Clinical trial NCT02305849: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: ASP015K
Rheumatoid Arthritis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 519
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  * ≥ 6 tender/painful joints (using 68-joint assessment)
  * ≥ 6 swollen joints (using 66-joint assessment)
* CRP (latex agglutination test) of ≥ 1.00 mg/dL at screening.
* Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening
* Inadequate responders to MTX which was continuously administered for at least 90 days prior to screening and MTX ≥ 8 mg/week for at least 28 days prior to baseline. However, inadequate responder to MTX \< 8 mg/week is eligible if intolerance precludes dose increase and defined as MTX-IR
* Subject is able to continue stable dose of MTX (a maximum of 16 mg/week) from at least 28 days prior to screening until the end of treatment
* Subject has bone erosion at the joint (as evidenced by x-rays of hands and feet) assessed in mTSS and any of the following apply at screening. Bone erosion may be evidenced by x-rays within 90 days prior to baseline.

  * Positive anti-CCP antibody: ≥ 4.5 U/mL
  * Positive rheumatoid factor: \> 15 IU/mL

Exclusion Criteria:

* Subject has received a biologic DMARD within the specified period
* Inadequate responders to biologic DMARD as determined by investigator/sub-investigator
* Subject has received intra-articular, intravenous, intramuscular or endorectal (excluding suppositories for anal diseases) corticosteroid within 28 days prior to baseline
* Subject has participated in any study of ASP015K and has received ASP015K or placebo
* Subject has received other investigational drugs within 90 days or within 5 half-lives, whichever is longer, prior to baseline
* Subject has received plasma exchange therapy within 60 days prior to baseline
* Subject has undergone joint drainage, has received local anesthesia and nerve block, or has received articular cartilage protectant at the assessed joint within 28 days prior to baseline
* Subject has undergone surgery and has residual effects in the assessed joints at the discretion of investigator/sub-investigator, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints at the discretion of investigator/sub-investigator
* A diagnosis of inflammatory arthritis (psoriatic arthritis, ankylosing spondylitis, SLE, sarcoidosis, etc.) other than RA
* Any of the following laboratory values at screening:

  * Hemoglobin \< 9.0 g/dL
  * Absolute neutrophil count \< 1000/μL
  * Absolute lymphocyte count \< 800/μL
  * Platelet count \< 75000/μL
  * ALT ≥ 2 ×ULN
  * AST ≥ 2 × ULN
  * Total bilirubin (TBL) ≥ 1.5 × ULN
  * Estimated GFR ≤ 40 mL/min as measured by the MDRD method
  * β-D-glucan ≥ 11 pg/mL
  * Positive HBs antigen, HBc antibody, HBs antibody or HBV-DNA quantitation (However, subject with negative HBs antigen and HBV-DNA quantitation, and positive HBc antibody and/or HBs antibody is eligible if HBV-DNA is monitored by HBV-DNA quantitation at every scheduled visit after initiation of study drug administration.)
  * Positive HCV antibody
* Subject has a history of or concurrent active tuberculosis (TB)
* Subject has a history of or concurrent interstitial pneumonia and investigator/sub-investigator judges that it is inappropriate for the subject to participate in this study
* Subject has a history of or concurrent malignant tumor (except for successfully treated basal cell carcinoma)
* Subject has received live or live attenuated virus vaccination within 56 days prior to baseline. (Inactivated vaccines including influenza and pneumococcal vaccines are allowed.)
* Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA (excluding Sjogren's syndrome and chronic thyroiditis), or any ongoing illness which would make the subject unsuitable for the study as determined by the investigator/sub-investigator
* Subject has a history of clinically significant allergy. (Clinically significant allergy includes allergies such as systemic urticaria induced by specific antigens and drugs, anaphylaxis, and allergy associated with shock necessitating hospitalized treatment.)
