A Study to Evaluate Efficacy and Safety of ASP015K in Pat... | NCT02305849 | Trialant
NCT02305849
Sponsor
Astellas Pharma Inc
Status
Completed
Last Update Posted
Oct 28, 2024Actual
Enrollment
519Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Peficitinib
Placebo
Methotrexate
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02305849
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
015K-CL-RAJ4
Secondary IDs
Not provided
Brief Title
A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment
Official Title
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX
Acronym
Not provided
Organization
Astellas Pharma IncINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 25, 2014Actual
Primary Completion Date
Jun 20, 2017Actual
Completion Date
Nov 28, 2017Actual
First Submitted Date
Dec 1, 2014
First Submission Date that Met QC Criteria
Dec 1, 2014
First Posted Date
Dec 3, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 3, 2020
Results First Submitted that Met QC Criteria
Jul 16, 2020
Results First Posted Date
Aug 3, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 6, 2018
Certification/Extension First Submitted that Passed QC Review
Jun 6, 2018
Certification/Extension First Posted Date
Jun 11, 2018Actual
Last Update Submitted Date
Oct 17, 2024
Last Update Posted Date
Oct 28, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Astellas Pharma IncINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of this study was to verify the efficacy of ASP015K versus placebo administrated in combination with methotrexate (MTX) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to MTX
Detailed Description
This study was a multi-center, randomized, placebo-controlled, double-blind, parallel-group, confirmatory study to evaluate the efficacy and safety of ASP015K (100 and 150 mg/day) administered in combination with MTX in participants with RA who had an inadequate response to MTX.
Participants orally received ASP015K 100 mg, ASP015K 150 mg or placebo once daily (QD) in combination with MTX after breakfast for 52 weeks.
At Week 12, inadequate responders in the placebo group, as determined by a < 20% improvement from baseline (i.e., treatment initiation day) in tender or painful joint count (TJC) and swollen joint count (SJC), were switched to either ASP015K 100 mg or ASP015K 150 mg, and the dosage was maintained until the end of treatment (EOT). In addition, participants who received placebo at Week 28 were switched to either ASP015K 100 mg or ASP015K 150 mg, and the dosage was maintained until the EOT.
The ASP015K dose that was started for placebo group participants at Week 12 or Week 28 was randomly chosen at baseline. The dose was switched under the blinded condition.
Participants who completed this study were eligible for participation in the open-label extension study (015K-CL-RAJ2). Participants made a follow-up visit after the week 52 visit if they did not enroll into the extension study on the day of the week 52 visit.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
ASP015K
Rheumatoid Arthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
519Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Peficitinib 100 mg
Experimental
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Drug: Peficitinib
Drug: Methotrexate
Peficitinib 150 mg
Experimental
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Drug: Peficitinib
Drug: Methotrexate
Placebo
Placebo Comparator
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
Drug: Placebo
Drug: Methotrexate
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Peficitinib
Drug
oral tablet
Peficitinib 100 mg
Peficitinib 150 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Baseline and week 12/Early termination (ET)
Change From Baseline in mTSS at Week 28
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and week 28/ET
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an ACR20-CRP Response Through Week 52
ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject has RA of < 10 years duration at baseline that was diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria
Subject who did not receive the following drugs, or received the drugs with stable dosage for at least 28 days prior to the baseline (start of treatment) for RA treatment:
Non-steroidal anti-inflammatory drugs (NSAIDs; excluding topical formulations with a local action), oral morphine or equivalent opioid analgesics (≤ 30 mg/day), acetaminophen, or oral corticosteroids (≤ 10 mg/day in prednisolone equivalent)
At screening subject has active RA as evidenced by both of the following:
CRP (latex agglutination test) of ≥ 1.00 mg/dL at screening.
Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening
Inadequate responders to MTX which was continuously administered for at least 90 days prior to screening and MTX ≥ 8 mg/week for at least 28 days prior to baseline. However, inadequate responder to MTX < 8 mg/week is eligible if intolerance precludes dose increase and defined as MTX-IR
Subject is able to continue stable dose of MTX (a maximum of 16 mg/week) from at least 28 days prior to screening until the end of treatment
Subject has bone erosion at the joint (as evidenced by x-rays of hands and feet) assessed in mTSS and any of the following apply at screening. Bone erosion may be evidenced by x-rays within 90 days prior to baseline.
Positive anti-CCP antibody: ≥ 4.5 U/mL
Positive rheumatoid factor: > 15 IU/mL
Exclusion Criteria:
Subject has received a biologic DMARD within the specified period
Inadequate responders to biologic DMARD as determined by investigator/sub-investigator
Subject has received intra-articular, intravenous, intramuscular or endorectal (excluding suppositories for anal diseases) corticosteroid within 28 days prior to baseline
Subject has participated in any study of ASP015K and has received ASP015K or placebo
Subject has received other investigational drugs within 90 days or within 5 half-lives, whichever is longer, prior to baseline
Subject has received plasma exchange therapy within 60 days prior to baseline
Subject has undergone joint drainage, has received local anesthesia and nerve block, or has received articular cartilage protectant at the assessed joint within 28 days prior to baseline
Subject has undergone surgery and has residual effects in the assessed joints at the discretion of investigator/sub-investigator, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints at the discretion of investigator/sub-investigator
A diagnosis of inflammatory arthritis (psoriatic arthritis, ankylosing spondylitis, SLE, sarcoidosis, etc.) other than RA
Any of the following laboratory values at screening:
Hemoglobin < 9.0 g/dL
Absolute neutrophil count < 1000/μL
Absolute lymphocyte count < 800/μL
Platelet count < 75000/μL
ALT ≥ 2 ×ULN
AST ≥ 2 × ULN
Total bilirubin (TBL) ≥ 1.5 × ULN
Estimated GFR ≤ 40 mL/min as measured by the MDRD method
β-D-glucan ≥ 11 pg/mL
Positive HBs antigen, HBc antibody, HBs antibody or HBV-DNA quantitation (However, subject with negative HBs antigen and HBV-DNA quantitation, and positive HBc antibody and/or HBs antibody is eligible if HBV-DNA is monitored by HBV-DNA quantitation at every scheduled visit after initiation of study drug administration.)
Positive HCV antibody
Subject has a history of or concurrent active tuberculosis (TB)
Subject has a history of or concurrent interstitial pneumonia and investigator/sub-investigator judges that it is inappropriate for the subject to participate in this study
Subject has a history of or concurrent malignant tumor (except for successfully treated basal cell carcinoma)
Subject has received live or live attenuated virus vaccination within 56 days prior to baseline. (Inactivated vaccines including influenza and pneumococcal vaccines are allowed.)
Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA (excluding Sjogren's syndrome and chronic thyroiditis), or any ongoing illness which would make the subject unsuitable for the study as determined by the investigator/sub-investigator
Subject has a history of clinically significant allergy. (Clinically significant allergy includes allergies such as systemic urticaria induced by specific antigens and drugs, anaphylaxis, and allergy associated with shock necessitating hospitalized treatment.)
Subject has concurrent cardiac failure, defined as NYHA classification Class III or higher, or a history of it
Subject has concurrent prolonged QT syndrome or a history of it. Subject has prolonged QT interval (defined as QTc ≥ 500 msec. Subject has QTc ≥ 500 msec at retest will be excluded) at screening
Subject has a history of positive HIV infection
Subject has congenital short QT syndrome or a history of it. Subject has shortened QT interval (defined as QTc < 330 msec. Subject has QTc < 330 msec at retest will be excluded) at screening.
