Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
1 other identifier
observational
3,000
1 country
47
Brief Summary
The objective of this study is to investigate the safety and effectiveness in routine clinical practice and actual clinical setting for all patients with rheumatoid arthritis (RA) treated with peficitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
September 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
May 4, 2026
April 1, 2026
6.7 years
May 30, 2019
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (21)
Safety assessed by frequency of adverse events (AEs)
An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment.
Up to 52 weeks
Safety assessed by frequency of adverse drug reactions (ADRs)
AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "AEs whose relationship to the study drugs could not be ruled out."
Up to 52 weeks
Safety assessed by frequency of serious infections
Serious infections include tuberculosis, pneumonia, pneumocystis pneumonia, ichorrhemia and opportunistic infection.
Up to 156 weeks
Safety assessed by frequency of malignancy
Frequency of malignancy found after drug administration.
Up to 156 weeks
Safety assessed by frequency of events leading to death
Any events leading to death will be reported as serious AEs.
Up to 156 weeks
Safety assessed by frequency of AEs of special interests
AEs of special interests include neutrophil decrease, lymphocyte decrease, hemoglobin decrease, Herpes zoster, gastrointestinal perforation, interstitial pneumonia, reactivation of Hepatitis B virus, hepatic function disorder, venous thromboembolism, cardiovascular events, rhabdomyolysis and myopathy.
Up to 156 weeks
Safety assessed by frequency of serious adverse events (SAEs)
An AE is considered "serious" if, in the view of either the investigator, it results in any of the following outcomes: death, life-threatening, persistent or significant disability/incapacity or substantial disruption, congenital anomaly or birth defect, hospitalization or prolongation of hospitalization, or medically important events.
Up to 156 weeks
Safety assessed by frequency of serious adverse drug reactions (SADRs)
SAEs whose relationship to the study drugs could not be ruled out is considered serious ADR. SAEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "SAEs whose relationship to the study drugs could not be ruled out."
Up to 156 weeks
Disease activity score (DAS28) - C-reactive protein (CRP)
DAS28-CRP will be calculated using data from Tender Joint Count (TJC) (28 joints), Swollen Joint Count (SJC) (28 joints), C-reactive protein (CRP) and Subject's Global Assessment of Arthritis (SGA) with the formula; DAS28-CRP = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP (mg/dL) x 10 + 1) + 0.014 x SGA (mm) + 0.96. DAS28-CRP exceeding 5.1 is considered high disease activity; exceeding 3.2 and not greater than 5.1, moderate disease activity; exceeding 2.6 and not greater than 3.2, low disease activity.
Up to 52 weeks
DAS28- erythrocyte sedimentation rate (ESR) score
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR (mm/h) + 0.014 x SGA (mm). DAS28-ESR exceeding 5.1 is considered high disease activity; exceeding 3.2 and not greater than 5.1, moderate disease activity; exceeding 2.6 and not greater than 3.2, low disease activity.
Up to 52 weeks
Simplified Disease Activity Index (SDAI) score
SDAI score will be calculated with formula SDAI = TJC + SJC + SGA + Physician's Global Assessment of Arthritis (PGA) + CRP. SDAI score exceeding 26 is considered high disease activity; exceeding 11 and not greater than 26, moderate disease activity; exceeding 3.3 and not greater than 11, low disease activity.
Up to 52 weeks
Clinical Disease Activity Index (CDAI) score
CDAI score will be calculated with formula CDAI = TJC + SJC + SGA + PGA. CDAI score exceeding 22 is considered high disease activity; exceeding 10 and not greater than 22, moderate disease activity; exceeding 2.8 and not greater than 10, low disease activity.
Up to 52 weeks
Tender Joint Count (TJC) (28 joints)
The investigator/sub-investigator will examine the participant for tender joints, assessing the 28 joints and confirm the location of each tender joint.
Up to 52 weeks
Swollen Joint Count (SJC) (28 joints)
The investigator/sub-investigator will examine the participants for swollen joints, assessing the 28 joints and confirm the location of the swollen joints.
Up to 52 weeks
Erythrocyte sedimentation rate (ESR)
ESR will be recorded from blood samples collected.
Up to 52 weeks
C-reactive protein (CRP)
CRP will be recorded from blood samples collected.
Up to 52 weeks
Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS))
The participant assesses his/her own disease activity on a VAS of 0 - 100 mm, corresponding from 'no disease activity' to 'very severe disease activity', on the questionnaire form.
Up to 52 weeks
Physician's Global Assessment of Arthritis (PGA) (VAS)
The investigator assesses participant's disease activity on a VAS of 0 - 100 mm, corresponding from 'no disease activity' to 'very severe disease activity', on the questionnaire form.
Up to 52 weeks
European League Against Rheumatism (EULAR) Response Criteria
Based on DAS28 scores and changes in DAS28 scores before and after treatment with the study drug, EULAR Response Criteria categorize response to treatment as "No response", "Moderate response," or "Good response."
Up to 52 weeks
Percentage of participants achieving DAS28-CRP scores for remission
Percentage of participants with DAS28 scores less than 2.6.
Up to 52 weeks
Percentage of participants achieving DAS28-ESR scores for remission
Percentage of participants with DAS28 scores less than 2.6.
Up to 52 weeks
Study Arms (1)
Peficitinib
Participants will receive peficitinib once daily after meal.
Interventions
Eligibility Criteria
Patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
You may qualify if:
- All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Site JP00023
Aichi, Japan
Site JP00005
Akita, Japan
Site JP00002
Aomori, Japan
Site JP00012
Chiba, Japan
Site JP00038
Ehime, Japan
Site JP00018
Fukui, Japan
Site JP00040
Fukuoka, Japan
Site JP00007
Fukushima, Japan
Site JP00021
Gifu, Japan
Site JP00010
Gunma, Japan
Site JP00034
Hiroshima, Japan
Site JP00001
Hokkaido, Japan
Site JP00028
Hyōgo, Japan
Site JP00008
Ibaraki, Japan
Site JP00017
Ishikawa, Japan
Site JP00037
Kagawa, Japan
Site JP00046
Kagoshima, Japan
Site JP00014
Kanagawa, Japan
Site JP00039
Kochi, Japan
Site JP00043
Kumamoto, Japan
Site JP00026
Kyoto, Japan
Site JP00024
Mie, Japan
Site JP00004
Miyagi, Japan
Site JP00045
Miyazaki, Japan
Site JP00020
Nagano, Japan
Site JP00042
Nagasaki, Japan
Site JP00029
Nara, Japan
Site JP00015
Niigata, Japan
Site JP00003
Numakunai, Japan
Site JP00033
Okayama, Japan
Site JP00047
Okinawa, Japan
Site JP00027
Osaka, Japan
Site JP00044
Ōita, Japan
Site JP00041
Saga, Japan
Site JP00011
Saitama, Japan
Site JP00025
Shiga, Japan
Site JP00032
Shimane, Japan
Site JP00022
Shizuoka, Japan
Site JP00009
Tochigi, Japan
Site JP00036
Tokushima, Japan
Site JP00013
Tokyo, Japan
Site JP00031
Tottori, Japan
Site JP00016
Toyama, Japan
Site JP00030
Wakayama, Japan
Site JP00006
Yamagata, Japan
Site JP00035
Yamaguchi, Japan
Site JP00019
Yamanashi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Inc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 3, 2019
Study Start
September 2, 2019
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.