Clinical trial NCT02308163: A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
ASP015K
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 509
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 superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs

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

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

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

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

Eligibility criteria: Inclusion Criteria:

* Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria
* Subject who did not receive the following drugs, or received the drugs with stable dosage for at least 28 days prior to the baseline (start of treatment) for RA treatment:

  * Non-steroidal anti-inflammatory drugs (NSAIDs; excluding topical formulations), oral morphine or equivalent opioid analgesics (≤ 30 mg/day), acetaminophen, or oral corticosteroids (≤ 10 mg/day in prednisolone equivalent)
* At screening subject has active RA as evidenced by both of the following:

  * ≥ 6 tender/painful joints (using 68-joint assessment)
  * ≥ 6 swollen joints (using 66-joint assessment)
* CRP \> 0.50 mg/dL at screening
* Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening.
* Inadequate responder to (including subjects who were intolerant of) at least one DMARD administered for at least 90 days prior to screening

Exclusion Criteria:

* Subject has received a biologic DMARD within the specified period
* Subject has received etanercept
* Inadequate responder to at least 3 biologic DMARDs as determined by investigator/sub-investigator
* Subject has received intra-articular, intravenous, intramuscular or endorectal (excluding suppositories for anal diseases) corticosteroid within 28 days prior to baseline
* Subject has participated in any study of ASP015K and has received ASP015K or placebo
* Subject has received other investigational drugs within 90 days or within 5 half-lives, whichever is longer, prior to baseline
* Subject has received plasma exchange therapy within 60 days prior to baseline
* Subject has undergone joint drainage, has received local anesthesia and nerve block, or has received articular cartilage protectant at the assessed joint within 28 days prior to baseline
* Subject has undergone surgery and has residual effects in the assessed joints at the discretion of investigator/sub-investigator, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints at the discretion of investigator/sub-investigator
* A diagnosis of inflammatory arthritis (psoriatic arthritis, ankylosing spondylitis, SLE, sarcoidosis, etc.) other than RA
* Any of the following laboratory values at screening:

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

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)
Secondary outcomes:
measure: Percentage of Participants With an ACR20-CRP Response Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants With an American College of Rheumatology 50% (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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants With an American College of Rheumatology 70% (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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline DAS28-CRP Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in DAS28-ESR Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Swollen Joint Count (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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12
timeFrame: Baseline and Week 12/ET
measure: Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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, and 52
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, and 52
measure: Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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, and 52
measure: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving SDAI Remission Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12
timeFrame: Week 12/ET
measure: Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in CDAI Score at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in CDAI Score Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in PGA Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Subject's SGA at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in SGA Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Subject's Assessment of Pain at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in Subject's Assessment of Pain Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Number of Participants Who Withdrew Due to Lack of Efficacy
timeFrame: Up to week 12
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in HAQ-DI Through Week 52
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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 and Week 4, 8, 12, 28, and 52
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 and Week 4, 8, 12, 28, and 52
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 and Week 4, 8, 12, 28, and 52
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 and Week 4, 8, 12, 28, and 52
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 and Week 4, 8, 12, 28, and 52
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 and Week 4, 8, 12, 28, and 52
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 and Week 4, 8, 12, 28, and 52
measure: Number of Participants With Adverse Events During the First 12 Weeks
timeFrame: Week 0 to Week 12
measure: Number of Participants With Adverse Events From Week 12
timeFrame: Week 12 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: Okazaki
country: Japan
facility: JP00066
state: Aichi
city: Toyoake
country: Japan
facility: JP00140
state: Aichi
city: Toyohashi
country: Japan
facility: JP00108
state: Aichi
city: Toyota
country: Japan
facility: JP00156
state: Aichi
city: Yatomi
country: Japan
facility: JP00068
state: Aichi
city: Kamagaya
country: Japan
facility: JP00102
state: Chiba
city: Matsudo
country: Japan
facility: JP00127
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: 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: JP00097
state: Fukuoka
city: Kurume
country: Japan
facility: JP00106
state: Fukuoka
city: Takasaki
country: Japan
facility: JP00033
state: Gunma
city: Asahikawa
country: Japan
facility: JP00026
state: Hokkaido
city: Hakodate
country: Japan
facility: JP00090
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: JP00031
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00038
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00114
state: Hokkaido
city: Sapporo
country: Japan
facility: JP00158
state: Hokkaido
city: Akashi
country: Japan
facility: JP00056
state: Hyogo
city: Himeji
country: Japan
facility: JP00069
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: Nishinomiya
country: Japan
facility: JP00117
state: Hyogo
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: Morioka
country: Japan
facility: JP00049
state: Iwate
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: Yokosuka
country: Japan
facility: JP00128
state: Kanagawa
city: Tamana
country: Japan
facility: JP00057
state: Kumamoto
city: Sendai
country: Japan
facility: JP00004
state: Miyagi
city: Sendai
country: Japan
facility: JP00027
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: 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: 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: JP00086
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: Iruma
country: Japan
facility: JP00082
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: Bunkyo
country: Japan
facility: JP00024
state: Tokyo
city: Bunkyo
country: Japan
facility: JP00043
state: Tokyo
city: Bunkyo
country: Japan
facility: JP00149
state: Tokyo
city: Bunkyo
country: Japan
facility: JP00152
state: Tokyo
city: Chiyoda
country: Japan
facility: JP00095
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: Meguro
country: Japan
facility: JP00083
state: Tokyo
city: Ota
country: Japan
facility: JP00148
state: Tokyo
city: Setagaya
country: Japan
facility: JP00100
state: Tokyo
city: Shinjuku
country: Japan
facility: JP00032
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: 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: Hiroshima
country: Japan
facility: JP00013
city: Hiroshima
country: Japan
facility: JP00014
city: Hiroshima
country: Japan
facility: JP00015
city: Hiroshima
country: Japan
facility: JP00016
city: Hiroshima
country: Japan
facility: JP00055
city: Kagoshima
country: Japan
facility: JP00065
city: Kagoshima
country: Japan
facility: JP00074
city: Kochi
country: Japan
facility: JP00093
city: Kumamoto
country: Japan
facility: JP00022
city: Kumamoto
country: Japan
facility: JP00046
city: Kyoto
country: Japan
facility: JP00123
city: Kyoto
country: Japan
facility: JP00159
city: Miyagi
country: Japan
facility: JP00023
city: Miyazaki
country: Japan
facility: JP00122
city: Nagano
country: Japan
facility: JP00080
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: Shizuoka
country: Japan
facility: JP00089
city: Shizuoka
country: Japan
facility: JP00135
city: Toyama
country: Japan
facility: JP00139
city: Daegu
country: Korea, Republic of
facility: KR00504
city: Daegu
country: Korea, Republic of
facility: KR00510
city: Gwangju
country: Korea, Republic of
facility: KR00505
city: Incheon
country: Korea, Republic of
facility: KR00506
city: Jeonju
country: Korea, Republic of
facility: KR00508
city: Seoul
country: Korea, Republic of
facility: KR00501
city: Seoul
country: Korea, Republic of
facility: KR00502
city: Seoul
country: Korea, Republic of
facility: KR00503
city: Seoul
country: Korea, Republic of
facility: KR00509
city: Seoul
country: Korea, Republic of
facility: KR00511
city: Suwon
country: Korea, Republic of
facility: KR00507
city: Kaohsiung
country: Taiwan
facility: TW00708
city: Kaohsiung
country: Taiwan
facility: TW00709
city: Taichung
country: Taiwan
facility: TW00704
city: Taichung
country: Taiwan
facility: TW00705
city: Taichung
country: Taiwan
facility: TW00710
city: Tainan
country: Taiwan
facility: TW00712
city: Taipei
country: Taiwan
facility: TW00701
city: Taipei
country: Taiwan
facility: TW00702
city: Taipei
country: Taiwan
facility: TW00711
city: Taoyuan
country: Taiwan
facility: TW00703
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
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