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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Peficitinib

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.

• Study Type: Interventional
• Enrollment (Actual): 843
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukui, Japan
    • JP00176
  • Fukuoka, Japan
    • JP00018
  • Fukuoka, Japan
    • JP00020
  • Fukuoka, Japan
    • JP00035
  • Fukuoka, Japan
    • JP00059
  • Fukuoka, Japan
    • JP00076
  • Fukuoka, Japan
    • JP00131
  • Fukuoka, Japan
    • JP00164
  • Fukushima, Japan
    • JP00165
  • Hiroshima, Japan
    • JP00013
  • Hiroshima, Japan
    • JP00014
  • Hiroshima, Japan
    • JP00016
  • Hiroshima, Japan
    • JP00055
  • Hiroshima, Japan
    • JP00015
  • Kagoshima, Japan
    • JP00074
  • Kagoshima, Japan
    • JP00167
  • Kagoshima, Japan
    • JP00065
  • Kochi, Japan
    • JP00093
  • Kumamoto, Japan
    • JP00022
  • Kumamoto, Japan
    • JP00046
  • Kyoto, Japan
    • JP00085
  • Kyoto, Japan
    • JP00123
  • Kyoto, Japan
    • JP00159
  • Miyazaki, Japan
    • JP00122
  • Nagano, Japan
    • JP00080
  • Nagano, Japan
    • JP00174
  • Nagasaki, Japan
    • JP00098
  • Nagasaki, Japan
    • JP00112
  • Nagasaki, Japan
    • JP00147
  • Niigata, Japan
    • JP00006
  • Oita, Japan
    • JP00017
  • Okayama, Japan
    • JP00118
  • Osaka, Japan
    • JP00150
  • Osaka, Japan
    • JP00157
  • Shizuoka, Japan
    • JP00044
  • Shizuoka, Japan
    • JP00089
  • Shizuoka, Japan
    • JP00135
  • Toyama, Japan
    • JP00139
  • Toyama, Japan
    • JP00009
  • Aichi
    • Nagoya, Aichi, Japan
      • JP00037
    • Nagoya, Aichi, Japan
      • JP00109
    • Nagoya, Aichi, Japan
      • JP00130
    • Nagoya, Aichi, Japan
      • JP00175
    • Okazaki, Aichi, Japan
      • JP00066
    • Toyoake, Aichi, Japan
      • JP00140
    • Toyohashi, Aichi, Japan
      • JP00108
    • Toyohashi, Aichi, Japan
      • JP00170
    • Toyota, Aichi, Japan
      • JP00156
    • Yatomi, Aichi, Japan
      • JP00068
  • Chiba
    • Asahi, Chiba, Japan
      • JP00180
    • Funabashi, Chiba, Japan
      • JP00166
    • Kamagaya, Chiba, Japan
      • JP00102
    • Narashino, Chiba, Japan
      • JP00115
    • Yotsukaido, Chiba, Japan
      • JP00138
  • Fukuoka
    • Iizuka, Fukuoka, Japan
      • JP00120
    • Kitakyushu, Fukuoka, Japan
      • JP00040
    • Kitakyushu, Fukuoka, Japan
      • JP00119
    • Kurume, Fukuoka, Japan
      • JP00071
    • Kurume, Fukuoka, Japan
      • JP00106
  • Gunma
    • Takasaki, Gunma, Japan
      • JP00033
  • Hiroshima
    • Higashihiroshima, Hiroshima, Japan
      • JP00163
  • Hokaido
    • Tomakomai, Hokaido, Japan
      • JP00124
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
      • JP00026
    • Hakodate, Hokkaido, Japan
      • JP00090
    • Kitami, Hokkaido, Japan
      • JP00172
    • Kushiro, Hokkaido, Japan
      • JP00125
    • Sapporo, Hokkaido, Japan
      • JP00001
    • Sapporo, Hokkaido, Japan
      • JP00002
    • Sapporo, Hokkaido, Japan
      • JP00003
    • Sapporo, Hokkaido, Japan
      • JP00038
    • Sapporo, Hokkaido, Japan
      • JP00114
    • Sapporo, Hokkaido, Japan
      • JP00031
    • Sapporo, Hokkaido, Japan
      • JP00158
  • Hyogo
    • Akashi, Hyogo, Japan
      • JP00056
    • Himeji, Hyogo, Japan
      • JP00069
    • Itami, Hyogo, Japan
      • JP00136
    • Kato, Hyogo, Japan
      • JP00041
    • Kobe, Hyogo, Japan
      • JP00042
    • Kobe, Hyogo, Japan
      • JP00092
    • Kobe, Hyogo, Japan
      • JP00154
    • Kobe, Hyogo, Japan
      • JP00171
    • Kobe, Hyogo, Japan
      • JP00012
    • Nishinomiya, Hyogo, Japan
      • JP00117
  • Ibaraki
    • Hitachi, Ibaraki, Japan
      • JP00107
    • Hitachinaka, Ibaraki, Japan
      • JP00181
    • Koga, Ibaraki, Japan
      • JP00073
    • Mito, Ibaraki, Japan
      • JP00054
    • Tsukuba, Ibaraki, Japan
      • JP00039
  • Ishikawa
    • Komatsu, Ishikawa, Japan
      • JP00179
    • Komatsu, Ishikawa, Japan
      • JP00034
  • Iwate
    • Morioka, Iwate, Japan
