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AzTrials

Rheumatoid ArthritisPhase 3NCT02308163

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

A Phase 3 study testing Peficitinib and Etanercept in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 153 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Peficitinib and Etanercept
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
509 participants
Where
153 sitesin 3 countries
Study dates
8 Aug 2014to 22 Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria
  • Subject who did not receive the following drugs, or received the drugs with stable dosage for at least 28 days prior to the baseline (start of treatment) for RA treatment:
  • Non-steroidal anti-inflammatory drugs (NSAIDs; excluding topical formulations), oral morphine or equivalent opioid analgesics (≤ 30 mg/day), acetaminophen, or oral corticosteroids (≤ 10 mg/day in prednisolone equivalent)
  • At screening subject has active RA as evidenced by both of the following:
  • ≥ 6 tender/painful joints (using 68-joint assessment)
  • ≥ 6 swollen joints (using 66-joint assessment)
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  • CRP > 0.50 mg/dL at screening
  • Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening.
  • Inadequate responder to (including subjects who were intolerant of) at least one DMARD administered for at least 90 days prior to screening

Who cannot join

  • Subject has received a biologic DMARD within the specified period
  • Subject has received etanercept
  • Inadequate responder to at least 3 biologic DMARDs as determined by investigator/sub-investigator
  • Subject has received intra-articular, intravenous, intramuscular or endorectal (excluding suppositories for anal diseases) corticosteroid within 28 days prior to baseline
  • Subject has participated in any study of ASP015K and has received ASP015K or placebo
  • Subject has received other investigational drugs within 90 days or within 5 half-lives, whichever is longer, prior to baseline
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  • Subject has received plasma exchange therapy within 60 days prior to baseline
  • Subject has undergone joint drainage, has received local anesthesia and nerve block, or has received articular cartilage protectant at the assessed joint within 28 days prior to baseline
  • Subject has undergone surgery and has residual effects in the assessed joints at the discretion of investigator/sub-investigator, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints at the discretion of investigator/sub-investigator
  • A diagnosis of inflammatory arthritis (psoriatic arthritis, ankylosing spondylitis, SLE, sarcoidosis, etc.) other than RA
  • Any of the following laboratory values at screening:
  • Hemoglobin < 9.0 g/dL
  • Absolute neutrophil count < 1000/μL
  • Absolute lymphocyte count < 800/μL
  • Platelet count < 75000/μL
  • ALT ≥ 2 ×ULN
  • AST ≥ 2 × ULN
  • Total bilirubin (TBL) ≥ 1.5 × ULN
  • Estimated GFR ≤ 40 mL/min as measured by the MDRD method
  • β-D-glucan > ULN [in case of Japan: ≥ 11 pg/mL]
  • Positive HBs antigen, HBc antibody, HBs antibody or HBV-DNA quantitation (However, subject with negative HBs antigen and HBV-DNA quantitation, and positive HBc antibody and/or HBs antibody is eligible if HBV-DNA is monitored by HBV-DNA quantitation at every scheduled visit after initiation of study drug or reference drug administration.)
  • Positive HCV antibody
  • Subject has a history of or concurrent active tuberculosis (TB)
  • Subject has a history of or concurrent interstitial pneumonia and investigator/sub-investigator judges that it is inappropriate for the subject to participate in this study
  • Subject has a history of or concurrent malignant tumor (except for successfully treated basal cell carcinoma)
  • Subject has received live or live attenuated virus vaccination within 56 days prior to baseline. (Inactivated vaccines including influenza and pneumococcal vaccines are allowed.)
  • Subject has a history of or concurrent demyelinating disorders
  • Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA (excluding Sjogren's syndrome and chronic thyroiditis), or any ongoing illness which would make the subject unsuitable for the study as determined by the investigator/sub-investigator
  • Subject has a history of clinically significant allergy. (Clinically significant allergy includes allergies such as systemic urticaria induced by specific antigens and drugs, anaphylaxis, and allergy associated with shock necessitating hospitalized treatment.)
  • Subject has concurrent cardiac failure, defined as NYHA classification Class III or higher, or a history of it
  • Subject has concurrent prolonged QT syndrome or a history of it. Subject has prolonged QT interval (defined as QTc ≥ 500 msec. Subject has QTc ≥ 500 msec at retest will be excluded) at screening
  • Subject has a history of positive HIV infection
  • Subject has congenital short QT syndrome or a history of it. Subject has shortened QT interval (defined as QTc < 330 msec. Subject has QTc < 330 msec at retest will be excluded) at screening.

