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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01638013
Date of registration:	09/07/2012
Prospective Registration:	No
Primary sponsor:	Astellas Pharma Inc
Public title:	A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K
Scientific title:	Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K
Date of first enrolment:	June 13, 2012
Target sample size:	843
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01638013
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Japan	Korea, Republic of	Taiwan

Contacts

Name:	Medical Director
Address:
Telephone:
Email:
Affiliation:	Astellas Pharma Inc

Key inclusion & exclusion 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.

Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Peficitinib

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: Baseline up to end of study (EOS) (up to week 376)]

Secondary Outcome(s)

Change From Baseline of Preceding Study CDAI Score Through Week 372 [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]

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

Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 [Time Frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 [Time Frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 [Time Frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 [Time Frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT]

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

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

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

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

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

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

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

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

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

Number of Participants Who Withdrew Due to Lack of Efficacy [Time Frame: Baseline up to week 372]

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

Secondary ID(s)

015K-CL-RAJ2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	23/10/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01638013

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