Tanaka Y, Takeuchi T, Kato D, Kaneko Y, Fukuda M, Izutsu H, Rokuda M, van der Heijde D. Post hoc analysis of clinical characteristics of patients with radiographic progression in a Japanese phase 3 trial of peficitinib and methotrexate treatment (RAJ4). Mod Rheumatol. 2023 Jan 3;33(1):73-80. doi: 10.1093/mr/roac021.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Types
Study Protocol
Clinical Study Report (CSR)
Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Participants were randomized in a 1:1:1 ratio to peficitinib 100 milligram (mg), 150 mg or placebo groups in combination with MTX at baseline. At week 12 or 28, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg, which was determined in advance randomly.
Recruitment Details
Participants with rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) were enrolled in this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
FG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Percentage of Participants With an ACR50-CRP Response at Week 12
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Baseline and week 12/ET
Percentage of Participants With an ACR50-CRP Response Through Week 52
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Percentage of Participants With an ACR70-CRP Response at Week 12
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Baseline and week 12/ET
Percentage of Participants With an ACR70-CRP Response Through Week 52
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and week 52/ET
Change From Baseline in JSN Score at Week 28 and Week 52
JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity.
Baseline and weeks 28/ET and 52/ET
Change From Baseline in Erosion Score at Week 28 and Week 52
The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.
Baseline and weeks 28/ET and 52/ET
Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and week 28/ET and 52/ET
Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Baseline and week 12/ET
Change From Baseline in DAS28-CRP Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Change From Baseline in TJC (68 Joints) at Week 12
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Baseline and week 12/ET
Change From Baseline in TJC (68 Joints) Through Week 52
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Change From Baseline in SJC (66 Joints) at Week 12
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Baseline and week 12/ET
Change From Baseline in SJC (66 Joints) Through Week 52
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Week 12/ET
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Week 12/ET
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Week 12/ET
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Week 12/ET
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.
Week 12/ET
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Week 12/ET
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure.
Week 12/ET
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Week 12/ET
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Percentage of Participants Achieving ACR / EULAR Remission at Week 12
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
Week 12/ET
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
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.
Baseline and week 12/ET
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.
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.
Baseline and week 12/ET
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.
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Baseline and week 12/ET
Change From Baseline in SGAP Through Week 52
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Number of Participants Who Withdrew Due to Lack of Efficacy
Participants who discontinued due to lack of efficacy have been reported.
Up to week 52
Change From Baseline in HAQ-DI at Week 12
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Baseline and week 12/ET
Change From Baseline in HAQ-DI Through Week 52
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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.
Baseline and week 12/ET
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.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
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.
Baseline and week 12/ET
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.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
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.
Baseline and week 12/ET
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.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Baseline and week 12/ET
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
Change From Baseline in WPAI Percent Impairment While Working at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.
Baseline and week 12/ET
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculates as Q5/10. Negative values indicate improvement from baseline.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
Change From Baseline in Percent Overall Work Impairment at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline.
Baseline and week 12/ET
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
Change From Baseline in WPAI Percent Activity Impairment at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Baseline and week 12/ET
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Baseline, weeks 4, 8, 12, 28, 52 and EOT
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Week 0 to week 12
Number of Participants With TEAEs From Week 12 to Week 28
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE
Week 12 to week 28
Number of Participants With TEAEs From Week 28 to Week 52
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study
Nagoya
Aichi-ken
Japan
JP00130
Nagoya
Aichi-ken
Japan
JP00175
Nagoya
Aichi-ken
Japan
JP00066
Okazaki
Aichi-ken
Japan
JP00108
Toyohashi
Aichi-ken
Japan
JP00170
Toyohashi
Aichi-ken
Japan
JP00156
Toyota
Aichi-ken
Japan
JP00068
Yatomi
Aichi-ken
Japan
JP00180
Asahi
Chiba
Japan
JP00166
Funabashi
Chiba
Japan
JP00115
Narashino
Chiba
Japan
JP00138
Yotsukaidō
Chiba
Japan
JP00120
Iizuka
Fukuoka
Japan
JP00110
Kasuga
Fukuoka
Japan
JP00040
Kitakyushu
Fukuoka
Japan
JP00119
Kitakyushu
Fukuoka
Japan
JP00071
Kurume
Fukuoka
Japan
JP00106
Kurume
Fukuoka
Japan
JP00033
Takasaki
Gunma
Japan
JP00163
Higashihiroshima
Hiroshima
Japan
JP00124
Tomakomai
Hokaido
Japan
JP00026
Asahikawa
Hokkaido
Japan
JP00090
Hakodate
Hokkaido
Japan
JP00172
Kitami
Hokkaido
Japan
JP00125
Kushiro
Hokkaido
Japan
JP00001
Sapporo
Hokkaido
Japan
JP00002
Sapporo
Hokkaido
Japan
JP00003
Sapporo
Hokkaido
Japan
JP00038
Sapporo
Hokkaido
Japan
JP00114
Sapporo
Hokkaido
Japan
JP00056
Akashi
Hyōgo
Japan
JP00069
Himeji
Hyōgo
Japan
JP00136
Itami
Hyōgo
Japan
JP00113
Kakogawa
Hyōgo
Japan
JP00041
Katō
Hyōgo
Japan
JP00042
Kobe
Hyōgo
Japan
JP00092
Kobe
Hyōgo
Japan
JP00154
Kobe
Hyōgo
Japan
JP00171
Kobe
Hyōgo
Japan
JP00117
Nishinomiya
Hyōgo
Japan
JP00107
Hitachi
Ibaraki
Japan
JP00181
Hitachi-Naka
Ibaraki
Japan
JP00073
Koga
Ibaraki
Japan
JP00054
Mito
Ibaraki
Japan
JP00039
Tsukuba
Ibaraki
Japan
JP00179
Komatsu
Ishikawa-ken
Japan
JP00049
Morioka
Iwate
Japan
JP00088
Kida
Kagawa-ken
Japan
JP00084
Isehara
Kanagawa
Japan
JP00048
Kawasaki
Kanagawa
Japan
JP00058
Kawasaki
Kanagawa
Japan
JP00141
Sagamihara
Kanagawa
Japan
JP00096
Yokohama
Kanagawa
Japan
JP00045
Zushi
Kanagawa
Japan
JP00019
Kōshi
Kumamoto
Japan
JP00057
Tamana
Kumamoto
Japan
JP00168
Yokkaichi
Mie-ken
Japan
JP00169
Ōsaki
Miyagi
Japan
JP00004
Sendai
Miyagi
Japan
JP00036
Sendai
Miyagi
Japan
JP00105
Sendai
Miyagi
Japan
JP00151
Sendai
Miyagi
Japan
JP00050
Hyūga
Miyazaki
Japan
JP00129
Matsumoto
Nagano
Japan
JP00162
Isehaya
Nagasaki
Japan
JP00101
Ōmura
Nagasaki
Japan
JP00103
Ōmura
Nagasaki
Japan
JP00153
Sasebo
Nagasaki
Japan
JP00094
Kashihara
Nara
Japan
JP00025
Nagaoka
Niigata
Japan
JP00144
Shibata
Niigata
Japan
JP00064
Beppu
Oita Prefecture
Japan
JP00051
Setouchi
Okayama-ken
Japan
JP00011
Hannan
Osaka
Japan
JP00134
Higashiosaka
Osaka
Japan
JP00178
Hirakata
Osaka
Japan
JP00078
Kawachi-Nagano
Osaka
Japan
JP00137
Sakai
Osaka
Japan
JP00070
Suita
Osaka
Japan
JP00146
Suita
Osaka
Japan
JP00061
Toyonaka
Osaka
Japan
JP00075
Ureshino
Saga-ken
Japan
JP00126
Gyōda
Saitama
Japan
JP00007
Hiki
Saitama
Japan
JP00060
Kawagoe
Saitama
Japan
JP00161
Kawagoe
Saitama
Japan
JP00062
Kawaguchi
Saitama
Japan
JP00052
Sayama
Saitama
Japan
JP00008
Tokorozawa
Saitama
Japan
JP00133
Kakegawa
Shizuoka
Japan
JP00077
Kanuma
Tochigi
Japan
JP00145
Shimotsuke
Tochigi
Japan
JP00024
Bunkyo
Tokyo
Japan
JP00143
Bunkyo
Tokyo
Japan
JP00149
Bunkyo
Tokyo
Japan
JP00152
Bunkyo
Tokyo
Japan
JP00099
Chiyoda City
Tokyo
Japan
JP00142
Chūō
Tokyo
Japan
JP00063
Hachiōji
Tokyo
Japan
JP00053
Kiyose
Tokyo
Japan
JP00072
Meguro City
Tokyo
Japan
JP00148
Ōta-ku
Tokyo
Japan
JP00081
Shibuya City
Tokyo
Japan
JP00010
Takaoka
Toyama
Japan
JP00155
Nishimuro
Wakayama
Japan
JP00104
Shimonoseki
Yamaguchi
Japan
JP00047
Shūnan
Yamaguchi
Japan
JP00176
Fukui
Japan
JP00018
Fukuoka
Japan
JP00020
Fukuoka
Japan
JP00035
Fukuoka
Japan
JP00059
Fukuoka
Japan
JP00067
Fukuoka
Japan
JP00076
Fukuoka
Japan
JP00131
Fukuoka
Japan
JP00164
Fukuoka
Japan
JP00165
Fukushima
Japan
JP00013
Hiroshima
Japan
JP00014
Hiroshima
Japan
JP00016
Hiroshima
Japan
JP00055
Hiroshima
Japan
JP00074
Kagoshima
Japan
JP00167
Kagoshima
Japan
JP00093
Kochi
Japan
JP00022