* Subject has concurrent cardiac failure, defined as NYHA classification Class III or higher, or a history of it
* Subject has concurrent prolonged QT syndrome or a history of it. Subject has prolonged QT interval (defined as QTc ≥ 500 msec. Subject has QTc ≥ 500 msec at retest will be excluded) at screening
* Subject has a history of positive HIV infection
* Subject has congenital short QT syndrome or a history of it. Subject has shortened QT interval (defined as QTc \< 330 msec. Subject has QTc \< 330 msec at retest will be excluded) at screening.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
timeFrame: Baseline and week 12/Early termination (ET)
measure: Change From Baseline in mTSS at Week 28
timeFrame: Baseline and week 28/ET
Secondary outcomes:
measure: Percentage of Participants With an ACR20-CRP Response Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants With an ACR50-CRP Response at Week 12
timeFrame: Baseline and week 12/ET
measure: Percentage of Participants With an ACR50-CRP Response Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants With an ACR70-CRP Response at Week 12
timeFrame: Baseline and week 12/ET
measure: Percentage of Participants With an ACR70-CRP Response Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in mTSS at Week 52
timeFrame: Baseline and week 52/ET
measure: Change From Baseline in JSN Score at Week 28 and Week 52
timeFrame: Baseline and weeks 28/ET and 52/ET
measure: Change From Baseline in Erosion Score at Week 28 and Week 52
timeFrame: Baseline and weeks 28/ET and 52/ET
measure: Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52
timeFrame: Baseline and week 28/ET and 52/ET
measure: Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in DAS28-CRP Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in DAS28-ESR at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in DAS28-ESR Score Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in TJC (68 Joints) at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in TJC (68 Joints) Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in SJC (66 Joints) at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SJC (66 Joints) Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in CRP at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in CRP Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in ESR at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in ESR Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants Achieving ACR / EULAR Remission at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in SDAI Score at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SDAI Score Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in PGA at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in PGA Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in SGA at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SGA Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in SGAP at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SGAP Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Number of Participants Who Withdrew Due to Lack of Efficacy
timeFrame: Up to week 52
measure: Change From Baseline in HAQ-DI at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in HAQ-DI Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
measure: Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in WPAI Percent Work Time Missed Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Change From Baseline in WPAI Percent Impairment While Working at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in WPAI Percent Impairment While Working Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Change From Baseline in Percent Overall Work Impairment at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Change From Baseline in WPAI Percent Activity Impairment at Week 12
timeFrame: Baseline and week 12/ET
measure: Change From Baseline in WPAI Percent Activity Impairment Through Week 52
timeFrame: Baseline, weeks 4, 8, 12, 28, 52 and EOT
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks
timeFrame: Week 0 to week 12
measure: Number of Participants With TEAEs From Week 12 to Week 28
timeFrame: Week 12 to week 28
measure: Number of Participants With TEAEs From Week 28 to Week 52
