Rheumatoid Arthritis
Conditions
Keywords
ASP015K, Rheumatoid Arthritis
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
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.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change From Baseline in CRP at Week 12 | Baseline and week 12/ET | Higher CRP indicates greater disease activity. |
| 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. |
| Change From Baseline in ESR at Week 12 | Baseline and week 12/ET | Higher ESR indicates greater disease activity. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
Japan
Participant flow
Recruitment details
Participants with rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) were enrolled in this study.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Peficitinib 100 mg Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. | 174 |
| Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks. | 174 |
| 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. | 170 |
| Total | 518 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 12 | 7 | 3 |
| Overall Study | Lab data met discontinuation criteria | 0 | 1 | 2 | 1 |
| Overall Study | Lack of Efficacy | 10 | 6 | 3 | 9 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 |
| Overall Study | Miscellaneous | 1 | 2 | 4 | 1 |
| Overall Study | Not fulfill eligibility criteria | 1 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 | 4 |
Baseline characteristics
| Characteristic | Peficitinib 100 mg | Total | Placebo | Peficitinib 150 mg |
|---|---|---|---|---|
| Age, Continuous | 58.5 Years STANDARD_DEVIATION 10.8 | 56.7 Years STANDARD_DEVIATION 11.6 | 55.3 Years STANDARD_DEVIATION 12.1 | 56.2 Years STANDARD_DEVIATION 11.6 |
| C-Reactive Protein (CRP) | 2.432 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.076 | 2.525 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.132 | 2.622 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.146 | 2.524 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.183 |
| Erosion Score | 10.34 units on a scale STANDARD_DEVIATION 17.47 | 10.37 units on a scale STANDARD_DEVIATION 17.11 | 11.03 units on a scale STANDARD_DEVIATION 17.96 | 9.76 units on a scale STANDARD_DEVIATION 15.93 |
| Erythrocyte Sedimentation Rate (ESR) | 50.4 millimeter per hour (mm/h) STANDARD_DEVIATION 26.2 | 51.9 millimeter per hour (mm/h) STANDARD_DEVIATION 26.6 | 53.8 millimeter per hour (mm/h) STANDARD_DEVIATION 26.9 | 51.5 millimeter per hour (mm/h) STANDARD_DEVIATION 26.8 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 0.91 units on a scale STANDARD_DEVIATION 0.65 | 0.99 units on a scale STANDARD_DEVIATION 0.65 | 1.05 units on a scale STANDARD_DEVIATION 0.66 | 1.02 units on a scale STANDARD_DEVIATION 0.62 |
| Joint Space Narrowing (JSN) Score | 14.89 units on a scale STANDARD_DEVIATION 19.47 | 15.82 units on a scale STANDARD_DEVIATION 19.31 | 17.37 units on a scale STANDARD_DEVIATION 20.13 | 15.23 units on a scale STANDARD_DEVIATION 18.33 |
| Modified Total Sharp Score (mTSS) | 25.23 units on a scale STANDARD_DEVIATION 35.5 | 26.19 units on a scale STANDARD_DEVIATION 34.71 | 28.4 units on a scale STANDARD_DEVIATION 36.28 | 25 units on a scale STANDARD_DEVIATION 32.38 |
| Physician's Global Assessment of Arthritis (PGA) | 58.87 units on a scale STANDARD_DEVIATION 19.67 | 60.23 units on a scale STANDARD_DEVIATION 19.43 | 60.98 units on a scale STANDARD_DEVIATION 19.59 | 60.86 units on a scale STANDARD_DEVIATION 19.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 174 Participants | 518 Participants | 170 Participants | 174 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 118 Participants | 364 Participants | 121 Participants | 125 Participants |
| Sex: Female, Male Male | 56 Participants | 154 Participants | 49 Participants | 49 Participants |
| Subject's Global Assessment of Arthritis Pain (SGAP) | 51.12 units on a scale STANDARD_DEVIATION 26.14 | 54.3 units on a scale STANDARD_DEVIATION 25.51 | 56.75 units on a scale STANDARD_DEVIATION 25.29 | 55.09 units on a scale STANDARD_DEVIATION 24.89 |
| Subject's Global Assessment of Arthritis (SGA) | 51.7 units on a scale STANDARD_DEVIATION 25.25 | 55.07 units on a scale STANDARD_DEVIATION 24.65 | 58.18 units on a scale STANDARD_DEVIATION 23.9 | 55.44 units on a scale STANDARD_DEVIATION 24.49 |
| Swollen Joint Count (SJC) (66 Joints) | 12.8 swollen joint count STANDARD_DEVIATION 6.8 | 13.2 swollen joint count STANDARD_DEVIATION 6.9 | 13.6 swollen joint count STANDARD_DEVIATION 7 | 13.1 swollen joint count STANDARD_DEVIATION 6.9 |
| Tender Joint Count (TJC) (68 Joints) | 14 tender joint count STANDARD_DEVIATION 8.6 | 14.6 tender joint count STANDARD_DEVIATION 8.6 | 15.4 tender joint count STANDARD_DEVIATION 9.4 | 14.5 tender joint count STANDARD_DEVIATION 7.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 170 | 0 / 174 | 0 / 174 | 0 / 82 | 0 / 167 | 0 / 165 | 0 / 37 | 0 / 38 | 0 / 158 | 0 / 158 | 0 / 36 | 0 / 36 | 1 / 39 | 0 / 34 |
| other Total, other adverse events | 42 / 170 | 54 / 174 | 61 / 174 | 26 / 82 | 56 / 167 | 60 / 165 | 14 / 37 | 11 / 38 | 63 / 158 | 73 / 158 | 16 / 36 | 22 / 36 | 15 / 39 | 20 / 34 |
| serious Total, serious adverse events | 4 / 170 | 5 / 174 | 3 / 174 | 2 / 82 | 5 / 167 | 3 / 165 | 0 / 37 | 0 / 38 | 10 / 158 | 8 / 158 | 2 / 36 | 1 / 36 | 1 / 39 | 1 / 34 |
Outcome results
Primary
Change From Baseline in mTSS at Week 28
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and week 28/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in mTSS at Week 28 | 3.37 units on a scale | Standard Deviation 5.46 |
| Peficitinib 100 mg | Change From Baseline in mTSS at Week 28 | 1.62 units on a scale | Standard Deviation 4.23 |
| Peficitinib 150 mg | Change From Baseline in mTSS at Week 28 | 1.03 units on a scale | Standard Deviation 2.86 |
Comparison: Treatment Difference vs Placebop-value: <0.001RANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.001RANCOVA
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time frame: Baseline and week 12/Early termination (ET)
Population: FAS. Last observation carried forward (LOCF) was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 | 21.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 | 58.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 | 64.4 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [26.7, 47]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [32.6, 52.6]Fisher Exact
Secondary
Change From Baseline in CRP at Week 12
Higher CRP indicates greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in CRP at Week 12 | -0.001 mg/dL | Standard Deviation 2.038 |
| Peficitinib 100 mg | Change From Baseline in CRP at Week 12 | -1.499 mg/dL | Standard Deviation 1.855 |
| Peficitinib 150 mg | Change From Baseline in CRP at Week 12 | -1.421 mg/dL | Standard Deviation 2.182 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.948, -1.247]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.852, -1.065]ANCOVA
Secondary
Change From Baseline in CRP Through Week 52
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CRP Through Week 52 | Week 4 | -1.055 mg/dL | Standard Deviation 1.539 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 8 | -1.207 mg/dL | Standard Deviation 1.839 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 12 | -1.532 mg/dL | Standard Deviation 1.849 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 16 | -1.666 mg/dL | Standard Deviation 1.828 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 20 | -1.660 mg/dL | Standard Deviation 2.05 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 24 | -1.774 mg/dL | Standard Deviation 2.022 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 28 | -1.803 mg/dL | Standard Deviation 2.15 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 32 | -1.844 mg/dL | Standard Deviation 2.214 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 36 | -1.832 mg/dL | Standard Deviation 2.005 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 40 | -1.833 mg/dL | Standard Deviation 2.156 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 44 | -1.815 mg/dL | Standard Deviation 1.948 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 48 | -1.771 mg/dL | Standard Deviation 2.189 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 52 | -1.841 mg/dL | Standard Deviation 2.102 |
| Placebo | Change From Baseline in CRP Through Week 52 | EOT | -1.545 mg/dL | Standard Deviation 2.315 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 44 | -1.725 mg/dL | Standard Deviation 2.324 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 4 | -1.411 mg/dL | Standard Deviation 1.652 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 32 | -1.640 mg/dL | Standard Deviation 2.411 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 8 | -1.569 mg/dL | Standard Deviation 1.769 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 52 | -1.912 mg/dL | Standard Deviation 1.992 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 12 | -1.458 mg/dL | Standard Deviation 2.17 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 36 | -1.696 mg/dL | Standard Deviation 2.5 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 16 | -1.513 mg/dL | Standard Deviation 2.083 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 48 | -1.751 mg/dL | Standard Deviation 2.338 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 20 | -1.660 mg/dL | Standard Deviation 2.179 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 40 | -1.716 mg/dL | Standard Deviation 2.329 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 24 | -1.721 mg/dL | Standard Deviation 2.055 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | EOT | -1.629 mg/dL | Standard Deviation 2.386 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 28 | -1.721 mg/dL | Standard Deviation 2.151 |
Secondary
Change From Baseline in DAS28-CRP Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 36 | -2.55 units on a scale | Standard Deviation 1.12 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 24 | -2.40 units on a scale | Standard Deviation 1.21 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 48 | -2.62 units on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 44 | -2.65 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 16 | -2.01 units on a scale | Standard Deviation 1.18 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 8 | -1.48 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 20 | -2.21 units on a scale | Standard Deviation 1.24 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 4 | -1.11 units on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 52 | -2.67 units on a scale | Standard Deviation 1.19 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 28 | -2.42 units on a scale | Standard Deviation 1.21 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 40 | -2.66 units on a scale | Standard Deviation 1.16 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | EOT | -2.43 units on a scale | Standard Deviation 1.37 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 32 | -2.50 units on a scale | Standard Deviation 1.18 |
| Placebo | Change From Baseline in DAS28-CRP Through Week 52 | Week 12 | -1.72 units on a scale | Standard Deviation 1.19 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 24 | -2.71 units on a scale | Standard Deviation 1.18 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 32 | -2.77 units on a scale | Standard Deviation 1.19 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 8 | -1.87 units on a scale | Standard Deviation 1.16 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 40 | -2.86 units on a scale | Standard Deviation 1.14 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 36 | -2.83 units on a scale | Standard Deviation 1.2 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 4 | -1.39 units on a scale | Standard Deviation 0.98 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 12 | -2.15 units on a scale | Standard Deviation 1.29 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 52 | -2.96 units on a scale | Standard Deviation 1.24 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 16 | -2.40 units on a scale | Standard Deviation 1.3 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 20 | -2.53 units on a scale | Standard Deviation 1.29 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 48 | -2.92 units on a scale | Standard Deviation 1.14 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | EOT | -2.76 units on a scale | Standard Deviation 1.4 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 44 | -2.88 units on a scale | Standard Deviation 1.15 |
