Clinical trial NCT03971253: Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Official title: Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis (RA)
Keywords: Post-Marketing Surveillance
ASP015K
Smyraf
Rheumatoid arthritis (RA)
Peficitinib
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.

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.

Detailed description: This is a mandatory Post-Marketing Surveillance (PMS) requested by Pharmaceuticals and Medical Devices Agency (PMDA) as a part of the Japan-Risk Management Plan (J-RMP).

Eligibility criteria: Inclusion Criteria:

* All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Safety assessed by frequency of adverse events (AEs)
timeFrame: Up to 52 weeks
measure: Safety assessed by frequency of adverse drug reactions (ADRs)
timeFrame: Up to 52 weeks
measure: Safety assessed by frequency of serious infections
timeFrame: Up to 156 weeks
measure: Safety assessed by frequency of malignancy
timeFrame: Up to 156 weeks
measure: Safety assessed by frequency of events leading to death
timeFrame: Up to 156 weeks
measure: Safety assessed by frequency of AEs of special interests
timeFrame: Up to 156 weeks
measure: Safety assessed by frequency of serious adverse events (SAEs)
timeFrame: Up to 156 weeks
measure: Safety assessed by frequency of serious adverse drug reactions (SADRs)
timeFrame: Up to 156 weeks
measure: Disease activity score (DAS28) - C-reactive protein (CRP)
timeFrame: Up to 52 weeks
measure: DAS28- erythrocyte sedimentation rate (ESR) score
timeFrame: Up to 52 weeks
measure: Simplified Disease Activity Index (SDAI) score
timeFrame: Up to 52 weeks
measure: Clinical Disease Activity Index (CDAI) score
timeFrame: Up to 52 weeks
measure: Tender Joint Count (TJC) (28 joints)
timeFrame: Up to 52 weeks
measure: Swollen Joint Count (SJC) (28 joints)
timeFrame: Up to 52 weeks
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: Up to 52 weeks
measure: C-reactive protein (CRP)
timeFrame: Up to 52 weeks
measure: Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS))
timeFrame: Up to 52 weeks
measure: Physician's Global Assessment of Arthritis (PGA) (VAS)
timeFrame: Up to 52 weeks
measure: European League Against Rheumatism (EULAR) Response Criteria
timeFrame: Up to 52 weeks
measure: Percentage of participants achieving DAS28-CRP scores for remission
timeFrame: Up to 52 weeks
measure: Percentage of participants achieving DAS28-ESR scores for remission
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00023
city: Akita
country: Japan
facility: Site JP00005
city: Aomori
country: Japan
facility: Site JP00002
city: Chiba
country: Japan
facility: Site JP00012
city: Ehime
country: Japan
facility: Site JP00038
city: Fukui
country: Japan
facility: Site JP00018
city: Fukuoka
country: Japan
facility: Site JP00040
city: Fukushima
country: Japan
facility: Site JP00007
city: Gifu
country: Japan
facility: Site JP00021
city: Gunma
country: Japan
facility: Site JP00010
city: Hiroshima
country: Japan
facility: Site JP00034
city: Hokkaido
country: Japan
facility: Site JP00001
city: Hyogo
country: Japan
facility: Site JP00028
city: Ibaraki
country: Japan
facility: Site JP00008
city: Ishikawa
country: Japan
facility: Site JP00017
city: Iwate
country: Japan
facility: Site JP00003
city: Kagawa
country: Japan
facility: Site JP00037
city: Kagoshima
country: Japan
facility: Site JP00046
city: Kanagawa
country: Japan
facility: Site JP00014
city: Kochi
country: Japan
facility: Site JP00039
city: Kumamoto
country: Japan
facility: Site JP00043
city: Kyoto
country: Japan
facility: Site JP00026
city: Mie
country: Japan
facility: Site JP00024
city: Miyagi
country: Japan
facility: Site JP00004
city: Miyazaki
country: Japan
facility: Site JP00045
city: Nagano
country: Japan
facility: Site JP00020
city: Nagasaki
country: Japan
facility: Site JP00042
city: Nara
country: Japan
facility: Site JP00029
city: Niigata
country: Japan
facility: Site JP00015
city: Oita
country: Japan
facility: Site JP00044
city: Okayama
country: Japan
facility: Site JP00033
city: Okinawa
country: Japan
facility: Site JP00047
city: Osaka
country: Japan
facility: Site JP00027
city: Saga
country: Japan
facility: Site JP00041
city: Saitama
country: Japan
facility: Site JP00011
city: Shiga
country: Japan
facility: Site JP00025
city: Shimane
country: Japan
facility: Site JP00032
city: Shizuoka
country: Japan
facility: Site JP00022
city: Tochigi
country: Japan
facility: Site JP00009
city: Tokushima
country: Japan
facility: Site JP00036
city: Tokyo
country: Japan
facility: Site JP00013
city: Tottori
country: Japan
facility: Site JP00031
city: Toyama
country: Japan
facility: Site JP00016
city: Wakayama
country: Japan
facility: Site JP00030
city: Yamagata
country: Japan
facility: Site JP00006
city: Yamaguchi
country: Japan
facility: Site JP00035
city: Yamanashi
country: Japan
facility: Site JP00019
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_DIRECTOR
References: