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

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Peficitinib

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Smyraf, Rheumatoid Arthritis, Peficitinib, ASP015K

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Participants who completed 015K-CL-RAJ1

Participants who completed 015K-CL-RAJ3

Participants who completed 015K-CL-RAJ4

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Percentage of Participants With an ACR50-ESR Response Through Week 372

Percentage of Participants With an ACR70-ESR Response Through Week 372

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.

Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372

Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372

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.

Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372

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.

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.

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.

Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372

Higher CRP indicates greater disease activity.

Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372

Higher ESR indicates greater disease activity.

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).

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.

Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372

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.

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.

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.

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.

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.

Change From Baseline of Preceding Study CDAI Score Through Week 372

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.

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.

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.

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.

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.

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.

Change From Baseline of Preceding Study in HAQ-DI Through Week 372

Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372

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.

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.

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.

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.

Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372

Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372

Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372

Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372

Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372

Number of Participants Who Withdrew Due to Lack of Efficacy

Participants who discontinued due to lack of efficacy have been reported.

Full Information

NCT ID

NCT01638013

First Posted

July 9, 2012

Last Updated

September 25, 2020

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01638013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 13, 2012 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K [015K-CL-RAJ1 (hereinafter referred to as study RAJ1)], Phase III Study of ASP015K [015K-CL-RAJ3 (RAJ3)], or Phase III Study of ASP015K [015K-CL-RAJ4 (RAJ4)]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study". Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy. The duration of treatment with the study drug was differed depending upon the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Smyraf, Rheumatoid Arthritis, Peficitinib, ASP015K

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

843 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants who completed 015K-CL-RAJ1

Arm Type

Experimental

Arm Description

Arm Title

Participants who completed 015K-CL-RAJ3

Arm Type

Experimental

Arm Description

Arm Title

Participants who completed 015K-CL-RAJ4

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Peficitinib

Other Intervention Name(s)

ASP015K, Smyraf

Intervention Description

Oral Tablet

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

Baseline up to end of study (EOS) (up to week 376)

Secondary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372

Description

Time Frame

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

Title

Percentage of Participants With an ACR50-CRP Response Through Week 372

Description

Time Frame

Title

Percentage of Participants With an ACR70-CRP Response Through Week 372

Description

Time Frame

Title

Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372

Description

Time Frame

Title

Percentage of Participants With an ACR50-ESR Response Through Week 372

Description

Time Frame

Title

Percentage of Participants With an ACR70-ESR Response Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in DAS28-CRP Through Week 372

Description

Time Frame

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

Title

Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372

Description

Time Frame

Title

Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372

Description

Time Frame

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

Title

Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372

Description

Time Frame

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

Title

Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372

Description

Time Frame

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

Title

Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372

Description

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.

Time Frame

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

Title

Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372

Description

Higher CRP indicates greater disease activity.

Time Frame

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

Title

Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372

Description

Higher ESR indicates greater disease activity.

Time Frame

Title

Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372

Description

Time Frame

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

Title

Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372

Description

Time Frame

Title

Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372

Description

Time Frame

Title

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372

Description

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.

Time Frame

Title

Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372

Description

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.

Time Frame

Title

Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372

Description

Time Frame

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

Title

Change From Baseline of Preceding Study in SDAI Score Through Week 372

Description

Time Frame

Title

Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study CDAI Score Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108

Description

Time Frame

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

Title

Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192

Description

Time Frame

Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Title

Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192

Description

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.

Time Frame

Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Title

Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192

Description

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.

Time Frame

Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Title

Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192

Description

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.

Time Frame

Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT

Title

Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372

Description

Time Frame

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

Title

Change From Baseline of Preceding Study in HAQ-DI Through Week 372

Description

Time Frame

Title

Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372

Description

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.

Time Frame

Title

Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372

Description

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.

Time Frame

Title

Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372

Description

Time Frame

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

Title

Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372

Description

Time Frame

Title

Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372

Description

Time Frame

Title

Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372

Description

Time Frame

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

Title

Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372

Description

Time Frame

Title

Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372

Description

Time Frame

Title

Number of Participants Who Withdrew Due to Lack of Efficacy

Description

Participants who discontinued due to lack of efficacy have been reported.