| Peficitinib 100 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 28 | -2.70 units on a scale | Standard Deviation 1.25 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 28 | -2.24 units on a scale | Standard Deviation 1.11 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 4 | -0.28 units on a scale | Standard Deviation 0.67 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 12 | 0.24 units on a scale | Standard Deviation 0.75 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 52 | -2.80 units on a scale | Standard Deviation 1.46 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 24 | -2.01 units on a scale | Standard Deviation 1.26 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 36 | -2.49 units on a scale | Standard Deviation 1.14 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 44 | -2.68 units on a scale | Standard Deviation 1.23 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 32 | -2.49 units on a scale | Standard Deviation 1.24 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 8 | -0.21 units on a scale | Standard Deviation 0.86 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 48 | -2.86 units on a scale | Standard Deviation 1.26 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 16 | -1.11 units on a scale | Standard Deviation 1.15 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 40 | -2.66 units on a scale | Standard Deviation 1.24 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | Week 20 | -1.69 units on a scale | Standard Deviation 1.22 |
| Peficitinib 150 mg | Change From Baseline in DAS28-CRP Through Week 52 | EOT | -2.61 units on a scale | Standard Deviation 1.62 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 44 | -2.72 units on a scale | Standard Deviation 1.19 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 4 | -0.30 units on a scale | Standard Deviation 0.56 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 8 | -0.10 units on a scale | Standard Deviation 0.63 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 12 | 0.27 units on a scale | Standard Deviation 0.6 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 16 | -1.37 units on a scale | Standard Deviation 1.18 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 20 | -1.76 units on a scale | Standard Deviation 1.24 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 24 | -2.26 units on a scale | Standard Deviation 1.07 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 28 | -2.51 units on a scale | Standard Deviation 1.13 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 32 | -2.72 units on a scale | Standard Deviation 1.27 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 36 | -2.70 units on a scale | Standard Deviation 1.22 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 40 | -2.72 units on a scale | Standard Deviation 1.13 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 48 | -2.90 units on a scale | Standard Deviation 1.18 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | Week 52 | -2.74 units on a scale | Standard Deviation 1.13 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-CRP Through Week 52 | EOT | -2.52 units on a scale | Standard Deviation 1.25 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 32 | -2.18 units on a scale | Standard Deviation 1.27 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 4 | -0.82 units on a scale | Standard Deviation 1.09 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 40 | -2.62 units on a scale | Standard Deviation 1.05 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 28 | -1.53 units on a scale | Standard Deviation 1.39 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 24 | -1.41 units on a scale | Standard Deviation 1.32 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 12 | -1.34 units on a scale | Standard Deviation 1 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 44 | -2.63 units on a scale | Standard Deviation 1.35 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 20 | -1.38 units on a scale | Standard Deviation 1.19 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 48 | -2.66 units on a scale | Standard Deviation 1.49 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 16 | -1.37 units on a scale | Standard Deviation 1.35 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | EOT | -2.72 units on a scale | Standard Deviation 1.26 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 52 | -2.70 units on a scale | Standard Deviation 1.32 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 8 | -0.94 units on a scale | Standard Deviation 0.97 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 36 | -2.22 units on a scale | Standard Deviation 1.23 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 32 | -2.47 units on a scale | Standard Deviation 0.89 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 48 | -2.96 units on a scale | Standard Deviation 0.97 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 4 | -0.74 units on a scale | Standard Deviation 0.62 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 40 | -2.73 units on a scale | Standard Deviation 0.93 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 12 | -1.20 units on a scale | Standard Deviation 0.66 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 24 | -1.64 units on a scale | Standard Deviation 0.92 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 8 | -0.90 units on a scale | Standard Deviation 0.65 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 28 | -1.71 units on a scale | Standard Deviation 0.97 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 36 | -2.57 units on a scale | Standard Deviation 0.89 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 44 | -2.87 units on a scale | Standard Deviation 0.89 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 20 | -1.48 units on a scale | Standard Deviation 0.78 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 52 | -2.89 units on a scale | Standard Deviation 0.92 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | Week 16 | -1.31 units on a scale | Standard Deviation 0.74 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-CRP Through Week 52 | EOT | -2.87 units on a scale | Standard Deviation 0.92 |
Secondary
Change From Baseline in DAS28-ESR at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in DAS28-ESR at Week 12 | -0.51 units on a scale | Standard Deviation 1.11 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR at Week 12 | -1.66 units on a scale | Standard Deviation 1.22 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR at Week 12 | -2.12 units on a scale | Standard Deviation 1.36 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.44, -0.94]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.89, -1.36]ANCOVA
Secondary
Change From Baseline in DAS28-ESR Score Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 28 | -2.47 units on a scale | Standard Deviation 1.31 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 52 | -2.70 units on a scale | Standard Deviation 1.27 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 44 | -2.71 units on a scale | Standard Deviation 1.19 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 8 | -1.47 units on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 16 | -1.98 units on a scale | Standard Deviation 1.22 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 48 | -2.64 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 4 | -1.07 units on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 40 | -2.70 units on a scale | Standard Deviation 1.22 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 12 | -1.68 units on a scale | Standard Deviation 1.21 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 36 | -2.59 units on a scale | Standard Deviation 1.23 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 20 | -2.23 units on a scale | Standard Deviation 1.27 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 24 | -2.43 units on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | EOT | -2.47 units on a scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 32 | -2.56 units on a scale | Standard Deviation 1.31 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 32 | -2.87 units on a scale | Standard Deviation 1.27 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 28 | -2.79 units on a scale | Standard Deviation 1.29 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 24 | -2.78 units on a scale | Standard Deviation 1.25 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 52 | -3.07 units on a scale | Standard Deviation 1.28 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 8 | -1.88 units on a scale | Standard Deviation 1.18 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 4 | -1.37 units on a scale | Standard Deviation 1.02 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 48 | -3.01 units on a scale | Standard Deviation 1.22 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 12 | -2.18 units on a scale | Standard Deviation 1.32 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | EOT | -2.86 units on a scale | Standard Deviation 1.44 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 44 | -3.00 units on a scale | Standard Deviation 1.25 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 40 | -2.96 units on a scale | Standard Deviation 1.2 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 16 | -2.46 units on a scale | Standard Deviation 1.32 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 36 | -2.91 units on a scale | Standard Deviation 1.25 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 20 | -2.60 units on a scale | Standard Deviation 1.35 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 16 | -1.01 units on a scale | Standard Deviation 1.14 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 4 | -0.26 units on a scale | Standard Deviation 0.66 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 8 | -0.24 units on a scale | Standard Deviation 0.88 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 12 | 0.24 units on a scale | Standard Deviation 0.76 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 20 | -1.61 units on a scale | Standard Deviation 1.23 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 24 | -1.94 units on a scale | Standard Deviation 1.24 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 28 | -2.11 units on a scale | Standard Deviation 1.16 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 32 | -2.39 units on a scale | Standard Deviation 1.26 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 36 | -2.45 units on a scale | Standard Deviation 1.2 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 40 | -2.60 units on a scale | Standard Deviation 1.34 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 44 | -2.63 units on a scale | Standard Deviation 1.25 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 48 | -2.80 units on a scale | Standard Deviation 1.36 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 52 | -2.77 units on a scale | Standard Deviation 1.54 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Score Through Week 52 | EOT | -2.60 units on a scale | Standard Deviation 1.69 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 4 | -0.26 units on a scale | Standard Deviation 0.59 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 40 | -2.78 units on a scale | Standard Deviation 1.11 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 24 | -2.24 units on a scale | Standard Deviation 1.16 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | EOT | -2.56 units on a scale | Standard Deviation 1.34 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 52 | -2.78 units on a scale | Standard Deviation 1.24 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 12 | 0.25 units on a scale | Standard Deviation 0.59 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 44 | -2.76 units on a scale | Standard Deviation 1.25 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 28 | -2.48 units on a scale | Standard Deviation 1.15 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 32 | -2.68 units on a scale | Standard Deviation 1.3 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 36 | -2.71 units on a scale | Standard Deviation 1.2 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 20 | -1.78 units on a scale | Standard Deviation 1.26 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 8 | -0.12 units on a scale | Standard Deviation 0.64 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 16 | -1.38 units on a scale | Standard Deviation 1.21 |
