39.9%) 73/158 (46.2%) 16/36 (44.4%) 22/36 (61.1%) 15/39 (38.5%) 20/34 (58.8%)
    Gastrointestinal disorders
    Diarrhoea 0/170 (0%) 0 4/174 (2.3%) 4 5/174 (2.9%) 5 1/82 (1.2%) 1 3/167 (1.8%) 3 3/165 (1.8%) 3 0/37 (0%) 0 0/38 (0%) 0 1/158 (0.6%) 1 3/158 (1.9%) 4 0/36 (0%) 0 1/36 (2.8%) 1 0/39 (0%) 0 2/34 (5.9%) 2
    Dyspepsia 0/170 (0%) 0 0/174 (0%) 0 1/174 (0.6%) 1 1/82 (1.2%) 1 0/167 (0%) 0 1/165 (0.6%) 1 0/37 (0%) 0 2/38 (5.3%) 2 1/158 (0.6%) 1 0/158 (0%) 0 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Nausea 1/170 (0.6%) 1 5/174 (2.9%) 5 3/174 (1.7%) 3 1/82 (1.2%) 1 1/167 (0.6%) 1 1/165 (0.6%) 1 1/37 (2.7%) 1 1/38 (2.6%) 1 2/158 (1.3%) 2 3/158 (1.9%) 3 1/36 (2.8%) 1 0/36 (0%) 0 3/39 (7.7%) 3 0/34 (0%) 0
    Stomatitis 1/170 (0.6%) 1 2/174 (1.1%) 2 4/174 (2.3%) 4 1/82 (1.2%) 1 1/167 (0.6%) 1 2/165 (1.2%) 2 0/37 (0%) 0 2/38 (5.3%) 2 2/158 (1.3%) 2 4/158 (2.5%) 4 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 0/34 (0%) 0
    Vomiting 0/170 (0%) 0 2/174 (1.1%) 2 2/174 (1.1%) 2 0/82 (0%) 0 0/167 (0%) 0 1/165 (0.6%) 1 2/37 (5.4%) 2 0/38 (0%) 0 2/158 (1.3%) 2 2/158 (1.3%) 2 1/36 (2.8%) 1 0/36 (0%) 0 0/39 (0%) 0 2/34 (5.9%) 2
    Hepatobiliary disorders
    Hepatic function abnormal 4/170 (2.4%) 4 5/174 (2.9%) 5 6/174 (3.4%) 6 1/82 (1.2%) 1 4/167 (2.4%) 4 5/165 (3%) 5 0/37 (0%) 0 0/38 (0%) 0 5/158 (3.2%) 5 2/158 (1.3%) 2 1/36 (2.8%) 1 1/36 (2.8%) 1 1/39 (2.6%) 1 4/34 (11.8%) 5
    Infections and infestations
    Bronchitis 0/170 (0%) 0 3/174 (1.7%) 3 3/174 (1.7%) 3 2/82 (2.4%) 2 3/167 (1.8%) 3 4/165 (2.4%) 5 1/37 (2.7%) 2 1/38 (2.6%) 1 2/158 (1.3%) 2 5/158 (3.2%) 5 1/36 (2.8%) 1 4/36 (11.1%) 4 0/39 (0%) 0 3/34 (8.8%) 3
    Cystitis 2/170 (1.2%) 2 1/174 (0.6%) 1 2/174 (1.1%) 2 0/82 (0%) 0 3/167 (1.8%) 3 2/165 (1.2%) 3 2/37 (5.4%) 2 1/38 (2.6%) 1 3/158 (1.9%) 3 4/158 (2.5%) 4 0/36 (0%) 0 2/36 (5.6%) 2 0/39 (0%) 0 0/34 (0%) 0
    Gastroenteritis 0/170 (0%) 0 1/174 (0.6%) 1 2/174 (1.1%) 2 0/82 (0%) 0 3/167 (1.8%) 3 3/165 (1.8%) 3 1/37 (2.7%) 1 0/38 (0%) 0 4/158 (2.5%) 4 3/158 (1.9%) 3 3/36 (8.3%) 5 0/36 (0%) 0 1/39 (2.6%) 1 0/34 (0%) 0
    Influenza 0/170 (0%) 0 1/174 (0.6%) 1 2/174 (1.1%) 2 0/82 (0%) 0 0/167 (0%) 0 1/165 (0.6%) 1 0/37 (0%) 0 0/38 (0%) 0 3/158 (1.9%) 3 1/158 (0.6%) 1 2/36 (5.6%) 2 0/36 (0%) 0 2/39 (5.1%) 2 0/34 (0%) 0
    Nasopharyngitis 14/170 (8.2%) 17 19/174 (10.9%) 19 16/174 (9.2%) 16 12/82 (14.6%) 14 20/167 (12%) 24 19/165 (11.5%) 22 6/37 (16.2%) 6 2/38 (5.3%) 2 25/158 (15.8%) 27 38/158 (24.1%) 40 6/36 (16.7%) 7 6/36 (16.7%) 6 4/39 (10.3%) 6 6/34 (17.6%) 8
    Pharyngitis 6/170 (3.5%) 6 3/174 (1.7%) 3 6/174 (3.4%) 6 1/82 (1.2%) 1 5/167 (3%) 5 2/165 (1.2%) 2 0/37 (0%) 0 2/38 (5.3%) 2 4/158 (2.5%) 4 6/158 (3.8%) 6 2/36 (5.6%) 2 1/36 (2.8%) 1 1/39 (2.6%) 1 0/34 (0%) 0
