Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, ASP015K
Brief summary
The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs
Detailed description
This was a multi-center, randomized, placebo-controlled, double-blind, parallel-group, confirmatory study to evaluate the efficacy and safety of ASP015K alone or in combination with DMARDs in participants with RA who had an inadequate response to DMARDs. Etanercept was also administered as the reference drug in an open-label manner. The study drug was orally administered once daily (QD) after breakfast for 52 weeks. Etanercept was administered subcutaneously QD for 52 weeks. At Week 12, participants in the placebo group were switched to ASP015K. The dose of ASP015K to be started at Week 12 for the placebo group was determined randomly at baseline in advance and switched in a blinded manner. Participants in ASP015K group or placebo groups who had completed the study were eligible for participation in an open-label extension study (015K-CL-RAJ2).
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 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), 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 \> 0.50 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 responder to (including subjects who were intolerant of) at least one DMARD administered for at least 90 days prior to screening
Exclusion criteria
* Subject has received a biologic DMARD within the specified period * Subject has received etanercept * Inadequate responder to at least 3 biologic DMARDs 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 \> ULN \[in case of Japan: ≥ 11 pg/mL\] * 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 or reference 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 a history of or concurrent demyelinating disorders * 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) | The ACR20 response required that all criteria from (1) to (3) below be met. 1. Tender joint count (TJC) : ≥ 20% reduction compared with baseline. 2. Swollen joint count (SJC) : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline (3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12 | Baseline and Week 12/ET | The ACR50 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 50% reduction compared with baseline. 2. SJC : ≥ 50% reduction compared with baseline. 3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP. |
| Percentage of Participants With an ACR50-CRP Response Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The ACR50 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 50% reduction compared with baseline. 2. SJC : ≥ 50% reduction compared with baseline. 3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP. |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12 | Baseline and Week 12/ET | The ACR70 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 70% reduction compared with baseline. 2. SJC : ≥ 70% reduction compared with baseline. 3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP. |
| Percentage of Participants With an ACR70-CRP Response Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The ACR70 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 70% reduction compared with baseline. 2. SJC : ≥ 70% reduction compared with baseline. 3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP. |
| 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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. |
| Change From Baseline DAS28-CRP Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. |
| Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. |
| Change From Baseline in DAS28-ESR Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. |
| Change From Baseline in TJC (68 Joints) at Week 12 | Baseline and Week 12/ET | The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). |
| Change From Baseline in TJC (68 Joints) Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). |
| Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12 | Baseline and Week 12/ET | The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). |
| Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. |
| Change From Baseline in SJC (66 Joints) Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). |
| Percentage of Participants Achieving DAS28-CRP < 2.6 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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. |
| Percentage of Participants Achieving DAS28-ESR < 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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. |
| Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. |
| Percentage of Participants Achieving DAS28-CRP <= 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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. |
| Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. |
| Percentage of Participants Achieving DAS28-ESR <= 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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. |
| Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. |
| 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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 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 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2. |
| 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, and 52 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2. |
| Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | Week 12/ET | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2. |
| 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, and 52 | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2. |
| Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12 | Week 12/ET | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2. |
| Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2. |
| Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12 | Week 12/ET | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2. |
| Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2. |
| 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 subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups. |
| Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm). |
| Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission 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 below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups. |
| Percentage of Participants Achieving SDAI Remission Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. |
| 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 below 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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. |
| Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12 | Week 12/ET | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups. |
| Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. |
| Change From Baseline in CDAI Score at Week 12 | Baseline and Week 12/ET | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. |
| Change From Baseline in CDAI Score Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. |
| Change From Baseline in Physician's Global Assessment of Arthritis (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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 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. |
| Change From Baseline in Subject's 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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 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. |
| Change From Baseline in Subject's Assessment of Pain at Week 12 | Baseline and Week 12/ET | The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. |
| Change From Baseline in Subject's Assessment of Pain Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. |
| Number of Participants Who Withdrew Due to Lack of Efficacy | Up to week 12 | The number of participants who withdrew due to lack of efficacy up to week 12 was calculated. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | Baseline and Week 12/ET | The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. |
| Change From Baseline in HAQ-DI Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. |
| 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 and Week 4, 8, 12, 28, and 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. |
| 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 and Week 4, 8, 12, 28, and 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. |
| 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 and Week 4, 8, 12, 28, and 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. |
| 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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). |
| Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Baseline and Week 4, 8, 12, 28, and 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). |
| Percentage of Participants With an ACR20-CRP Response Through Week 52 | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | The ACR20 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 20% reduction compared with baseline. 2. SJC : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP. |
| Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Baseline and Week 4, 8, 12, 28, and 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. |
| 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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. |
| Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Baseline and Week 4, 8, 12, 28, and 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. |
| 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 indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. |
| Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Baseline and Week 4, 8, 12, 28, and 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. |
| Number of Participants With Adverse Events During the First 12 Weeks | Week 0 to Week 12 | Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. |
| Number of Participants With Adverse Events From Week 12 | Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study | Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. |
| 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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. |
Countries
Japan, South Korea, Taiwan
Participant flow
Recruitment details
Participants with rheumatoid arthritis (RA) who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were enrolled in 142 sites in Japan, 11 sites in Korea and 12 sites in Taiwan.
Pre-assignment details
Participants were randomized in a 1:1:1:2 ratio to peficitinib 100 mg, 150 mg, placebo or etanercept groups at baseline. At week 12, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg. The dose of peficitinib administered to the placebo group from week 12 was determined in advance randomly.
Participants by arm
| Arm | Count |
|---|---|
| Peficitinib 100 mg Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | 104 |
| Peficitinib 150 mg Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | 102 |
| Etanercept Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. | 200 |
| Placebo Participants were assigned to receive placebo to peficitinib once a day until week 12. | 101 |
| Total | 507 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 5 | 2 | 2 | 11 |
| Overall Study | Lab data met discontinuation criteria | 3 | 0 | 0 | 2 | 0 |
| Overall Study | Lack of Efficacy | 11 | 3 | 8 | 4 | 6 |
| Overall Study | Miscellaneous | 2 | 2 | 1 | 0 | 5 |
| Overall Study | Not fulfill eligible criteria | 1 | 2 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 3 | 3 | 2 | 5 |
| Overall Study | Withdrawal of consent | 2 | 3 | 0 | 2 | 6 |
Baseline characteristics
| Characteristic | Peficitinib 100 mg | Total | Placebo | Etanercept | Peficitinib 150 mg |
|---|---|---|---|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 12.2 | 55.3 Years STANDARD_DEVIATION 12 | 56.3 Years STANDARD_DEVIATION 11.7 | 55.5 Years STANDARD_DEVIATION 11.6 | 55 Years STANDARD_DEVIATION 12.8 |
| Concomitant DMARD at Baseline No | 13 Participants | 64 Participants | 14 Participants | 24 Participants | 13 Participants |
| Concomitant DMARD at Baseline Yes | 91 Participants | 443 Participants | 87 Participants | 176 Participants | 89 Participants |
| C-Reactive Protein (CRP) | 2.296 mg/dL STANDARD_DEVIATION 2.566 | 2.247 mg/dL STANDARD_DEVIATION 2.346 | 2.258 mg/dL STANDARD_DEVIATION 2.224 | 2.055 mg/dL STANDARD_DEVIATION 2.144 | 2.561 mg/dL STANDARD_DEVIATION 2.597 |
| Erythrocyte Sedimentation Rate (ESR) | 49.6 mm/h STANDARD_DEVIATION 27.4 | 48.6 mm/h STANDARD_DEVIATION 28.8 | 47.9 mm/h STANDARD_DEVIATION 27.6 | 47.4 mm/h STANDARD_DEVIATION 29.8 | 50.6 mm/h STANDARD_DEVIATION 29.7 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 0.92 units on a scale STANDARD_DEVIATION 0.69 | 1 units on a scale STANDARD_DEVIATION 0.7 | 1 units on a scale STANDARD_DEVIATION 0.66 | 1.03 units on a scale STANDARD_DEVIATION 0.75 | 1.03 units on a scale STANDARD_DEVIATION 0.67 |
| Physician's Global Assessment of Arthritis | 60.21 units on a scale STANDARD_DEVIATION 20.11 | 59.39 units on a scale STANDARD_DEVIATION 19.71 | 61.93 units on a scale STANDARD_DEVIATION 19.35 | 58.17 units on a scale STANDARD_DEVIATION 19.87 | 58.46 units on a scale STANDARD_DEVIATION 19.35 |
| Prior Biologic Disease-modifying Antirheumatic Drug-inadequate Response (DMARD-IR) No | 95 Participants | 471 Participants | 96 Participants | 185 Participants | 95 Participants |
| Prior Biologic Disease-modifying Antirheumatic Drug-inadequate Response (DMARD-IR) Yes | 9 Participants | 36 Participants | 5 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 104 Participants | 507 Participants | 101 Participants | 200 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 77 Participants | 366 Participants | 73 Participants | 138 Participants | 78 Participants |
| Sex: Female, Male Male | 27 Participants | 141 Participants | 28 Participants | 62 Participants | 24 Participants |
| Study Region Japan | 85 Participants | 415 Participants | 83 Participants | 164 Participants | 83 Participants |
| Study Region Korea | 11 Participants | 54 Participants | 10 Participants | 22 Participants | 11 Participants |
| Study Region Taiwan | 8 Participants | 38 Participants | 8 Participants | 14 Participants | 8 Participants |
| Subject's Global Assessment of Arthritis | 57.54 units on a scale STANDARD_DEVIATION 24.78 | 58.22 units on a scale STANDARD_DEVIATION 25.95 | 58.99 units on a scale STANDARD_DEVIATION 25.7 | 57.52 units on a scale STANDARD_DEVIATION 26.92 | 59.52 units on a scale STANDARD_DEVIATION 25.73 |
| Subject's Global Assessment of Arthritis Pain | 57.31 units on a scale STANDARD_DEVIATION 26.71 | 56.9 units on a scale STANDARD_DEVIATION 26.05 | 57.56 units on a scale STANDARD_DEVIATION 25.07 | 55.79 units on a scale STANDARD_DEVIATION 26.54 | 58.02 units on a scale STANDARD_DEVIATION 25.66 |
| Swollen Joint Count (66 Joints) | 12.4 swollen joints STANDARD_DEVIATION 6.3 | 12.4 swollen joints STANDARD_DEVIATION 6.8 | 12.9 swollen joints STANDARD_DEVIATION 7.2 | 11.9 swollen joints STANDARD_DEVIATION 6.8 | 12.8 swollen joints STANDARD_DEVIATION 7.1 |
| Tender Joint Count (68 Joints) | 15 tender joints STANDARD_DEVIATION 9.4 | 15.3 tender joints STANDARD_DEVIATION 9.6 | 16.2 tender joints STANDARD_DEVIATION 10.7 | 14.9 tender joints STANDARD_DEVIATION 9.3 | 15.4 tender joints STANDARD_DEVIATION 9.5 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 104 | 0 / 102 | 0 / 200 | 0 / 96 | 0 / 93 | 0 / 43 | 0 / 47 | 0 / 191 |
| other Total, other adverse events | 27 / 101 | 30 / 104 | 39 / 102 | 63 / 200 | 50 / 96 | 42 / 93 | 28 / 43 | 23 / 47 | 94 / 191 |
| serious Total, serious adverse events | 4 / 101 | 3 / 104 | 2 / 102 | 4 / 200 | 5 / 96 | 6 / 93 | 4 / 43 | 5 / 47 | 14 / 191 |
Outcome results
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
The ACR20 response required that all criteria from (1) to (3) below be met. 1. Tender joint count (TJC) : ≥ 20% reduction compared with baseline. 2. Swollen joint count (SJC) : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline (3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP).