| Placebo / Peficitinib 150 mg at Week 12 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 48 | -2.88 units on a scale | Standard Deviation 1.23 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 20 | -1.45 units on a scale | Standard Deviation 1.19 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 32 | -2.27 units on a scale | Standard Deviation 1.34 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 16 | -1.47 units on a scale | Standard Deviation 1.39 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 4 | -0.87 units on a scale | Standard Deviation 1.08 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 36 | -2.38 units on a scale | Standard Deviation 1.29 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 40 | -2.71 units on a scale | Standard Deviation 1.16 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 12 | -1.40 units on a scale | Standard Deviation 0.99 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 44 | -2.74 units on a scale | Standard Deviation 1.43 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 8 | -1.00 units on a scale | Standard Deviation 0.93 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 48 | -2.72 units on a scale | Standard Deviation 1.58 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | EOT | -2.80 units on a scale | Standard Deviation 1.27 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 24 | -1.47 units on a scale | Standard Deviation 1.31 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 52 | -2.79 units on a scale | Standard Deviation 1.33 |
| Placebo / Peficitinib 100 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 28 | -1.63 units on a scale | Standard Deviation 1.41 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 20 | -1.37 units on a scale | Standard Deviation 0.81 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 48 | -2.93 units on a scale | Standard Deviation 1.06 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 36 | -2.54 units on a scale | Standard Deviation 1.02 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 4 | -0.67 units on a scale | Standard Deviation 0.64 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 28 | -1.62 units on a scale | Standard Deviation 1.07 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 16 | -1.21 units on a scale | Standard Deviation 0.82 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 52 | -2.85 units on a scale | Standard Deviation 1.08 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | EOT | -2.82 units on a scale | Standard Deviation 1.08 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 24 | -1.56 units on a scale | Standard Deviation 0.99 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 44 | -2.78 units on a scale | Standard Deviation 1.04 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 8 | -0.85 units on a scale | Standard Deviation 0.76 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 32 | -2.37 units on a scale | Standard Deviation 1.05 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 40 | -2.68 units on a scale | Standard Deviation 0.96 |
| Placebo / Peficitinib 150 mg at Week 28 | Change From Baseline in DAS28-ESR Score Through Week 52 | Week 12 | -1.10 units on a scale | Standard Deviation 0.76 |
Secondary
Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -0.51 units on a scale | Standard Deviation 1.1 |
| Peficitinib 100 mg | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -1.70 units on a scale | Standard Deviation 1.2 |
| Peficitinib 150 mg | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -2.09 units on a scale | Standard Deviation 1.33 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.46, -0.97]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.85, -1.33]ANCOVA
Secondary
Change From Baseline in Erosion Score at Week 28 and Week 52
The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.
Time frame: Baseline and weeks 28/ET and 52/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Erosion Score at Week 28 and Week 52 | Week 28/ET | 1.35 units on a scale | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Erosion Score at Week 28 and Week 52 | Week 52/ET | 2.52 units on a scale | Standard Deviation 5.58 |
| Peficitinib 100 mg | Change From Baseline in Erosion Score at Week 28 and Week 52 | Week 28/ET | 0.63 units on a scale | Standard Deviation 2.03 |
| Peficitinib 100 mg | Change From Baseline in Erosion Score at Week 28 and Week 52 | Week 52/ET | 0.82 units on a scale | Standard Deviation 3.14 |
| Peficitinib 150 mg | Change From Baseline in Erosion Score at Week 28 and Week 52 | Week 28/ET | 0.18 units on a scale | Standard Deviation 1.1 |
| Peficitinib 150 mg | Change From Baseline in Erosion Score at Week 28 and Week 52 | Week 52/ET | 0.32 units on a scale | Standard Deviation 1.87 |
Comparison: Week 28/ET: Treatment Difference vs Placebop-value: 0.036RANCOVA
Comparison: Week 28/ET: Treatment Difference vs Placebop-value: <0.001RANCOVA
Comparison: Week 52/ET: Treatment Difference vs Placebop-value: 0.013RANCOVA
Comparison: Week 52/ET: Treatment Difference vs Placebop-value: <0.001RANCOVA
Secondary
Change From Baseline in ESR at Week 12
Higher ESR indicates greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in ESR at Week 12 | -2.42 mm/h | Standard Deviation 19.71 |
| Peficitinib 100 mg | Change From Baseline in ESR at Week 12 | -18.90 mm/h | Standard Deviation 19.85 |
| Peficitinib 150 mg | Change From Baseline in ESR at Week 12 | -22.17 mm/h | Standard Deviation 22.79 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-21.61, -14.17]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-24.67, -16.56]ANCOVA
Secondary
Change From Baseline in ESR Through Week 52
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in ESR Through Week 52 | Week 20 | -23.22 mm/h | Standard Deviation 20.78 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 24 | -25.35 mm/h | Standard Deviation 22.48 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 4 | -11.09 mm/h | Standard Deviation 14.34 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 8 | -14.96 mm/h | Standard Deviation 18.73 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 12 | -19.14 mm/h | Standard Deviation 19.81 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 16 | -21.42 mm/h | Standard Deviation 19.7 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 28 | -26.03 mm/h | Standard Deviation 23.7 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 32 | -26.92 mm/h | Standard Deviation 23.85 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 36 | -25.95 mm/h | Standard Deviation 22.68 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 40 | -25.86 mm/h | Standard Deviation 24.41 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 44 | -27.13 mm/h | Standard Deviation 22.73 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 48 | -25.63 mm/h | Standard Deviation 24.72 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 52 | -26.86 mm/h | Standard Deviation 23.6 |
| Placebo | Change From Baseline in ESR Through Week 52 | EOT | -24.00 mm/h | Standard Deviation 24.49 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 44 | -27.99 mm/h | Standard Deviation 23.93 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 32 | -27.21 mm/h | Standard Deviation 24.92 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 52 | -29.12 mm/h | Standard Deviation 23.28 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 4 | -16.59 mm/h | Standard Deviation 16.68 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 36 | -27.25 mm/h | Standard Deviation 25.1 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 8 | -21.10 mm/h | Standard Deviation 20.37 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 48 | -27.83 mm/h | Standard Deviation 23.29 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 12 | -22.92 mm/h | Standard Deviation 22.66 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 40 | -27.74 mm/h | Standard Deviation 24.86 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 16 | -24.29 mm/h | Standard Deviation 23.14 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 20 | -26.20 mm/h | Standard Deviation 24.12 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 24 | -27.36 mm/h | Standard Deviation 23.23 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | EOT | -26.11 mm/h | Standard Deviation 25.22 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 28 | -27.88 mm/h | Standard Deviation 24.27 |
Secondary
Change From Baseline in HAQ-DI at Week 12
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAQ-DI at Week 12 | 0.01 units on a scale | Standard Deviation 0.47 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI at Week 12 | -0.22 units on a scale | Standard Deviation 0.44 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI at Week 12 | -0.37 units on a scale | Standard Deviation 0.48 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-0.36, -0.17]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-0.48, -0.29]ANCOVA
Secondary
Change From Baseline in HAQ-DI Through Week 52
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | -0.08 units on a scale | Standard Deviation 0.3 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | -0.18 units on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | -0.23 units on a scale | Standard Deviation 0.44 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.30 units on a scale | Standard Deviation 0.46 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.33 units on a scale | Standard Deviation 0.48 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.36 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.36 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.37 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.39 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.42 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.45 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.44 units on a scale | Standard Deviation 0.49 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.43 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.36 units on a scale | Standard Deviation 0.55 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.54 units on a scale | Standard Deviation 0.53 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | -0.21 units on a scale | Standard Deviation 0.36 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.53 units on a scale | Standard Deviation 0.54 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | -0.32 units on a scale | Standard Deviation 0.42 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.56 units on a scale | Standard Deviation 0.54 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | -0.38 units on a scale | Standard Deviation 0.47 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.53 units on a scale | Standard Deviation 0.52 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.41 units on a scale | Standard Deviation 0.51 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.56 units on a scale | Standard Deviation 0.53 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.47 units on a scale | Standard Deviation 0.53 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.56 units on a scale | Standard Deviation 0.52 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.48 units on a scale | Standard Deviation 0.52 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.51 units on a scale | Standard Deviation 0.56 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.51 units on a scale | Standard Deviation 0.52 |
Secondary
Change From Baseline in JSN Score at Week 28 and Week 52
JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity.
Time frame: Baseline and weeks 28/ET and 52/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in JSN Score at Week 28 and Week 52 | Week 28/ET | 1.90 units on a scale | Standard Deviation 3.76 |
| Placebo | Change From Baseline in JSN Score at Week 28 and Week 52 | Week 52/ET | 3.55 units on a scale | Standard Deviation 7.01 |
| Peficitinib 100 mg | Change From Baseline in JSN Score at Week 28 and Week 52 | Week 28/ET | 0.99 units on a scale | Standard Deviation 2.86 |
| Peficitinib 100 mg | Change From Baseline in JSN Score at Week 28 and Week 52 | Week 52/ET | 1.30 units on a scale | Standard Deviation 3.37 |
| Peficitinib 150 mg | Change From Baseline in JSN Score at Week 28 and Week 52 | Week 28/ET | 0.82 units on a scale | Standard Deviation 2.39 |
| Peficitinib 150 mg | Change From Baseline in JSN Score at Week 28 and Week 52 | Week 52/ET | 1.19 units on a scale | Standard Deviation 3.03 |
Comparison: Week 28/ET: Treatment Difference vs Placebop-value: 0.018RANCOVA
Comparison: Week 28/ET: Treatment Difference vs Placebop-value: 0.002RANCOVA
Comparison: Week 52/ET: Treatment Difference vs Placebop-value: 0.039RANCOVA
Comparison: Week 52/ET: Treatment Difference vs Placebop-value: 0.006RANCOVA
Secondary
Change From Baseline in mTSS at Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and week 52/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in mTSS at Week 52 | 6.27 units on a scale | Standard Deviation 10.18 |
| Peficitinib 100 mg | Change From Baseline in mTSS at Week 52 | 2.12 units on a scale | Standard Deviation 5.83 |
| Peficitinib 150 mg | Change From Baseline in mTSS at Week 52 | 1.54 units on a scale | Standard Deviation 4.11 |
Comparison: Treatment Difference vs Placebop-value: <0.001RANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.001RANCOVA
Secondary
Change From Baseline in Percent Overall Work Impairment at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. Negative values indicate improvement from baseline.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Percent Overall Work Impairment at Week 12 | -2.75 percent overall work impairment | Standard Deviation 28.56 |
| Peficitinib 100 mg | Change From Baseline in Percent Overall Work Impairment at Week 12 | -11.58 percent overall work impairment | Standard Deviation 26.22 |
| Peficitinib 150 mg | Change From Baseline in Percent Overall Work Impairment at Week 12 | -16.91 percent overall work impairment | Standard Deviation 29.23 |
Comparison: Treatment Difference vs Placebop-value: 0.0195% CI: [-16.6, -2.25]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-21.92, -7.31]ANCOVA
Secondary
Change From Baseline in PGA at Week 12
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in PGA at Week 12 | -11.88 units on a scale | Standard Deviation 21.46 |
| Peficitinib 100 mg | Change From Baseline in PGA at Week 12 | -28.83 units on a scale | Standard Deviation 22.21 |
| Peficitinib 150 mg | Change From Baseline in PGA at Week 12 | -35.96 units on a scale | Standard Deviation 25 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-22.11, -13.22]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-28.66, -19.51]ANCOVA
Secondary
Change From Baseline in PGA Through Week 52
The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PGA Through Week 52 | Week 4 | -18.36 units on a scale | Standard Deviation 17.1 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 8 | -25.79 units on a scale | Standard Deviation 19.59 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 12 | -29.07 units on a scale | Standard Deviation 22.22 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 16 | -33.60 units on a scale | Standard Deviation 21.27 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 20 | -36.18 units on a scale | Standard Deviation 21.87 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 24 | -37.13 units on a scale | Standard Deviation 21.71 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 28 | -38.72 units on a scale | Standard Deviation 22.45 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 32 | -40.04 units on a scale | Standard Deviation 20.82 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 36 | -39.35 units on a scale | Standard Deviation 21.25 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 40 | -41.04 units on a scale | Standard Deviation 22.33 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 44 | -41.47 units on a scale | Standard Deviation 22.73 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 48 | -41.55 units on a scale | Standard Deviation 23.23 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 52 | -41.49 units on a scale | Standard Deviation 23.75 |
| Placebo | Change From Baseline in PGA Through Week 52 | EOT | -38.41 units on a scale | Standard Deviation 25.07 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 44 | -46.00 units on a scale | Standard Deviation 21.6 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 4 | -22.94 units on a scale | Standard Deviation 19.32 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 32 | -43.96 units on a scale | Standard Deviation 21.78 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 8 | -31.54 units on a scale | Standard Deviation 22.43 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 52 | -45.46 units on a scale | Standard Deviation 23.75 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 12 | -36.55 units on a scale | Standard Deviation 24.64 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 36 | -44.37 units on a scale | Standard Deviation 21.77 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 16 | -38.86 units on a scale | Standard Deviation 23.83 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 48 | -45.84 units on a scale | Standard Deviation 21.83 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 20 | -41.44 units on a scale | Standard Deviation 22.71 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 40 | -44.32 units on a scale | Standard Deviation 21.54 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 24 | -43.67 units on a scale | Standard Deviation 21.39 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | EOT | -43.33 units on a scale | Standard Deviation 24.31 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 28 | -42.43 units on a scale | Standard Deviation 21.27 |
Secondary
Change From Baseline in SDAI Score at Week 12
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SDAI Score at Week 12 | -4.90 units on a scale | Standard Deviation 12.32 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score at Week 12 | -15.66 units on a scale | Standard Deviation 12.69 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score at Week 12 | -19.57 units on a scale | Standard Deviation 13.53 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-13.84, -8.6]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-17.35, -11.98]ANCOVA
Secondary
Change From Baseline in SDAI Score Through Week 52
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -11.02 units on a scale | Standard Deviation 8.23 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -14.60 units on a scale | Standard Deviation 10.4 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -15.94 units on a scale | Standard Deviation 12.59 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -18.75 units on a scale | Standard Deviation 11.58 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -20.24 units on a scale | Standard Deviation 11.89 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -21.62 units on a scale | Standard Deviation 11.64 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -21.89 units on a scale | Standard Deviation 11.54 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -22.61 units on a scale | Standard Deviation 11.15 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -22.89 units on a scale | Standard Deviation 11.1 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -23.55 units on a scale | Standard Deviation 11.2 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -23.55 units on a scale | Standard Deviation 11.17 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -23.23 units on a scale | Standard Deviation 11.3 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -23.67 units on a scale | Standard Deviation 11.91 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | EOT | -21.48 units on a scale | Standard Deviation 13.42 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -26.44 units on a scale | Standard Deviation 12.15 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -13.79 units on a scale | Standard Deviation 10.43 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -25.38 units on a scale | Standard Deviation 11.91 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -18.36 units on a scale | Standard Deviation 11.76 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -26.63 units on a scale | Standard Deviation 12.82 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -20.08 units on a scale | Standard Deviation 13.08 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -25.55 units on a scale | Standard Deviation 11.74 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -22.21 units on a scale | Standard Deviation 12.56 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -26.50 units on a scale | Standard Deviation 12.12 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -23.03 units on a scale | Standard Deviation 13.26 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -26.14 units on a scale | Standard Deviation 11.93 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -24.68 units on a scale | Standard Deviation 11.52 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | EOT | -24.72 units on a scale | Standard Deviation 14.13 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -24.57 units on a scale | Standard Deviation 12.17 |
Secondary
Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 1.07 units on a scale | Standard Deviation 8.27 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 3.28 units on a scale | Standard Deviation 7.47 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 2.50 units on a scale | Standard Deviation 8.44 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [1.21, 4.18]ANCOVA
Comparison: Treatment Difference vs Placebop-value: 0.03695% CI: [0.11, 3.19]ANCOVA
Secondary
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 4 | 1.45 units on a scale | Standard Deviation 7.02 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 8 | 2.72 units on a scale | Standard Deviation 7.39 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 12 | 3.44 units on a scale | Standard Deviation 7.47 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 28 | 3.06 units on a scale | Standard Deviation 8.55 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 52 | 2.62 units on a scale | Standard Deviation 9.1 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | EOT | 2.21 units on a scale | Standard Deviation 8.89 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 52 | 1.85 units on a scale | Standard Deviation 8.71 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 4 | 1.33 units on a scale | Standard Deviation 7.93 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 28 | 3.12 units on a scale | Standard Deviation 8.2 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 8 | 2.44 units on a scale | Standard Deviation 8.47 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | EOT | 1.67 units on a scale | Standard Deviation 8.9 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 12 | 2.67 units on a scale | Standard Deviation 8.23 |
Secondary
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 4 | 3.84 units on a scale | Standard Deviation 8.91 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 8 | 4.92 units on a scale | Standard Deviation 10.82 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 12 | 6.68 units on a scale | Standard Deviation 11.08 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 28 | 9.89 units on a scale | Standard Deviation 11.86 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 52 | 11.27 units on a scale | Standard Deviation 12.05 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | EOT | 9.92 units on a scale | Standard Deviation 12.81 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 52 | 12.45 units on a scale | Standard Deviation 12.45 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 4 | 5.77 units on a scale | Standard Deviation 11.05 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 28 | 12.44 units on a scale | Standard Deviation 11.88 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 8 | 7.91 units on a scale | Standard Deviation 11.88 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | EOT | 11.51 units on a scale | Standard Deviation 12.77 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 12 | 9.32 units on a scale | Standard Deviation 11.55 |