Time Frame

Baseline up to week 372

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate Exclusion Criteria: There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy) Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Director

Facility Information:

Facility Name

JP00037

City

Nagoya

State/Province

Aichi

Country

Japan

Facility Name

JP00109

City

Nagoya

State/Province

Aichi

Country

Japan

Facility Name

JP00130

City

Nagoya

State/Province

Aichi

Country

Japan

Facility Name

JP00175

City

Nagoya

State/Province

Aichi

Country

Japan

Facility Name

JP00066

City

Okazaki

State/Province

Aichi

Country

Japan

Facility Name

JP00140

City

Toyoake

State/Province

Aichi

Country

Japan

Facility Name

JP00108

City

Toyohashi

State/Province

Aichi

Country

Japan

Facility Name

JP00170

City

Toyohashi

State/Province

Aichi

Country

Japan

Facility Name

JP00156

City

Toyota

State/Province

Aichi

Country

Japan

Facility Name

JP00068

City

Yatomi

State/Province

Aichi

Country

Japan

Facility Name

JP00180

City

Asahi

State/Province

Chiba

Country

Japan

Facility Name

JP00166

City

Funabashi

State/Province

Chiba

Country

Japan

Facility Name

JP00102

City

Kamagaya

State/Province

Chiba

Country

Japan

Facility Name

JP00115

City

Narashino

State/Province

Chiba

Country

Japan

Facility Name

JP00138

City

Yotsukaido

State/Province

Chiba

Country

Japan

Facility Name

JP00120

City

Iizuka

State/Province

Fukuoka

Country

Japan

Facility Name

JP00040

City

Kitakyushu

State/Province

Fukuoka

Country

Japan

Facility Name

JP00119

City

Kitakyushu

State/Province

Fukuoka

Country

Japan

Facility Name

JP00071

City

Kurume

State/Province

Fukuoka

Country

Japan

Facility Name

JP00106

City

Kurume

State/Province

Fukuoka

Country

Japan

Facility Name

JP00033

City

Takasaki

State/Province

Gunma

Country

Japan

Facility Name

JP00163

City

Higashihiroshima

State/Province

Hiroshima

Country

Japan

Facility Name

JP00124

City

Tomakomai

State/Province

Hokaido

Country

Japan

Facility Name

JP00026

City

Asahikawa

State/Province

Hokkaido

Country

Japan

Facility Name

JP00090

City

Hakodate

State/Province

Hokkaido

Country

Japan

Facility Name

JP00172

City

Kitami

State/Province

Hokkaido

Country

Japan

Facility Name

JP00125

City

Kushiro

State/Province

Hokkaido

Country

Japan

Facility Name

JP00001

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00002

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00003

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00031

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00038

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00114

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00158

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

JP00056

City

Akashi

State/Province

Hyogo

Country

Japan

Facility Name

JP00069

City

Himeji

State/Province

Hyogo

Country

Japan

Facility Name

JP00136

City

Itami

State/Province

Hyogo

Country

Japan

Facility Name

JP00041

City

Kato

State/Province

Hyogo

Country

Japan

Facility Name

JP00012

City

Kobe

State/Province

Hyogo

Country

Japan

Facility Name

JP00042

City

Kobe

State/Province

Hyogo

Country

Japan

Facility Name

JP00092

City

Kobe

State/Province

Hyogo

Country

Japan

Facility Name

JP00154

City

Kobe

State/Province

Hyogo

Country

Japan

Facility Name

JP00171

City

Kobe

State/Province

Hyogo

Country

Japan

Facility Name

JP00117

City

Nishinomiya

State/Province

Hyogo

Country

Japan

Facility Name

JP00181

City

Hitachinaka

State/Province

Ibaraki

Country

Japan

Facility Name

JP00107

City

Hitachi

State/Province

Ibaraki

Country

Japan

Facility Name

JP00073

City

Koga

State/Province

Ibaraki

Country

Japan

Facility Name

JP00054

City

Mito

State/Province

Ibaraki

Country

Japan

Facility Name

JP00039

City

Tsukuba

State/Province

Ibaraki

Country

Japan

Facility Name

JP00034

City

Komatsu

State/Province

Ishikawa

Country

Japan

Facility Name

JP00179

City

Komatsu

State/Province

Ishikawa

Country

Japan

Facility Name

JP00028

City

Morioka

State/Province

Iwate

Country

Japan

Facility Name

JP00049

City

Morioka

State/Province

Iwate

Country

Japan

Facility Name

JP00088

City

Kida-gun

State/Province

Kagawa

Country

Japan

Facility Name

JP00084

City

Isehara

State/Province

Kanagawa

Country

Japan

Facility Name

JP00058

City

Kawasaki

State/Province

Kanagawa

Country

Japan

Facility Name

JP00141

City

Sagamihara

State/Province

Kanagawa

Country

Japan

Facility Name

JP00096

City

Yokohama

State/Province

Kanagawa

Country

Japan

Facility Name

JP00045

City

Zushi

State/Province

Kanagawa

Country

Japan

Facility Name

JP00019

City

Koshi

State/Province

Kumamoto

Country

Japan

Facility Name

JP00057

City

Tamana

State/Province

Kumamoto

Country

Japan

Facility Name

JP00168

City

Yokkaichi

State/Province

Mie

Country

Japan

Facility Name

JP00023

City

Miyagi-gun

State/Province

Miyagi

Country

Japan

Facility Name

JP00169

City

Osaki

State/Province

Miyagi

Country

Japan

Facility Name

JP00004

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

JP00027

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

JP00036

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

JP00105

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

JP00151

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

JP00050

City

Hyuga

State/Province

Miyazaki

Country

Japan

Facility Name

JP00129

City

Matsumoto

State/Province

Nagano

Country

Japan

Facility Name

JP00162

City

Isehaya

State/Province

Nagasaki

Country

Japan

Facility Name

JP00101

City

Omura

State/Province

Nagasaki

Country

Japan

Facility Name

JP00103

City

Omura

State/Province

Nagasaki

Country

Japan

Facility Name

JP00153

City

Sasebo

State/Province

Nagasaki

Country

Japan

Facility Name

JP00094

City

Kashihara

State/Province

Nara

Country

Japan

Facility Name

JP00025

City

Nagaoka

State/Province

Niigata

Country

Japan

Facility Name

JP00144

City

Shibata

State/Province

Niigata

Country

Japan

Facility Name

JP00064

City

Beppu

State/Province

Oita

Country

Japan

Facility Name

JP00051

City

Setouchi

State/Province

Okayama

Country

Japan

Facility Name

JP00011

City

Hannan

State/Province

Osaka

Country

Japan

Facility Name

JP00134

City

Higashiosaka

State/Province

Osaka

Country

Japan

Facility Name

JP00078

City

Kawachinagano

State/Province

Osaka

Country

Japan

Facility Name

JP00137

City

Sakai

State/Province

Osaka

Country

Japan

Facility Name

JP00070

City

Suita

State/Province

Osaka

Country

Japan

Facility Name

JP00086

City

Suita

State/Province

Osaka

Country

Japan

Facility Name

JP00146

City

Suita

State/Province

Osaka

Country

Japan

Facility Name

JP00061

City

Toyonaka

State/Province

Osaka

Country

Japan

Facility Name

JP00075

City

Ureshino

State/Province

Saga

Country

Japan

Facility Name

JP00126

City

Gyoda

State/Province

Saitama

Country

Japan

Facility Name

JP00007

City

Hiki-gun

State/Province

Saitama

Country

Japan

Facility Name

JP00060

City

Kawagoe

State/Province

Saitama

Country

Japan

Facility Name

JP00161

City

Kawagoe

State/Province

Saitama

Country

Japan

Facility Name

JP00062

City

Kawaguchi

State/Province

Saitama

Country

Japan

Facility Name

JP00052

City

Sayama

State/Province

Saitama

Country

Japan

Facility Name

JP00008

City

Tokorozawa

State/Province

Saitama

Country

Japan

Facility Name

JP00133

City

Kakegawa

State/Province

Shizuoka

Country

Japan

Facility Name

JP00077

City

Kanuma

State/Province

Tochigi

Country

Japan

Facility Name

JP00145

City

Shimotsuke

State/Province

Tochigi

Country

Japan

Facility Name

JP00024

City

Bunkyo-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00043

City

Bunkyo-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00143

City

Bunkyo-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00149

City

Bunkyo-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00152

City

Bunkyo-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00095

City

Chiyoda-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00099

City

Chiyoda-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00142

City

Chuo-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00063

City

Hachioji

State/Province

Tokyo

Country

Japan

Facility Name

JP00053

City

Kiyose

State/Province

Tokyo

Country

Japan

Facility Name

JP00072

City

Meguro-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00083

City

Meguro-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00148

City

Ota-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00100

City

Setagaya-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00081

City

Shibuya-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00032

City

Shinjuku-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00021

City

Sumida-ku

State/Province

Tokyo

Country

Japan

Facility Name

JP00010

City

Takaoka

State/Province

Toyama

Country

Japan

Facility Name

JP00155

City

Nishimuro-gun

State/Province

Wakayama

Country

Japan

Facility Name

JP00104

City

Shimonoseki

State/Province

Yamaguchi

Country

Japan

Facility Name

JP00047

City

Shunan

State/Province

Yamaguchi

Country

Japan

Facility Name

JP00176

City

Fukui

Country

Japan

Facility Name

JP00018

City

Fukuoka

Country

Japan

Facility Name

JP00020

City

Fukuoka

Country

Japan

Facility Name

JP00035

City

Fukuoka

Country

Japan

Facility Name

JP00059

City

Fukuoka

Country

Japan

Facility Name

JP00076

City

Fukuoka

Country

Japan

Facility Name

JP00131

City

Fukuoka

Country

Japan

Facility Name

JP00164

City

Fukuoka

Country

Japan

Facility Name

JP00165

City

Fukushima

Country

Japan

Facility Name

JP00013

City

Hiroshima

Country

Japan

Facility Name

JP00014

City

Hiroshima

Country

Japan

Facility Name

JP00015

City

Hiroshima

Country

Japan

Facility Name

JP00016

City

Hiroshima

Country

Japan

Facility Name

JP00055

City

Hiroshima

Country

Japan

Facility Name

JP00065

City

Kagoshima

Country

Japan

Facility Name

JP00074

City

Kagoshima

Country

Japan

Facility Name

JP00167

City

Kagoshima

Country

Japan

Facility Name

JP00093

City

Kochi

Country

Japan

Facility Name

JP00022

City

Kumamoto

Country

Japan

Facility Name

JP00046

City

Kumamoto

Country

Japan

Facility Name

JP00085

City

Kyoto

Country

Japan

Facility Name

JP00123

City

Kyoto

Country

Japan

Facility Name

JP00159

City

Kyoto

Country

Japan

Facility Name

JP00122

City

Miyazaki

Country

Japan

Facility Name

JP00080

City

Nagano

Country

Japan

Facility Name

JP00174

City

Nagano

Country

Japan

Facility Name

JP00098

City

Nagasaki

Country

Japan

Facility Name

JP00112

City

Nagasaki

Country

Japan

Facility Name

JP00147

City

Nagasaki

Country

Japan

Facility Name

JP00006

City

Niigata

Country

Japan

Facility Name

JP00017

City

Oita

Country

Japan

Facility Name

JP00118

City

Okayama

Country

Japan

Facility Name

JP00150

City

Osaka

Country

Japan

Facility Name

JP00157

City

Osaka

Country

Japan

Facility Name

JP00044

City

Shizuoka

Country

Japan

Facility Name

JP00089

City

Shizuoka

Country

Japan

Facility Name

JP00135

City

Shizuoka

Country

Japan

Facility Name

JP00009

City

Toyama

Country

Japan

Facility Name

JP00139

City

Toyama

Country

Japan

Facility Name

KR00504

City

Daegu

Country

Korea, Republic of

Facility Name

KR00505

City

Gwangju

Country

Korea, Republic of

Facility Name

KR00506

City

Incheon

Country

Korea, Republic of

Facility Name

KR00508

City

Jeonju

Country

Korea, Republic of

Facility Name

KR00501

City

Seoul

Country

Korea, Republic of

Facility Name

KR00502

City

Seoul

Country

Korea, Republic of

Facility Name

KR00509

City

Seoul

Country

Korea, Republic of

Facility Name

KR00511

City

Seoul

Country

Korea, Republic of

Facility Name

KR00507

City

Suwon

Country

Korea, Republic of

Facility Name

TW00709

City

Kaohsiung

Country

Taiwan

Facility Name

TW00710

City

Taichung

Country

Taiwan

Facility Name

TW00712

City

Tainan

Country

Taiwan

Facility Name

TW00701

City

Taipei

Country

Taiwan

Facility Name

TW00702

City

Taipei

Country

Taiwan

Facility Name

TW00711

City

Taipei

Country

Taiwan

Facility Name

TW00703

City

Taoyuan

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

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 URL

https://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

33656739

Citation

Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song YW, Chen YH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y. Safety and Effectiveness of Peficitinib (ASP015K) in Patients with Rheumatoid Arthritis: Final Results (32 Months of Mean Peficitinib Treatment) From a Long-Term, Open-Label Extension Study in Japan, Korea, and Taiwan. Rheumatol Ther. 2021 Mar;8(1):425-442. doi: 10.1007/s40744-021-00280-5. Epub 2021 Mar 3.

Results Reference

derived

PubMed Identifier

32164762

Citation

Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, Song YW, Chen YH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y, Nakashima Y, Shiomi T, Yamada E. Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan. Arthritis Res Ther. 2020 Mar 12;22(1):47. doi: 10.1186/s13075-020-2125-2. Erratum In: Arthritis Res Ther. 2020 Jun 23;22(1):155.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=370

Description

Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

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

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

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial