Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
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Phase
—
Status
Completed
Study type
Observational
Enrollment
3,000actual
Sites
47
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-09-02 | actual | When the study began enrolling |
| Primary completion | 2026-05-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-29 | actual | The whole study's end, after follow-up |
| First posted | 2019-06-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Rheumatoid Arthritis (RA)
Intervention
- Drug: Peficitinib — also filed as ASP015K, Smyraf
Primary outcomes
what the primary-completion date above is the date OFSafety assessed by frequency of adverse events (AEs)
measured Up to 52 weeks
Safety assessed by frequency of adverse drug reactions (ADRs)
measured Up to 52 weeks
Safety assessed by frequency of serious infections
measured Up to 156 weeks
Safety assessed by frequency of malignancy
measured Up to 156 weeks
Safety assessed by frequency of events leading to death
measured Up to 156 weeks
Safety assessed by frequency of AEs of special interests
measured Up to 156 weeks
Safety assessed by frequency of serious adverse events (SAEs)
measured Up to 156 weeks
Safety assessed by frequency of serious adverse drug reactions (SADRs)
measured Up to 156 weeks
Disease activity score (DAS28) - C-reactive protein (CRP)
measured Up to 52 weeks
DAS28- erythrocyte sedimentation rate (ESR) score
measured Up to 52 weeks
Simplified Disease Activity Index (SDAI) score
measured Up to 52 weeks
Clinical Disease Activity Index (CDAI) score
measured Up to 52 weeks
Tender Joint Count (TJC) (28 joints)
measured Up to 52 weeks
Swollen Joint Count (SJC) (28 joints)
measured Up to 52 weeks
Erythrocyte sedimentation rate (ESR)
measured Up to 52 weeks
C-reactive protein (CRP)
measured Up to 52 weeks
Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS))
measured Up to 52 weeks
Physician's Global Assessment of Arthritis (PGA) (VAS)
measured Up to 52 weeks
European League Against Rheumatism (EULAR) Response Criteria
measured Up to 52 weeks
Percentage of participants achieving DAS28-CRP scores for remission
measured Up to 52 weeks
Percentage of participants achieving DAS28-ESR scores for remission
measured Up to 52 weeks
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