Secondary
Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | -0.09 units on a scale | Standard Deviation 16.69 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | 2.30 units on a scale | Standard Deviation 13.92 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | 3.90 units on a scale | Standard Deviation 13.35 |
Comparison: Treatment Difference vs Placebop-value: 0.09995% CI: [-0.44, 5.02]ANCOVA
Comparison: Treatment Difference vs Placebop-value: 0.00295% CI: [1.53, 6.91]ANCOVA
Secondary
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 4 | 1.41 units on a scale | Standard Deviation 11.51 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 8 | 2.50 units on a scale | Standard Deviation 13.79 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 12 | 2.32 units on a scale | Standard Deviation 14.05 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 28 | 4.06 units on a scale | Standard Deviation 14.92 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 52 | 4.30 units on a scale | Standard Deviation 15.31 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | EOT | 3.49 units on a scale | Standard Deviation 14.85 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 52 | 7.17 units on a scale | Standard Deviation 14.05 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 4 | 1.70 units on a scale | Standard Deviation 11.44 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 28 | 4.81 units on a scale | Standard Deviation 13.83 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 8 | 3.30 units on a scale | Standard Deviation 13.43 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | EOT | 5.88 units on a scale | Standard Deviation 14.31 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 12 | 3.92 units on a scale | Standard Deviation 13.31 |
Secondary
Change From Baseline in SGA at Week 12
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SGA at Week 12 | -7.11 units on a scale | Standard Deviation 23.05 |
| Peficitinib 100 mg | Change From Baseline in SGA at Week 12 | -21.09 units on a scale | Standard Deviation 23.63 |
| Peficitinib 150 mg | Change From Baseline in SGA at Week 12 | -26.57 units on a scale | Standard Deviation 25.43 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-21.09, -12.19]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-25.07, -15.61]ANCOVA
Secondary
Change From Baseline in SGAP at Week 12
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SGAP at Week 12 | -6.64 units on a scale | Standard Deviation 25.22 |
| Peficitinib 100 mg | Change From Baseline in SGAP at Week 12 | -21.09 units on a scale | Standard Deviation 27.04 |
| Peficitinib 150 mg | Change From Baseline in SGAP at Week 12 | -26.87 units on a scale | Standard Deviation 26.65 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-22, -12.38]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-25.8, -15.98]ANCOVA
Secondary
Change From Baseline in SGAP Through Week 52
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 16 | -24.03 units on a scale | Standard Deviation 26.09 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 32 | -31.32 units on a scale | Standard Deviation 25.76 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 4 | -12.94 units on a scale | Standard Deviation 20.75 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 36 | -31.95 units on a scale | Standard Deviation 26.17 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 20 | -25.57 units on a scale | Standard Deviation 28.52 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 12 | -21.27 units on a scale | Standard Deviation 27.03 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 44 | -32.73 units on a scale | Standard Deviation 26.67 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 24 | -27.34 units on a scale | Standard Deviation 27.54 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 48 | -33.60 units on a scale | Standard Deviation 25.87 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 8 | -19.10 units on a scale | Standard Deviation 25.81 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 52 | -33.34 units on a scale | Standard Deviation 26.98 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 28 | -28.54 units on a scale | Standard Deviation 27.24 |
| Placebo | Change From Baseline in SGAP Through Week 52 | EOT | -28.94 units on a scale | Standard Deviation 28.63 |
| Placebo | Change From Baseline in SGAP Through Week 52 | Week 40 | -32.17 units on a scale | Standard Deviation 26.81 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | EOT | -32.68 units on a scale | Standard Deviation 28.48 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 4 | -16.18 units on a scale | Standard Deviation 22.06 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 8 | -24.98 units on a scale | Standard Deviation 23.68 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 12 | -27.81 units on a scale | Standard Deviation 26.13 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 16 | -28.42 units on a scale | Standard Deviation 26.88 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 20 | -30.63 units on a scale | Standard Deviation 26.68 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 24 | -32.72 units on a scale | Standard Deviation 26.04 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 28 | -34.18 units on a scale | Standard Deviation 25.89 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 32 | -33.74 units on a scale | Standard Deviation 25.44 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 36 | -32.66 units on a scale | Standard Deviation 26.25 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 40 | -34.07 units on a scale | Standard Deviation 25.22 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 44 | -34.88 units on a scale | Standard Deviation 25.27 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 48 | -35.07 units on a scale | Standard Deviation 25.05 |
| Peficitinib 100 mg | Change From Baseline in SGAP Through Week 52 | Week 52 | -35.00 units on a scale | Standard Deviation 27.37 |
Secondary
Change From Baseline in SGA Through Week 52
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SGA Through Week 52 | Week 8 | -19.11 units on a scale | Standard Deviation 23.22 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 4 | -13.80 units on a scale | Standard Deviation 19.47 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 12 | -21.59 units on a scale | Standard Deviation 23.43 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 16 | -25.20 units on a scale | Standard Deviation 24.41 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 20 | -26.94 units on a scale | Standard Deviation 25.49 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 24 | -29.00 units on a scale | Standard Deviation 25.51 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 28 | -30.04 units on a scale | Standard Deviation 24.96 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 32 | -31.92 units on a scale | Standard Deviation 24.99 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 36 | -32.38 units on a scale | Standard Deviation 25.34 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 40 | -32.80 units on a scale | Standard Deviation 25.85 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 44 | -33.49 units on a scale | Standard Deviation 25.86 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 48 | -33.69 units on a scale | Standard Deviation 26.18 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 52 | -33.18 units on a scale | Standard Deviation 27.83 |
| Placebo | Change From Baseline in SGA Through Week 52 | EOT | -29.34 units on a scale | Standard Deviation 28.78 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 44 | -35.31 units on a scale | Standard Deviation 25.23 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 32 | -33.46 units on a scale | Standard Deviation 24.28 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 4 | -17.59 units on a scale | Standard Deviation 20.25 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 8 | -24.97 units on a scale | Standard Deviation 22.65 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 52 | -36.16 units on a scale | Standard Deviation 25.27 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 12 | -27.40 units on a scale | Standard Deviation 24.84 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 36 | -34.01 units on a scale | Standard Deviation 23.83 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 16 | -30.14 units on a scale | Standard Deviation 24.29 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 48 | -35.33 units on a scale | Standard Deviation 23.77 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 20 | -31.20 units on a scale | Standard Deviation 25.39 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 40 | -34.24 units on a scale | Standard Deviation 23.85 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 24 | -32.79 units on a scale | Standard Deviation 25.68 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | EOT | -34.05 units on a scale | Standard Deviation 26.6 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 28 | -34.25 units on a scale | Standard Deviation 25.01 |
Secondary
Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | 0.57 units on a scale | Standard Deviation 12.08 |
| Peficitinib 100 mg | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | 6.60 units on a scale | Standard Deviation 11.06 |
| Peficitinib 150 mg | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | 9.02 units on a scale | Standard Deviation 11.54 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.09, 8.74]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [6.36, 10.86]ANCOVA
Secondary
Change From Baseline in SJC (66 Joints) at Week 12
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SJC (66 Joints) at Week 12 | -2.2 swollen joint count | Standard Deviation 6.6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) at Week 12 | -5.9 swollen joint count | Standard Deviation 6.7 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) at Week 12 | -7.6 swollen joint count | Standard Deviation 6.1 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-5.3, -2.6]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-6.9, -4.3]ANCOVA
Secondary
Change From Baseline in SJC (66 Joints) Through Week 52
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -4.3 swollen joint count | Standard Deviation 4.5 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -5.6 swollen joint count | Standard Deviation 5.5 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -6.0 swollen joint count | Standard Deviation 6.7 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -7.5 swollen joint count | Standard Deviation 6.2 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -8.1 swollen joint count | Standard Deviation 6.1 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -8.8 swollen joint count | Standard Deviation 6.4 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -8.8 swollen joint count | Standard Deviation 6.2 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -9.0 swollen joint count | Standard Deviation 6.2 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -9.0 swollen joint count | Standard Deviation 6.1 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -9.4 swollen joint count | Standard Deviation 6.1 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -9.4 swollen joint count | Standard Deviation 6.1 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -9.2 swollen joint count | Standard Deviation 6.2 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -9.6 swollen joint count | Standard Deviation 6.2 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -8.8 swollen joint count | Standard Deviation 6.6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -10.8 swollen joint count | Standard Deviation 6.4 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -5.3 swollen joint count | Standard Deviation 5.6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -10.3 swollen joint count | Standard Deviation 5.8 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -7.1 swollen joint count | Standard Deviation 5.5 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -11.0 swollen joint count | Standard Deviation 6.1 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -7.8 swollen joint count | Standard Deviation 5.9 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -10.5 swollen joint count | Standard Deviation 5.9 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -8.9 swollen joint count | Standard Deviation 6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -11.0 swollen joint count | Standard Deviation 6.3 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -9.2 swollen joint count | Standard Deviation 5.7 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -10.7 swollen joint count | Standard Deviation 6.1 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -9.9 swollen joint count | Standard Deviation 5.6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -10.3 swollen joint count | Standard Deviation 6.4 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -9.8 swollen joint count | Standard Deviation 5.7 |
Secondary
Change From Baseline in TJC (68 Joints) at Week 12
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in TJC (68 Joints) at Week 12 | -2.1 tender joint count | Standard Deviation 8.2 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) at Week 12 | -6.9 tender joint count | Standard Deviation 8.6 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) at Week 12 | -9.1 tender joint count | Standard Deviation 8 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-6.9, -3.5]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-8.9, -5.6]ANCOVA
Secondary
Change From Baseline in TJC (68 Joints) Through Week 52
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -5.1 tender joint count | Standard Deviation 5.8 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -6.8 tender joint count | Standard Deviation 7.2 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -7.1 tender joint count | Standard Deviation 8.6 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -8.1 tender joint count | Standard Deviation 7.8 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -9.1 tender joint count | Standard Deviation 7.9 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -9.9 tender joint count | Standard Deviation 7.5 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -9.6 tender joint count | Standard Deviation 7.4 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -9.7 tender joint count | Standard Deviation 7.2 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -10.4 tender joint count | Standard Deviation 7.6 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -10.8 tender joint count | Standard Deviation 7.2 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -10.6 tender joint count | Standard Deviation 7.4 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -10.5 tender joint count | Standard Deviation 7.1 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -10.8 tender joint count | Standard Deviation 7.4 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -9.8 tender joint count | Standard Deviation 7.8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -12.1 tender joint count | Standard Deviation 7.8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -6.3 tender joint count | Standard Deviation 6.9 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -12.1 tender joint count | Standard Deviation 7.6 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -8.3 tender joint count | Standard Deviation 7.3 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -11.9 tender joint count | Standard Deviation 8.6 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -9.3 tender joint count | Standard Deviation 7.7 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -11.8 tender joint count | Standard Deviation 7.7 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -10.5 tender joint count | Standard Deviation 7.4 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -12.1 tender joint count | Standard Deviation 7.7 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -10.8 tender joint count | Standard Deviation 8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -11.9 tender joint count | Standard Deviation 8.2 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -11.3 tender joint count | Standard Deviation 7.6 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -11.2 tender joint count | Standard Deviation 8.8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -11.4 tender joint count | Standard Deviation 7.8 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | -0.82 percent work time missed | Standard Deviation 17.77 |
| Peficitinib 100 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | 0.36 percent work time missed | Standard Deviation 18.15 |
| Peficitinib 150 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | -1.46 percent work time missed | Standard Deviation 15.26 |
Comparison: Treatment Difference vs Placebop-value: 0.87995% CI: [-5.16, 4.42]ANCOVA
Comparison: Treatment Difference vs Placebop-value: 0.37795% CI: [-5.86, 2.23]ANCOVA
Secondary
Change From Baseline in WPAI Percent Activity Impairment at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -2.50 percent activity impairment | Standard Deviation 28.19 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -13.98 percent activity impairment | Standard Deviation 27.17 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -19.35 percent activity impairment | Standard Deviation 24.28 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-18.23, -8.16]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-22.57, -12.66]ANCOVA
Secondary
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 4 | -9.23 percent activity impairment | Standard Deviation 22.81 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 8 | -13.07 percent activity impairment | Standard Deviation 26.12 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 12 | -13.71 percent activity impairment | Standard Deviation 27.3 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 28 | -22.17 percent activity impairment | Standard Deviation 27.25 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 52 | -24.10 percent activity impairment | Standard Deviation 31.72 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | EOT | -21.58 percent activity impairment | Standard Deviation 31.67 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 52 | -26.71 percent activity impairment | Standard Deviation 24.78 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 4 | -10.65 percent activity impairment | Standard Deviation 22.18 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 28 | -26.99 percent activity impairment | Standard Deviation 24.72 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 8 | -17.44 percent activity impairment | Standard Deviation 24.28 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | EOT | -23.47 percent activity impairment | Standard Deviation 25.96 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 12 | -19.88 percent activity impairment | Standard Deviation 24.32 |
Secondary
Change From Baseline in WPAI Percent Impairment While Working at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.
Time frame: Baseline and week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | -2.42 percent work impairment | Standard Deviation 27.78 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | -11.71 percent work impairment | Standard Deviation 25.62 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | -15.96 percent work impairment | Standard Deviation 28.3 |
Comparison: Treatment Difference vs Placebop-value: 0.00795% CI: [-16.54, -2.73]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-21.24, -7.1]ANCOVA
Secondary
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculates as Q5/10. Negative values indicate improvement from baseline.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 4 | -10.00 percent work impairment | Standard Deviation 22.39 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 8 | -12.50 percent work impairment | Standard Deviation 24.93 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 12 | -11.97 percent work impairment | Standard Deviation 26.33 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 28 | -20.00 percent work impairment | Standard Deviation 25.27 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 52 | -22.97 percent work impairment | Standard Deviation 29.9 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | EOT | -17.35 percent work impairment | Standard Deviation 29.1 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 52 | -22.41 percent work impairment | Standard Deviation 28.16 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 4 | -6.56 percent work impairment | Standard Deviation 29.31 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 28 | -21.40 percent work impairment | Standard Deviation 25.21 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 8 | -13.98 percent work impairment | Standard Deviation 26.37 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | EOT | -20.43 percent work impairment | Standard Deviation 28.85 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 12 | -16.29 percent work impairment | Standard Deviation 27.77 |
Secondary
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. Negative values indicate improvement from baseline.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 12 | -12.15 percent overall work impairment | Standard Deviation 26.81 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 52 | -22.48 percent overall work impairment | Standard Deviation 30.96 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 8 | -13.13 percent overall work impairment | Standard Deviation 25.07 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | EOT | -17.43 percent overall work impairment | Standard Deviation 30.01 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 28 | -20.76 percent overall work impairment | Standard Deviation 25.78 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 4 | -10.61 percent overall work impairment | Standard Deviation 22.36 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 28 | -22.49 percent overall work impairment | Standard Deviation 26.69 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 8 | -14.67 percent overall work impairment | Standard Deviation 26.94 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 12 | -17.15 percent overall work impairment | Standard Deviation 28.94 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 4 | -7.51 percent overall work impairment | Standard Deviation 30.12 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 52 | -23.40 percent overall work impairment | Standard Deviation 29.54 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | EOT | -21.59 percent overall work impairment | Standard Deviation 29.88 |
Secondary
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Time frame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 4 | -0.90 percent work time missed | Standard Deviation 16.5 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 8 | -1.48 percent work time missed | Standard Deviation 15.72 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 12 | -0.70 percent work time missed | Standard Deviation 14.69 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 28 | -0.58 percent work time missed | Standard Deviation 19.15 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 52 | -1.93 percent work time missed | Standard Deviation 12.14 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | EOT | -1.76 percent work time missed | Standard Deviation 14.68 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 52 | -1.66 percent work time missed | Standard Deviation 18.74 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 4 | 0.02 percent work time missed | Standard Deviation 16.53 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 28 | -3.49 percent work time missed | Standard Deviation 13.77 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 8 | -1.73 percent work time missed | Standard Deviation 16.59 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | EOT | -1.66 percent work time missed | Standard Deviation 20.31 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 12 | -1.97 percent work time missed | Standard Deviation 12.14 |
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy
Participants who discontinued due to lack of efficacy have been reported.
