A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

Arthritis, Rheumatoid Clinical Trial

Official title:

Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638013
• Other study ID #: 015K-CL-RAJ2
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2012
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Peficitinib
Oral Tablet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 = 0.56v(TJC) + 0.28v(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
Secondary	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 = 0.56v(TJC) + 0.28v(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
Secondary	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 = 0.56v(TJC) + 0.28v(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
Secondary	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 = 0.56v(TJC) + 0.28v(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
Secondary	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 = 0.56v(TJC) + 0.28v(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
Secondary	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 = 0.56v(TJC) + 0.28v(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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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