Time frame: Baseline and Week 12/early termination (ET)
Population: The analysis population consisted of the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 | 30.7 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 | 57.7 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 | 74.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 | 83.5 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [1.76, 5.58]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [3.56, 12.2]Wald's chi-squared test
Secondary
Change From Baseline DAS28-CRP Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 24 | -2.06 Units on a Scale | Standard Deviation 1.39 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 16 | -1.96 Units on a Scale | Standard Deviation 1.37 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 4 | -1.11 Units on a Scale | Standard Deviation 0.97 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 20 | -2.01 Units on a Scale | Standard Deviation 1.41 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 48 | -2.26 Units on a Scale | Standard Deviation 1.31 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 8 | -1.48 Units on a Scale | Standard Deviation 1.24 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | EOT | -2.01 Units on a Scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 44 | -2.34 Units on a Scale | Standard Deviation 1.29 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 40 | -2.31 Units on a Scale | Standard Deviation 1.36 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 36 | -2.31 Units on a Scale | Standard Deviation 1.34 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 12 | -1.66 Units on a Scale | Standard Deviation 1.34 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 52 | -2.28 Units on a Scale | Standard Deviation 1.38 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 32 | -2.26 Units on a Scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline DAS28-CRP Through Week 52 | Week 28 | -2.12 Units on a Scale | Standard Deviation 1.37 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 16 | -2.40 Units on a Scale | Standard Deviation 1.26 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 4 | -1.29 Units on a Scale | Standard Deviation 0.83 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 8 | -1.92 Units on a Scale | Standard Deviation 0.96 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 12 | -2.27 Units on a Scale | Standard Deviation 1.12 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 28 | -2.80 Units on a Scale | Standard Deviation 1.27 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 20 | -2.57 Units on a Scale | Standard Deviation 1.2 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 24 | -2.68 Units on a Scale | Standard Deviation 1.24 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 32 | -2.77 Units on a Scale | Standard Deviation 1.29 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 36 | -2.87 Units on a Scale | Standard Deviation 1.22 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 40 | -2.88 Units on a Scale | Standard Deviation 1.27 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 44 | -2.86 Units on a Scale | Standard Deviation 1.37 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 48 | -2.98 Units on a Scale | Standard Deviation 1.27 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 52 | -2.99 Units on a Scale | Standard Deviation 1.26 |
| Peficitinib 100 mg | Change From Baseline DAS28-CRP Through Week 52 | EOT | -2.75 Units on a Scale | Standard Deviation 1.36 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 36 | -2.21 Units on a Scale | Standard Deviation 1.4 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 52 | -2.51 Units on a Scale | Standard Deviation 1.29 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 44 | -2.39 Units on a Scale | Standard Deviation 1.35 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 20 | -1.58 Units on a Scale | Standard Deviation 1.42 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 4 | -0.49 Units on a Scale | Standard Deviation 0.78 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 40 | -2.17 Units on a Scale | Standard Deviation 1.46 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 12 | -0.70 Units on a Scale | Standard Deviation 1.23 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 8 | -0.70 Units on a Scale | Standard Deviation 1.02 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 28 | -1.90 Units on a Scale | Standard Deviation 1.5 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 32 | -1.98 Units on a Scale | Standard Deviation 1.47 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 24 | -1.60 Units on a Scale | Standard Deviation 1.34 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 16 | -1.60 Units on a Scale | Standard Deviation 1.29 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | Week 48 | -2.58 Units on a Scale | Standard Deviation 1.32 |
| Peficitinib 150 mg | Change From Baseline DAS28-CRP Through Week 52 | EOT | -2.11 Units on a Scale | Standard Deviation 1.59 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 32 | -2.22 Units on a Scale | Standard Deviation 1.35 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 24 | -2.28 Units on a Scale | Standard Deviation 1.3 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 12 | -0.82 Units on a Scale | Standard Deviation 1.15 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 28 | -2.35 Units on a Scale | Standard Deviation 1.31 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 52 | -2.73 Units on a Scale | Standard Deviation 1.3 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 36 | -2.26 Units on a Scale | Standard Deviation 1.35 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 8 | -0.65 Units on a Scale | Standard Deviation 1 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 40 | -2.47 Units on a Scale | Standard Deviation 1.48 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 44 | -2.47 Units on a Scale | Standard Deviation 1.42 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 48 | -2.73 Units on a Scale | Standard Deviation 1.29 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 4 | -0.56 Units on a Scale | Standard Deviation 0.86 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 16 | -1.92 Units on a Scale | Standard Deviation 1.25 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | EOT | -2.50 Units on a Scale | Standard Deviation 1.41 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 20 | -2.15 Units on a Scale | Standard Deviation 1.22 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 52 | -3.04 Units on a Scale | Standard Deviation 1.08 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 8 | -2.27 Units on a Scale | Standard Deviation 1.03 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 28 | -2.90 Units on a Scale | Standard Deviation 0.97 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 48 | -3.03 Units on a Scale | Standard Deviation 1.01 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 24 | -2.79 Units on a Scale | Standard Deviation 1.04 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 20 | -2.73 Units on a Scale | Standard Deviation 1.04 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 16 | -2.61 Units on a Scale | Standard Deviation 1.01 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 32 | -2.94 Units on a Scale | Standard Deviation 1.05 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 40 | -2.99 Units on a Scale | Standard Deviation 0.97 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | EOT | -2.80 Units on a Scale | Standard Deviation 1.19 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 36 | -2.91 Units on a Scale | Standard Deviation 1.03 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 12 | -2.49 Units on a Scale | Standard Deviation 1.06 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 44 | -2.97 Units on a Scale | Standard Deviation 0.95 |
| Etanercept | Change From Baseline DAS28-CRP Through Week 52 | Week 4 | -1.89 Units on a Scale | Standard Deviation 1.05 |
Secondary
Change From Baseline in CDAI Score at Week 12
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in CDAI Score at Week 12 | -7.25 Units on a Scale | Standard Deviation 13.42 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score at Week 12 | -14.91 Units on a Scale | Standard Deviation 13.46 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score at Week 12 | -19.20 Units on a Scale | Standard Deviation 11.04 |
| Etanercept | Change From Baseline in CDAI Score at Week 12 | -20.74 Units on a Scale | Standard Deviation 10.64 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-12.19, -5.2]ANCOVA
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-15.96, -9.71]ANCOVA
Secondary
Change From Baseline in CDAI Score Through Week 52
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 16 | -18.17 Units on a Scale | Standard Deviation 12.81 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 20 | -18.51 Units on a Scale | Standard Deviation 13.13 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 52 | -20.05 Units on a Scale | Standard Deviation 11.94 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 24 | -18.92 Units on a Scale | Standard Deviation 12.65 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 28 | -18.97 Units on a Scale | Standard Deviation 12.06 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 12 | -15.55 Units on a Scale | Standard Deviation 12.71 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | EOT | -17.82 Units on a Scale | Standard Deviation 14.69 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 44 | -20.34 Units on a Scale | Standard Deviation 11.43 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 4 | -11.01 Units on a Scale | Standard Deviation 9.47 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 48 | -20.11 Units on a Scale | Standard Deviation 11.47 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 8 | -13.74 Units on a Scale | Standard Deviation 11.77 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 40 | -20.41 Units on a Scale | Standard Deviation 12.12 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 32 | -20.52 Units on a Scale | Standard Deviation 12.07 |
| Placebo | Change From Baseline in CDAI Score Through Week 52 | Week 36 | -20.03 Units on a Scale | Standard Deviation 12.22 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 48 | -24.50 Units on a Scale | Standard Deviation 11.77 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 52 | -24.93 Units on a Scale | Standard Deviation 11.9 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 12 | -19.81 Units on a Scale | Standard Deviation 11.21 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 20 | -21.55 Units on a Scale | Standard Deviation 11.42 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 32 | -23.30 Units on a Scale | Standard Deviation 11.53 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 16 | -20.06 Units on a Scale | Standard Deviation 11.91 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 8 | -17.06 Units on a Scale | Standard Deviation 9.58 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 24 | -22.28 Units on a Scale | Standard Deviation 11.75 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 36 | -23.58 Units on a Scale | Standard Deviation 11.41 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 44 | -23.84 Units on a Scale | Standard Deviation 12.25 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 40 | -23.76 Units on a Scale | Standard Deviation 12.03 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 4 | -11.42 Units on a Scale | Standard Deviation 8.99 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | Week 28 | -23.38 Units on a Scale | Standard Deviation 11.76 |
| Peficitinib 100 mg | Change From Baseline in CDAI Score Through Week 52 | EOT | -23.12 Units on a Scale | Standard Deviation 12.04 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 28 | -16.74 Units on a Scale | Standard Deviation 14.06 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 36 | -19.48 Units on a Scale | Standard Deviation 12.86 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 44 | -21.34 Units on a Scale | Standard Deviation 12.56 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 32 | -16.46 Units on a Scale | Standard Deviation 14.45 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 40 | -19.00 Units on a Scale | Standard Deviation 13.77 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 4 | -5.61 Units on a Scale | Standard Deviation 9.16 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 52 | -21.44 Units on a Scale | Standard Deviation 12.72 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 8 | -7.29 Units on a Scale | Standard Deviation 11.46 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 12 | -7.52 Units on a Scale | Standard Deviation 13.88 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | EOT | -17.96 Units on a Scale | Standard Deviation 15.14 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 16 | -14.40 Units on a Scale | Standard Deviation 13.13 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 20 | -15.08 Units on a Scale | Standard Deviation 14.22 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 24 | -15.71 Units on a Scale | Standard Deviation 13.08 |
| Peficitinib 150 mg | Change From Baseline in CDAI Score Through Week 52 | Week 48 | -21.58 Units on a Scale | Standard Deviation 12.56 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 44 | -22.00 Units on a Scale | Standard Deviation 13.79 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 28 | -21.48 Units on a Scale | Standard Deviation 12.7 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 4 | -7.28 Units on a Scale | Standard Deviation 8.76 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 8 | -8.35 Units on a Scale | Standard Deviation 11.1 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 12 | -10.04 Units on a Scale | Standard Deviation 11.47 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 16 | -17.72 Units on a Scale | Standard Deviation 11.75 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 20 | -19.31 Units on a Scale | Standard Deviation 12.3 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 24 | -20.93 Units on a Scale | Standard Deviation 12.88 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 32 | -20.17 Units on a Scale | Standard Deviation 13.87 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 36 | -20.83 Units on a Scale | Standard Deviation 13.1 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 40 | -21.86 Units on a Scale | Standard Deviation 14.11 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 48 | -23.20 Units on a Scale | Standard Deviation 13.03 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 52 | -23.67 Units on a Scale | Standard Deviation 13.42 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | EOT | -21.39 Units on a Scale | Standard Deviation 14.85 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 32 | -24.25 Units on a Scale | Standard Deviation 10.38 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 24 | -23.30 Units on a Scale | Standard Deviation 9.93 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 12 | -21.21 Units on a Scale | Standard Deviation 10.39 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 48 | -24.96 Units on a Scale | Standard Deviation 10.7 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 20 | -22.92 Units on a Scale | Standard Deviation 10.04 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 16 | -22.08 Units on a Scale | Standard Deviation 10.12 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 4 | -15.73 Units on a Scale | Standard Deviation 10.51 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | EOT | -23.52 Units on a Scale | Standard Deviation 11.45 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 52 | -25.17 Units on a Scale | Standard Deviation 11.14 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 40 | -24.87 Units on a Scale | Standard Deviation 10.76 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 28 | -24.09 Units on a Scale | Standard Deviation 10.26 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 8 | -19.31 Units on a Scale | Standard Deviation 9.69 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 44 | -24.54 Units on a Scale | Standard Deviation 10.81 |
| Etanercept | Change From Baseline in CDAI Score Through Week 52 | Week 36 | -24.30 Units on a Scale | Standard Deviation 10.86 |
Secondary
Change From Baseline in CRP at Week 12
Higher CRP indicates greater disease activity.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in CRP at Week 12 | 0.022 mg/dL | Standard Deviation 1.498 |
| Peficitinib 100 mg | Change From Baseline in CRP at Week 12 | -1.056 mg/dL | Standard Deviation 1.908 |
| Peficitinib 150 mg | Change From Baseline in CRP at Week 12 | -1.734 mg/dL | Standard Deviation 1.906 |
| Etanercept | Change From Baseline in CRP at Week 12 | -1.207 mg/dL | Standard Deviation 2.694 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.546, -0.679]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-2.114, -1.241]Covariance model
Secondary
Change From Baseline in CRP Through Week 52
Higher CRP indicates greater disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CRP Through Week 52 | Week 28 | -1.323 mg/dL | Standard Deviation 1.976 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 36 | -1.310 mg/dL | Standard Deviation 1.874 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 20 | -0.964 mg/dL | Standard Deviation 2.551 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 12 | -1.045 mg/dL | Standard Deviation 1.827 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 4 | -0.817 mg/dL | Standard Deviation 1.566 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 52 | -1.138 mg/dL | Standard Deviation 2.056 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 16 | -1.083 mg/dL | Standard Deviation 2.062 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 32 | -1.200 mg/dL | Standard Deviation 1.973 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 44 | -1.202 mg/dL | Standard Deviation 1.961 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 40 | -1.199 mg/dL | Standard Deviation 2.011 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 24 | -1.225 mg/dL | Standard Deviation 2.168 |
| Placebo | Change From Baseline in CRP Through Week 52 | EOT | -0.949 mg/dL | Standard Deviation 2.368 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 8 | -0.967 mg/dL | Standard Deviation 1.877 |
| Placebo | Change From Baseline in CRP Through Week 52 | Week 48 | -0.964 mg/dL | Standard Deviation 2.074 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 36 | -2.043 mg/dL | Standard Deviation 2.202 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 4 | -1.359 mg/dL | Standard Deviation 1.575 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 40 | -2.019 mg/dL | Standard Deviation 2.24 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 44 | -1.978 mg/dL | Standard Deviation 2.221 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 8 | -1.664 mg/dL | Standard Deviation 1.768 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 24 | -1.824 mg/dL | Standard Deviation 2.2 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 12 | -1.810 mg/dL | Standard Deviation 1.908 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 52 | -2.068 mg/dL | Standard Deviation 2.228 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 16 | -1.849 mg/dL | Standard Deviation 2.099 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 20 | -1.819 mg/dL | Standard Deviation 2.156 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 28 | -1.904 mg/dL | Standard Deviation 2.197 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | EOT | -1.832 mg/dL | Standard Deviation 2.221 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 32 | -1.979 mg/dL | Standard Deviation 2.223 |
| Peficitinib 100 mg | Change From Baseline in CRP Through Week 52 | Week 48 | -1.833 mg/dL | Standard Deviation 2.882 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 32 | -1.239 mg/dL | Standard Deviation 2.227 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 20 | -0.581 mg/dL | Standard Deviation 2.471 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 8 | 0.198 mg/dL | Standard Deviation 1.662 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 4 | 0.013 mg/dL | Standard Deviation 1.07 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 28 | -1.013 mg/dL | Standard Deviation 2.247 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 36 | -1.084 mg/dL | Standard Deviation 2.46 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 48 | -1.610 mg/dL | Standard Deviation 2.103 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 44 | -1.292 mg/dL | Standard Deviation 2.366 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 24 | -0.434 mg/dL | Standard Deviation 2.251 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 40 | -1.325 mg/dL | Standard Deviation 2.566 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 16 | -0.802 mg/dL | Standard Deviation 2.127 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | EOT | -0.797 mg/dL | Standard Deviation 2.879 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 12 | 0.026 mg/dL | Standard Deviation 1.852 |
| Peficitinib 150 mg | Change From Baseline in CRP Through Week 52 | Week 52 | -1.566 mg/dL | Standard Deviation 2.034 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 44 | -1.225 mg/dL | Standard Deviation 1.729 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 24 | -1.318 mg/dL | Standard Deviation 1.486 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 4 | 0.073 mg/dL | Standard Deviation 1.643 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 8 | -0.076 mg/dL | Standard Deviation 0.93 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 12 | -0.142 mg/dL | Standard Deviation 1.076 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 16 | -1.180 mg/dL | Standard Deviation 1.109 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 28 | -1.266 mg/dL | Standard Deviation 1.635 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 32 | -0.975 mg/dL | Standard Deviation 3.345 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 36 | -1.192 mg/dL | Standard Deviation 1.453 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 40 | -1.232 mg/dL | Standard Deviation 1.609 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 20 | -1.294 mg/dL | Standard Deviation 1.152 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 48 | -1.407 mg/dL | Standard Deviation 1.747 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 52 | -1.534 mg/dL | Standard Deviation 1.589 |
| Etanercept | Change From Baseline in CRP Through Week 52 | EOT | -0.987 mg/dL | Standard Deviation 3.366 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 32 | -1.593 mg/dL | Standard Deviation 1.886 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 28 | -1.611 mg/dL | Standard Deviation 2 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 20 | -1.525 mg/dL | Standard Deviation 1.643 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 48 | -1.611 mg/dL | Standard Deviation 1.858 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 16 | -1.383 mg/dL | Standard Deviation 1.639 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 12 | -1.205 mg/dL | Standard Deviation 2.735 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 8 | -1.337 mg/dL | Standard Deviation 1.822 |
| Etanercept | Change From Baseline in CRP Through Week 52 | EOT | -1.326 mg/dL | Standard Deviation 2.724 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 52 | -1.595 mg/dL | Standard Deviation 1.873 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 4 | -1.360 mg/dL | Standard Deviation 1.511 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 40 | -1.594 mg/dL | Standard Deviation 2.146 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 24 | -1.473 mg/dL | Standard Deviation 1.847 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 44 | -1.627 mg/dL | Standard Deviation 1.81 |
| Etanercept | Change From Baseline in CRP Through Week 52 | Week 36 | -1.467 mg/dL | Standard Deviation 2.233 |