Time frame: Up to week 52
Population: FAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Lack of Efficacy | 10 Participants |
| Peficitinib 100 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 6 Participants |
| Peficitinib 150 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 3 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants Who Withdrew Due to Lack of Efficacy | 9 Participants |
Secondary
Number of Participants With TEAEs From Week 12 to Week 28
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE
Time frame: Week 12 to week 28
Population: SAF. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs | 50 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related TEAEs | 27 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to death | 0 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | Serious TEAEs | 2 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related serious TEAEs | 2 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | ≥ Grade 3 TEAEs | 5 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to permanent discontinuation | 4 Participants |
| Placebo | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-Related TEAE leading to permanent dicont. | 3 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to death | 0 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | ≥ Grade 3 TEAEs | 7 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs | 95 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Serious TEAEs | 5 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related TEAEs | 63 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-Related TEAE leading to permanent dicont. | 3 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related serious TEAEs | 3 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to permanent discontinuation | 4 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to permanent discontinuation | 1 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-Related TEAE leading to permanent dicont. | 1 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Serious TEAEs | 3 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | ≥ Grade 3 TEAEs | 6 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to death | 0 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related TEAEs | 72 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs | 104 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related serious TEAEs | 1 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related TEAEs | 16 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to death | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | Serious TEAEs | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related serious TEAEs | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | ≥ Grade 3 TEAEs | 1 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-Related TEAE leading to permanent dicont. | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs | 21 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to permanent discontinuation | 0 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | Serious TEAEs | 0 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-Related TEAE leading to permanent dicont. | 0 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to death | 0 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs leading to permanent discontinuation | 0 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | TEAEs | 25 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | ≥ Grade 3 TEAEs | 1 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related TEAEs | 11 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 12 to Week 28 | Drug-related serious TEAEs | 0 Participants |
Secondary
Number of Participants With TEAEs From Week 28 to Week 52
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
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
Population: SAF. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs | 114 Participants |
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related serious TEAEs | 4 Participants |
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related TEAEs | 72 Participants |
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to permanent discontinuation | 4 Participants |
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to death | 0 Participants |
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | ≥ Grade 3 TEAEs | 15 Participants |
| Placebo | Number of Participants With TEAEs From Week 28 to Week 52 | Serious TEAEs | 10 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related TEAEs | 74 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | Serious TEAEs | 8 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to death | 0 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related serious TEAEs | 5 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs | 112 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to permanent discontinuation | 6 Participants |
| Peficitinib 100 mg | Number of Participants With TEAEs From Week 28 to Week 52 | ≥ Grade 3 TEAEs | 15 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to death | 0 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related TEAEs | 14 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs | 22 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related serious TEAEs | 2 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | ≥ Grade 3 TEAEs | 2 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | Serious TEAEs | 2 Participants |
| Peficitinib 150 mg | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to permanent discontinuation | 3 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | Serious TEAEs | 1 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs | 27 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related TEAEs | 18 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to death | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related serious TEAEs | 1 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | ≥ Grade 3 TEAEs | 2 Participants |
| Placebo / Peficitinib 150 mg at Week 12 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to permanent discontinuation | 2 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to death | 1 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related TEAEs | 17 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to permanent discontinuation | 2 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs | 25 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | ≥ Grade 3 TEAEs | 2 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | Serious TEAEs | 1 Participants |
| Placebo / Peficitinib 100 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related serious TEAEs | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to permanent discontinuation | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related serious TEAEs | 1 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs leading to death | 0 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | Drug-related TEAEs | 17 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | ≥ Grade 3 TEAEs | 2 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | TEAEs | 26 Participants |
| Placebo / Peficitinib 150 mg at Week 28 | Number of Participants With TEAEs From Week 28 to Week 52 | Serious TEAEs | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Time frame: Week 0 to week 12
Population: SAF.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs | 84 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-related TEAEs | 47 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Serious TEAEs | 4 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-related serious TEAEs | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | ≥ Grade 3 TEAEs | 8 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs leading to permanent discontinuation | 7 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-Related AE leading to permanent discont. | 6 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs leading to permanent discontinuation | 5 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Serious TEAEs | 5 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-related serious TEAEs | 3 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | ≥ Grade 3 TEAEs | 9 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs | 89 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-related TEAEs | 57 Participants |
| Peficitinib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-Related AE leading to permanent discont. | 3 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-related TEAEs | 80 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs | 104 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Serious TEAEs | 3 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | TEAEs leading to permanent discontinuation | 5 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | ≥ Grade 3 TEAEs | 16 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-related serious TEAEs | 3 Participants |
| Peficitinib 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks | Drug-Related AE leading to permanent discont. | 5 Participants |
Secondary
Percentage of Participants Achieving ACR / EULAR Remission at Week 12
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 0.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 5.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 9.9 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: 0.01195% CI: [1, 9.5]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.1, 14.6]Fisher Exact
Secondary
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 6.0 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 9.0 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 11.0 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 11.8 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 14.6 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 17.2 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 17.0 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 19.1 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 16.1 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 48 | 17.6 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 52 | 21.4 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 19.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 20.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 1.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 25.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 3.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 52 | 26.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 10.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 27.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 12.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 48 | 21.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 14.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 20.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 18.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 23.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 20.1 percentage of participants |
Secondary
Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and week 28/ET and 52/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 | Week 28/ET | 45.8 percentage of participants |
| Placebo | Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 | Week 52/ET | 42.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 | Week 28/ET | 67.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 | Week 52/ET | 64.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 | Week 28/ET | 72.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 | Week 52/ET | 68.9 percentage of participants |
Comparison: Week 28/ET: Treatment Difference vs Placebop-value: <0.00195% CI: [10, 32.6]Fisher Exact
Comparison: Week 28/ET: Treatment Difference vs Placebop-value: <0.00195% CI: [15.7, 37.9]Fisher Exact
Comparison: Week 52/ET: Treatment Difference vs Placebop-value: <0.00195% CI: [10.2, 32.9]Fisher Exact
Comparison: Week 52/ET: Treatment Difference vs Placebop-value: <0.00195% CI: [15.2, 37.6]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12 | 7.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12 | 31.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12 | 35.1 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [15.1, 32.3]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [18.6, 36.2]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 28 | 51.9 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 52 | 60.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 44 | 57.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 8 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 16 | 39.2 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 48 | 56.1 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 4 | 11.2 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 40 | 59.9 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 12 | 31.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 36 | 53.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 20 | 45.7 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 24 | 51.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | EOT | 56.4 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 32 | 54.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 32 | 52.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 28 | 52.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 24 | 56.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 52 | 62.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 8 | 21.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 4 | 14.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 48 | 60.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 12 | 36.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | EOT | 57.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 44 | 55.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 40 | 58.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 16 | 43.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 36 | 53.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 20 | 52.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 16 | 8.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 4 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 8 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 12 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 20 | 21.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 24 | 27.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 28 | 30.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 32 | 44.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 36 | 50.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 40 | 42.9 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 44 | 50.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 48 | 54.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 52 | 54.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | EOT | 54.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 40 | 50.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 24 | 33.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | EOT | 34.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 52 | 39.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 12 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 44 | 42.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 28 | 38.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 32 | 50.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 36 | 48.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 20 | 16.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 8 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 16 | 13.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 48 | 54.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 20 | 17.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 32 | 30.8 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 16 | 20.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 4 | 15.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 36 | 35.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 40 | 61.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 12 | 20.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 44 | 55.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 8 | 10.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 48 | 62.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | EOT | 56.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 24 | 20.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 52 | 55.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 28 | 25.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 20 | 29.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 48 | 66.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 36 | 54.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 4 | 5.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 28 | 26.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 16 | 8.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 52 | 63.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | EOT | 64.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 24 | 32.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 44 | 57.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 8 | 11.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 32 | 44.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 40 | 54.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 | Week 12 | 11.8 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12 | 12.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12 | 47.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12 | 57.9 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [25.1, 44.2]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [36, 55]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 4 | 22.4 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 8 | 36.3 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 12 | 47.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 16 | 55.4 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 20 | 62.2 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 24 | 67.1 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 28 | 67.7 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 32 | 65.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 36 | 69.3 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 40 | 76.3 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 44 | 70.5 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 48 | 73.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 52 | 71.7 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | EOT | 66.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 44 | 82.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 4 | 24.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 32 | 70.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 8 | 44.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 52 | 77.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 12 | 59.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 36 | 73.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 16 | 63.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 48 | 78.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 20 | 69.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 40 | 80.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 24 | 71.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | EOT | 71.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 | Week 28 | 76.7 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12 | 2.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12 | 12.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12 | 19.3 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.3, 16.5]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [10, 23.9]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 28 | 30.4 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 52 | 38.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 44 | 34.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 8 | 8.9 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 16 | 18.1 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 48 | 33.3 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 4 | 4.1 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 40 | 37.1 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 12 | 13.1 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 36 | 32.7 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 20 | 22.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 24 | 28.0 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | EOT | 34.9 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 32 | 33.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 32 | 41.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 28 | 32.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 24 | 31.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 52 | 42.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 8 | 12.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 4 | 5.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 48 | 40.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 12 | 19.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | EOT | 38.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 44 | 37.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 40 | 36.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 16 | 24.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 36 | 40.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 20 | 33.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 16 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 4 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 8 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 12 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 20 | 5.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 24 | 5.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 28 | 11.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 32 | 22.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 36 | 13.9 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 40 | 20.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 44 | 17.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 48 | 21.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 52 | 27.3 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | EOT | 24.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 40 | 35.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 24 | 27.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | EOT | 31.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 52 | 36.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 12 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 44 | 24.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 28 | 22.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 32 | 30.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 36 | 37.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 20 | 10.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 8 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 16 | 10.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 48 | 39.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 20 | 7.7 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 32 | 15.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 16 | 10.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 4 | 2.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 36 | 13.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 40 | 22.2 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 12 | 5.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 44 | 25.0 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 8 | 2.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 48 | 34.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | EOT | 25.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 24 | 12.8 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 52 | 26.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 28 | 12.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 20 | 5.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 48 | 36.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 36 | 24.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 28 | 8.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 16 | 2.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 52 | 39.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | EOT | 41.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 24 | 5.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 44 | 30.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 8 | 2.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 32 | 26.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 40 | 30.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 | Week 12 | 5.9 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12 | 4.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12 | 25.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12 | 36.3 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [12.5, 28.1]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [23.1, 40]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 4 | 10.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 8 | 17.9 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 12 | 25.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 16 | 34.9 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 20 | 44.5 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 24 | 52.2 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 28 | 49.4 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 32 | 52.2 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 36 | 53.6 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 40 | 58.3 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 44 | 53.7 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 48 | 55.8 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 52 | 55.2 percentage of participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | EOT | 50.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 44 | 60.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 4 | 12.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 32 | 56.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 8 | 29.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 52 | 60.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 12 | 37.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 36 | 56.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 16 | 44.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 48 | 62.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 20 | 48.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 40 | 60.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 24 | 57.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | EOT | 57.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 | Week 28 | 56.0 percentage of participants |