Kumamoto
Japan
JP00046
Kumamoto
Japan
JP00085
Kyoto
Japan
JP00123
Kyoto
Japan
JP00160
Kyoto
Japan
JP00023
Miyagi
Japan
JP00122
Miyazaki
Japan
JP00080
Nagano
Japan
JP00174
Nagano
Japan
JP00098
Nagasaki
Japan
JP00112
Nagasaki
Japan
JP00147
Nagasaki
Japan
JP00118
Okayama
Japan
JP00150
Osaka
Japan
JP00157
Osaka
Japan
JP00177
Osaka
Japan
JP00017
Ōita
Japan
JP00044
Shizuoka
Japan
JP00089
Shizuoka
Japan
JP00135
Shizuoka
Japan
JP00139
Toyama
Japan
Tanaka Y, Takeuchi T, Izutsu H, Kaneko Y, Kato D, Fukuda M, Rokuda M, Schultz NM. Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis. Arthritis Res Ther. 2021 Aug 24;23(1):221. doi: 10.1186/s13075-021-02590-z.
Toyoshima J, Kaibara A, Shibata M, Kaneko Y, Izutsu H, Nishimura T. Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacol Res Perspect. 2021 May;9(3):e00744. doi: 10.1002/prp2.744.
Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Iwasaki M, Katayama K, Rokuda M, Izutsu H, Ushijima S, Kaneko Y, Shiomi T, Yamada E, van der Heijde D. Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan. Ann Rheum Dis. 2019 Oct;78(10):1305-1319. doi: 10.1136/annrheumdis-2019-215164. Epub 2019 Jul 26.
FG002
Placebo / Peficitinib 100 mg
Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
FG003
Placebo / Peficitinib 150 mg
Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
FG000175 subjects
FG001174 subjects
FG00285 subjects
FG00385 subjects
COMPLETED
FG000148 subjects
FG001146 subjects
FG00267 subjects
FG00366 subjects
NOT COMPLETED
FG00027 subjects
FG00128 subjects
FG00218 subjects
FG00319 subjects
Type
Comment
Reasons
Adverse Event
FG00010 subjects
FG00112 subjects
FG0027 subjects
FG0033 subjects
Lack of Efficacy
FG00010 subjects
FG0016 subjects
FG0023 subjects
FG0039 subjects
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0034 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Lab data met discontinuation criteria
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
Miscellaneous
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0031 subjects
Not fulfill eligibility criteria
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Safety analysis set (SAF) was defined as all participants who received at least 1 dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
BG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
BG002
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000174
BG001174
BG002170
BG003518
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002170
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
C-Reactive Protein (CRP)
Higher CRP indicates greater disease activity.
Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
milligram/deciliter (mg/dL)
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Erosion Score
The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000173
ParticipantsBG001
Erythrocyte Sedimentation Rate (ESR)
FAS.
Mean
Standard Deviation
millimeter per hour (mm/h)
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001
Joint Space Narrowing (JSN) Score
JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher joint space narrowing score indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000173
ParticipantsBG001
Modified Total Sharp Score (mTSS)
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints and JSN scores graded by assessing narrowing of joint spaces in 42 joints. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000173
ParticipantsBG001
Physician's Global Assessment of Arthritis (PGA)
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm visual analog scale (VAS) where 0 = very well and 100 = very poorly.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
Participants
Subject's Global Assessment of Arthritis (SGA)
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Subject's Global Assessment of Arthritis Pain (SGAP)
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGAP (100 mm VAS) scores indicated greater activity pain.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Swollen Joint Count (SJC) (66 Joints)
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the 66 joints. Higher SJC indicated greater disease activity.
FAS.
Mean
Standard Deviation
swollen joint count
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Tender Joint Count (TJC) (68 Joints)
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the 68 joints. Higher TJC indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data.
Mean
Standard Deviation
tender joint count
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
FAS. Last observation carried forward (LOCF) was used for missing imputations.
Posted
Number
percentage of participants
Baseline and week 12/Early termination (ET)
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000170
OG001174
OG002174
Title
Denominators
Categories
Title
Measurements
OG00021.8
OG00158.6
OG00264.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
Closed testing procedure was used for multiplicity adjustment.
Percent Difference
36.9
2-Sided
95
26.7
47.0
CI was based on normal approximation to the binomial distribution.
Superiority
Primary
Change From Baseline in mTSS at Week 28
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 28/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Secondary
Percentage of Participants With an ACR20-CRP Response Through Week 52
ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52.
FAS. Here, number of participants analyzed signifies participants with available data.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Percentage of Participants With an ACR50-CRP Response at Week 12
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
FAS. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With an ACR50-CRP Response Through Week 52
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
FAS. Here, Number of participants analyzed signifies participants with available data.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Percentage of Participants With an ACR70-CRP Response at Week 12
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
FAS. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With an ACR70-CRP Response Through Week 52
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
FAS. Here, Number of participants analyzed signifies participants with available data.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Change From Baseline in mTSS at Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 52/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Secondary
Change From Baseline in JSN Score at Week 28 and Week 52
JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
Posted
Mean
Standard Deviation
units on a scale
Baseline and weeks 28/ET and 52/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in Erosion Score at Week 28 and Week 52
The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
Posted
Mean
Standard Deviation
units on a scale
Baseline and weeks 28/ET and 52/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.
Posted
Number
percentage of participants
Baseline and week 28/ET and 52/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Secondary
Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in DAS28-CRP Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
FAS. Here, number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Change From Baseline in DAS28-ESR at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in DAS28-ESR Score Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Change From Baseline in TJC (68 Joints) at Week 12
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
tender joint count
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in TJC (68 Joints) Through Week 52
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in SJC (66 Joints) at Week 12
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
swollen joint count
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in SJC (66 Joints) Through Week 52
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
FAS. Here, Number of participants analyzed signifies participants with available data.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
FAS. Here, Number of participants analyzed signifies participants with available data.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Secondary
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
Secondary
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in CRP at Week 12
Higher CRP indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
mg/dL
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Secondary
Change From Baseline in CRP Through Week 52
Higher CRP indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in ESR at Week 12
Higher ESR indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
mm/h
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Secondary
Change From Baseline in ESR Through Week 52
Higher ESR indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving ACR / EULAR Remission at Week 12
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Number
percentage of participants
Week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in SDAI Score at Week 12
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in SDAI Score Through Week 52
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in PGA at Week 12
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
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.
FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in SGA at Week 12
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
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.
FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in SGAP at Week 12
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in SGAP Through Week 52
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy
Participants who discontinued due to lack of efficacy have been reported.
FAS.
Posted
Count of Participants
Participants
Up to week 52
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG003
Placebo / Peficitinib 150 mg
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
Secondary
Change From Baseline in HAQ-DI at Week 12
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Secondary
Change From Baseline in HAQ-DI Through Week 52
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
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.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
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.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned
Posted
Mean
Standard Deviation
units on a scale
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
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.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
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.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Posted
Mean
Standard Deviation
units on a scale
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
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.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
units on a scale
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
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.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Posted
Mean
Standard Deviation
units on a scale
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
percent work time missed
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Posted
Mean
Standard Deviation
percent work time missed
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in WPAI Percent Impairment While Working at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
percent work impairment
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Secondary
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculates as Q5/10. Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Posted
Mean
Standard Deviation
percent work impairment
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in Percent Overall Work Impairment at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
percent overall work impairment
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Posted
Mean
Standard Deviation
percent overall work impairment
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in WPAI Percent Activity Impairment at Week 12
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.
Posted
Mean
Standard Deviation
percent activity impairment
Baseline and week 12/ET
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.
Posted
Mean
Standard Deviation
percent activity impairment
Baseline, weeks 4, 8, 12, 28, 52 and EOT
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
SAF.
Posted
Count of Participants
Participants
Week 0 to week 12
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Secondary
Number of Participants With TEAEs From Week 12 to Week 28
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE
SAF. Here, Number of participants analyzed signifies participants with available data.
Posted
Count of Participants
Participants
Week 12 to week 28
ID
Title
Description
OG000
Placebo
Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
OG001
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Secondary
Number of Participants With TEAEs From Week 28 to Week 52
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
SAF. Here, Number of participants analyzed signifies participants with available data.
Posted
Count of Participants
Participants
Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study
ID
Title
Description
OG000
Peficitinib 100 mg
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Placebo / Peficitinib 100 mg at Week 12
Time Frame
Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
Description
SAF.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Week 0 to Week 12: Placebo
Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12.
0
170
4
170
42
170
EG001
Week 0 to Week 12: Peficitinib 100 mg
Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.
0
174
5
174
54
174
EG002
Week 0 to Week 12: Peficitinib 150 mg
Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.
0
174
3
174
61
174
EG003
Week 12 to Week 28: Placebo
Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.
0
82
2
82
26
82
EG004
Week 12 to Week 28: Peficitinib 100 mg
Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.
0
167
5
167
56
167
EG005
Week 12 to Week 28: Peficitinib 150 mg
Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.
0
165
3
165
60
165
EG006
Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 28.
0
37
0
37
14
37
EG007
Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 28.
0
38
0
38
11
38
EG008
Week 28 to Week 52: Peficitinib 100 mg
Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.
0
158
10
158
63
158
EG009
Week 28 to Week 52: Peficitinib 150 mg
Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.
0
158
8
158
73
158
EG010
Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 52.
0
36
2
36
16
36
EG011
Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 52.
0
36
1
36
22
36
EG012
Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
1
39
1
39
15
39
EG013
Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
0
34
1
34
20
34
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericarditis
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG0030 events0 affected82 at risk
EG0040 events0 affected167 at risk
EG0050 events0 affected165 at risk
EG0060 events0 affected37 at risk
EG0070 events0 affected38 at risk
EG0081 events1 affected158 at risk
EG0090 events0 affected158 at risk
EG0100 events0 affected36 at risk
EG0110 events0 affected36 at risk
EG0120 events0 affected39 at risk
EG0130 events0 affected34 at risk
Vertigo positional
Ear and labyrinth disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Pneumocystis jiroveci pneumonia
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Pneumonia cryptococcal
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected174 at risk
EG003
Brachial plexus injury
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Investigation
Investigations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Borderline ovarian tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Small cell lung cancer stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected174 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Mania
Psychiatric disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected174 at risk
EG003
Alveolitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Status asthmaticus
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected174 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0014 events4 affected174 at risk
EG0025 events5 affected174 at risk
EG0031 events1 affected82 at risk
EG0043 events3 affected167 at risk
EG0053 events3 affected165 at risk
EG0060 events0 affected37 at risk
EG0070 events0 affected38 at risk
EG0081 events1 affected158 at risk
EG0094 events3 affected158 at risk
EG0100 events0 affected36 at risk
EG0111 events1 affected36 at risk
EG0120 events0 affected39 at risk
EG0132 events2 affected34 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected174 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0015 events5 affected174 at risk
EG0023 events3 affected174 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0012 events2 affected174 at risk
EG0024 events4 affected174 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0012 events2 affected174 at risk
EG0022 events2 affected174 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0004 events4 affected170 at risk
EG0015 events5 affected174 at risk
EG0026 events6 affected174 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0013 events3 affected174 at risk
EG0023 events3 affected174 at risk
EG003
Cystitis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0002 events2 affected170 at risk
EG0011 events1 affected174 at risk
EG0022 events2 affected174 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0022 events2 affected174 at risk
EG003
Influenza
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0011 events1 affected174 at risk
EG0022 events2 affected174 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG00017 events14 affected170 at risk
EG00119 events19 affected174 at risk
EG00216 events16 affected174 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0006 events6 affected170 at risk
EG0013 events3 affected174 at risk
EG0026 events6 affected174 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0004 events4 affected170 at risk
EG0013 events3 affected174 at risk
EG0023 events3 affected174 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0013 events3 affected174 at risk
EG0025 events5 affected174 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0014 events4 affected174 at risk
EG0023 events3 affected174 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected170 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected174 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0011 events1 affected174 at risk
EG0021 events1 affected174 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0007 events6 affected170 at risk
EG0015 events4 affected174 at risk
EG0022 events2 affected174 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0013 events3 affected174 at risk
EG0022 events2 affected174 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected170 at risk
EG0010 events0 affected174 at risk
EG0023 events3 affected174 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0002 events2 affected170 at risk
EG0010 events0 affected174 at risk
EG0023 events3 affected174 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Closed testing procedure was used for multiplicity adjustment.
Percent difference
42.6
2-Sided
95
32.6
52.6
CI was based on normal approximation to the binomial distribution.
Superiority
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000153
OG001164
OG002164
Title
Denominators
Categories
Title
Measurements
OG0003.37± 5.46
OG0011.62± 4.23
OG0021.03± 2.86
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
RANCOVA
Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
<0.001
Closed testing procedure was used for multiplicity adjustment.
Superiority
OG000
OG002
Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
<0.001
Closed testing procedure was used for multiplicity adjustment.