Trial locations and contacts

153 sites in 3 countries.

153 sites in 3 countries

Japan132 sites

  • JP00056

    Akashi, Hyōgo

  • JP00026

    Asahikawa, Hokkaido

  • JP00064

    Beppu, Oita Prefecture

  • JP00024

    Bunkyo, Tokyo

  • JP00043

    Bunkyo, Tokyo

  • JP00149

    Bunkyo, Tokyo

  • JP00152

    Bunkyo, Tokyo

  • JP00095

    Chiyoda City, Tokyo

  • JP00099

    Chiyoda City, Tokyo

  • JP00142

    Chūō, Tokyo

  • JP00018

    Fukuoka

  • JP00020

    Fukuoka

  • JP00035

    Fukuoka

  • JP00059

    Fukuoka

  • JP00067

    Fukuoka

  • JP00076

    Fukuoka

  • JP00131

    Fukuoka

  • JP00164

    Fukuoka

  • JP00126

    Gyōda, Saitama

  • JP00063

    Hachiōji, Tokyo

  • JP00090

    Hakodate, Hokkaido

  • JP00011

    Hannan, Osaka

  • JP00134

    Higashiosaka, Osaka

  • JP00007

    Hiki, Saitama

  • JP00069

    Himeji, Hyōgo

  • JP00013

    Hiroshima

  • JP00014

    Hiroshima

  • JP00015

    Hiroshima

  • JP00016

    Hiroshima

  • JP00055

    Hiroshima

  • JP00107

    Hitachi, Ibaraki

  • JP00050

    Hyūga, Miyazaki

  • JP00120

    Iizuka, Fukuoka

  • JP00082

    Iruma, Saitama

  • JP00084

    Isehara, Kanagawa

  • JP00162

    Isehaya, Nagasaki

  • JP00065

    Kagoshima

  • JP00074

    Kagoshima

  • JP00133

    Kakegawa, Shizuoka

  • JP00113

    Kakogawa, Hyōgo

  • JP00102

    Kamagaya, Chiba

  • JP00077

    Kanuma, Tochigi

  • JP00094

    Kashihara, Nara

  • JP00041

    Katō, Hyōgo

  • JP00078

    Kawachi-Nagano, Osaka

  • JP00060

    Kawagoe, Saitama

  • JP00161

    Kawagoe, Saitama

  • JP00062

    Kawaguchi, Saitama

  • JP00048

    Kawasaki, Kanagawa

  • JP00058

    Kawasaki, Kanagawa

  • JP00040

    Kitakyushu, Fukuoka

  • JP00119

    Kitakyushu, Fukuoka

  • JP00053

    Kiyose, Tokyo

  • JP00042

    Kobe, Hyōgo

  • JP00092

    Kobe, Hyōgo

  • JP00154

    Kobe, Hyōgo

  • JP00093

    Kochi

  • JP00073

    Koga, Ibaraki

  • JP00022

    Kumamoto

  • JP00046

    Kumamoto

  • JP00071

    Kurume, Fukuoka

  • JP00097

    Kurume, Fukuoka

  • JP00106

    Kurume, Fukuoka

  • JP00125

    Kushiro, Hokkaido

  • JP00123

    Kyoto

  • JP00159

    Kyoto

  • JP00127

    Matsudo, Chiba

  • JP00072

    Meguro City, Tokyo

  • JP00083

    Meguro City, Tokyo

  • JP00054

    Mito, Ibaraki

  • JP00023

    Miyagi

  • JP00122

    Miyazaki

  • JP00049

    Morioka, Iwate

  • JP00080

    Nagano

  • JP00025

    Nagaoka, Niigata

  • JP00098

    Nagasaki

  • JP00112

    Nagasaki

  • JP00147

    Nagasaki

  • JP00037

    Nagoya, Aichi-ken

  • JP00109

    Nagoya, Aichi-ken

  • JP00130

    Nagoya, Aichi-ken

  • JP00115

    Narashino, Chiba

  • JP00155

    Nishimuro, Wakayama

  • JP00117

    Nishinomiya, Hyōgo

  • JP00017

    Ōita

  • JP00118

    Okayama

  • JP00066

    Okazaki, Aichi-ken

  • JP00101

    Ōmura, Nagasaki

  • JP00103

    Ōmura, Nagasaki

  • JP00150

    Osaka

  • JP00157

    Osaka

  • JP00148

    Ōta-ku, Tokyo

  • JP00141

    Sagamihara, Kanagawa

  • JP00137

    Sakai, Osaka

  • JP00001

    Sapporo, Hokkaido

  • JP00002

    Sapporo, Hokkaido

  • JP00003

    Sapporo, Hokkaido

  • JP00031

    Sapporo, Hokkaido

  • JP00038

    Sapporo, Hokkaido

  • JP00114

    Sapporo, Hokkaido

  • JP00158

    Sapporo, Hokkaido

  • JP00153

    Sasebo, Nagasaki

  • JP00052

    Sayama, Saitama

  • JP00004

    Sendai, Miyagi

  • JP00027

    Sendai, Miyagi

  • JP00036

    Sendai, Miyagi

  • JP00105

    Sendai, Miyagi

  • JP00151

    Sendai, Miyagi

  • JP00100

    Setagaya City, Tokyo

  • JP00051

    Setouchi, Okayama-ken

  • JP00144

    Shibata, Niigata

  • JP00104

    Shimonoseki, Yamaguchi

  • JP00032

    Shinjuku, Tokyo

  • JP00089

    Shizuoka

  • JP00135

    Shizuoka

  • JP00047

    Shūnan, Yamaguchi

  • JP00070

    Suita, Osaka

  • JP00086

    Suita, Osaka

  • JP00010

    Takaoka, Toyama

  • JP00033

    Takasaki, Gunma

  • JP00057

    Tamana, Kumamoto

  • JP00008

    Tokorozawa, Saitama

  • JP00139

    Toyama

  • JP00140

    Toyoake, Aichi-ken

  • JP00108

    Toyohashi, Aichi-ken

  • JP00061

    Toyonaka, Osaka

  • JP00156

    Toyota, Aichi-ken

  • JP00075

    Ureshino, Saga-ken

  • JP00068

    Yatomi, Aichi-ken

  • JP00096

    Yokohama, Kanagawa

  • JP00128

    Yokosuka, Kanagawa

  • JP00138

    Yotsukaidō, Chiba

Other trials in Japan

South Korea11 sites

  • KR00504

    Daegu

  • KR00510

    Daegu

  • KR00505

    Gwangju

  • KR00506

    Incheon

  • KR00508

    Jeonju

  • KR00501

    Seoul

  • KR00502

    Seoul

  • KR00503

    Seoul

  • KR00509

    Seoul

  • KR00511

    Seoul

  • KR00507

    Suwon

Other trials in South Korea

Taiwan10 sites

  • TW00708

    Kaohsiung City

  • TW00709

    Kaohsiung City

  • TW00704

    Taichung

  • TW00705

    Taichung

  • TW00710

    Taichung

  • TW00712

    Tainan

  • TW00701

    Taipei

  • TW00702

    Taipei

  • TW00711

    Taipei

  • TW00703

    Taoyuan

Other trials in Taiwan

About this study

Official title: Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs

Read the detailed description

This was a multi-center, randomized, placebo-controlled, double-blind, parallel-group, confirmatory study to evaluate the efficacy and safety of ASP015K alone or in combination with DMARDs in participants with RA who had an inadequate response to DMARDs.

Etanercept was also administered as the reference drug in an open-label manner. The study drug was orally administered once daily (QD) after breakfast for 52 weeks. Etanercept was administered subcutaneously QD for 52 weeks. At Week 12, participants in the placebo group were switched to ASP015K.

The dose of ASP015K to be started at Week 12 for the placebo group was determined randomly at baseline in advance and switched in a blinded manner.

Participants in ASP015K group or placebo groups who had completed the study were eligible for participation in an open-label extension study (015K-CL-RAJ2).

Being tested
Peficitinib, Placebo, Etanercept
Keywords
Rheumatoid Arthritis, ASP015K
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PeficitinibDrug

    Also called ASP015K

    oral

  • PlaceboDrug

    oral

  • EtanerceptBiological

    subcutaneous injection

Study groups in NCT02308163
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants were assigned to receive placebo to peficitinib once a day until week 12.
Receives: Drug: Placebo
Peficitinib 100 mgExperimentalParticipants were assigned to receive peficitinib 100 mg/day for 52 weeks.
Receives: Drug: Peficitinib
Peficitinib 150 mgExperimentalParticipants were assigned to receive peficitinib 150 mg/day for 52 weeks.
Receives: Drug: Peficitinib
EtanerceptActive comparatorParticipants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
Receives: Biological: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12

    The ACR20 response required that all criteria from (1) to (3) below be met.

    1. Tender joint count (TJC) : ≥ 20% reduction compared with baseline.
    2. Swollen joint count (SJC) : ≥ 20% reduction compared with baseline.
    3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline (3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP).

    Measured: Baseline and Week 12/early termination (ET)

Secondary outcomes (68)

  1. Percentage of Participants With an ACR20-CRP Response Through Week 52

    The ACR20 response required that all criteria from (1) to (3) below be met.

    1. TJC : ≥ 20% reduction compared with baseline.
    2. SJC : ≥ 20% reduction compared with baseline.
    3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  2. Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12

    The ACR50 response required that all criteria from (1) to (3) below be met.

    1. TJC : ≥ 50% reduction compared with baseline.
    2. SJC : ≥ 50% reduction compared with baseline.
    3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.

    Measured: Baseline and Week 12/ET

  3. Percentage of Participants With an ACR50-CRP Response Through Week 52

    The ACR50 response required that all criteria from (1) to (3) below be met.

    1. TJC : ≥ 50% reduction compared with baseline.
    2. SJC : ≥ 50% reduction compared with baseline.
    3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  4. Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12

    The ACR70 response required that all criteria from (1) to (3) below be met.

    1. TJC : ≥ 70% reduction compared with baseline.
    2. SJC : ≥ 70% reduction compared with baseline.
    3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.

    Measured: Baseline and Week 12/ET

  5. Percentage of Participants With an ACR70-CRP Response Through Week 52

    The ACR70 response required that all criteria from (1) to (3) below be met.

    1. TJC : ≥ 70% reduction compared with baseline.
    2. SJC : ≥ 70% reduction compared with baseline.
    3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  6. Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12

    DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.

    Measured: Baseline and Week 12/ET

  7. Change From Baseline DAS28-CRP Through Week 52

    DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  8. Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12

    DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.

    Measured: Baseline and Week 12/ET

  9. Change From Baseline in DAS28-ESR Through Week 52

    DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  10. Change From Baseline in TJC (68 Joints) at Week 12

    The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.

    Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).

    Measured: Baseline and Week 12/ET

  11. Change From Baseline in TJC (68 Joints) Through Week 52

    The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.

    Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  12. Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12

    The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.

    Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).

    Measured: Baseline and Week 12/ET

  13. Change From Baseline in SJC (66 Joints) Through Week 52

    The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.

    Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  14. Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12

    DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

    Measured: Baseline and Week 12/ET

  15. Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52

    DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  16. Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12

    DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

    Measured: Week 12/ET

  17. Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52

    DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  18. Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12

    DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

    Measured: Week 12/ET

  19. Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52

    DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  20. Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12

    DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

    Measured: Week 12/ET

  21. Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52

    DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.

    DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  22. Change From Baseline in CRP at Week 12

    Higher CRP indicates greater disease activity.

    Measured: Baseline and Week 12/ET

  23. Change From Baseline in CRP Through Week 52

    Higher CRP indicates greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  24. Change From Baseline in ESR at Week 12

    Higher ESR indicates greater disease activity.

    Measured: Baseline and Week 12/ET

  25. Change From Baseline in ESR Through Week 52

    Higher ESR indicates greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  26. Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12

    Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.

    Measured: Week 12/ET

  27. Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52

    Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  28. Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12

    Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.

    Measured: Week 12/ET

  29. Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52

    Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  30. Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12

    Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.

    Measured: Week 12/ET

  31. Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52

    Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  32. Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12

    Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.

    Measured: Week 12/ET

  33. Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52

    Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  34. Percentage of Participants Achieving ACR / EULAR Remission at Week 12

    ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).

    Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.

    Measured: Week 12/ET

  35. Percentage of Participants Achieving ACR / EULAR Remission Through Week 52

    ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm).

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  36. Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12

    SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.

    SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.

    Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.

    Measured: Week 12/ET

  37. Percentage of Participants Achieving SDAI Remission Through Week 52

    SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.

    SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  38. Change From Baseline in SDAI Score at Week 12

    SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.

    SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.

    Measured: Baseline and Week 12/ET

  39. Change From Baseline in SDAI Score Through Week 52

    SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.

    SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  40. Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12

    CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.

    CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.

    Measured: Week 12/ET

  41. Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52

    CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.

    CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  42. Change From Baseline in CDAI Score at Week 12

    CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.

    CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.

    Measured: Baseline and Week 12/ET

  43. Change From Baseline in CDAI Score Through Week 52

    CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.

    CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  44. Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12

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

    Measured: Baseline and Week 12/ET

  45. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  46. Change From Baseline in Subject's SGA at Week 12

    The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.

    Measured: Baseline and Week 12/ET

  47. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  48. Change From Baseline in Subject's Assessment of Pain at Week 12

    The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.

    Measured: Baseline and Week 12/ET

  49. Change From Baseline in Subject's Assessment of Pain Through Week 52

    The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  50. Number of Participants Who Withdrew Due to Lack of Efficacy

    The number of participants who withdrew due to lack of efficacy up to week 12 was calculated.

    Measured: Up to week 12

  51. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12

    The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.

    Measured: Baseline and Week 12/ET

  52. Change From Baseline in HAQ-DI Through Week 52

    The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  53. 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.

    Measured: Baseline and Week 12/ET

  54. 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.

    Measured: Baseline and Week 4, 8, 12, 28, and 52

  55. 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.

    Measured: Baseline and Week 12/ET

  56. 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.

    Measured: Baseline and Week 4, 8, 12, 28, and 52

  57. 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.

    Measured: Baseline and Week 12/ET

  58. 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.

    Measured: Baseline and Week 4, 8, 12, 28, and 52

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

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).

    Measured: Baseline and Week 12/ET

  60. Change From Baseline in WPAI Percent Work Time Missed Through Week 52

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).

    Measured: Baseline and Week 4, 8, 12, 28, and 52

  61. Change From Baseline in WPAI Percent Impairment While Working at Week 12

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.

    Measured: Baseline and Week 12/ET

  62. Change From Baseline in WPAI Percent Impairment While Working Through Week 52

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.

    Measured: Baseline and Week 4, 8, 12, 28, and 52

  63. Change From Baseline in Percent Overall Work Impairment at Week 12

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)].

    Measured: Baseline and Week 12/ET

  64. Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)].

    Measured: Baseline and Week 4, 8, 12, 28, and 52

  65. Change From Baseline in WPAI Percent Activity Impairment at Week 12

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.

    Measured: Baseline and Week 12/ET

  66. Change From Baseline in WPAI Percent Activity Impairment Through Week 52

    WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.

    Measured: Baseline and Week 4, 8, 12, 28, and 52

  67. Number of Participants With Adverse Events During the First 12 Weeks

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

    Measured: Week 0 to Week 12

  68. Number of Participants With Adverse Events From Week 12

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

    Measured: Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study start8 Aug 2014
  3. Primary completion23 Jan 2017
  4. Study completion22 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02308163
Sponsor's protocol ID
015K-CL-RAJ3
Status last verified
Oct 2024
First submitted
2 Dec 2014
Last updated
28 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/.

Publications

  • 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.

    PubMed 34429152

  • 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.

    PubMed 33929089

  • 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.

    PubMed 33068028

  • Tanaka Y, Takeuchi T, Tanaka S, Kawakami A, Iwasaki M, Song YW, Chen YH, Wei JC, Lee SH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y, Akazawa R, Shiomi T, Yamada E. Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). Ann Rheum Dis. 2019 Oct;78(10):1320-1332. doi: 10.1136/annrheumdis-2019-215163. Epub 2019 Jul 26.

    PubMed 31350270

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peficitinib and Etanercept in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 153 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 (time frame: Baseline and Week 12/early termination (ET)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308163, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.

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