Clinical trial NCT01638013: A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K
Official title: Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Smyraf
Rheumatoid Arthritis
Peficitinib
ASP015K
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 843
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.

Detailed description: This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K \[015K-CL-RAJ1 (hereinafter referred to as study RAJ1)\], Phase III Study of ASP015K \[015K-CL-RAJ3 (RAJ3)\], or Phase III Study of ASP015K \[015K-CL-RAJ4 (RAJ4)\]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study".

Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy.

The duration of treatment with the study drug was differed depending upon the participants.

Eligibility criteria: Inclusion Criteria:

* Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
* The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

* There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
* Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
* Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
* Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
* Subject has QTc \< 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc \< 300 msec at retest.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to end of study (EOS) (up to week 376)
Secondary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With an ACR50-CRP Response Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With an ACR70-CRP Response Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With an ACR50-ESR Response Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With an ACR70-ESR Response Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in SDAI Score Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
timeFrame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study CDAI Score Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOS
measure: Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
timeFrame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
measure: Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
timeFrame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
measure: Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
timeFrame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
measure: Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
timeFrame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
measure: Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
timeFrame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in HAQ-DI Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
measure: Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
measure: Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
measure: Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
measure: Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
measure: Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
measure: Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
timeFrame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
measure: Number of Participants Who Withdrew Due to Lack of Efficacy
timeFrame: Baseline up to week 372
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: Toyoake
country: Japan
facility: JP00140
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: Kamagaya
country: Japan
facility: JP00102
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: 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: 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: Itami
country: Japan
facility: JP00136
state: Hyogo
city: Kato
country: Japan
facility: JP00041
state: Hyogo
city: Kobe
country: Japan
facility: JP00012
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: JP00034
state: Ishikawa
city: Komatsu
country: Japan
facility: JP00179
state: Ishikawa
city: Morioka
country: Japan
facility: JP00028
state: Iwate
city: Morioka
country: Japan
facility: JP00049
state: Iwate
city: Kida-gun
country: Japan
facility: JP00088
state: Kagawa
city: Isehara
country: Japan
facility: JP00084
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: Miyagi-gun
country: Japan
facility: JP00023
state: Miyagi
city: Osaki
country: Japan
facility: JP00169
state: Miyagi
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: 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: 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: 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-gun
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-ku
country: Japan
facility: JP00024
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: JP00043
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: JP00143
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: JP00149
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: JP00152
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: JP00095
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: JP00099
state: Tokyo
city: Chuo-ku
country: Japan
facility: JP00142
state: Tokyo
city: Hachioji
country: Japan
facility: JP00063
state: Tokyo
city: Kiyose
country: Japan
facility: JP00053
state: Tokyo
city: Meguro-ku
country: Japan
facility: JP00072
state: Tokyo
city: Meguro-ku
country: Japan
facility: JP00083
state: Tokyo
city: Ota-ku
country: Japan
facility: JP00148
state: Tokyo
city: Setagaya-ku
country: Japan
facility: JP00100
state: Tokyo
city: Shibuya-ku
country: Japan
facility: JP00081
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: JP00032
state: Tokyo
city: Sumida-ku
country: Japan
facility: JP00021
state: Tokyo
city: Takaoka
country: Japan
facility: JP00010
state: Toyama
city: Nishimuro-gun
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: 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: 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: 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: JP00159
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: Niigata
country: Japan
facility: JP00006
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: JP00044
city: Shizuoka
country: Japan
facility: JP00089
city: Shizuoka
country: Japan
facility: JP00135
city: Toyama
country: Japan
facility: JP00009
city: Toyama
country: Japan
facility: JP00139
city: Daegu
country: Korea, Republic of
facility: KR00504
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: KR00509
city: Seoul
country: Korea, Republic of
facility: KR00511
city: Suwon
country: Korea, Republic of
facility: KR00507
city: Kaohsiung
country: Taiwan
facility: TW00709
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:
citation: Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song YW, Chen YH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y. Safety and Effectiveness of Peficitinib (ASP015K) in Patients with Rheumatoid Arthritis: Final Results (32 Months of Mean Peficitinib Treatment) From a Long-Term, Open-Label Extension Study in Japan, Korea, and Taiwan. Rheumatol Ther. 2021 Mar;8(1):425-442. doi: 10.1007/s40744-021-00280-5. Epub 2021 Mar 3.
citation: Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song YW, Chen YH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y, Nakashima Y, Shiomi T, Yamada E. Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan. Arthritis Res Ther. 2020 Mar 12;22(1):47. doi: 10.1186/s13075-020-2125-2.