timeFrame: Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: JP00037
state: Aichi
city: Nagoya
country: Japan
facility: JP00109
state: Aichi
city: Nagoya
country: Japan
facility: JP00130
state: Aichi
city: Nagoya
country: Japan
facility: JP00175
state: Aichi
city: Okazaki
country: Japan
facility: JP00066
state: Aichi
city: Toyohashi
country: Japan
facility: JP00108
state: Aichi
city: Toyohashi
country: Japan
facility: JP00170
state: Aichi
city: Toyota
country: Japan
facility: JP00156
state: Aichi
city: Yatomi
country: Japan
facility: JP00068
state: Aichi
city: Asahi
country: Japan
facility: JP00180
state: Chiba
city: Funabashi
country: Japan
facility: JP00166
state: Chiba
city: Narashino
country: Japan
facility: JP00115
state: Chiba
city: Yotsukaido
country: Japan
facility: JP00138
state: Chiba
city: Iizuka
country: Japan
facility: JP00120
state: Fukuoka
city: Kasuga
country: Japan
facility: JP00110
state: Fukuoka
city: Kitakyushu
country: Japan
facility: JP00040
state: Fukuoka
city: Kitakyushu
country: Japan
facility: JP00119
state: Fukuoka
city: Kurume
country: Japan
facility: JP00071
state: Fukuoka
city: Kurume
country: Japan
facility: JP00106
state: Fukuoka
city: Takasaki
country: Japan
facility: JP00033
state: Gunma
city: Higashihiroshima
country: Japan
facility: JP00163
state: Hiroshima
city: Tomakomai
country: Japan
facility: JP00124
state: Hokaido
city: Asahikawa
country: Japan
facility: JP00026
state: Hokkaido
city: Hakodate
country: Japan
facility: JP00090
state: Hokkaido
city: Kitami
country: Japan
facility: JP00172
state: Hokkaido
city: Kushiro
country: Japan
facility: JP00125
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00001
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00002
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00003
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00038
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00114
state: Hokkaido
city: Akashi
country: Japan
facility: JP00056
state: Hyogo
city: Himeji
country: Japan
facility: JP00069
state: Hyogo
city: Itami
country: Japan
facility: JP00136
state: Hyogo
city: Kakogawa
country: Japan
facility: JP00113
state: Hyogo
city: Kato
country: Japan
facility: JP00041
state: Hyogo
city: Kobe
country: Japan
facility: JP00042
state: Hyogo
city: Kobe
country: Japan
facility: JP00092
state: Hyogo
city: Kobe
country: Japan
facility: JP00154
state: Hyogo
city: Kobe
country: Japan
facility: JP00171
state: Hyogo
city: Nishinomiya
country: Japan
facility: JP00117
state: Hyogo
city: Hitachinaka
country: Japan
facility: JP00181
state: Ibaraki
city: Hitachi
country: Japan
facility: JP00107
state: Ibaraki
city: Koga
country: Japan
facility: JP00073
state: Ibaraki
city: Mito
country: Japan
facility: JP00054
state: Ibaraki
city: Tsukuba
country: Japan
facility: JP00039
state: Ibaraki
city: Komatsu
country: Japan
facility: JP00179
state: Ishikawa
city: Morioka
country: Japan
facility: JP00049
state: Iwate
city: Kida
country: Japan
facility: JP00088
state: Kagawa
city: Isehara
country: Japan
facility: JP00084
state: Kanagawa
city: Kawasaki
country: Japan
facility: JP00048
state: Kanagawa
city: Kawasaki
country: Japan
facility: JP00058
state: Kanagawa
city: Sagamihara
country: Japan
facility: JP00141
state: Kanagawa
city: Yokohama
country: Japan
facility: JP00096
state: Kanagawa
city: Zushi
country: Japan
facility: JP00045
state: Kanagawa
city: Koshi
country: Japan
facility: JP00019
state: Kumamoto
city: Tamana
country: Japan
facility: JP00057
state: Kumamoto
city: Yokkaichi
country: Japan
facility: JP00168
state: Mie
city: Osaki
country: Japan
facility: JP00169
state: Miyagi
city: Sendai
country: Japan
facility: JP00004
state: Miyagi
city: Sendai
country: Japan
facility: JP00036
state: Miyagi
city: Sendai
country: Japan
facility: JP00105
state: Miyagi
city: Sendai
country: Japan
facility: JP00151
state: Miyagi
city: Hyuga
country: Japan
facility: JP00050
state: Miyazaki
city: Matsumoto
country: Japan
facility: JP00129
state: Nagano
city: Isehaya
country: Japan
facility: JP00162
state: Nagasaki
city: Omura
country: Japan
facility: JP00101
state: Nagasaki
city: Omura
country: Japan
facility: JP00103
state: Nagasaki
city: Sasebo
country: Japan
facility: JP00153
state: Nagasaki
city: Kashihara
country: Japan
facility: JP00094
state: Nara
city: Nagaoka
country: Japan
facility: JP00025
state: Niigata
city: Shibata
country: Japan
facility: JP00144
state: Niigata
city: Beppu
country: Japan
facility: JP00064
state: Oita
city: Setouchi
country: Japan
facility: JP00051
state: Okayama
city: Hannan
country: Japan
facility: JP00011
state: Osaka
city: Higashiosaka
country: Japan
facility: JP00134
state: Osaka
city: Hirakata
country: Japan
facility: JP00178
state: Osaka
city: Kawachinagano
country: Japan
facility: JP00078
state: Osaka
city: Sakai
country: Japan
facility: JP00137
state: Osaka
city: Suita
country: Japan
facility: JP00070
state: Osaka
city: Suita
country: Japan
facility: JP00146
state: Osaka
city: Toyonaka
country: Japan
facility: JP00061
state: Osaka
city: Ureshino
country: Japan
facility: JP00075
state: Saga
city: Gyoda
country: Japan
facility: JP00126
state: Saitama
city: Hiki
country: Japan
facility: JP00007
state: Saitama
city: Kawagoe
country: Japan
facility: JP00060
state: Saitama
city: Kawagoe
country: Japan
facility: JP00161
state: Saitama
city: Kawaguchi
country: Japan
facility: JP00062
state: Saitama
city: Sayama
country: Japan
facility: JP00052
state: Saitama
city: Tokorozawa
country: Japan
facility: JP00008
state: Saitama
city: Kakegawa
country: Japan
facility: JP00133
state: Shizuoka
city: Kanuma
country: Japan
facility: JP00077
state: Tochigi
city: Shimotsuke
country: Japan
facility: JP00145
state: Tochigi
city: Bunkyo
country: Japan
facility: JP00024
state: Tokyo
city: Bunkyo
country: Japan
facility: JP00143
state: Tokyo
city: Bunkyo
country: Japan
facility: JP00149
state: Tokyo
city: Bunkyo
country: Japan
facility: JP00152
state: Tokyo
city: Chiyoda
country: Japan
facility: JP00099
state: Tokyo
city: Chuo
country: Japan
facility: JP00142
state: Tokyo
city: Hachioji
country: Japan
facility: JP00063
state: Tokyo
city: Kiyose
country: Japan
facility: JP00053
state: Tokyo
city: Meguro
country: Japan
facility: JP00072
state: Tokyo
city: Ota
country: Japan
facility: JP00148
state: Tokyo
city: Shibuya
country: Japan
facility: JP00081
state: Tokyo
city: Takaoka
country: Japan
facility: JP00010
state: Toyama
city: Nishimuro
country: Japan
facility: JP00155
state: Wakayama
city: Shimonoseki
country: Japan
facility: JP00104
state: Yamaguchi
city: Shunan
country: Japan
facility: JP00047
state: Yamaguchi
city: Fukui
country: Japan
facility: JP00176
city: Fukuoka
country: Japan
facility: JP00018
city: Fukuoka
country: Japan
facility: JP00020
city: Fukuoka
country: Japan
facility: JP00035
city: Fukuoka
country: Japan
facility: JP00059
city: Fukuoka
country: Japan
facility: JP00067
city: Fukuoka
country: Japan
facility: JP00076
city: Fukuoka
country: Japan
facility: JP00131
city: Fukuoka
country: Japan
facility: JP00164
city: Fukushima
country: Japan
facility: JP00165
city: Hiroshima
country: Japan
facility: JP00013
city: Hiroshima
country: Japan
facility: JP00014
city: Hiroshima
country: Japan
facility: JP00016
city: Hiroshima
country: Japan
facility: JP00055
city: Kagoshima
country: Japan
facility: JP00074
city: Kagoshima
country: Japan
facility: JP00167
city: Kochi
country: Japan
facility: JP00093
city: Kumamoto
country: Japan
facility: JP00022
city: Kumamoto
country: Japan
facility: JP00046
city: Kyoto
country: Japan
facility: JP00085
city: Kyoto
country: Japan
facility: JP00123
city: Kyoto
country: Japan
facility: JP00160
city: Miyagi
country: Japan
facility: JP00023
city: Miyazaki
country: Japan
facility: JP00122
city: Nagano
country: Japan
facility: JP00080
city: Nagano
country: Japan
facility: JP00174
city: Nagasaki
country: Japan
facility: JP00098
city: Nagasaki
country: Japan
facility: JP00112
city: Nagasaki
country: Japan
facility: JP00147
city: Oita
country: Japan
facility: JP00017
city: Okayama
country: Japan
facility: JP00118
city: Osaka
country: Japan
facility: JP00150
city: Osaka
country: Japan
facility: JP00157
city: Osaka
country: Japan
facility: JP00177
city: Shizuoka
country: Japan
facility: JP00044
city: Shizuoka
country: Japan
facility: JP00089
city: Shizuoka
country: Japan
facility: JP00135
city: Toyama
country: Japan
facility: JP00139
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.