Secondary
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 16 | 14.5 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 32 | 25.5 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 4 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 36 | 24.2 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 20 | 18.3 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 40 | 31.6 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 12 | 7.1 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 24 | 20.5 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 48 | 25.7 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 8 | 3.0 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 52 | 30.3 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 28 | 22.2 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | EOT | 28.5 percentage of participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 44 | 27.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | EOT | 35.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 4 | 2.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 8 | 8.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 12 | 14.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 16 | 18.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 20 | 20.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 24 | 22.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 28 | 23.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 32 | 28.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 36 | 32.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 40 | 28.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 44 | 30.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 48 | 32.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 | Week 52 | 39.5 percentage of participants |
Secondary
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12 | 0.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12 | 7.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12 | 14.0 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: 0.00395% CI: [1.8, 11]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [7.5, 19.4]Fisher Exact
Secondary
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12 | 32.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12 | 74.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12 | 78.9 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [32.3, 52.6]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [37.1, 56.9]Fisher Exact
Secondary
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 4 | 55.9 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 8 | 72.0 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 12 | 75.0 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 16 | 80.7 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 20 | 82.3 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 24 | 87.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 28 | 88.0 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 32 | 90.4 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 36 | 94.1 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 40 | 92.7 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 44 | 96.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 48 | 94.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 52 | 93.8 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | EOT | 86.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 44 | 94.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 4 | 68.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 32 | 92.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 8 | 76.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 52 | 94.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 12 | 80.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 36 | 94.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 16 | 87.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 48 | 95.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 20 | 92.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 40 | 94.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 24 | 91.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | EOT | 90.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 | Week 28 | 91.2 percentage of participants |
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in this outcome measure.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 19.4 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 30.4 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 42.9 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 51.8 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 59.1 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 65.2 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 28 | 63.3 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 63.1 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 67.3 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 73.7 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 65.8 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 71.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 69.0 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 64.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 81.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 21.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 69.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 41.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 76.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 57.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 72.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 60.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 78.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 68.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 79.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 70.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 70.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 28 | 74.2 percentage of participants |
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in the outcome measure.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12 | 4.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12 | 23.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12 | 34.5 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [12.1, 27.3]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [22, 38.7]Fisher Exact
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in this outcome measure.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 4 | 7.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 8 | 16.1 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 12 | 24.4 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 16 | 34.3 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 20 | 43.3 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 24 | 51.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 28 | 48.1 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 32 | 51.0 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 36 | 53.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 40 | 57.6 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 44 | 52.4 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 48 | 53.7 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 52 | 53.8 percentage of participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | EOT | 49.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 44 | 59.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 4 | 12.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 32 | 54.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 8 | 28.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 52 | 59.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 12 | 35.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 36 | 54.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 16 | 43.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 48 | 60.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 20 | 46.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 40 | 58.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 24 | 55.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | EOT | 56.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 | Week 28 | 54.1 percentage of participants |
Secondary
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in this outcome measure.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 10.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 43.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 55.6 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [23.7, 42.2]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [36.2, 54.8]Fisher Exact
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Time frame: Week 12/ET
Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 35.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 77.9 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 84.8 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [32.3, 52.5]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [39.7, 58.9]Fisher Exact
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 4 | 67.1 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 73.8 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 78.6 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 16 | 84.3 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 86.6 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 89.4 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 91.1 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 32 | 93.0 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 94.8 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 92.8 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 44 | 95.3 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 95.3 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 95.2 percentage of participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 88.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 44 | 94.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 4 | 77.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 32 | 94.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 80.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 94.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 85.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 95.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 16 | 89.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 97.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 91.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 96.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 95.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 92.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 93.7 percentage of participants |
Secondary
Percentage of Participants With an ACR20-CRP Response Through Week 52
ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 79.1 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 84.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 79.9 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 51.2 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 70.5 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 83.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 38.2 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 80.9 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 59.5 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 78.4 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 74.4 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 74.5 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | EOT | 76.4 percentage of participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 79.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 85.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 83.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 85.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 87.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 62.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 48.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 89.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 66.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | EOT | 81.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 86.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 86.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 77.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 86.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 79.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 43.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 8.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 10.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 59.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 63.9 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 72.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 77.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 80.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 80.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 76.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 81.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 75.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | EOT | 73.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 2.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 88.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 80.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | EOT | 78.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 90.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 90.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 83.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 86.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 85.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 67.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 51.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 90.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 61.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 84.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 64.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 38.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 78.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 88.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 51.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 88.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 33.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 85.7 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | EOT | 92.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 59.0 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 91.2 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 64.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 61.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 90.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 75.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 14.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 64.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 58.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 90.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | EOT | 91.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 52.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 87.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 29.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 76.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 78.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 38.2 percentage of participants |
Secondary
Percentage of Participants With an ACR50-CRP Response at Week 12
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Time frame: Baseline and week 12/ET
Population: FAS. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an ACR50-CRP Response at Week 12 | 7.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response at Week 12 | 29.9 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response at Week 12 | 46.0 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [13.8, 30.7]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [29.3, 47.3]Fisher Exact
Secondary
Percentage of Participants With an ACR50-CRP Response Through Week 52
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 53.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 66.9 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 57.7 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 19.6 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 46.4 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 60.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 10.0 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 61.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 29.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 55.6 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 51.2 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 56.5 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 60.3 percentage of participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 59.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 65.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 63.5 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 60.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 68.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 33.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 15.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 64.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 48.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 62.6 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 71.2 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 68.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 53.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 67.7 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 54.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 13.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 2.7 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 2.7 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 35.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 47.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 50.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 52.8 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 58.3 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 48.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 52.9 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 60.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 63.6 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 62.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 67.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 52.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 55.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 63.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 72.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 69.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 61.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 71.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 37.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 21.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 69.7 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 35.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 56.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 38.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 10.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 64.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 66.7 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 23.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 72.2 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 12.8 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 71.4 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 69.2 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 33.3 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 67.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 28.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 29.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 66.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 60.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 23.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 8.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 69.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 70.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 29.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 63.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 2.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 52.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 66.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 5.9 percentage of participants |
Secondary
Percentage of Participants With an ACR70-CRP Response at Week 12
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Time frame: Baseline and week 12/ET
Population: FAS. LOCF was used for missing imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an ACR70-CRP Response at Week 12 | 2.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response at Week 12 | 12.1 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response at Week 12 | 23.6 percentage of participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [13.9, 28.5]Fisher Exact
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [3.8, 15.6]Fisher Exact
Secondary
Percentage of Participants With an ACR70-CRP Response Through Week 52
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Population: FAS. Here, Number of participants analyzed signifies participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 38.3 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 39.3 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 33.8 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 26.2 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 24.1 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 36.3 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 31.7 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 12.5 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 34.0 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 7.7 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 1.2 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 34.9 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 29.1 percentage of participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 35.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 52.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 48.4 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 42.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 13.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 49.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 48.3 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 36.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 47.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 32.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 35.0 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 41.8 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 43.9 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 4.1 percentage of participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 24.7 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 22.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 33.3 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 33.3 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 33.3 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 31.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 41.2 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 45.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 42.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 40.5 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 0.0 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 5.4 percentage of participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 8.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 38.2 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 2.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 42.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 16.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 42.1 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 44.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 36.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 42.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 38.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 48.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 2.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 12 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 7.7 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 44.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 36.1 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 43.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 13.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 2.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 12.8 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 2.6 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 20.5 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 17.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 17.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 12.8 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 38.9 percentage of participants |
| Placebo / Peficitinib 100 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 45.7 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 8.8 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 50.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 33.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 39.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 2.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 39.4 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 48.5 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 33.3 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 0.0 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 2.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 20.6 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 2.9 percentage of participants |
| Placebo / Peficitinib 150 mg at Week 28 | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 2.9 percentage of participants |