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000174
OG001174
OG00237
OG00338
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00337
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG00038.2
OG00148.2
OG0028.1
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 12
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001163
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001160
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000152
ParticipantsOG001153
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000149
ParticipantsOG001153
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000148
ParticipantsOG001151
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001147
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000174
ParticipantsOG001174
ParticipantsOG00237
ParticipantsOG00338
Units
Counts
Participants
OG000170
OG001174
OG002174
Title
Denominators
Categories
Title
Measurements
OG0007.6
OG00129.9
OG00246.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
22.2
2-Sided
95
13.8
30.7
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
38.3
2-Sided
95
29.3
47.3
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000174
OG001174
OG00237
OG00338
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00337
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG00010.0
OG00115.9
OG0022.7
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 12
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001163
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001160
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000152
ParticipantsOG001153
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000149
ParticipantsOG001153
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000148
ParticipantsOG001151
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001147
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000174
ParticipantsOG001174
ParticipantsOG00237
ParticipantsOG00338
Units
Counts
Participants
OG000170
OG001174
OG002174
Title
Denominators
Categories
Title
Measurements
OG0002.4
OG00112.1
OG00223.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
9.7
2-Sided
95
3.8
15.6
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
21.2
2-Sided
95
13.9
28.5
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000174
OG001174
OG00237
OG00338
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00337
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG0001.2
OG0014.1
OG0020.0
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 12
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001163
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001161
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000152
ParticipantsOG001153
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000149
ParticipantsOG001153
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000148
ParticipantsOG001151
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001147
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000174
ParticipantsOG001174
ParticipantsOG00237
ParticipantsOG00338
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000153
OG001164
OG002164
Title
Denominators
Categories
Title
Measurements
OG0006.27± 10.18
OG0012.12± 5.83
OG0021.54± 4.11
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
RANCOVA
<0.001
Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
Superiority
OG000
OG002
Treatment Difference vs Placebo
RANCOVA
<0.001
Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.
Superiority
Units
Counts
Participants
OG000153
OG001164
OG002164
Title
Denominators
Categories
Week 28/ET
Title
Measurements
OG0001.90± 3.76
OG0010.99± 2.86
OG0020.82± 2.39
Week 52/ET
Title
Measurements
OG0003.55± 7.01
OG0011.30± 3.37
OG0021.19± 3.03
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 28/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.
0.018
Superiority
OG000
OG002
Week 28/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.
0.002
Superiority
OG000
OG001
Week 52/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.
0.039
Superiority
OG000
OG002
Week 52/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.
0.006
Superiority
Units
Counts
Participants
OG000153
OG001164
OG002164
Title
Denominators
Categories
Week 28/ET
Title
Measurements
OG0001.35± 3.01
OG0010.63± 2.03
OG0020.18± 1.10
Week 52/ET
Title
Measurements
OG0002.52± 5.58
OG0010.82± 3.14
OG0020.32± 1.87
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 28/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
0.036
Superiority
OG000
OG002
Week 28/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
<0.001
Superiority
OG000
OG001
Week 52/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
0.013
Superiority
OG000
OG002
Week 52/ET: Treatment Difference vs Placebo
RANCOVA
Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.
<0.001
Superiority
Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000153
OG001164
OG002164
Title
Denominators
Categories
Week 28/ET
Title
Measurements
OG00045.8
OG00167.1
OG00272.6
Week 52/ET
Title
Measurements
OG00042.5
OG00164.0
OG00268.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 28/ET: Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
21.3
2-Sided
95
10.0
32.6
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Week 28/ET: Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
26.8
2-Sided
95
15.7
37.9
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG001
Week 52/ET: Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
21.5
2-Sided
95
10.2
32.9
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Week 52/ET: Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
26.4
2-Sided
95
15.2
37.6
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-0.51± 1.10
OG001-1.70± 1.20
OG002-2.09± 1.33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.
<0.001
No multiplicity adjustment.
LS Mean difference
-1.21
Standard Error of the Mean
0.13
2-Sided
95
-1.46
-0.97
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.
<0.001
No multiplicity adjustment.
LS Mean difference
-1.59
Standard Error of the Mean
0.13
2-Sided
95
-1.85
-1.33
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000172
OG001171
OG00237
OG00337
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00337
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG000-1.11± 0.81
OG001-1.39± 0.98
OG002-0.28± 0.67
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 12
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001163
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001160
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000152
ParticipantsOG001153
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000149
ParticipantsOG001153
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000148
ParticipantsOG001151
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001147
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000172
ParticipantsOG001171
ParticipantsOG00237
ParticipantsOG00337
Units
Counts
Participants
OG000168
OG001172
OG002170
Title
Denominators
Categories
Title
Measurements
OG000-0.51± 1.11
OG001-1.66± 1.22
OG002-2.12± 1.36
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.
<0.001
No multiplicity adjustment.
LS Mean difference
-1.19
Standard Error of the Mean
0.13
2-Sided
95
-1.44
-0.94
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.
<0.001
No multiplicity adjustment.
LS Mean difference
-1.63
Standard Error of the Mean
0.13
2-Sided
95
-1.89
-1.36
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000172
OG001170
OG00237
OG00337
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001169
ParticipantsOG00237
ParticipantsOG00337
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG000-1.07± 0.83
OG001-1.37± 1.02
OG002-0.26± 0.66
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 12
ParticipantsOG000168
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001164
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001162
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001158
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001154
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001154
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000151
ParticipantsOG001151
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000147
ParticipantsOG001152
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000147
ParticipantsOG001150
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001146
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000172
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00337
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 8.2
OG001-6.9± 8.6
OG002-9.1± 8.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.
<0.001
No multiplicity adjustment.
LS Mean difference
-5.2
Standard Error of the Mean
0.9
95
-6.9
-3.5
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.
<0.001
No multiplicity adjustment.
LS Mean difference
-7.2
Standard Error of the Mean
0.8
2-Sided
95
-8.9
-5.6
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-5.1± 5.8
OG001-6.3± 6.9
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-6.8± 7.2
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-7.1± 8.6
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-8.1± 7.8
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-9.1± 7.9
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG000-9.9± 7.5
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-9.6± 7.4
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-9.7± 7.2
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-10.4± 7.6
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-10.8± 7.2
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-10.6± 7.4
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-10.5± 7.1
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-10.8± 7.4
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-9.8± 7.8
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-2.2± 6.6
OG001-5.9± 6.7
OG002-7.6± 6.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.
<0.001
No multiplicity adjustment.
LS Mean difference
-3.9
Standard Error of the Mean
0.7
2-Sided
95
-5.3
-2.6
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.
<0.001
No multiplicity adjustment.
LS Mean difference
-5.6
Standard Error of the Mean
0.6
2-Sided
95
-6.9
-4.3
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-4.3± 4.5
OG001-5.3± 5.6
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-5.6± 5.5
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-6.0± 6.7
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-7.5± 6.2
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-8.1± 6.1
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG000-8.8± 6.4
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-8.8± 6.2
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-9.0± 6.2
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-9.0± 6.1
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-9.4± 6.1
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-9.4± 6.1
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-9.2± 6.2
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-9.6± 6.2
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-8.8± 6.6
OG001
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0007.7
OG00131.4
OG00235.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
23.7
2-Sided
95
15.1
32.3
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
27.4
2-Sided
95
18.6
36.2
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000172
OG001171
OG00237
OG00338
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00338
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG00011.2
OG00114.7
OG0020.0
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00338
Week 12
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001163
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001160
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000152
ParticipantsOG001153
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000149
ParticipantsOG001153
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000148
ParticipantsOG001151
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001147
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000172
ParticipantsOG001171
ParticipantsOG00237
ParticipantsOG00338
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0002.4
OG00112.8
OG00219.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
10.4
2-Sided
95
4.3
16.5
C.I. was based on normal approximation to the binomial distribution (continuity corrected)
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
16.9
2-Sided
95
10.0
23.9
C.I. was based on normal approximation to the binomial distribution (continuity corrected)
Superiority
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Units
Counts
Participants
OG000172
OG001171
OG00237
OG00338
OG00439
OG00534
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
ParticipantsOG00237
ParticipantsOG00338
ParticipantsOG00439
ParticipantsOG00534
Title
Measurements
OG0004.1
OG0015.9
OG0020.0
OG003
Week 8
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00338
Week 12
ParticipantsOG000168
ParticipantsOG001166
ParticipantsOG00237
ParticipantsOG00337
Week 16
ParticipantsOG000166
ParticipantsOG001165
ParticipantsOG00237
ParticipantsOG00337
Week 20
ParticipantsOG000164
ParticipantsOG001163
ParticipantsOG00237
ParticipantsOG00337
Week 24
ParticipantsOG000161
ParticipantsOG001160
ParticipantsOG00236
ParticipantsOG00336
Week 28
ParticipantsOG000158
ParticipantsOG001159
ParticipantsOG00236
ParticipantsOG00336
Week 32
ParticipantsOG000157
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00336
Week 36
ParticipantsOG000153
ParticipantsOG001155
ParticipantsOG00236
ParticipantsOG00335
Week 40
ParticipantsOG000151
ParticipantsOG001152
ParticipantsOG00235
ParticipantsOG00334
Week 44
ParticipantsOG000147
ParticipantsOG001153
ParticipantsOG00234
ParticipantsOG00333
Week 48
ParticipantsOG000147
ParticipantsOG001151
ParticipantsOG00233
ParticipantsOG00333
Week 52
ParticipantsOG000145
ParticipantsOG001147
ParticipantsOG00233
ParticipantsOG00333
EOT
ParticipantsOG000172
ParticipantsOG001171
ParticipantsOG00237
ParticipantsOG00338
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG00012.4
OG00147.1
OG00257.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
34.7
2-Sided
95
25.1
44.2
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
45.5
2-Sided
95
36.0
55.0
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG00022.4
OG00124.1
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00036.3
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00047.0
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00055.4
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00062.2
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00067.1
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00067.7
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00065.6
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00069.3
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG00076.3
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG00070.5
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG00073.6
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00071.7
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00066.9
OG001
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0004.7
OG00125.0
OG00236.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
20.3
2-Sided
95
12.5
28.1
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
31.5
2-Sided
95
23.1
40.0
C.I. was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG00010.6
OG00112.9
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00017.9
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00025.6
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00034.9
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00044.5
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00052.2
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00049.4
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00052.2
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00053.6
OG001
Week 40
ParticipantsOG000151
ParticipantsOG001152
Title
Measurements
OG00058.3
OG001
Week 44
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00053.7
OG001
Week 48
ParticipantsOG000147
ParticipantsOG001151
Title
Measurements
OG00055.8
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00055.2
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00050.6
OG001
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-0.001± 2.038
OG001-1.499± 1.855
OG002-1.421± 2.182
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.
<0.001
No multiplicity adjustment.
LS Mean Difference
-1.597
Standard Error of the Mean
0.178
2-Sided
95
-1.948
-1.247
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
<0.001
No multiplicity adjustment.
LS Mean Difference
-1.458
Standard Error of the Mean
0.200
2-Sided
95
-1.852
-1.065
Superiority
172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-1.055± 1.539
OG001-1.411± 1.652
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-1.207± 1.839
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-1.532± 1.849
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-1.666± 1.828
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-1.660± 2.050
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001161
Title
Measurements
OG000-1.774± 2.022
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-1.803± 2.150
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-1.844± 2.214
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-1.832± 2.005
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-1.833± 2.156
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-1.815± 1.948
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-1.771± 2.189
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-1.841± 2.102
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-1.545± 2.315
OG001
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-2.42± 19.71
OG001-18.90± 19.85
OG002-22.17± 22.79
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.
<0.001
No multiplicity adjustment.
LS Mean Difference
-17.89
Standard Error of the Mean
1.89
2-Sided
95
-21.61
-14.17
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.
<0.001
No multiplicity adjustment.
LS Mean Difference
-20.61
Standard Error of the Mean
2.06
2-Sided
95
-24.67
-16.56
Superiority
172
OG001170
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001169
Title
Measurements
OG000-11.09± 14.34
OG001-16.59± 16.68
Week 8
ParticipantsOG000168
ParticipantsOG001165
Title
Measurements
OG000-14.96± 18.73
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001165
Title
Measurements
OG000-19.14± 19.81
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001164
Title
Measurements
OG000-21.42± 19.70
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001162
Title
Measurements
OG000-23.22± 20.78
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG000-25.35± 22.48
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001158
Title
Measurements
OG000-26.03± 23.70
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001154
Title
Measurements
OG000-26.92± 23.85
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001154
Title
Measurements
OG000-25.95± 22.68
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001151
Title
Measurements
OG000-25.86± 24.41
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001152
Title
Measurements
OG000-27.13± 22.73
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001150
Title
Measurements
OG000-25.63± 24.72
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001146
Title
Measurements
OG000-26.86± 23.60
OG001
EOT
ParticipantsOG000172
ParticipantsOG001170
Title
Measurements
OG000-24.00± 24.49
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG00010.1
OG00143.0
OG00255.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
33.0
2-Sided
95
23.7
42.2
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
45.5
2-Sided
95
36.2
54.8
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG00019.4
OG00121.8
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00030.4
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00042.9
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00051.8
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00059.1
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00065.2
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00063.3
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00063.1
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00067.3
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG00073.7
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG00065.8
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG00071.6
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00069.0
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00064.5
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG00035.5
OG00177.9
OG00284.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
42.4
2-Sided
95
32.3
52.5
CI was based on normal approximation to the binomial distribution (continuity corrected
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
49.3
2-Sided
95
39.7
58.9
CI was based on normal approximation to the binomial distribution (continuity corrected
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG00067.1
OG00177.1
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00073.8
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00078.6
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00084.3
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00086.6
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00089.4
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00091.1
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00093.0
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00094.8
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG00092.8
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG00095.3
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG00095.3
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00095.2
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00088.4
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0004.1
OG00123.8
OG00234.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
No multiplicity adjustment.
<0.001
Percent Difference
19.7
2-Sided
95
12.1
27.3
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
30.4
2-Sided
95
22.0
38.7
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG0007.6
OG00112.4
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00016.1
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00024.4
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00034.3
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00043.3
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00051.6
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00048.1
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00051.0
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00053.6
OG001
Week 40
ParticipantsOG000151
ParticipantsOG001152
Title
Measurements
OG00057.6
OG001
Week 44
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00052.4
OG001
Week 48
ParticipantsOG000147
ParticipantsOG001151
Title
Measurements
OG00053.7
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00053.8
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00049.4
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG00032.0
OG00174.4
OG00278.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
42.5
2-Sided
95
32.3
52.6
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
47.0
2-Sided
95
37.1
56.9
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG00055.9
OG00168.2
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00072.0
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG00075.0
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00080.7
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00082.3
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00087.6
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00088.0
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00090.4
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00094.1
OG001
Week 40
ParticipantsOG000151
ParticipantsOG001152
Title
Measurements
OG00092.7
OG001
Week 44
ParticipantsOG000147
ParticipantsOG001153
Title
Measurements
OG00096.6
OG001
Week 48
ParticipantsOG000147
ParticipantsOG001151
Title
Measurements
OG00094.6
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00093.8
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00086.0
OG001
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0000.6
OG0015.8
OG0029.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
0.011
No multiplicity adjustment.
Percent Difference
5.2
2-Sided
95
1.0
9.5
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
9.3
2-Sided
95
4.1
14.6
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG0001.2
OG0011.2
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0001.2
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0006.0
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG0009.0
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00011.0
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00011.8
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00014.6
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00017.2
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00017.0
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG00019.1
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG00016.1
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG00017.6
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00021.4
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00019.2
OG001
Units
Counts
Participants
OG000169
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0000.6
OG0017.0
OG00214.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
Fisher Exact
0.003
Percent Difference
6.4
2-Sided
95
1.8
11.0
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
No multiplicity adjustment.