      • JP00049
    • Morioka, Iwate, Japan
      • JP00028
  • Kagawa
    • Kida-gun, Kagawa, Japan
      • JP00088
  • Kanagawa
    • Isehara, Kanagawa, Japan
      • JP00084
    • Kawasaki, Kanagawa, Japan
      • JP00058
    • Sagamihara, Kanagawa, Japan
      • JP00141
    • Yokohama, Kanagawa, Japan
      • JP00096
    • Zushi, Kanagawa, Japan
      • JP00045
  • Kumamoto
    • Koshi, Kumamoto, Japan
      • JP00019
    • Tamana, Kumamoto, Japan
      • JP00057
  • Mie
    • Yokkaichi, Mie, Japan
      • JP00168
  • Miyagi
    • Miyagi-gun, Miyagi, Japan
      • JP00023
    • Osaki, Miyagi, Japan
      • JP00169
    • Sendai, Miyagi, Japan
      • JP00004
    • Sendai, Miyagi, Japan
      • JP00036
    • Sendai, Miyagi, Japan
      • JP00105
    • Sendai, Miyagi, Japan
      • JP00151
    • Sendai, Miyagi, Japan
      • JP00027
  • Miyazaki
    • Hyuga, Miyazaki, Japan
      • JP00050
  • Nagano
    • Matsumoto, Nagano, Japan
      • JP00129
  • Nagasaki
    • Isehaya, Nagasaki, Japan
      • JP00162
    • Omura, Nagasaki, Japan
      • JP00101
    • Omura, Nagasaki, Japan
      • JP00103
    • Sasebo, Nagasaki, Japan
      • JP00153
  • Nara
    • Kashihara, Nara, Japan
      • JP00094
  • Niigata
    • Nagaoka, Niigata, Japan
      • JP00025
    • Shibata, Niigata, Japan
      • JP00144
  • Oita
    • Beppu, Oita, Japan
      • JP00064
  • Okayama
    • Setouchi, Okayama, Japan
      • JP00051
  • Osaka
    • Hannan, Osaka, Japan
      • JP00011
    • Higashiosaka, Osaka, Japan
      • JP00134
    • Kawachinagano, Osaka, Japan
      • JP00078
    • Sakai, Osaka, Japan
      • JP00137
    • Suita, Osaka, Japan
      • JP00070
    • Suita, Osaka, Japan
      • JP00146
    • Suita, Osaka, Japan
      • JP00086
    • Toyonaka, Osaka, Japan
      • JP00061
  • Saga
    • Ureshino, Saga, Japan
      • JP00075
  • Saitama
    • Gyoda, Saitama, Japan
      • JP00126
    • Hiki-gun, Saitama, Japan
      • JP00007
    • Kawagoe, Saitama, Japan
      • JP00060
    • Kawagoe, Saitama, Japan
      • JP00161
    • Kawaguchi, Saitama, Japan
      • JP00062
    • Sayama, Saitama, Japan
      • JP00052
    • Tokorozawa, Saitama, Japan
      • JP00008
  • Shizuoka
    • Kakegawa, Shizuoka, Japan
      • JP00133
  • Tochigi
    • Kanuma, Tochigi, Japan
      • JP00077
    • Shimotsuke, Tochigi, Japan
      • JP00145
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • JP00024
    • Bunkyo-ku, Tokyo, Japan
      • JP00043
    • Bunkyo-ku, Tokyo, Japan
      • JP00143
    • Bunkyo-ku, Tokyo, Japan
      • JP00149
    • Bunkyo-ku, Tokyo, Japan
      • JP00152
    • Chiyoda-ku, Tokyo, Japan
      • JP00095
    • Chiyoda-ku, Tokyo, Japan
      • JP00099
    • Chuo-ku, Tokyo, Japan
      • JP00142
    • Hachioji, Tokyo, Japan
      • JP00063
    • Kiyose, Tokyo, Japan
      • JP00053
    • Meguro-ku, Tokyo, Japan
      • JP00072
    • Meguro-ku, Tokyo, Japan
      • JP00083
    • Ota-ku, Tokyo, Japan
      • JP00148
    • Setagaya-ku, Tokyo, Japan
      • JP00100
    • Shibuya-ku, Tokyo, Japan
      • JP00081
    • Shinjuku-ku, Tokyo, Japan
      • JP00032
    • Sumida-ku, Tokyo, Japan
      • JP00021
  • Toyama
    • Takaoka, Toyama, Japan
      • JP00010
  • Wakayama
    • Nishimuro-gun, Wakayama, Japan
      • JP00155
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan
      • JP00104
    • Shunan, Yamaguchi, Japan
      • JP00047
• Korea, Republic of
  • Daegu, Korea, Republic of
    • KR00504
  • Gwangju, Korea, Republic of
    • KR00505
  • Incheon, Korea, Republic of
    • KR00506
  • Jeonju, Korea, Republic of
    • KR00508
  • Seoul, Korea, Republic of
    • KR00501
  • Seoul, Korea, Republic of
    • KR00502
  • Seoul, Korea, Republic of
    • KR00509
  • Seoul, Korea, Republic of
    • KR00511
  • Suwon, Korea, Republic of
    • KR00507
• Taiwan
  • Kaohsiung, Taiwan
    • TW00709
  • Taichung, Taiwan
    • TW00710
  • Tainan, Taiwan
    • TW00712
  • Taipei, Taiwan
    • TW00701
  • Taipei, Taiwan
    • TW00702
  • Taipei, Taiwan
    • TW00711
  • Taoyuan, Taiwan
    • TW00703