    Upper respiratory tract infection 4/170 (2.4%) 4 3/174 (1.7%) 3 3/174 (1.7%) 3 1/82 (1.2%) 1 3/167 (1.8%) 3 6/165 (3.6%) 6 0/37 (0%) 0 0/38 (0%) 0 4/158 (2.5%) 5 5/158 (3.2%) 5 2/36 (5.6%) 2 4/36 (11.1%) 4 2/39 (5.1%) 4 1/34 (2.9%) 1
    Investigations
    Blood creatine phosphokinase increased 1/170 (0.6%) 1 3/174 (1.7%) 3 5/174 (2.9%) 5 0/82 (0%) 0 1/167 (0.6%) 1 7/165 (4.2%) 8 1/37 (2.7%) 1 1/38 (2.6%) 1 6/158 (3.8%) 6 9/158 (5.7%) 10 2/36 (5.6%) 2 3/36 (8.3%) 3 2/39 (5.1%) 2 3/34 (8.8%) 3
    Metabolism and nutrition disorders
    Dyslipidaemia 0/170 (0%) 0 4/174 (2.3%) 4 3/174 (1.7%) 3 0/82 (0%) 0 2/167 (1.2%) 2 1/165 (0.6%) 1 0/37 (0%) 0 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 2/34 (5.9%) 2
    Hyperlipidaemia 0/170 (0%) 0 0/174 (0%) 0 0/174 (0%) 0 0/82 (0%) 0 0/167 (0%) 0 2/165 (1.2%) 2 2/37 (5.4%) 2 0/38 (0%) 0 0/158 (0%) 0 1/158 (0.6%) 1 1/36 (2.8%) 1 0/36 (0%) 0 0/39 (0%) 0 1/34 (2.9%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/170 (0.6%) 1 1/174 (0.6%) 1 1/174 (0.6%) 1 3/82 (3.7%) 3 5/167 (3%) 5 1/165 (0.6%) 1 0/37 (0%) 0 1/38 (2.6%) 1 1/158 (0.6%) 1 4/158 (2.5%) 4 0/36 (0%) 0 0/36 (0%) 0 0/39 (0%) 0 4/34 (11.8%) 4
    Rheumatoid arthritis 6/170 (3.5%) 7 4/174 (2.3%) 5 2/174 (1.1%) 2 3/82 (3.7%) 3 3/167 (1.8%) 5 1/165 (0.6%) 1 1/37 (2.7%) 1 0/38 (0%) 0 1/158 (0.6%) 1 3/158 (1.9%) 3 1/36 (2.8%) 2 2/36 (5.6%) 2 1/39 (2.6%) 1 0/34 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation 1/170 (0.6%) 1 3/174 (1.7%) 3 2/174 (1.1%) 2 0/82 (0%) 0 7/167 (4.2%) 9 2/165 (1.2%) 2 0/37 (0%) 0 1/38 (2.6%) 1 0/158 (0%) 0 1/158 (0.6%) 1 0/36 (0%) 0 3/36 (8.3%) 4 2/39 (5.1%) 2 0/34 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash 1/170 (0.6%) 1 0/174 (0%) 0 3/174 (1.7%) 3 1/82 (1.2%) 1 2/167 (1.2%) 2 1/165 (0.6%) 1 1/37 (2.7%) 1 1/38 (2.6%) 1 2/158 (1.3%) 2 0/158 (0%) 0 0/36 (0%) 0 2/36 (5.6%) 2 1/39 (2.6%) 1 0/34 (0%) 0
    Vascular disorders
    Hypertension 2/170 (1.2%) 2 0/174 (0%) 0 3/174 (1.7%) 3 1/82 (1.2%) 1 2/167 (1.2%) 2 3/165 (1.8%) 3 0/37 (0%) 0 1/38 (2.6%) 1 5/158 (3.2%) 5 6/158 (3.8%) 6 0/36 (0%) 0 0/36 (0%) 0 1/39 (2.6%) 1 3/34 (8.8%) 3

    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.

    Results Point of Contact

    Name/Title Clinical Trial Disclosure
    Organization Astellas Pharma Inc.
    Phone +81-3-3244-6500 Japanese only
    Email Astellas.resultsdisclosure@astellas.com
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT02305849
    Other Study ID Numbers:
    • 015K-CL-RAJ4
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Aug 3, 2020
    Last Verified:
    Jun 1, 2020