OG000
OG002
Treatment Difference vs Placebo
Fisher Exact
<0.001
No multiplicity adjustment.
Percent Difference
13.4
2-Sided
95
7.5
19.4
CI was based on normal approximation to the binomial distribution (continuity corrected).
Superiority
OG000
172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG0001.2
OG0012.4
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0003.0
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0007.1
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG00014.5
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG00018.3
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG00020.5
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG00022.2
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG00025.5
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG00024.2
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG00031.6
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG00027.5
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG00025.7
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00030.3
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG00028.5
OG001
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-4.90± 12.32
OG001-15.66± 12.69
OG002-19.57± 13.53
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-11.22
Standard Error of the Mean
1.33
2-Sided
95
-13.84
-8.60
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-14.67
Standard Error of the Mean
1.36
2-Sided
95
-17.35
-11.98
Superiority
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-11.02± 8.23
OG001-13.79± 10.43
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-14.60± 10.40
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-15.94± 12.59
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-18.75± 11.58
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-20.24± 11.89
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG000-21.62± 11.64
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-21.89± 11.54
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-22.61± 11.15
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-22.89± 11.10
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-23.55± 11.20
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-23.55± 11.17
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-23.23± 11.30
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-23.67± 11.91
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-21.48± 13.42
OG001
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-11.88± 21.46
OG001-28.83± 22.21
OG002-35.96± 25.00
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).
<0.001
No multiplicity adjustment.
LS Mean difference
-17.67
Standard Error of the Mean
2.26
2-Sided
95
-22.11
-13.22
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).
<0.001
No multiplicity adjustment.
LS Mean Difference
-24.09
Standard Error of the Mean
2.33
95
-28.66
-19.51
Superiority
172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-18.36± 17.10
OG001-22.94± 19.32
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-25.79± 19.59
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-29.07± 22.22
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-33.60± 21.27
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-36.18± 21.87
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001160
Title
Measurements
OG000-37.13± 21.71
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-38.72± 22.45
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-40.04± 20.82
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-39.35± 21.25
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-41.04± 22.33
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-41.47± 22.73
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-41.55± 23.23
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-41.49± 23.75
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-38.41± 25.07
OG001
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-7.11± 23.05
OG001-21.09± 23.63
OG002-26.57± 25.43
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)
<0.001
No multiplicity adjustment.
LS Mean Difference
-16.64
Standard Error of the Mean
2.26
2-Sided
95
-21.09
-12.19
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).
<0.001
No multiplicity adjustment.
LS Mean difference
-20.34
Standard Error of the Mean
2.40
2-Sided
95
-25.07
-15.61
Superiority
172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-13.80± 19.47
OG001-17.59± 20.25
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-19.11± 23.22
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-21.59± 23.43
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-25.20± 24.41
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-26.94± 25.49
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001161
Title
Measurements
OG000-29.00± 25.51
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-30.04± 24.96
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-31.92± 24.99
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-32.38± 25.34
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-32.80± 25.85
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-33.49± 25.86
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-33.69± 26.18
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-33.18± 27.83
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-29.34± 28.78
OG001
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-6.64± 25.22
OG001-21.09± 27.04
OG002-26.87± 26.65
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).
<0.001
No multiplicity adjustment.
LS Mean Difference
-17.19
Standard Error of the Mean
2.44
2-Sided
95
-22.00
-12.38
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).
<0.001
No multiplicity adjustment.
LS Mean difference
-20.89
Standard Error of the Mean
2.50
2-Sided
95
-25.80
-15.98
Superiority
172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-12.94± 20.75
OG001-16.18± 22.06
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-19.10± 25.81
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-21.27± 27.03
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-24.03± 26.09
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-25.57± 28.52
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001161
Title
Measurements
OG000-27.34± 27.54
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-28.54± 27.24
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-31.32± 25.76
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-31.95± 26.17
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-32.17± 26.81
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-32.73± 26.67
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-33.60± 25.87
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-33.34± 26.98
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-28.94± 28.63
OG001
Units
Counts
Participants
OG000175
OG001174
OG00285
OG00385
Title
Denominators
Categories
Title
Measurements
OG00010
OG0016
OG0023
OG0039
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.47
OG001-0.22± 0.44
OG002-0.37± 0.48
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-0.27
Standard Error of the Mean
0.05
2-Sided
95
-0.36
-0.17
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-0.39
Standard Error of the Mean
0.05
2-Sided
95
-0.48
-0.29
Superiority
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG000-0.08± 0.30
OG001-0.21± 0.36
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-0.18± 0.41
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG000-0.23± 0.44
OG001
Week 16
ParticipantsOG000166
ParticipantsOG001165
Title
Measurements
OG000-0.30± 0.46
OG001
Week 20
ParticipantsOG000164
ParticipantsOG001163
Title
Measurements
OG000-0.33± 0.48
OG001
Week 24
ParticipantsOG000161
ParticipantsOG001161
Title
Measurements
OG000-0.36± 0.50
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG000-0.36± 0.51
OG001
Week 32
ParticipantsOG000157
ParticipantsOG001155
Title
Measurements
OG000-0.37± 0.51
OG001
Week 36
ParticipantsOG000153
ParticipantsOG001155
Title
Measurements
OG000-0.39± 0.50
OG001
Week 40
ParticipantsOG000152
ParticipantsOG001153
Title
Measurements
OG000-0.42± 0.50
OG001
Week 44
ParticipantsOG000149
ParticipantsOG001153
Title
Measurements
OG000-0.45± 0.50
OG001
Week 48
ParticipantsOG000148
ParticipantsOG001151
Title
Measurements
OG000-0.44± 0.49
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG000-0.43± 0.51
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG000-0.36± 0.55
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0000.57± 12.08
OG0016.60± 11.06
OG0029.02± 11.54
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
<0.001
No multiplicity adjustment.
LS Mean Difference
6.41
Standard Error of the Mean
1.18
2-Sided
95
4.09
8.74
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
<0.001
No multiplicity adjustment.
LS Mean Difference
8.61
Standard Error of the Mean
1.14
2-Sided
95
6.36
10.86
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG0003.84± 8.91
OG0015.77± 11.05
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0004.92± 10.82
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0006.68± 11.08
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG0009.89± 11.86
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG00011.27± 12.05
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG0009.92± 12.81
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG0001.07± 8.27
OG0013.28± 7.47
OG0022.50± 8.44
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
<0.001
No multiplicity adjustment.
LS Mean Difference
2.70
Standard Error of the Mean
0.76
2-Sided
95
1.21
4.18
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
0.036
No multiplicity adjustment.
LS Mean Difference
1.65
Standard Error of the Mean
0.78
2-Sided
95
0.11
3.19
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG0001.45± 7.02
OG0011.33± 7.93
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0002.72± 7.39
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0003.44± 7.47
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG0003.06± 8.55
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG0002.62± 9.10
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG0002.21± 8.89
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001172
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-0.09± 16.69
OG0012.30± 13.92
OG0023.90± 13.35
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
0.099
No multiplicity adjustment.
LS Mean Difference
2.29
Standard Error of the Mean
1.39
2-Sided
95
-0.44
5.02
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.
0.002
No multiplicity adjustment.
LS Mean Difference
4.22
Standard Error of the Mean
1.37
2-Sided
95
1.53
6.91
Superiority
Units
Counts
Participants
OG000172
OG001171
Title
Denominators
Categories
Week 4
ParticipantsOG000170
ParticipantsOG001170
Title
Measurements
OG0001.41± 11.51
OG0011.70± 11.44
Week 8
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0002.50± 13.79
OG001
Week 12
ParticipantsOG000168
ParticipantsOG001166
Title
Measurements
OG0002.32± 14.05
OG001
Week 28
ParticipantsOG000158
ParticipantsOG001159
Title
Measurements
OG0004.06± 14.92
OG001
Week 52
ParticipantsOG000145
ParticipantsOG001147
Title
Measurements
OG0004.30± 15.31
OG001
EOT
ParticipantsOG000172
ParticipantsOG001171
Title
Measurements
OG0003.49± 14.85
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG00098
OG00182
OG00295
Title
Denominators
Categories
Title
Measurements
OG000-0.82± 17.77
OG0010.36± 18.15
OG002-1.46± 15.26
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
0.879
No multiplicity adjustment.
LS Mean Difference
-0.37
Standard Error of the Mean
2.43
2-Sided
95
-5.16
4.42
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
0.377
No multiplicity adjustment.
LS Mean Difference
-1.81
Standard Error of the Mean
2.05
2-Sided
95
-5.86
2.23
Superiority
Units
Counts
Participants
OG00082
OG00195
Title
Denominators
Categories
Week 4
ParticipantsOG00080
ParticipantsOG00191
Title
Measurements
OG000-0.90± 16.50
OG0010.02± 16.53
Week 8
ParticipantsOG00077
ParticipantsOG00189
Title
Measurements
OG000-1.48± 15.72
OG001
Week 12
ParticipantsOG00077
ParticipantsOG00189
Title
Measurements
OG000-0.70± 14.69
OG001
Week 28
ParticipantsOG00070
ParticipantsOG00186
Title
Measurements
OG000-0.58± 19.15
OG001
Week 52
ParticipantsOG00064
ParticipantsOG00179
Title
Measurements
OG000-1.93± 12.14
OG001
EOT
ParticipantsOG00082
ParticipantsOG00195
Title
Measurements
OG000-1.76± 14.68
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG00095
OG00182
OG00294
Title
Denominators
Categories
Title
Measurements
OG000-2.42± 27.78
OG001-11.71± 25.62
OG002-15.96± 28.30
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
0.007
No multiplicity adjustment.
LS Mean Difference
-9.63
Standard Error of the Mean
3.50
2-Sided
95
-16.54
-2.73
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-14.17
Standard Error of the Mean
3.58
2-Sided
95
-21.24
-7.10
Superiority
Units
Counts
Participants
OG00083
OG00194
Title
Denominators
Categories
Week 4
ParticipantsOG00080
ParticipantsOG00190
Title
Measurements
OG000-10.00± 22.39
OG001-6.56± 29.31
Week 8
ParticipantsOG00076
ParticipantsOG00188
Title
Measurements
OG000-12.50± 24.93
OG001
Week 12
ParticipantsOG00076
ParticipantsOG00189
Title
Measurements
OG000-11.97± 26.33
OG001
Week 28
ParticipantsOG00068
ParticipantsOG00186
Title
Measurements
OG000-20.00± 25.27
OG001
Week 52
ParticipantsOG00064
ParticipantsOG00179
Title
Measurements
OG000-22.97± 29.90
OG001
EOT
ParticipantsOG00083
ParticipantsOG00194
Title
Measurements
OG000-17.35± 29.10
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG00095
OG00181
OG00294
Title
Denominators
Categories
Title
Measurements
OG000-2.75± 28.56
OG001-11.58± 26.22
OG002-16.91± 29.23
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
0.010
No multiplicity adjustment.
LS Mean Difference
-9.43
Standard Error of the Mean
3.63
2-Sided
95
-16.60
-2.25
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-14.61
Standard Error of the Mean
3.70
2-Sided
95
-21.92
-7.31
Superiority
Units
Counts
Participants
OG00082
OG00194
Title
Denominators
Categories
Week 4
ParticipantsOG00079
ParticipantsOG00190
Title
Measurements
OG000-10.61± 22.36
OG001-7.51± 30.12
Week 8
ParticipantsOG00076
ParticipantsOG00188
Title
Measurements
OG000-13.13± 25.07
OG001
Week 12
ParticipantsOG00076
ParticipantsOG00189
Title
Measurements
OG000-12.15± 26.81
OG001
Week 28
ParticipantsOG00068
ParticipantsOG00186
Title
Measurements
OG000-20.76± 25.78
OG001
Week 52
ParticipantsOG00064
ParticipantsOG00179
Title
Measurements
OG000-22.48± 30.96
OG001
EOT
ParticipantsOG00082
ParticipantsOG00194
Title
Measurements
OG000-17.43± 30.01
OG001
OG002
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000168
OG001171
OG002170
Title
Denominators
Categories
Title
Measurements
OG000-2.50± 28.19
OG001-13.98± 27.17
OG002-19.35± 24.28
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-13.19
Standard Error of the Mean
2.56
2-Sided
95
-18.23
-8.16
Superiority
OG000
OG002
Treatment Difference vs Placebo
ANCOVA
Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.
<0.001
No multiplicity adjustment.
LS Mean Difference
-17.61
Standard Error of the Mean
2.52
2-Sided
95
-22.57
-12.66
Superiority
Units
Counts
Participants
OG000171
OG001170
Title
Denominators
Categories
Week 4
ParticipantsOG000169
ParticipantsOG001169
Title
Measurements
OG000-9.23± 22.81
OG001-10.65± 22.18
Week 8
ParticipantsOG000166
ParticipantsOG001164
Title
Measurements
OG000-13.07± 26.12
OG001
Week 12
ParticipantsOG000167
ParticipantsOG001165
Title
Measurements
OG000-13.71± 27.30
OG001
Week 28
ParticipantsOG000157
ParticipantsOG001156
Title
Measurements
OG000-22.17± 27.25
OG001
Week 52
ParticipantsOG000144
ParticipantsOG001146
Title
Measurements
OG000-24.10± 31.72
OG001
EOT
ParticipantsOG000171
ParticipantsOG001170
Title
Measurements
OG000-21.58± 31.67
OG001
Peficitinib 150 mg
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
Units
Counts
Participants
OG000170
OG001174
OG002174
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00084
OG00189
OG002104
Drug-related TEAEs
Title
Measurements
OG00047
OG00157
OG00280
TEAEs leading to death
Title
Measurements
OG0000
OG0010
OG0020
Serious TEAEs
Title
Measurements
OG0004
OG0015
OG0023
Drug-related serious TEAEs
Title
Measurements
OG0002
OG0013
OG0023
≥ Grade 3 TEAEs
Title
Measurements
OG0008
OG0019
OG00216
TEAEs leading to permanent discontinuation
Title
Measurements
OG0007
OG0015
OG0025
Drug-Related AE leading to permanent discont.
Title
Measurements
OG0006
OG0013
OG0025
Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.
OG003
Placebo / Peficitinib 100 mg at Week 12
Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
Units
Counts
Participants
OG00082
OG001167
OG002165
OG00337
OG00438
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00050
OG00195
OG002104
OG00321
OG00425
Drug-related TEAEs
Title
Measurements
OG00027
OG00163
OG00272
OG003
TEAEs leading to death
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serious TEAEs
Title
Measurements
OG0002
OG0015
OG0023
OG003
Drug-related serious TEAEs
Title
Measurements
OG0002
OG0013
OG0021
OG003
≥ Grade 3 TEAEs
Title
Measurements
OG0005
OG0017
OG0026
OG003
TEAEs leading to permanent discontinuation
Title
Measurements
OG0004
OG0014
OG0021
OG003
Drug-Related TEAE leading to permanent dicont.
Title
Measurements
OG0003
OG0013
OG0021
OG003
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG003
Placebo / Peficitinib 150 mg at Week 12
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.
OG004
Placebo / Peficitinib 100 mg at Week 28
Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
OG005
Placebo / Peficitinib 150 mg at Week 28
Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.