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants who completed 015K-CL-RAJ1; Participants 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.	Drug: Peficitinib; Oral Tablet; Other Names: ASP015K; Smyraf
Experimental: Participants who completed 015K-CL-RAJ3; Participants 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.	Drug: Peficitinib; Oral Tablet; Other Names: ASP015K; Smyraf
Experimental: Participants who completed 015K-CL-RAJ4; Participants 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.	Drug: Peficitinib; Oral Tablet; Other Names: ASP015K; Smyraf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372	ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT.	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	ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.	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	ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.	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	ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit.	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	ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.	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-ESR Response Through Week 372	ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.	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
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372	DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.	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
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372	DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.	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
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372	DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission, DAS28-CRP <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity.	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 Achieving DAS28-ESR Score < 2.6 Through Week 372	DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission, DAS28-ESR <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity.	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 Achieving DAS28-CRP Score <= 3.2 Through Week 372	DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission.	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 Achieving DAS28-ESR Score <= 3.2 Through Week 372	DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission.	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
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372	The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.	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
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372	The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.	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
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372	Higher CRP indicates greater disease activity.	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
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372	Higher ESR indicates greater disease activity.	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
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372	ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).	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 a EULAR Good Response Using DAS28-CRP Through Week 372	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure.	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 a EULAR Good Response Using DAS28-ESR Through Week 372	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure.	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
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.	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 a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372	The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.	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 a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372	SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3.	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
Change From Baseline of Preceding Study in SDAI Score Through Week 372	SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.	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
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372	CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8.	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
Change From Baseline of Preceding Study CDAI Score Through Week 372	CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.	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
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108	FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue.	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
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline.	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192	WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.	Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372	Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	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
Change From Baseline of Preceding Study in HAQ-DI Through Week 372	Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	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
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372	Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	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
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly.	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
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372	The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.	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
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372	The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.	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
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.	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
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.	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
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.	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
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.	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
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.	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
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372	The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.	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
Number of Participants Who Withdrew Due to Lack of Efficacy	Participants who discontinued due to lack of efficacy have been reported.	Baseline up to week 372

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Arthritis Res Ther. 2020 Jun 23;22(1):155. doi: 10.1186/s13075-020-02247-3.

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2012
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimated): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; ASP015K; Smyraf; Peficitinib
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Peficitinib
• Other Study ID Numbers: 015K-CL-RAJ2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes