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JASPER study-MTX tapering

Japan post-marketing study of Peficitinib use in RA patients study-MTX tapering

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1031240384
Enrollment
200
Registered
2024-10-09
Start date
2024-10-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Rheumatoid arthritis

Interventions

None listed

Sponsors

Yamaoka Kunihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 20 years old and older as of the index date and the reason for receiving peficitinib during peficitinib PMS (SMR001) is RA 2.Patients who were administered MTX (oral formulation: 8 mg/week higher or subcutaneous injection preparation: 7.5 mg/week higher ) concomitantly at the start of initial administration with peficitinib 100 mg or 150 mg 3.Patients who are registered to Peficitinib PMS (SMR001) 4.Patients who provided written informed consent to study participation 5.Patients who have been followed up for at least 104 weeks from the index date (including those who are discontinued before 104 weeks)

Exclusion criteria

Exclusion criteria: 1.Patients who were administered Peficitinib for diseases other than RA 2.Patients who were administered Peficitinib 50 mg from the index date to 104 weeks

Design outcomes

Primary

MeasureTime frame
The change in CDAI

Secondary

MeasureTime frame
1)Adverse Events and adverse reactions after the start of peficitinib administration 2)DAS28-ESR 3)DAS28-CRP 4)SDAI 5)CDAI 6)The change in the subjective global assessment 7)The change in the physician global assessment 8)The change in tender joint count 9)The change in swollen joint count 10)The change in ESR 11)The change in CRP 12)Dose reduction 13)Association between the patient characteristics and MTX dose level reduction 14)Determination of Good response/Moderate response based on DAS28-ESR EULAR improvement criteria

Contacts

Public ContactKunihiro Yamaoka

Kitasato University Hospial

JASPER-MTX@tri-kobe.org+81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026