Secondary
Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12 | -0.62 Units on a Scale | Standard Deviation 1.17 |
| Peficitinib 100 mg | Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12 | -1.60 Units on a Scale | Standard Deviation 1.39 |
| Peficitinib 150 mg | Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12 | -2.24 Units on a Scale | Standard Deviation 1.23 |
| Etanercept | Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12 | -2.51 Units on a Scale | Standard Deviation 1.27 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.38, -0.67]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.96, -1.31]Covariance model
Secondary
Change From Baseline in DAS28-ESR Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 28 | -2.14 Units on a Scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 24 | -2.11 Units on a Scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 20 | -2.06 Units on a Scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 16 | -1.95 Units on a Scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | EOT | -2.06 Units on a Scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 48 | -2.32 Units on a Scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 44 | -2.40 Units on a Scale | Standard Deviation 1.39 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 8 | -1.50 Units on a Scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 52 | -2.35 Units on a Scale | Standard Deviation 1.48 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 40 | -2.38 Units on a Scale | Standard Deviation 1.44 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 36 | -2.38 Units on a Scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 32 | -2.28 Units on a Scale | Standard Deviation 1.41 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 12 | -1.65 Units on a Scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline in DAS28-ESR Through Week 52 | Week 4 | -1.13 Units on a Scale | Standard Deviation 0.94 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 8 | -1.96 Units on a Scale | Standard Deviation 1.04 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 52 | -3.06 Units on a Scale | Standard Deviation 1.4 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 4 | -1.26 Units on a Scale | Standard Deviation 0.84 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 12 | -2.35 Units on a Scale | Standard Deviation 1.21 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 16 | -2.50 Units on a Scale | Standard Deviation 1.36 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 20 | -2.65 Units on a Scale | Standard Deviation 1.29 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 24 | -2.79 Units on a Scale | Standard Deviation 1.39 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 28 | -2.87 Units on a Scale | Standard Deviation 1.37 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 32 | -2.88 Units on a Scale | Standard Deviation 1.41 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 36 | -3.00 Units on a Scale | Standard Deviation 1.36 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 40 | -3.02 Units on a Scale | Standard Deviation 1.38 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 44 | -3.02 Units on a Scale | Standard Deviation 1.51 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 48 | -3.09 Units on a Scale | Standard Deviation 1.44 |
| Peficitinib 100 mg | Change From Baseline in DAS28-ESR Through Week 52 | EOT | -2.81 Units on a Scale | Standard Deviation 1.47 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 24 | -1.60 Units on a Scale | Standard Deviation 1.37 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 4 | -0.46 Units on a Scale | Standard Deviation 0.74 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 36 | -2.18 Units on a Scale | Standard Deviation 1.39 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 28 | -1.94 Units on a Scale | Standard Deviation 1.51 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | EOT | -2.06 Units on a Scale | Standard Deviation 1.56 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 40 | -2.12 Units on a Scale | Standard Deviation 1.44 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 8 | -0.68 Units on a Scale | Standard Deviation 0.99 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 20 | -1.57 Units on a Scale | Standard Deviation 1.43 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 16 | -1.53 Units on a Scale | Standard Deviation 1.33 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 48 | -2.67 Units on a Scale | Standard Deviation 1.39 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 52 | -2.45 Units on a Scale | Standard Deviation 1.3 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 32 | -1.98 Units on a Scale | Standard Deviation 1.46 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 12 | -0.66 Units on a Scale | Standard Deviation 1.18 |
| Peficitinib 150 mg | Change From Baseline in DAS28-ESR Through Week 52 | Week 44 | -2.39 Units on a Scale | Standard Deviation 1.34 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | EOT | -2.44 Units on a Scale | Standard Deviation 1.44 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 24 | -2.25 Units on a Scale | Standard Deviation 1.16 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 52 | -2.67 Units on a Scale | Standard Deviation 1.23 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 28 | -2.31 Units on a Scale | Standard Deviation 1.29 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 32 | -2.26 Units on a Scale | Standard Deviation 1.44 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 8 | -0.57 Units on a Scale | Standard Deviation 0.92 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 36 | -2.28 Units on a Scale | Standard Deviation 1.35 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 40 | -2.49 Units on a Scale | Standard Deviation 1.6 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 44 | -2.55 Units on a Scale | Standard Deviation 1.38 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 4 | -0.63 Units on a Scale | Standard Deviation 0.87 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 16 | -1.84 Units on a Scale | Standard Deviation 1.2 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 48 | -2.79 Units on a Scale | Standard Deviation 1.28 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 20 | -2.15 Units on a Scale | Standard Deviation 1.2 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 12 | -0.80 Units on a Scale | Standard Deviation 1.13 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 12 | -2.58 Units on a Scale | Standard Deviation 1.22 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 44 | -3.05 Units on a Scale | Standard Deviation 1.04 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 20 | -2.76 Units on a Scale | Standard Deviation 1.15 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 52 | -3.10 Units on a Scale | Standard Deviation 1.16 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 8 | -2.33 Units on a Scale | Standard Deviation 1.12 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 28 | -2.97 Units on a Scale | Standard Deviation 1.14 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 24 | -2.86 Units on a Scale | Standard Deviation 1.18 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | EOT | -2.86 Units on a Scale | Standard Deviation 1.27 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 36 | -3.00 Units on a Scale | Standard Deviation 1.14 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 16 | -2.68 Units on a Scale | Standard Deviation 1.15 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 40 | -3.10 Units on a Scale | Standard Deviation 1.06 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 4 | -1.90 Units on a Scale | Standard Deviation 1.12 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 48 | -3.16 Units on a Scale | Standard Deviation 1.09 |
| Etanercept | Change From Baseline in DAS28-ESR Through Week 52 | Week 32 | -3.01 Units on a Scale | Standard Deviation 1.13 |
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 below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -0.64 Units on a Scale | Standard Deviation 1.2 |
| Peficitinib 100 mg | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -1.62 Units on a Scale | Standard Deviation 1.41 |
| Peficitinib 150 mg | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -2.17 Units on a Scale | Standard Deviation 1.14 |
| Etanercept | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | -2.42 Units on a Scale | Standard Deviation 1.11 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.41, -0.71]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-1.86, -1.24]Covariance model
Secondary
Change From Baseline in ESR at Week 12
Higher ESR indicates greater disease activity.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in ESR at Week 12 | -1.96 mm/hour | Standard Deviation 17.82 |
| Peficitinib 100 mg | Change From Baseline in ESR at Week 12 | -12.96 mm/hour | Standard Deviation 21.51 |
| Peficitinib 150 mg | Change From Baseline in ESR at Week 12 | -23.92 mm/hour | Standard Deviation 21.26 |
| Etanercept | Change From Baseline in ESR at Week 12 | -20.92 mm/hour | Standard Deviation 21.66 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-15.95, -5.84]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-26.01, -16.27]Covariance model
Secondary
Change From Baseline in ESR Through Week 52
Higher ESR indicates greater disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in ESR Through Week 52 | Week 4 | -9.98 mm/hour | Standard Deviation 15.44 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 36 | -18.67 mm/hour | Standard Deviation 23.77 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 28 | -16.47 mm/hour | Standard Deviation 21.9 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 32 | -16.35 mm/hour | Standard Deviation 23.09 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 52 | -16.77 mm/hour | Standard Deviation 26.05 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 12 | -13.49 mm/hour | Standard Deviation 21.25 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 48 | -15.43 mm/hour | Standard Deviation 25.7 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 16 | -15.34 mm/hour | Standard Deviation 20.98 |
| Placebo | Change From Baseline in ESR Through Week 52 | EOT | -14.94 mm/hour | Standard Deviation 27.2 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 44 | -17.77 mm/hour | Standard Deviation 25.35 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 20 | -16.77 mm/hour | Standard Deviation 21.88 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 8 | -15.27 mm/hour | Standard Deviation 19.29 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 40 | -17.74 mm/hour | Standard Deviation 25.65 |
| Placebo | Change From Baseline in ESR Through Week 52 | Week 24 | -17.61 mm/hour | Standard Deviation 22.6 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 24 | -27.02 mm/hour | Standard Deviation 26 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 20 | -27.34 mm/hour | Standard Deviation 21.95 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 16 | -28.32 mm/hour | Standard Deviation 21.66 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 28 | -27.21 mm/hour | Standard Deviation 23.97 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 8 | -21.59 mm/hour | Standard Deviation 19.81 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 32 | -27.02 mm/hour | Standard Deviation 23.81 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 36 | -29.50 mm/hour | Standard Deviation 25.26 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 4 | -14.99 mm/hour | Standard Deviation 15.9 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 52 | -28.59 mm/hour | Standard Deviation 24.97 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 44 | -29.07 mm/hour | Standard Deviation 24.47 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 40 | -29.79 mm/hour | Standard Deviation 24 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 12 | -25.26 mm/hour | Standard Deviation 21.22 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | EOT | -26.15 mm/hour | Standard Deviation 25.02 |
| Peficitinib 100 mg | Change From Baseline in ESR Through Week 52 | Week 48 | -28.70 mm/hour | Standard Deviation 24.69 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 24 | -13.18 mm/hour | Standard Deviation 21.9 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 4 | -0.63 mm/hour | Standard Deviation 11.77 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 8 | -0.95 mm/hour | Standard Deviation 12.47 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 12 | -2.62 mm/hour | Standard Deviation 18.31 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 16 | -11.76 mm/hour | Standard Deviation 19.87 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 20 | -12.69 mm/hour | Standard Deviation 23.03 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 28 | -16.29 mm/hour | Standard Deviation 17.77 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 32 | -19.54 mm/hour | Standard Deviation 21.98 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 36 | -19.65 mm/hour | Standard Deviation 22.64 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 40 | -19.45 mm/hour | Standard Deviation 23.06 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 44 | -21.43 mm/hour | Standard Deviation 24.12 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 48 | -23.40 mm/hour | Standard Deviation 23.87 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | Week 52 | -21.03 mm/hour | Standard Deviation 19.81 |
| Peficitinib 150 mg | Change From Baseline in ESR Through Week 52 | EOT | -15.37 mm/hour | Standard Deviation 24.27 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 24 | -20.04 mm/hour | Standard Deviation 18.45 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 36 | -21.99 mm/hour | Standard Deviation 21.52 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 20 | -20.62 mm/hour | Standard Deviation 17.65 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 40 | -21.71 mm/hour | Standard Deviation 25.48 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 16 | -16.89 mm/hour | Standard Deviation 17.7 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 4 | -3.87 mm/hour | Standard Deviation 12.99 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 44 | -22.31 mm/hour | Standard Deviation 23.12 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 12 | -4.43 mm/hour | Standard Deviation 17.07 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 48 | -25.66 mm/hour | Standard Deviation 22.3 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 8 | -2.07 mm/hour | Standard Deviation 14.31 |
| Etanercept | Change From Baseline in ESR Through Week 52 | EOT | -18.61 mm/hour | Standard Deviation 27.67 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 28 | -18.02 mm/hour | Standard Deviation 24.26 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 52 | -23.24 mm/hour | Standard Deviation 24.28 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 32 | -19.93 mm/hour | Standard Deviation 25.8 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 28 | -23.52 mm/hour | Standard Deviation 22.35 |
| Etanercept | Change From Baseline in ESR Through Week 52 | EOT | -20.75 mm/hour | Standard Deviation 26.25 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 36 | -24.66 mm/hour | Standard Deviation 22.32 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 20 | -21.91 mm/hour | Standard Deviation 20.59 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 32 | -24.75 mm/hour | Standard Deviation 21.27 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 4 | -19.20 mm/hour | Standard Deviation 17.51 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 48 | -25.98 mm/hour | Standard Deviation 22 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 40 | -25.87 mm/hour | Standard Deviation 24.84 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 16 | -22.05 mm/hour | Standard Deviation 19.53 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 8 | -20.88 mm/hour | Standard Deviation 19.43 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 24 | -22.20 mm/hour | Standard Deviation 23.87 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 52 | -24.23 mm/hour | Standard Deviation 21.7 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 44 | -25.73 mm/hour | Standard Deviation 21.09 |
| Etanercept | Change From Baseline in ESR Through Week 52 | Week 12 | -21.74 mm/hour | Standard Deviation 20.67 |
Secondary
Change From Baseline in HAQ-DI Through Week 52
The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.36 units on a scale | Standard Deviation 0.57 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | -0.30 units on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | -0.10 units on a scale | Standard Deviation 0.35 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.30 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.39 units on a scale | Standard Deviation 0.58 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.36 units on a scale | Standard Deviation 0.58 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.34 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.34 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.42 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | -0.25 units on a scale | Standard Deviation 0.48 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.41 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.35 units on a scale | Standard Deviation 0.58 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.40 units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.35 units on a scale | Standard Deviation 0.58 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.51 units on a scale | Standard Deviation 0.58 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.51 units on a scale | Standard Deviation 0.57 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.50 units on a scale | Standard Deviation 0.54 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.49 units on a scale | Standard Deviation 0.59 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | -0.19 units on a scale | Standard Deviation 0.4 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.52 units on a scale | Standard Deviation 0.57 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | -0.31 units on a scale | Standard Deviation 0.48 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.50 units on a scale | Standard Deviation 0.57 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.46 units on a scale | Standard Deviation 0.53 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | -0.38 units on a scale | Standard Deviation 0.5 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.41 units on a scale | Standard Deviation 0.48 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.46 units on a scale | Standard Deviation 0.53 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.54 units on a scale | Standard Deviation 0.56 |
| Peficitinib 100 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.50 units on a scale | Standard Deviation 0.58 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | -0.04 units on a scale | Standard Deviation 0.32 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | -0.07 units on a scale | Standard Deviation 0.45 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | -0.09 units on a scale | Standard Deviation 0.55 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.21 units on a scale | Standard Deviation 0.49 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.22 units on a scale | Standard Deviation 0.58 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.33 units on a scale | Standard Deviation 0.59 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.33 units on a scale | Standard Deviation 0.53 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.36 units on a scale | Standard Deviation 0.54 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.36 units on a scale | Standard Deviation 0.51 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.35 units on a scale | Standard Deviation 0.5 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.42 units on a scale | Standard Deviation 0.63 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.40 units on a scale | Standard Deviation 0.59 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.46 units on a scale | Standard Deviation 0.57 |
| Peficitinib 150 mg | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.37 units on a scale | Standard Deviation 0.64 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.21 units on a scale | Standard Deviation 0.47 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.25 units on a scale | Standard Deviation 0.52 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.12 units on a scale | Standard Deviation 0.48 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.28 units on a scale | Standard Deviation 0.47 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | 0.02 units on a scale | Standard Deviation 0.39 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | 0.03 units on a scale | Standard Deviation 0.5 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.27 units on a scale | Standard Deviation 0.51 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | 0.01 units on a scale | Standard Deviation 0.38 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.31 units on a scale | Standard Deviation 0.5 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.24 units on a scale | Standard Deviation 0.5 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.23 units on a scale | Standard Deviation 0.49 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.26 units on a scale | Standard Deviation 0.45 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.29 units on a scale | Standard Deviation 0.51 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.29 units on a scale | Standard Deviation 0.46 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 28 | -0.47 units on a scale | Standard Deviation 0.51 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 52 | -0.51 units on a scale | Standard Deviation 0.53 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | EOT | -0.47 units on a scale | Standard Deviation 0.53 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 36 | -0.47 units on a scale | Standard Deviation 0.55 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 32 | -0.47 units on a scale | Standard Deviation 0.56 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 16 | -0.44 units on a scale | Standard Deviation 0.5 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 48 | -0.51 units on a scale | Standard Deviation 0.53 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 40 | -0.48 units on a scale | Standard Deviation 0.54 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 12 | -0.39 units on a scale | Standard Deviation 0.47 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 8 | -0.35 units on a scale | Standard Deviation 0.45 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 24 | -0.47 units on a scale | Standard Deviation 0.53 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 20 | -0.46 units on a scale | Standard Deviation 0.52 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 44 | -0.49 units on a scale | Standard Deviation 0.55 |
| Etanercept | Change From Baseline in HAQ-DI Through Week 52 | Week 4 | -0.24 units on a scale | Standard Deviation 0.43 |
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | 0.03 Units on a Scale | Standard Deviation 0.55 |
| Peficitinib 100 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | -0.28 Units on a Scale | Standard Deviation 0.55 |
| Peficitinib 150 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | -0.37 Units on a Scale | Standard Deviation 0.5 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | -0.39 Units on a Scale | Standard Deviation 0.48 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-0.48, -0.2]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-0.53, -0.26]Covariance model
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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\].
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Percent Overall Work Impairment at Week 12 | 3.62 Percent iImpairment | Standard Deviation 30.49 |
| Peficitinib 100 mg | Change From Baseline in Percent Overall Work Impairment at Week 12 | -12.20 Percent iImpairment | Standard Deviation 31.39 |
| Peficitinib 150 mg | Change From Baseline in Percent Overall Work Impairment at Week 12 | -18.68 Percent iImpairment | Standard Deviation 33.81 |
| Etanercept | Change From Baseline in Percent Overall Work Impairment at Week 12 | -24.68 Percent iImpairment | Standard Deviation 26.54 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-30.38, -10.06]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-34.16, -13.17]Covariance model
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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PGA Through Week 52 | Week 8 | -25.92 units on a scale | Standard Deviation 23.49 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 4 | -18.71 units on a scale | Standard Deviation 17.32 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 32 | -39.14 units on a scale | Standard Deviation 22.04 |
| Placebo | Change From Baseline in PGA Through Week 52 | EOT | -34.09 units on a scale | Standard Deviation 25.92 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 52 | -37.85 units on a scale | Standard Deviation 23.45 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 48 | -38.29 units on a scale | Standard Deviation 22.29 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 40 | -39.95 units on a scale | Standard Deviation 23.16 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 24 | -36.67 units on a scale | Standard Deviation 23.23 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 44 | -38.53 units on a scale | Standard Deviation 22.64 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 36 | -38.29 units on a scale | Standard Deviation 23.55 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 16 | -34.84 units on a scale | Standard Deviation 23.77 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 12 | -28.91 units on a scale | Standard Deviation 25.08 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 28 | -37.17 units on a scale | Standard Deviation 22.57 |
| Placebo | Change From Baseline in PGA Through Week 52 | Week 20 | -34.83 units on a scale | Standard Deviation 24.45 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 24 | -38.50 units on a scale | Standard Deviation 23.05 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 20 | -38.65 units on a scale | Standard Deviation 21.19 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 28 | -39.29 units on a scale | Standard Deviation 21.74 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 32 | -40.49 units on a scale | Standard Deviation 21.08 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 4 | -19.49 units on a scale | Standard Deviation 18.14 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 8 | -30.55 units on a scale | Standard Deviation 21.05 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 12 | -35.53 units on a scale | Standard Deviation 21.28 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 16 | -34.68 units on a scale | Standard Deviation 22.76 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 36 | -40.76 units on a scale | Standard Deviation 21.04 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 40 | -41.88 units on a scale | Standard Deviation 21.29 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 44 | -42.16 units on a scale | Standard Deviation 21.19 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 48 | -43.41 units on a scale | Standard Deviation 20.74 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | Week 52 | -44.02 units on a scale | Standard Deviation 22.47 |
| Peficitinib 100 mg | Change From Baseline in PGA Through Week 52 | EOT | -40.56 units on a scale | Standard Deviation 22.93 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 52 | -39.43 units on a scale | Standard Deviation 21.85 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 8 | -11.70 units on a scale | Standard Deviation 20.42 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | EOT | -33.01 units on a scale | Standard Deviation 25.17 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 12 | -14.85 units on a scale | Standard Deviation 24.59 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 20 | -28.43 units on a scale | Standard Deviation 22.91 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 16 | -26.10 units on a scale | Standard Deviation 22.44 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 24 | -30.62 units on a scale | Standard Deviation 21.72 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 36 | -35.44 units on a scale | Standard Deviation 22.26 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 40 | -36.31 units on a scale | Standard Deviation 23.59 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 44 | -38.01 units on a scale | Standard Deviation 23.72 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 48 | -39.09 units on a scale | Standard Deviation 20.99 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 32 | -30.22 units on a scale | Standard Deviation 21.37 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 4 | -8.77 units on a scale | Standard Deviation 17.97 |
| Peficitinib 150 mg | Change From Baseline in PGA Through Week 52 | Week 28 | -31.69 units on a scale | Standard Deviation 24.41 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 32 | -37.27 units on a scale | Standard Deviation 23.1 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 52 | -43.24 units on a scale | Standard Deviation 24.17 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 36 | -38.90 units on a scale | Standard Deviation 21.79 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 28 | -37.90 units on a scale | Standard Deviation 22.5 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 40 | -38.83 units on a scale | Standard Deviation 22.58 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 44 | -37.74 units on a scale | Standard Deviation 23.46 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 20 | -33.80 units on a scale | Standard Deviation 21.18 |
| Etanercept | Change From Baseline in PGA Through Week 52 | EOT | -39.28 units on a scale | Standard Deviation 24.37 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 8 | -16.04 units on a scale | Standard Deviation 22.64 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 12 | -18.99 units on a scale | Standard Deviation 23.44 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 24 | -37.43 units on a scale | Standard Deviation 21.86 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 48 | -41.99 units on a scale | Standard Deviation 22 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 4 | -12.37 units on a scale | Standard Deviation 16.6 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 16 | -31.35 units on a scale | Standard Deviation 20.54 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 28 | -41.51 units on a scale | Standard Deviation 20.87 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 16 | -39.20 units on a scale | Standard Deviation 20.77 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 32 | -41.95 units on a scale | Standard Deviation 20.76 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 12 | -37.99 units on a scale | Standard Deviation 20.16 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 36 | -41.27 units on a scale | Standard Deviation 21.41 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 20 | -41.10 units on a scale | Standard Deviation 20.77 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 52 | -44.11 units on a scale | Standard Deviation 20.69 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 8 | -33.80 units on a scale | Standard Deviation 19.61 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 24 | -41.18 units on a scale | Standard Deviation 20.68 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 40 | -42.93 units on a scale | Standard Deviation 20.16 |
| Etanercept | Change From Baseline in PGA Through Week 52 | EOT | -41.07 units on a scale | Standard Deviation 22.71 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 48 | -43.71 units on a scale | Standard Deviation 20.63 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 4 | -27.48 units on a scale | Standard Deviation 20.1 |
| Etanercept | Change From Baseline in PGA Through Week 52 | Week 44 | -42.65 units on a scale | Standard Deviation 20.13 |
Secondary
Change From Baseline in Physician's Global Assessment of Arthritis (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, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12 | -13.94 Units on a Scale | Standard Deviation 24.85 |
| Peficitinib 100 mg | Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12 | -27.69 Units on a Scale | Standard Deviation 25.39 |
| Peficitinib 150 mg | Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12 | -34.65 Units on a Scale | Standard Deviation 21.19 |
| Etanercept | Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12 | -37.40 Units on a Scale | Standard Deviation 20.69 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-21.4, -9]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-28.78, -17.51]Covariance model
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 below 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, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SDAI Score at Week 12 | -7.22 Units on a Scale | Standard Deviation 14.11 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score at Week 12 | -16.08 Units on a Scale | Standard Deviation 14.37 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score at Week 12 | -20.93 Units on a Scale | Standard Deviation 11.32 |
| Etanercept | Change From Baseline in SDAI Score at Week 12 | -21.94 Units on a Scale | Standard Deviation 11.21 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-13.66, -6.22]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-17.71, -11.15]Covariance model
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 below 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 Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -11.83 Units on a Scale | Standard Deviation 9.97 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -21.34 Units on a Scale | Standard Deviation 12.65 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -20.29 Units on a Scale | Standard Deviation 12.71 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -21.72 Units on a Scale | Standard Deviation 12.82 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -21.19 Units on a Scale | Standard Deviation 12.83 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -16.59 Units on a Scale | Standard Deviation 13.47 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -21.11 Units on a Scale | Standard Deviation 12.13 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -19.25 Units on a Scale | Standard Deviation 13.76 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | EOT | -18.92 Units on a Scale | Standard Deviation 15.76 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -21.54 Units on a Scale | Standard Deviation 12.22 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -19.47 Units on a Scale | Standard Deviation 14.16 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -14.71 Units on a Scale | Standard Deviation 12.53 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -21.55 Units on a Scale | Standard Deviation 13.04 |
| Placebo | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -20.14 Units on a Scale | Standard Deviation 13.96 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -25.78 Units on a Scale | Standard Deviation 12.54 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -25.82 Units on a Scale | Standard Deviation 12.92 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -24.40 Units on a Scale | Standard Deviation 12 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -25.29 Units on a Scale | Standard Deviation 12.32 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -18.66 Units on a Scale | Standard Deviation 9.73 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -25.28 Units on a Scale | Standard Deviation 12.07 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -21.90 Units on a Scale | Standard Deviation 12.19 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -12.78 Units on a Scale | Standard Deviation 9.06 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -26.99 Units on a Scale | Standard Deviation 12.52 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -23.37 Units on a Scale | Standard Deviation 11.94 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -26.33 Units on a Scale | Standard Deviation 12.58 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -25.62 Units on a Scale | Standard Deviation 11.95 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -21.62 Units on a Scale | Standard Deviation 11.48 |
| Peficitinib 100 mg | Change From Baseline in SDAI Score Through Week 52 | EOT | -24.95 Units on a Scale | Standard Deviation 12.77 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -16.13 Units on a Scale | Standard Deviation 14.4 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -5.57 Units on a Scale | Standard Deviation 9.5 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -7.07 Units on a Scale | Standard Deviation 12.26 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -7.48 Units on a Scale | Standard Deviation 14.8 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -15.20 Units on a Scale | Standard Deviation 14.25 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -15.67 Units on a Scale | Standard Deviation 15.41 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -17.75 Units on a Scale | Standard Deviation 15.21 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -17.71 Units on a Scale | Standard Deviation 15.34 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -20.57 Units on a Scale | Standard Deviation 14.03 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -20.34 Units on a Scale | Standard Deviation 14.9 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -22.65 Units on a Scale | Standard Deviation 13.74 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -23.21 Units on a Scale | Standard Deviation 13.47 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -23.04 Units on a Scale | Standard Deviation 13.57 |
| Peficitinib 150 mg | Change From Baseline in SDAI Score Through Week 52 | EOT | -18.76 Units on a Scale | Standard Deviation 16.83 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -22.02 Units on a Scale | Standard Deviation 13.54 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -18.90 Units on a Scale | Standard Deviation 12.08 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -24.61 Units on a Scale | Standard Deviation 13.35 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -20.61 Units on a Scale | Standard Deviation 12.44 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -8.43 Units on a Scale | Standard Deviation 11.37 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -7.21 Units on a Scale | Standard Deviation 9.35 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | EOT | -22.38 Units on a Scale | Standard Deviation 15.91 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -23.23 Units on a Scale | Standard Deviation 14.31 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -22.74 Units on a Scale | Standard Deviation 13 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -25.20 Units on a Scale | Standard Deviation 13.91 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -21.14 Units on a Scale | Standard Deviation 14.69 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -23.09 Units on a Scale | Standard Deviation 14.63 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -10.18 Units on a Scale | Standard Deviation 11.82 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -22.25 Units on a Scale | Standard Deviation 13.22 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 8 | -20.64 Units on a Scale | Standard Deviation 10.09 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 36 | -25.77 Units on a Scale | Standard Deviation 11.33 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 16 | -23.46 Units on a Scale | Standard Deviation 10.37 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 4 | -17.09 Units on a Scale | Standard Deviation 10.83 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 40 | -26.46 Units on a Scale | Standard Deviation 11.11 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 12 | -22.54 Units on a Scale | Standard Deviation 10.79 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 44 | -26.17 Units on a Scale | Standard Deviation 11.06 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 52 | -26.77 Units on a Scale | Standard Deviation 11.57 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | EOT | -24.85 Units on a Scale | Standard Deviation 12.19 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 48 | -26.57 Units on a Scale | Standard Deviation 11.02 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 20 | -24.44 Units on a Scale | Standard Deviation 10.15 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 28 | -25.70 Units on a Scale | Standard Deviation 10.51 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 32 | -25.84 Units on a Scale | Standard Deviation 10.79 |
| Etanercept | Change From Baseline in SDAI Score Through Week 52 | Week 24 | -24.78 Units on a Scale | Standard Deviation 10.14 |
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, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 0.00 Units on a Scale | Standard Deviation 8.65 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 2.70 Units on a Scale | Standard Deviation 7.59 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 3.69 Units on a Scale | Standard Deviation 8.23 |
| Etanercept | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | 3.23 Units on a Scale | Standard Deviation 8.24 |
Comparison: Treatment Difference vs Placebop-value: 0.00495% CI: [0.91, 4.87]Covariance model
Comparison: Treatment Difference vs Placebop-value: 0.00195% CI: [1.3, 5.19]Covariance model
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 and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 28 | 2.95 units on a scale | Standard Deviation 8.07 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 8 | 2.91 units on a scale | Standard Deviation 7.39 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 52 | 4.23 units on a scale | Standard Deviation 8.17 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 4 | 1.53 units on a scale | Standard Deviation 7.19 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 12 | 2.38 units on a scale | Standard Deviation 7.53 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 4 | 1.72 units on a scale | Standard Deviation 7.58 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 28 | 3.52 units on a scale | Standard Deviation 8.14 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 12 | 4.01 units on a scale | Standard Deviation 8.17 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 52 | 4.39 units on a scale | Standard Deviation 8.08 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 8 | 3.55 units on a scale | Standard Deviation 9.08 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 52 | 3.79 units on a scale | Standard Deviation 8.38 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 8 | 3.56 units on a scale | Standard Deviation 8.49 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 12 | 3.63 units on a scale | Standard Deviation 7.95 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 28 | 3.80 units on a scale | Standard Deviation 7.66 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | Week 4 | 2.85 units on a scale | Standard Deviation 8.07 |
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 and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 52 | 13.07 Units on a Scale | Standard Deviation 12.41 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 28 | 10.85 Units on a Scale | Standard Deviation 12.79 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 8 | 6.43 Units on a Scale | Standard Deviation 10.98 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 12 | 9.93 Units on a Scale | Standard Deviation 12.38 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 4 | 3.82 Units on a Scale | Standard Deviation 10.21 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 28 | 10.95 Units on a Scale | Standard Deviation 12.04 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 8 | 6.78 Units on a Scale | Standard Deviation 9.99 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 12 | 9.63 Units on a Scale | Standard Deviation 10.33 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 52 | 9.88 Units on a Scale | Standard Deviation 12.51 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 4 | 3.20 Units on a Scale | Standard Deviation 10.49 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 4 | 6.10 Units on a Scale | Standard Deviation 10.07 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 52 | 11.18 Units on a Scale | Standard Deviation 11.77 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 8 | 7.35 Units on a Scale | Standard Deviation 10.23 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 28 | 10.28 Units on a Scale | Standard Deviation 10.67 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | Week 12 | 8.40 Units on a Scale | Standard Deviation 10.51 |
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, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | 0.17 Units on a Scale | Standard Deviation 15.12 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | 1.24 Units on a Scale | Standard Deviation 14.4 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | 7.04 Units on a Scale | Standard Deviation 14.56 |
| Etanercept | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | 7.16 Units on a Scale | Standard Deviation 13.23 |
Comparison: Treatment Difference vs Placebop-value: 0.2195% CI: [-1.29, 5.83]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.74, 9.71]Covariance model
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 and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 52 | 3.88 Units on a Scale | Standard Deviation 15.12 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 4 | 0.40 Units on a Scale | Standard Deviation 12.75 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 8 | 3.80 Units on a Scale | Standard Deviation 13.23 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 12 | 1.68 Units on a Scale | Standard Deviation 14.33 |
| Placebo | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 28 | 4.18 Units on a Scale | Standard Deviation 14.21 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 12 | 7.82 Units on a Scale | Standard Deviation 14.66 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 28 | 8.78 Units on a Scale | Standard Deviation 14.2 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 4 | 4.27 Units on a Scale | Standard Deviation 12.02 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 52 | 9.15 Units on a Scale | Standard Deviation 13.39 |
| Peficitinib 100 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 8 | 5.96 Units on a Scale | Standard Deviation 14.6 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 28 | 7.31 Units on a Scale | Standard Deviation 14.74 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 8 | 6.51 Units on a Scale | Standard Deviation 12.54 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 12 | 7.49 Units on a Scale | Standard Deviation 13.04 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 52 | 8.36 Units on a Scale | Standard Deviation 14.03 |
| Peficitinib 150 mg | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | Week 4 | 4.06 Units on a Scale | Standard Deviation 13.08 |
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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SGA Through Week 52 | Week 20 | -29.82 units on a scale | Standard Deviation 32.87 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 16 | -29.98 units on a scale | Standard Deviation 30.36 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 12 | -25.09 units on a scale | Standard Deviation 31.56 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 48 | -35.53 units on a scale | Standard Deviation 32.53 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 44 | -34.87 units on a scale | Standard Deviation 32.36 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 40 | -34.66 units on a scale | Standard Deviation 32.19 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 36 | -32.11 units on a scale | Standard Deviation 30.55 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 4 | -14.66 units on a scale | Standard Deviation 24.11 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 32 | -34.49 units on a scale | Standard Deviation 30.49 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 28 | -31.19 units on a scale | Standard Deviation 33.76 |
| Placebo | Change From Baseline in SGA Through Week 52 | EOT | -28.52 units on a scale | Standard Deviation 35.62 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 24 | -30.09 units on a scale | Standard Deviation 31.93 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 8 | -21.29 units on a scale | Standard Deviation 30.24 |
| Placebo | Change From Baseline in SGA Through Week 52 | Week 52 | -35.61 units on a scale | Standard Deviation 33.45 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 4 | -18.30 units on a scale | Standard Deviation 24.25 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 16 | -34.37 units on a scale | Standard Deviation 28.43 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 8 | -29.55 units on a scale | Standard Deviation 26.34 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 12 | -32.75 units on a scale | Standard Deviation 27.51 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 20 | -36.21 units on a scale | Standard Deviation 26.97 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 24 | -37.51 units on a scale | Standard Deviation 29.32 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 28 | -37.91 units on a scale | Standard Deviation 27.72 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 32 | -38.71 units on a scale | Standard Deviation 28.92 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 36 | -39.08 units on a scale | Standard Deviation 26.81 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 40 | -40.85 units on a scale | Standard Deviation 28 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 44 | -39.51 units on a scale | Standard Deviation 29.51 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 48 | -41.60 units on a scale | Standard Deviation 27.74 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | Week 52 | -41.54 units on a scale | Standard Deviation 28.6 |
| Peficitinib 100 mg | Change From Baseline in SGA Through Week 52 | EOT | -38.84 units on a scale | Standard Deviation 29.05 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 16 | -21.29 units on a scale | Standard Deviation 24.56 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 24 | -25.96 units on a scale | Standard Deviation 25.72 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 4 | -1.83 units on a scale | Standard Deviation 18.03 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 28 | -25.66 units on a scale | Standard Deviation 27.71 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 32 | -27.97 units on a scale | Standard Deviation 28.37 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 36 | -31.56 units on a scale | Standard Deviation 25.36 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 52 | -32.06 units on a scale | Standard Deviation 28.15 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 40 | -30.76 units on a scale | Standard Deviation 27.65 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 44 | -36.01 units on a scale | Standard Deviation 27.49 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | EOT | -26.80 units on a scale | Standard Deviation 30.15 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 12 | -6.93 units on a scale | Standard Deviation 22.74 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 8 | -5.71 units on a scale | Standard Deviation 22.02 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 48 | -34.09 units on a scale | Standard Deviation 26.6 |
| Peficitinib 150 mg | Change From Baseline in SGA Through Week 52 | Week 20 | -17.76 units on a scale | Standard Deviation 26.75 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 32 | -26.17 units on a scale | Standard Deviation 28.46 |
| Etanercept | Change From Baseline in SGA Through Week 52 | EOT | -28.71 units on a scale | Standard Deviation 27.54 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 12 | -8.85 units on a scale | Standard Deviation 27.24 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 36 | -26.64 units on a scale | Standard Deviation 26 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 52 | -32.91 units on a scale | Standard Deviation 27.33 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 40 | -28.80 units on a scale | Standard Deviation 28.13 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 20 | -24.53 units on a scale | Standard Deviation 24.24 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 44 | -28.19 units on a scale | Standard Deviation 26.52 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 24 | -25.42 units on a scale | Standard Deviation 26.02 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 4 | -6.59 units on a scale | Standard Deviation 21.35 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 16 | -21.98 units on a scale | Standard Deviation 25.1 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 28 | -26.01 units on a scale | Standard Deviation 26.63 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 48 | -31.05 units on a scale | Standard Deviation 27.81 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 8 | -8.78 units on a scale | Standard Deviation 21.39 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 20 | -36.10 units on a scale | Standard Deviation 26.28 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 52 | -40.36 units on a scale | Standard Deviation 27.01 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 44 | -39.01 units on a scale | Standard Deviation 26.58 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 32 | -38.02 units on a scale | Standard Deviation 27.74 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 24 | -37.12 units on a scale | Standard Deviation 26.33 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 36 | -37.54 units on a scale | Standard Deviation 27.65 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 28 | -37.75 units on a scale | Standard Deviation 26.52 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 12 | -33.14 units on a scale | Standard Deviation 27.23 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 8 | -29.31 units on a scale | Standard Deviation 26.07 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 4 | -24.38 units on a scale | Standard Deviation 25.81 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 40 | -38.42 units on a scale | Standard Deviation 26.72 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 16 | -34.88 units on a scale | Standard Deviation 25.91 |
| Etanercept | Change From Baseline in SGA Through Week 52 | EOT | -37.09 units on a scale | Standard Deviation 27.62 |
| Etanercept | Change From Baseline in SGA Through Week 52 | Week 48 | -39.47 units on a scale | Standard Deviation 26.06 |
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, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| 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 | 1.95 Units on a Scale | Standard Deviation 12.2 |
| Peficitinib 100 mg | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | 8.36 Units on a Scale | Standard Deviation 14.05 |
| Peficitinib 150 mg | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | 8.81 Units on a Scale | Standard Deviation 10.54 |
| Etanercept | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | 8.53 Units on a Scale | Standard Deviation 10.61 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [3.69, 10.05]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.11, 9.85]Covariance model
Secondary
Change From Baseline in SJC (66 Joints) Through Week 52
The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -6.4 Swollen Joints | Standard Deviation 5.8 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -7.9 Swollen Joints | Standard Deviation 6 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -8.2 Swollen Joints | Standard Deviation 5.6 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -4.5 Swollen Joints | Standard Deviation 4.9 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -8.6 Swollen Joints | Standard Deviation 5.8 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -5.6 Swollen Joints | Standard Deviation 5.6 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -7.7 Swollen Joints | Standard Deviation 7.1 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -8.8 Swollen Joints | Standard Deviation 5.5 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -8.4 Swollen Joints | Standard Deviation 5.7 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -7.7 Swollen Joints | Standard Deviation 6 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -8.7 Swollen Joints | Standard Deviation 5.9 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -8.4 Swollen Joints | Standard Deviation 6.1 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -7.6 Swollen Joints | Standard Deviation 6.3 |
| Placebo | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -8.2 Swollen Joints | Standard Deviation 6.3 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -8.7 Swollen Joints | Standard Deviation 6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -10.4 Swollen Joints | Standard Deviation 5.7 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -10.4 Swollen Joints | Standard Deviation 6.3 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -9.7 Swollen Joints | Standard Deviation 6.5 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -10.8 Swollen Joints | Standard Deviation 6.4 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -8.7 Swollen Joints | Standard Deviation 6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -11.0 Swollen Joints | Standard Deviation 6 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -4.7 Swollen Joints | Standard Deviation 4.2 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -10.0 Swollen Joints | Standard Deviation 6.5 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -10.4 Swollen Joints | Standard Deviation 5.7 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -10.5 Swollen Joints | Standard Deviation 6.2 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -10.4 Swollen Joints | Standard Deviation 6.1 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -7.1 Swollen Joints | Standard Deviation 5.2 |
| Peficitinib 100 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -9.1 Swollen Joints | Standard Deviation 6.2 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -6.6 Swollen Joints | Standard Deviation 6.4 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -2.5 Swollen Joints | Standard Deviation 6 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -2.8 Swollen Joints | Standard Deviation 5.8 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -3.3 Swollen Joints | Standard Deviation 6.7 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -6.4 Swollen Joints | Standard Deviation 6.3 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -6.5 Swollen Joints | Standard Deviation 6.2 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -6.7 Swollen Joints | Standard Deviation 7.5 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -5.9 Swollen Joints | Standard Deviation 8.3 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -7.6 Swollen Joints | Standard Deviation 7.1 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -7.6 Swollen Joints | Standard Deviation 7 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -8.0 Swollen Joints | Standard Deviation 8 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -8.0 Swollen Joints | Standard Deviation 7.2 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -8.2 Swollen Joints | Standard Deviation 8.7 |
| Peficitinib 150 mg | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -6.7 Swollen Joints | Standard Deviation 9.7 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -6.3 Swollen Joints | Standard Deviation 5.3 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -9.1 Swollen Joints | Standard Deviation 8.1 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -3.9 Swollen Joints | Standard Deviation 5.6 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -2.2 Swollen Joints | Standard Deviation 4.5 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -8.2 Swollen Joints | Standard Deviation 7.5 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -9.3 Swollen Joints | Standard Deviation 8 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -8.6 Swollen Joints | Standard Deviation 8 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -8.2 Swollen Joints | Standard Deviation 7.6 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -9.1 Swollen Joints | Standard Deviation 8 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -9.4 Swollen Joints | Standard Deviation 8 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -8.7 Swollen Joints | Standard Deviation 7.4 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -8.5 Swollen Joints | Standard Deviation 7.7 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -7.8 Swollen Joints | Standard Deviation 6.9 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -3.4 Swollen Joints | Standard Deviation 4.7 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 16 | -8.7 Swollen Joints | Standard Deviation 5.3 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 32 | -9.8 Swollen Joints | Standard Deviation 6.1 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 12 | -8.3 Swollen Joints | Standard Deviation 5.5 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 36 | -9.8 Swollen Joints | Standard Deviation 6 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 8 | -7.6 Swollen Joints | Standard Deviation 5.2 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 52 | -10.2 Swollen Joints | Standard Deviation 6.5 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 40 | -10.0 Swollen Joints | Standard Deviation 6.2 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 4 | -6.3 Swollen Joints | Standard Deviation 5.8 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 44 | -9.9 Swollen Joints | Standard Deviation 6.4 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | EOT | -9.7 Swollen Joints | Standard Deviation 6.4 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 24 | -9.1 Swollen Joints | Standard Deviation 5.3 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 20 | -9.2 Swollen Joints | Standard Deviation 5.5 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 28 | -9.7 Swollen Joints | Standard Deviation 5.9 |
| Etanercept | Change From Baseline in SJC (66 Joints) Through Week 52 | Week 48 | -9.9 Swollen Joints | Standard Deviation 6 |
Secondary
Change From Baseline in Subject's Assessment of Pain at Week 12
The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Subject's Assessment of Pain at Week 12 | -6.64 Units on a Scale | Standard Deviation 24.61 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain at Week 12 | -23.78 Units on a Scale | Standard Deviation 30.75 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain at Week 12 | -30.65 Units on a Scale | Standard Deviation 27.91 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain at Week 12 | -30.82 Units on a Scale | Standard Deviation 27.68 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-24.36, -10.81]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-30.24, -17.57]Covariance model
Secondary
Change From Baseline in Subject's Assessment of Pain Through Week 52
The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 4 | -14.80 Units on a Scale | Standard Deviation 29.58 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 36 | -32.44 Units on a Scale | Standard Deviation 30.76 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 28 | -31.66 Units on a Scale | Standard Deviation 31.61 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 32 | -34.15 Units on a Scale | Standard Deviation 30.84 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 52 | -33.24 Units on a Scale | Standard Deviation 34.91 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 12 | -25.02 Units on a Scale | Standard Deviation 30.64 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 48 | -34.87 Units on a Scale | Standard Deviation 31.77 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 16 | -28.58 Units on a Scale | Standard Deviation 31.83 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | EOT | -28.49 Units on a Scale | Standard Deviation 34.27 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 44 | -34.59 Units on a Scale | Standard Deviation 30.82 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 20 | -29.68 Units on a Scale | Standard Deviation 32.42 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 8 | -22.45 Units on a Scale | Standard Deviation 31.06 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 40 | -35.06 Units on a Scale | Standard Deviation 31.74 |
| Placebo | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 24 | -29.78 Units on a Scale | Standard Deviation 32.23 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 24 | -37.78 Units on a Scale | Standard Deviation 28.87 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 20 | -35.83 Units on a Scale | Standard Deviation 28.4 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 16 | -34.41 Units on a Scale | Standard Deviation 27.22 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 28 | -36.48 Units on a Scale | Standard Deviation 29.18 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 8 | -29.58 Units on a Scale | Standard Deviation 26.18 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 32 | -37.65 Units on a Scale | Standard Deviation 28.66 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 36 | -38.48 Units on a Scale | Standard Deviation 27.27 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 4 | -18.36 Units on a Scale | Standard Deviation 24.49 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 52 | -42.01 Units on a Scale | Standard Deviation 28.18 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 44 | -38.76 Units on a Scale | Standard Deviation 29.25 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 40 | -40.67 Units on a Scale | Standard Deviation 27.68 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 12 | -31.83 Units on a Scale | Standard Deviation 28.13 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | EOT | -38.03 Units on a Scale | Standard Deviation 29.14 |
| Peficitinib 100 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 48 | -40.27 Units on a Scale | Standard Deviation 28.71 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 24 | -22.64 Units on a Scale | Standard Deviation 26.09 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 4 | -2.00 Units on a Scale | Standard Deviation 18.75 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 8 | -4.11 Units on a Scale | Standard Deviation 21.26 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 12 | -5.40 Units on a Scale | Standard Deviation 24.28 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 16 | -20.93 Units on a Scale | Standard Deviation 25.76 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 20 | -16.21 Units on a Scale | Standard Deviation 28.27 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 28 | -22.63 Units on a Scale | Standard Deviation 28.92 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 32 | -25.53 Units on a Scale | Standard Deviation 27.07 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 36 | -28.38 Units on a Scale | Standard Deviation 25.68 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 40 | -26.65 Units on a Scale | Standard Deviation 28.1 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 44 | -32.32 Units on a Scale | Standard Deviation 27.16 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 48 | -31.57 Units on a Scale | Standard Deviation 27.05 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 52 | -29.57 Units on a Scale | Standard Deviation 26.98 |
| Peficitinib 150 mg | Change From Baseline in Subject's Assessment of Pain Through Week 52 | EOT | -24.18 Units on a Scale | Standard Deviation 28.11 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 24 | -26.51 Units on a Scale | Standard Deviation 25.46 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 36 | -26.79 Units on a Scale | Standard Deviation 25.38 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 20 | -24.63 Units on a Scale | Standard Deviation 26.52 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 40 | -29.48 Units on a Scale | Standard Deviation 26.77 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 16 | -21.20 Units on a Scale | Standard Deviation 23.95 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 4 | -8.23 Units on a Scale | Standard Deviation 25.32 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 44 | -28.55 Units on a Scale | Standard Deviation 25.32 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 12 | -9.15 Units on a Scale | Standard Deviation 25.8 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 48 | -30.73 Units on a Scale | Standard Deviation 27.45 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 8 | -9.17 Units on a Scale | Standard Deviation 22.75 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | EOT | -28.51 Units on a Scale | Standard Deviation 27.74 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 28 | -24.93 Units on a Scale | Standard Deviation 26.19 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 52 | -32.11 Units on a Scale | Standard Deviation 27.54 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 32 | -27.09 Units on a Scale | Standard Deviation 26.2 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 28 | -36.23 Units on a Scale | Standard Deviation 27.15 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | EOT | -35.47 Units on a Scale | Standard Deviation 27.47 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 36 | -36.31 Units on a Scale | Standard Deviation 26.59 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 20 | -34.76 Units on a Scale | Standard Deviation 26.53 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 32 | -37.20 Units on a Scale | Standard Deviation 27.18 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 4 | -22.24 Units on a Scale | Standard Deviation 25.57 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 48 | -37.03 Units on a Scale | Standard Deviation 26.66 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 40 | -36.45 Units on a Scale | Standard Deviation 26.58 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 16 | -32.48 Units on a Scale | Standard Deviation 26.22 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 8 | -27.43 Units on a Scale | Standard Deviation 26.9 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 24 | -35.45 Units on a Scale | Standard Deviation 27.27 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 52 | -38.47 Units on a Scale | Standard Deviation 26.45 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 44 | -36.24 Units on a Scale | Standard Deviation 25.37 |
| Etanercept | Change From Baseline in Subject's Assessment of Pain Through Week 52 | Week 12 | -31.37 Units on a Scale | Standard Deviation 27.66 |
Secondary
Change From Baseline in Subject's 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, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Subject's SGA at Week 12 | -7.87 Units on a Scale | Standard Deviation 25.15 |
| Peficitinib 100 mg | Change From Baseline in Subject's SGA at Week 12 | -23.74 Units on a Scale | Standard Deviation 32.14 |
| Peficitinib 150 mg | Change From Baseline in Subject's SGA at Week 12 | -31.59 Units on a Scale | Standard Deviation 27.41 |
| Etanercept | Change From Baseline in Subject's SGA at Week 12 | -32.43 Units on a Scale | Standard Deviation 27.39 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-23.81, -9.95]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-29.83, -17.28]Covariance model
Secondary
Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12
The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12 | -3.2 Tender Joints | Standard Deviation 6 |
| Peficitinib 100 mg | Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12 | -6.0 Tender Joints | Standard Deviation 6.4 |
| Peficitinib 150 mg | Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12 | -8.4 Tender Joints | Standard Deviation 5.9 |
| Etanercept | Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12 | -8.3 Tender Joints | Standard Deviation 5.5 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-4.6, -1.4]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-6.8, -3.9]Covariance model
Secondary
Change From Baseline in TJC (68 Joints) at Week 12
The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in TJC (68 Joints) at Week 12 | -4.3 Tender Joints | Standard Deviation 9.2 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) at Week 12 | -8.2 Tender Joints | Standard Deviation 8.8 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) at Week 12 | -9.9 Tender Joints | Standard Deviation 8 |
| Etanercept | Change From Baseline in TJC (68 Joints) at Week 12 | -10.7 Tender Joints | Standard Deviation 7.8 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-6.8, -2.4]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-8.1, -4]Covariance model
Secondary
Change From Baseline in TJC (68 Joints) Through Week 52
The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -10.4 Tender Joints | Standard Deviation 8.5 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -7.8 Tender Joints | Standard Deviation 7.6 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -10.1 Tender Joints | Standard Deviation 7.1 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -9.2 Tender Joints | Standard Deviation 9.2 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -10.2 Tender Joints | Standard Deviation 8.6 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -5.9 Tender Joints | Standard Deviation 8 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -9.1 Tender Joints | Standard Deviation 9.7 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -10.6 Tender Joints | Standard Deviation 8.2 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -9.8 Tender Joints | Standard Deviation 9.2 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -10.1 Tender Joints | Standard Deviation 7.6 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -8.6 Tender Joints | Standard Deviation 8.8 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -10.5 Tender Joints | Standard Deviation 8.5 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -9.4 Tender Joints | Standard Deviation 9.4 |
| Placebo | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -9.7 Tender Joints | Standard Deviation 8.8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -11.5 Tender Joints | Standard Deviation 9.9 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -12.0 Tender Joints | Standard Deviation 9.3 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -12.2 Tender Joints | Standard Deviation 8.6 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -8.6 Tender Joints | Standard Deviation 7.1 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -12.8 Tender Joints | Standard Deviation 9.3 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -10.3 Tender Joints | Standard Deviation 8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -5.4 Tender Joints | Standard Deviation 6 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -12.4 Tender Joints | Standard Deviation 9.5 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -10.3 Tender Joints | Standard Deviation 8.8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -11.3 Tender Joints | Standard Deviation 9.7 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -12.0 Tender Joints | Standard Deviation 8.7 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -11.3 Tender Joints | Standard Deviation 8.6 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -11.8 Tender Joints | Standard Deviation 8.8 |
| Peficitinib 100 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -11.7 Tender Joints | Standard Deviation 8.4 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -8.1 Tender Joints | Standard Deviation 10.8 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -3.9 Tender Joints | Standard Deviation 8.1 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -4.4 Tender Joints | Standard Deviation 8.4 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -5.0 Tender Joints | Standard Deviation 9.7 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -7.7 Tender Joints | Standard Deviation 10.2 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -7.6 Tender Joints | Standard Deviation 9.9 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -8.4 Tender Joints | Standard Deviation 10.3 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -9.2 Tender Joints | Standard Deviation 10.3 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -10.1 Tender Joints | Standard Deviation 9.5 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -9.9 Tender Joints | Standard Deviation 9.6 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -10.7 Tender Joints | Standard Deviation 10 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -11.3 Tender Joints | Standard Deviation 9.6 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -11.4 Tender Joints | Standard Deviation 10.1 |
| Peficitinib 150 mg | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -9.6 Tender Joints | Standard Deviation 10.7 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -11.7 Tender Joints | Standard Deviation 7.9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -11.5 Tender Joints | Standard Deviation 8.1 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -10.3 Tender Joints | Standard Deviation 7.9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -12.2 Tender Joints | Standard Deviation 8.4 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -9.6 Tender Joints | Standard Deviation 7.5 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -4.3 Tender Joints | Standard Deviation 6.4 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -12.5 Tender Joints | Standard Deviation 7.8 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -5.5 Tender Joints | Standard Deviation 7.6 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -13.2 Tender Joints | Standard Deviation 7.7 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -3.9 Tender Joints | Standard Deviation 8.3 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -11.9 Tender Joints | Standard Deviation 8.5 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -11.5 Tender Joints | Standard Deviation 8.2 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -12.9 Tender Joints | Standard Deviation 7.9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -11.1 Tender Joints | Standard Deviation 8.5 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 28 | -12.6 Tender Joints | Standard Deviation 8.6 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | EOT | -11.9 Tender Joints | Standard Deviation 8.8 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 36 | -12.6 Tender Joints | Standard Deviation 8.6 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 20 | -12.0 Tender Joints | Standard Deviation 7.9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 32 | -12.4 Tender Joints | Standard Deviation 8.9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 4 | -8.3 Tender Joints | Standard Deviation 7.7 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 48 | -12.8 Tender Joints | Standard Deviation 8.7 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 40 | -12.9 Tender Joints | Standard Deviation 8.8 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 16 | -11.5 Tender Joints | Standard Deviation 7.6 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 8 | -10.3 Tender Joints | Standard Deviation 7.1 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 24 | -12.2 Tender Joints | Standard Deviation 8.2 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 52 | -12.8 Tender Joints | Standard Deviation 8.9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 44 | -12.8 Tender Joints | Standard Deviation 9 |
| Etanercept | Change From Baseline in TJC (68 Joints) Through Week 52 | Week 12 | -11.0 Tender Joints | Standard Deviation 7.6 |
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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | 6.78 Percent Work Time | Standard Deviation 25.76 |
| Peficitinib 100 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | -2.14 Percent Work Time | Standard Deviation 18.47 |
| Peficitinib 150 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | -6.80 Percent Work Time | Standard Deviation 19.4 |
| Etanercept | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | -5.60 Percent Work Time | Standard Deviation 20.63 |
Comparison: Treatment Difference vs Placebop-value: 0.02795% CI: [-16.11, -1]Covariance model
Comparison: Treatment Difference vs Placebop-value: 0.0195% CI: [-17.88, -2.47]Covariance model
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 indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -4.65 Percent Impairment | Standard Deviation 26.39 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -19.61 Percent Impairment | Standard Deviation 29.62 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -24.65 Percent Impairment | Standard Deviation 28.27 |
| Etanercept | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | -26.40 Percent Impairment | Standard Deviation 24.5 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-24, -10.61]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-26.59, -14.24]Covariance model
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 indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.
