A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K
Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K
1 other identifier
interventional
843
3 countries
175
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2012
Longer than P75 for phase_3
175 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2012
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedResults Posted
Study results publicly available
October 23, 2020
CompletedOctober 28, 2024
October 1, 2024
7.3 years
July 9, 2012
September 14, 2020
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug.
Baseline up to end of study (EOS) (up to week 376)
Secondary Outcomes (43)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
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
Percentage of Participants With an ACR50-CRP Response Through Week 372
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
Percentage of Participants With an ACR70-CRP Response Through Week 372
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
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
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
Percentage of Participants With an ACR50-ESR Response Through Week 372
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
- +38 more secondary outcomes
Study Arms (3)
Participants who completed 015K-CL-RAJ1
EXPERIMENTALParticipants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Participants who completed 015K-CL-RAJ3
EXPERIMENTALParticipants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Participants who completed 015K-CL-RAJ4
EXPERIMENTALParticipants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
Interventions
Oral Tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
JP00037
Nagoya, Aichi-ken, Japan
JP00109
Nagoya, Aichi-ken, Japan
JP00130
Nagoya, Aichi-ken, Japan
JP00175
Nagoya, Aichi-ken, Japan
JP00066
Okazaki, Aichi-ken, Japan
JP00140
Toyoake, Aichi-ken, Japan
JP00108
Toyohashi, Aichi-ken, Japan
JP00170
Toyohashi, Aichi-ken, Japan
JP00156
Toyota, Aichi-ken, Japan
JP00068
Yatomi, Aichi-ken, Japan
JP00180
Asahi, Chiba, Japan
JP00166
Funabashi, Chiba, Japan
JP00102
Kamagaya, Chiba, Japan
JP00115
Narashino, Chiba, Japan
JP00138
Yotsukaidō, Chiba, Japan
JP00120
Iizuka, Fukuoka, Japan
JP00040
Kitakyushu, Fukuoka, Japan
JP00119
Kitakyushu, Fukuoka, Japan
JP00071
Kurume, Fukuoka, Japan
JP00106
Kurume, Fukuoka, Japan
JP00033
Takasaki, Gunma, Japan
JP00163
Higashihiroshima, Hiroshima, Japan
JP00124
Tomakomai, Hokaido, Japan
JP00026
Asahikawa, Hokkaido, Japan
JP00090
Hakodate, Hokkaido, Japan
JP00172
Kitami, Hokkaido, Japan
JP00125
Kushiro, Hokkaido, Japan
JP00001
Sapporo, Hokkaido, Japan
JP00002
Sapporo, Hokkaido, Japan
JP00003
Sapporo, Hokkaido, Japan
JP00031
Sapporo, Hokkaido, Japan
JP00038
Sapporo, Hokkaido, Japan
JP00114
Sapporo, Hokkaido, Japan
JP00158
Sapporo, Hokkaido, Japan
JP00056
Akashi, Hyōgo, Japan
JP00069
Himeji, Hyōgo, Japan
JP00136
Itami, Hyōgo, Japan
JP00041
Katō, Hyōgo, Japan
JP00012
Kobe, Hyōgo, Japan
JP00042
Kobe, Hyōgo, Japan
JP00092
Kobe, Hyōgo, Japan
JP00154
Kobe, Hyōgo, Japan
JP00171
Kobe, Hyōgo, Japan
JP00117
Nishinomiya, Hyōgo, Japan
JP00107
Hitachi, Ibaraki, Japan
JP00181
Hitachi-Naka, Ibaraki, Japan
JP00073
Koga, Ibaraki, Japan
JP00054
Mito, Ibaraki, Japan
JP00039
Tsukuba, Ibaraki, Japan
JP00034
Komatsu, Ishikawa-ken, Japan
JP00179
Komatsu, Ishikawa-ken, Japan
JP00028
Morioka, Iwate, Japan
JP00049
Morioka, Iwate, Japan
JP00088
Kida-gun, Kagawa-ken, Japan
JP00084
Isehara, Kanagawa, Japan
JP00058
Kawasaki, Kanagawa, Japan
JP00141
Sagamihara, Kanagawa, Japan
JP00096
Yokohama, Kanagawa, Japan
JP00045
Zushi, Kanagawa, Japan
JP00019
Kōshi, Kumamoto, Japan
JP00057
Tamana, Kumamoto, Japan
JP00168
Yokkaichi, Mie-ken, Japan
JP00023
Miyagi-gun, Miyagi, Japan
JP00169
Ōsaki, Miyagi, Japan
JP00004
Sendai, Miyagi, Japan
JP00027
Sendai, Miyagi, Japan
JP00036
Sendai, Miyagi, Japan
JP00105
Sendai, Miyagi, Japan
JP00151
Sendai, Miyagi, Japan
JP00050
Hyūga, Miyazaki, Japan
JP00129
Matsumoto, Nagano, Japan
JP00162
Isehaya, Nagasaki, Japan
JP00101
Ōmura, Nagasaki, Japan
JP00103
Ōmura, Nagasaki, Japan
JP00153
Sasebo, Nagasaki, Japan
JP00094
Kashihara, Nara, Japan
JP00025
Nagaoka, Niigata, Japan
JP00144
Shibata, Niigata, Japan
JP00064
Beppu, Oita Prefecture, Japan
JP00051
Setouchi, Okayama-ken, Japan
JP00011
Hannan, Osaka, Japan
JP00134
Higashiosaka, Osaka, Japan
JP00078
Kawachi-Nagano, Osaka, Japan
JP00137
Sakai, Osaka, Japan
JP00070
Suita, Osaka, Japan
JP00086
Suita, Osaka, Japan
JP00146
Suita, Osaka, Japan
JP00061
Toyonaka, Osaka, Japan
JP00075
Ureshino, Saga-ken, Japan
JP00126
Gyōda, Saitama, Japan
JP00007
Hiki-gun, Saitama, Japan
JP00060
Kawagoe, Saitama, Japan
JP00161
Kawagoe, Saitama, Japan
JP00062
Kawaguchi, Saitama, Japan
JP00052
Sayama, Saitama, Japan
JP00008
Tokorozawa, Saitama, Japan
JP00133
Kakegawa, Shizuoka, Japan
JP00077
Kanuma, Tochigi, Japan
JP00145
Shimotsuke, Tochigi, Japan
JP00024
Bunkyo-ku, Tokyo, Japan
JP00043
Bunkyo-ku, Tokyo, Japan
JP00143
Bunkyo-ku, Tokyo, Japan
JP00149
Bunkyo-ku, Tokyo, Japan
JP00152
Bunkyo-ku, Tokyo, Japan
JP00095
Chiyoda-ku, Tokyo, Japan
JP00099
Chiyoda-ku, Tokyo, Japan
JP00142
Chuo-ku, Tokyo, Japan
JP00063
Hachiōji, Tokyo, Japan
JP00053
Kiyose, Tokyo, Japan
JP00072
Meguro-ku, Tokyo, Japan
JP00083
Meguro-ku, Tokyo, Japan
JP00148
Ōta-ku, Tokyo, Japan
JP00100
Setagaya-ku, Tokyo, Japan
JP00081
Shibuya-ku, Tokyo, Japan
JP00032
Shinjuku-ku, Tokyo, Japan
JP00021
Sumida-ku, Tokyo, Japan
JP00010
Takaoka, Toyama, Japan
JP00155
Nishimuro-gun, Wakayama, Japan
JP00104
Shimonoseki, Yamaguchi, Japan
JP00047
Shūnan, Yamaguchi, Japan
JP00176
Fukui, Japan
JP00018
Fukuoka, Japan
JP00020
Fukuoka, Japan
JP00035
Fukuoka, Japan
JP00059
Fukuoka, Japan
JP00076
Fukuoka, Japan
JP00131
Fukuoka, Japan
JP00164
Fukuoka, Japan
JP00165
Fukushima, Japan
JP00013
Hiroshima, Japan
JP00014
Hiroshima, Japan
JP00015
Hiroshima, Japan
JP00016
Hiroshima, Japan
JP00055
Hiroshima, Japan
JP00065
Kagoshima, Japan
JP00074
Kagoshima, Japan
JP00167
Kagoshima, Japan
JP00093
Kochi, Japan
JP00022
Kumamoto, Japan
JP00046
Kumamoto, Japan
JP00085
Kyoto, Japan
JP00123
Kyoto, Japan
JP00159
Kyoto, Japan
JP00122
Miyazaki, Japan
JP00080
Nagano, Japan
JP00174
Nagano, Japan
JP00098
Nagasaki, Japan
JP00112
Nagasaki, Japan
JP00147
Nagasaki, Japan
JP00006
Niigata, Japan
JP00118
Okayama, Japan
JP00150
Osaka, Japan
JP00157
Osaka, Japan
JP00017
Ōita, Japan
JP00044
Shizuoka, Japan
JP00089
Shizuoka, Japan
JP00135
Shizuoka, Japan
JP00009
Toyama, Japan
JP00139
Toyama, Japan
KR00504
Daegu, South Korea
KR00505
Gwangju, South Korea
KR00506
Incheon, South Korea
KR00508
Jeonju, South Korea
KR00501
Seoul, South Korea
KR00502
Seoul, South Korea
KR00509
Seoul, South Korea
KR00511
Seoul, South Korea
KR00507
Suwon, South Korea
TW00709
Kaohsiung City, Taiwan
TW00710
Taichung, Taiwan
TW00712
Tainan, Taiwan
TW00701
Taipei, Taiwan
TW00702
Taipei, Taiwan
TW00711
Taipei, Taiwan
TW00703
Taoyuan District, Taiwan
Related Publications (2)
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.
PMID: 33656739DERIVEDTakeuchi 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.
PMID: 32164762DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 11, 2012
Study Start
June 13, 2012
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
October 28, 2024
Results First Posted
October 23, 2020
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.