Time frame: Baseline and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 4 | -10.92 percent impairment | Standard Deviation 24.75 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 52 | -28.17 percent impairment | Standard Deviation 30.01 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 12 | -21.47 percent impairment | Standard Deviation 29.53 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 8 | -20.10 percent impairment | Standard Deviation 26.89 |
| Placebo | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 28 | -25.18 percent impairment | Standard Deviation 31.4 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 8 | -23.64 percent impairment | Standard Deviation 26.05 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 52 | -34.07 percent impairment | Standard Deviation 27.69 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 4 | -11.30 percent impairment | Standard Deviation 21.82 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 12 | -26.74 percent impairment | Standard Deviation 28.48 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 28 | -30.00 percent impairment | Standard Deviation 27.8 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 52 | -31.79 percent impairment | Standard Deviation 26.96 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 12 | -27.33 percent impairment | Standard Deviation 23.9 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 4 | -17.90 percent impairment | Standard Deviation 23.11 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 28 | -30.34 percent impairment | Standard Deviation 26.86 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | Week 8 | -25.33 percent impairment | Standard Deviation 23.95 |
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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | 4.13 Percent Impairment | Standard Deviation 30.15 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | -13.04 Percent Impairment | Standard Deviation 30.45 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | -16.12 Percent Impairment | Standard Deviation 31.94 |
| Etanercept | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | -24.43 Percent Impairment | Standard Deviation 25.82 |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-30.44, -10.89]Covariance model
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [-32.06, -11.97]Covariance model
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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.
Time frame: Baseline and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 8 | -14.31 percent impairment | Standard Deviation 26.1 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 4 | -6.42 percent impairment | Standard Deviation 22.28 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 12 | -13.33 percent impairment | Standard Deviation 30.96 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 28 | -17.35 percent impairment | Standard Deviation 34.63 |
| Placebo | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 52 | -20.79 percent impairment | Standard Deviation 36.27 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 52 | -23.89 percent impairment | Standard Deviation 30.55 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 4 | -6.46 percent impairment | Standard Deviation 27.48 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 8 | -15.42 percent impairment | Standard Deviation 27.75 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 12 | -19.77 percent impairment | Standard Deviation 31.66 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 28 | -25.85 percent impairment | Standard Deviation 28.1 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 12 | -24.11 percent impairment | Standard Deviation 25.95 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 52 | -31.36 percent impairment | Standard Deviation 31.18 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 28 | -29.53 percent impairment | Standard Deviation 26.78 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 8 | -20.52 percent impairment | Standard Deviation 25.31 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | Week 4 | -18.33 percent impairment | Standard Deviation 26.34 |
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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\].
Time frame: Baseline and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 28 | -17.48 Percent Impairment | Standard Deviation 34.87 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 8 | -14.16 Percent Impairment | Standard Deviation 27.22 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 52 | -21.53 Percent Impairment | Standard Deviation 35.95 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 4 | -5.72 Percent Impairment | Standard Deviation 21.61 |
| Placebo | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 12 | -13.16 Percent Impairment | Standard Deviation 32.11 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 28 | -28.68 Percent Impairment | Standard Deviation 29.66 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 12 | -22.84 Percent Impairment | Standard Deviation 33.22 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 8 | -17.44 Percent Impairment | Standard Deviation 29.05 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 52 | -24.75 Percent Impairment | Standard Deviation 31.45 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 4 | -8.67 Percent Impairment | Standard Deviation 28.2 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 52 | -32.18 Percent Impairment | Standard Deviation 31.81 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 4 | -18.20 Percent Impairment | Standard Deviation 26.96 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 8 | -20.94 Percent Impairment | Standard Deviation 25.88 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 12 | -25.35 Percent Impairment | Standard Deviation 26.68 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | Week 28 | -30.12 Percent Impairment | Standard Deviation 28.21 |
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) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).
Time frame: Baseline and Week 4, 8, 12, 28, and 52
Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 4 | -0.56 Percent Work Time | Standard Deviation 20.13 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 52 | -6.76 Percent Work Time | Standard Deviation 22.2 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 8 | -2.38 Percent Work Time | Standard Deviation 16.15 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 28 | -3.14 Percent Work Time | Standard Deviation 24.48 |
| Placebo | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 12 | -1.38 Percent Work Time | Standard Deviation 18.13 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 28 | -6.46 Percent Work Time | Standard Deviation 20.29 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 52 | -6.35 Percent Work Time | Standard Deviation 16.57 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 4 | -6.35 Percent Work Time | Standard Deviation 15.94 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 8 | -6.10 Percent Work Time | Standard Deviation 19.3 |
| Peficitinib 100 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 12 | -6.69 Percent Work Time | Standard Deviation 19.78 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 8 | -4.33 Percent Work Time | Standard Deviation 15.57 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 52 | -4.52 Percent Work Time | Standard Deviation 14.91 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 28 | -5.03 Percent Work Time | Standard Deviation 18.18 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 4 | -3.71 Percent Work Time | Standard Deviation 17.34 |
| Peficitinib 150 mg | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | Week 12 | -4.73 Percent Work Time | Standard Deviation 18.54 |
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy
The number of participants who withdrew due to lack of efficacy up to week 12 was calculated.
Time frame: Up to week 12
Population: Initial Randomization Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Lack of Efficacy | 7 Participants |
| Peficitinib 100 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 1 Participants |
| Peficitinib 150 mg | Number of Participants Who Withdrew Due to Lack of Efficacy | 1 Participants |
| Etanercept | Number of Participants Who Withdrew Due to Lack of Efficacy | 1 Participants |
Comparison: Treatment Difference vs Placebop-value: 0.033Fisher Exact
Comparison: Treatment Difference vs Placebop-value: 0.035Fisher Exact
Secondary
Number of Participants With Adverse Events During the First 12 Weeks
Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Time frame: Week 0 to Week 12
Population: SAF
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs | 4 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs | 29 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs leading to discontinuation | 2 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to discontinuation | 4 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs leading to discontinuation | 1 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs leading to discont. | 1 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | ≥ Grade 3 TEAEs | 8 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs | 54 Participants |
| Placebo | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs | 3 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs leading to discont. | 1 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | ≥ Grade 3 TEAEs | 6 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs leading to discontinuation | 4 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs | 33 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to discontinuation | 6 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs | 3 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs | 2 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs leading to discontinuation | 2 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs | 49 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs | 55 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs | 2 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs | 1 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs leading to discontinuation | 2 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs leading to discontinuation | 2 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to discontinuation | 3 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs | 38 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | ≥ Grade 3 TEAEs | 3 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs leading to discont. | 1 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to death | 0 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs | 4 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | Serious TEAEs leading to discontinuation | 2 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs | 4 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related serious TEAEs leading to discont. | 2 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | ≥ Grade 3 TEAEs | 6 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs leading to discontinuation | 5 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs leading to discontinuation | 5 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | Drug-related TEAEs | 75 Participants |
| Etanercept | Number of Participants With Adverse Events During the First 12 Weeks | TEAEs | 119 Participants |
Secondary
Number of Participants With Adverse Events From Week 12
Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Time frame: Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study
Population: SAF
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs | 50 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs leading to discont. | 2 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | ≥ Grade 3 TEAEs | 9 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | TEAEs | 78 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | Serious TEAEs leading to discontinuation | 4 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs | 2 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | TEAEs leading to discontinuation | 7 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | Serious TEAEs | 5 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs leading to discontinuation | 3 Participants |
| Placebo | Number of Participants With Adverse Events From Week 12 | TEAEs leading to death | 0 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs leading to discontinuation | 2 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | TEAEs leading to discontinuation | 3 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs leading to discont. | 0 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | Serious TEAEs leading to discontinuation | 0 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | TEAEs | 79 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs | 2 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | ≥ Grade 3 TEAEs | 16 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | TEAEs leading to death | 0 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs | 47 Participants |
| Peficitinib 100 mg | Number of Participants With Adverse Events From Week 12 | Serious TEAEs | 6 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | Serious TEAEs leading to discontinuation | 1 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | ≥ Grade 3 TEAEs | 2 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | TEAEs leading to discontinuation | 2 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs leading to discontinuation | 2 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs leading to discont. | 1 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | TEAEs | 41 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs | 27 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | TEAEs leading to death | 0 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | Serious TEAEs | 4 Participants |
| Peficitinib 150 mg | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs | 2 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs leading to discontinuation | 4 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs | 26 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Serious TEAEs leading to discontinuation | 2 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | TEAEs leading to death | 0 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | TEAEs leading to discontinuation | 4 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs leading to discont. | 2 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Serious TEAEs | 5 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | ≥ Grade 3 TEAEs | 12 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | TEAEs | 37 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs | 2 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Serious TEAEs leading to discontinuation | 3 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs leading to discontinuation | 6 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related TEAEs | 93 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Serious TEAEs | 14 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | TEAEs leading to discontinuation | 8 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs | 5 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | TEAEs | 156 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | TEAEs leading to death | 0 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | Drug-related serious TEAEs leading to discont. | 2 Participants |
| Etanercept | Number of Participants With Adverse Events From Week 12 | ≥ Grade 3 TEAEs | 23 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 subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 2.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 5.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 5.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | 13.5 Percentage of Participants |
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 subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm).
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 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 | 18.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 14.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 11.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 16.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 12.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 16.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 12.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 13.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 13.6 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 16.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 2.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 6.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 18.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 1.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 48 | 25.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 19.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 24.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 13.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 15.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 6.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 8.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 10.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 52 | 18.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 18.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 20.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 4.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 48 | 25.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 4.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 7.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 9.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 20.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 20.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 8.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 10.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 52 | 22.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 2.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 5.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 7.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 4.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 6.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 8.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 10.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 11.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 7.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 14.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 48 | 15.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 52 | 10.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 8.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 36 | 22.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 32 | 25.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 4 | 7.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 48 | 27.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 28 | 24.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 24 | 28.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 20 | 20.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | EOT | 25.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 52 | 30.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 12 | 14.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 8 | 11.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 16 | 18.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 44 | 25.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | Week 40 | 24.3 Percentage of Participants |
Secondary
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 12 | 9.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 16 | 14.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 44 | 21.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 36 | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 52 | 21.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 40 | 22.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 4 | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 48 | 23.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 20 | 18.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 28 | 20.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 32 | 17.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 8 | 4.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | EOT | 18.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 24 | 16.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 48 | 34.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 20 | 17.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 12 | 10.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 52 | 27.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 16 | 16.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 32 | 27.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | EOT | 23.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 36 | 26.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 40 | 29.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 28 | 27.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 4 | 2.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 44 | 36.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 24 | 15.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 8 | 6.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 32 | 16.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 48 | 28.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 52 | 22.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | EOT | 20.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 36 | 18.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 12 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 16 | 2.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 20 | 2.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 24 | 7.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 28 | 14.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 40 | 13.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 44 | 25.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 40 | 21.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 24 | 15.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 52 | 18.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 20 | 10.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 32 | 13.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 44 | 15.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 28 | 17.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 48 | 23.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 16 | 6.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 36 | 7.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 12 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | EOT | 17.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 8 | 14.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 20 | 28.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 4 | 9.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 24 | 31.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 36 | 30.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 44 | 33.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 40 | 31.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 28 | 31.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 52 | 38.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 48 | 36.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 32 | 32.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 12 | 19.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | Week 16 | 23.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | EOT | 32.5 Percentage of Participants |
Secondary
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12 | 0.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12 | 8.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12 | 9.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12 | 19.0 Percentage of Participants |
Secondary
Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Baseline and Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12 | 5.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12 | 24.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12 | 34.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12 | 45.5 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.31, 17.67]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [3.76, 27.27]Wald's chi-squared test
Secondary
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 4 | 10.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 36 | 49.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 28 | 36.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 32 | 38.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 52 | 43.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 12 | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 48 | 43.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 16 | 35.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | EOT | 39.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 44 | 46.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 20 | 37.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 8 | 19.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 40 | 45.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 24 | 37.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 24 | 51.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 20 | 51.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 16 | 39.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 28 | 55.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 8 | 23.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 32 | 55.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 36 | 54.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 4 | 5.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 52 | 66.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 44 | 57.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 40 | 53.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 12 | 37.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | EOT | 59.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 48 | 61.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 24 | 25.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 8 | 9.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 12 | 7.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 16 | 21.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 20 | 16.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 28 | 34.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 32 | 37.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 36 | 43.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 40 | 36.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 44 | 48.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 48 | 51.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 52 | 45.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | EOT | 41.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 24 | 33.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 36 | 39.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 20 | 32.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 40 | 45.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 16 | 23.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 4 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 44 | 41.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 12 | 4.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 48 | 56.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 8 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | EOT | 51.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 28 | 41.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 52 | 55.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 32 | 37.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 28 | 61.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | EOT | 61.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 36 | 61.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 20 | 59.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 32 | 68.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 4 | 26.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 48 | 70.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 40 | 68.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 16 | 53.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 8 | 37.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 24 | 59.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 52 | 67.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 44 | 69.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | Week 12 | 47.6 Percentage of Participants |
Secondary
Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12 | 11.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12 | 40.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12 | 53.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12 | 68.0 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.74, 12.29]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.57, 20.41]Wald's chi-squared test
Secondary
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 32 | 58.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 8 | 32.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 16 | 52.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 36 | 63.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 48 | 64.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 4 | 18.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 20 | 55.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | EOT | 54.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 52 | 63.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 44 | 61.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 12 | 41.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 24 | 50.6 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 28 | 55.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 40 | 62.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 4 | 21.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 28 | 76.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 32 | 70.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 8 | 40.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 52 | 84.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 12 | 55.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 36 | 75.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 48 | 81.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 16 | 64.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 44 | 75.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 20 | 67.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | EOT | 77.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 40 | 76.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 24 | 74.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 24 | 35.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 4 | 4.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 8 | 11.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 12 | 14.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 16 | 33.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 20 | 45.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 28 | 41.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 32 | 51.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 36 | 56.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 40 | 57.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 44 | 57.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 48 | 60.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 52 | 54.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | EOT | 48.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 36 | 67.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 20 | 47.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 48 | 79.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 12 | 10.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 4 | 4.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 8 | 12.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | EOT | 76.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 44 | 74.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 28 | 63.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 52 | 81.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 32 | 55.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 40 | 71.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 16 | 44.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 24 | 62.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 12 | 70.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 36 | 83.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 20 | 75.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 4 | 47.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 40 | 85.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 16 | 73.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 44 | 83.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 52 | 89.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | EOT | 81.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 48 | 86.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 8 | 59.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 28 | 81.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 32 | 83.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | Week 24 | 77.5 Percentage of Participants |
Secondary
Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12 | 1.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12 | 11.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12 | 17.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12 | 31.7 Percentage of Participants |
Comparison: Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.p-value: 0.00395% CI: [2.83, 166.66]Wald's chi-squared test
Secondary
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 4 | 2.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 36 | 25.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 28 | 27.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 32 | 22.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 52 | 25.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 12 | 11.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 48 | 24.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 16 | 18.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | EOT | 23.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 44 | 32.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 20 | 22.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 8 | 8.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 40 | 28.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 24 | 23.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 24 | 34.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 20 | 28.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 16 | 26.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 28 | 34.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 8 | 13.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 32 | 30.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 36 | 41.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 4 | 4.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 52 | 34.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 44 | 48.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 40 | 44.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 12 | 19.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | EOT | 28.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 48 | 39.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 24 | 15.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 12 | 2.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 16 | 11.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 20 | 14.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 28 | 26.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 32 | 19.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 36 | 25.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 40 | 32.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 44 | 35.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 48 | 37.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 52 | 29.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | EOT | 26.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 24 | 17.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 36 | 18.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 20 | 19.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 40 | 28.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 16 | 14.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 4 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 44 | 28.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 12 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 48 | 38.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | EOT | 27.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 28 | 21.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 52 | 28.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 32 | 24.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 28 | 39.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | EOT | 39.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 36 | 40.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 20 | 38.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 32 | 43.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 4 | 14.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 48 | 47.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 40 | 43.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 16 | 35.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 8 | 27.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 24 | 41.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 52 | 43.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 44 | 43.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | Week 12 | 33.2 Percentage of Participants |
Secondary
Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12 | 7.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12 | 19.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12 | 37.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12 | 49.7 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: 0.01295% CI: [1.29, 8.12]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00196% CI: [3.42, 19.63]Wald's chi-squared test
Secondary
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 24 | 37.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 20 | 36.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 16 | 32.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 8 | 20.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | EOT | 38.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 12 | 19.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 44 | 48.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 32 | 42.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 48 | 45.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 52 | 45.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 36 | 48.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 28 | 36.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 4 | 9.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 40 | 51.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 28 | 59.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 36 | 61.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 40 | 59.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 48 | 61.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 4 | 10.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 8 | 24.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 12 | 39.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 16 | 42.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 20 | 51.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 24 | 50.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 32 | 54.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 44 | 60.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 52 | 69.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | EOT | 61.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 52 | 41.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 48 | 54.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 28 | 36.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 20 | 19.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | EOT | 38.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 40 | 43.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 32 | 38.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 12 | 7.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 8 | 9.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 36 | 41.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 24 | 23.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 16 | 21.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 44 | 50.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 52 | 52.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 16 | 25.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 4 | 4.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 20 | 34.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 24 | 37.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 48 | 53.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 28 | 41.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 32 | 40.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 40 | 47.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 44 | 46.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 36 | 37.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | EOT | 46.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 8 | 2.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 12 | 8.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 28 | 60.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 24 | 58.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 52 | 62.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 48 | 72.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 16 | 53.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 4 | 33.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 12 | 51.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | EOT | 58.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 8 | 42.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 32 | 65.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 36 | 62.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 20 | 56.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 40 | 67.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | Week 44 | 64.3 Percentage of Participants |
Secondary
Percentage of Participants Achieving SDAI Remission Through Week 52
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 28 | 19.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 36 | 21.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 52 | 21.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 16 | 12.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 8 | 4.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 24 | 18.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 20 | 17.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 32 | 16.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 44 | 22.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 40 | 24.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 4 | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | EOT | 17.6 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 12 | 9.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 48 | 18.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 36 | 27.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 8 | 6.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 40 | 36.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 44 | 38.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 12 | 9.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 4 | 1.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 16 | 15.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 52 | 29.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 20 | 18.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 24 | 18.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 28 | 29.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | EOT | 25.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 32 | 27.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 48 | 38.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | EOT | 18.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 52 | 20.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 12 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 28 | 17.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 36 | 18.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 48 | 28.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 44 | 20.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 40 | 10.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 20 | 4.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 16 | 2.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 32 | 13.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 24 | 10.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 44 | 15.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 12 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 16 | 8.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 24 | 17.8 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 28 | 17.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 32 | 13.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 36 | 4.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 40 | 19.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 20 | 15.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 48 | 25.6 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 52 | 21.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | EOT | 17.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 32 | 35.2 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 28 | 33.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 20 | 29.7 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 48 | 39.3 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 24 | 34.1 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 16 | 23.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 12 | 19.4 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | EOT | 33.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 52 | 39.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 8 | 16.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 40 | 33.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 4 | 10.0 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 44 | 34.5 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving SDAI Remission Through Week 52 | Week 36 | 30.9 Percentage of Participants |
Secondary
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12 | 0.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12 | 8.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12 | 8.9 Percentage of Participants |
| Etanercept | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12 | 18.5 Percentage of Participants |
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 17.3 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 59.5 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 28 | 50.6 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 54.3 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 59.2 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 39.6 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 60.8 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 48.4 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 52.5 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 58.7 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 51.1 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 28.1 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 58.7 Percentage of Participants |
| Placebo | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 47.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 71.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 65.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 60.2 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 |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 39.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 68.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 74.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 16.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 81.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 74.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 75.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 53.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 75.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 79.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 33.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 4.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 11.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 12.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 34.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 46.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 28 | 40.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 50.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 55.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 54.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 55.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 55.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 52.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 47.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 57.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 62.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 43.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 66.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 40.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 71.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 8.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 79.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 6.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 72.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 28 | 58.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 78.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 46.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 28 | 80.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | EOT | 80.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 36 | 83.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 20 | 75.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 32 | 83.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 4 | 44.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 48 | 85.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 40 | 84.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 16 | 72.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 8 | 56.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 24 | 76.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 52 | 88.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 44 | 82.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Week 12 | 67.5 Percentage of Participants |
Secondary
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 9.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 38.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 51.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | 65.5 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.98, 14.83]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.91, 24.03]Wald's chi-squared test
Secondary
Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12 | 5.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12 | 18.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12 | 36.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12 | 49.0 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: 0.00695% CI: [1.52, 12.08]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [4.07, 29.74]Wald's chi-squared test
Secondary
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 44.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 8.2 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 39.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 32.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 43.7 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 16.8 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 41.9 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 18.8 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 34.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 45.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 31.2 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 47.4 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | EOT | 38.2 Percentage of Participants |
| Placebo | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 35.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 59.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 50.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 60.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 54.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 60.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 38.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 59.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 10.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 69.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 40.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 61.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | EOT | 61.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 24.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 51.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 40.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 9.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 4.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 22.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 20.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 21.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 35.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 37.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 41.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 48.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 52.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 39.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | EOT | 36.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 31.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 6.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 52.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 21.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 2.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 33.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | EOT | 43.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 48.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 37.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 43.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 43.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 34.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 36.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 31.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 56.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 50.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 62.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 67.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 41.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 63.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 63.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | EOT | 57.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 72.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 52.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 59.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 56.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 61.7 Percentage of Participants |
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 41.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 75.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 92.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | 92.5 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.38, 8.04]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [7.31, 38.51]Wald's chi-squared test
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 77.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 87.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 4 | 63.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 76.0 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 16 | 81.7 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 79.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 85.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 89.2 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 32 | 91.4 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 89.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 44 | 93.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 90.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 91.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 78.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 96.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 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 32 | 96.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 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 4 | 72.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 96.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 97.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 86.7 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 16 | 92.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 96.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 93.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 96.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 98.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 83.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 47.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 41.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 16 | 73.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 78.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 94.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 80.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 86.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 86.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 44 | 88.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 71.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 32 | 83.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 94.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 4 | 31.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 91.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 86.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 89.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 85.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 16 | 85.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 85.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 40.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 44 | 87.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 48.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 91.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 4 | 40.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 32 | 82.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 92.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 87.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 20 | 95.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 48 | 98.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 36 | 97.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | EOT | 95.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 16 | 96.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 4 | 87.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 8 | 92.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 40 | 100.0 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 28 | 99.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 32 | 98.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 24 | 97.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 52 | 98.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 44 | 99.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Week 12 | 94.2 Percentage of Participants |
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Time frame: Week 12/ET
Population: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12 | 37.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12 | 69.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12 | 88.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12 | 90.9 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.11, 6.93]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [6.39, 29.17]Wald's chi-squared test
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 84.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 86.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 76.3 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 83.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 84.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 70.8 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 90.7 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 79.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 90.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | EOT | 74.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 56.1 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 89.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 82.8 Percentage of Participants |
| Placebo | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 66.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 95.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 95.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 92.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 84.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR 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-ESR Through Week 52 | Week 4 | 65.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 97.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 90.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 95.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 88.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | EOT | 94.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 92.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 96.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 95.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 84.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 31.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 45.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 39.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 73.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 72.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 73.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 77.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 77.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 85.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 83.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 84.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 88.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | EOT | 75.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 83.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 43.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | EOT | 82.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 89.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 86.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 76.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 33.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 89.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 23.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 88.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 87.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 86.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 85.4 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 90.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 24 | 96.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 4 | 81.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 36 | 96.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 20 | 93.9 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 40 | 98.3 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 16 | 94.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | EOT | 93.5 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 44 | 98.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 12 | 92.6 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 48 | 98.2 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 8 | 92.8 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 28 | 97.7 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 52 | 98.1 Percentage of Participants |
| Etanercept | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Week 32 | 97.1 Percentage of Participants |
Secondary
Percentage of Participants With an ACR20-CRP Response Through Week 52
The ACR20 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 20% reduction compared with baseline. 2. SJC : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 76.5 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 74.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 72.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 64.5 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 43.9 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 73.2 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 74.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 72.2 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 64.1 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 59.4 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | End of Treatment (EOT) | 65.4 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 73.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 51.0 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 63.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 45.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 90.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 88.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 87.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 68.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 90.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 77.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 85.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 88.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 79.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | End of Treatment (EOT) | 84.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 90.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 81.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 90.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 79.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 21.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 38.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 31.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 58.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 51.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 61.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 60.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 63.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 66.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 67.6 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 79.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 73.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR20-CRP Response Through Week 52 | End of Treatment (EOT) | 67.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 81.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 34.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 83.3 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | End of Treatment (EOT) | 74.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 82.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 19.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 25.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 61.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 71.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 67.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 76.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 84.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 73.3 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 71.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 32 | 88.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 20 | 88.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 36 | 92.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 16 | 86.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 40 | 92.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 12 | 84.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | End of Treatment (EOT) | 86.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 44 | 91.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 8 | 80.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 48 | 90.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 4 | 61.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 28 | 92.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 24 | 90.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR20-CRP Response Through Week 52 | Week 52 | 90.7 Percentage of Participants |
Secondary
Percentage of Participants With an ACR50-CRP Response Through Week 52
The ACR50 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 50% reduction compared with baseline. 2. SJC : ≥ 50% reduction compared with baseline. 3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 8.2 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 53.2 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 44.6 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 50.6 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 49.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 32.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 48.6 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 43.0 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 43.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 50.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 41.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 47.4 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 43.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 62.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 54.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 45.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 60.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 35.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 65.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 68.6 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 14.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 75.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 69.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 69.8 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 45.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 66.7 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 73.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 38.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 4.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 4.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 7.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 31.7 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 22.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 40.0 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 | 47.2 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 45.9 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 50.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 58.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 47.1 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 41.9 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 44.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 44.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 43.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 52.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 25.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 53.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 12.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 69.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 6.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 55.3 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 50.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 65.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 44.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 28 | 69.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | EOT | 69.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 36 | 70.3 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 20 | 66.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 32 | 70.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 4 | 29.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 48 | 75.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 40 | 73.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 16 | 60.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 8 | 47.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 24 | 64.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 52 | 77.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 44 | 70.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR50-CRP Response Through Week 52 | Week 12 | 55.0 Percentage of Participants |
Secondary
Percentage of Participants With an ACR70-CRP Response Through Week 52
The ACR70 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 70% reduction compared with baseline. 2. SJC : ≥ 70% reduction compared with baseline. 3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS, number of participants with available data at each study visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 31.6 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 16 | 23.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 25.3 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 35.2 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 14.6 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 30.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 26.1 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 28.4 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 31.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 28.9 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 28.7 Percentage of Participants |
| Placebo | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 11.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 40.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 43.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 39.5 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 38.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 14.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 2.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 48.1 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 29.3 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 51.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 28.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 42.2 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 49.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 30.4 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 47.7 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 4 | 0.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 34.9 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 | 7.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 7.3 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 15.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 20.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 25.0 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 27.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 27.0 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 | 32.4 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 38.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 18.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 35.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 0.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 38.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 22.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 42.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 2.1 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 8.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 17.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 34.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 19.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 24.4 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 28.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 32 | 47.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 36 | 44.6 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 20 | 41.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 52 | 56.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 40 | 49.7 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 16 | 37.8 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 4 | 14.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 44 | 52.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 12 | 31.9 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 48 | 54.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 8 | 20.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 28 | 48.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | EOT | 48.0 Percentage of Participants |
| Etanercept | Percentage of Participants With an ACR70-CRP Response Through Week 52 | Week 24 | 44.5 Percentage of Participants |
Secondary
Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12
The ACR50 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 50% reduction compared with baseline. 2. SJC : ≥ 50% reduction compared with baseline. 3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Time frame: Baseline and Week 12/ET
Population: FAS. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12 | 8.9 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12 | 30.8 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12 | 42.2 Percentage of Participants |
| Etanercept | Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12 | 52.5 Percentage of Participants |
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [2.14, 10.75]Wald's chi-squared test
Comparison: Treatment Difference vs Placebop-value: <0.00195% CI: [3.53, 17.5]Wald's chi-squared test
Secondary
Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12
The ACR70 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 70% reduction compared with baseline. 2. SJC : ≥ 70% reduction compared with baseline. 3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Time frame: Baseline and Week 12/ET
Population: FAS. LOCF was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12 | 1.0 Percentage of Participants |
| Peficitinib 100 mg | Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12 | 13.5 Percentage of Participants |
| Peficitinib 150 mg | Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12 | 27.5 Percentage of Participants |
| Etanercept | Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12 | 30.5 Percentage of Participants |
Comparison: Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.p-value: <0.00195% CI: [5.29, 301.61]Wald's chi-squared test