JASPER study-MTX tapering

JRCT ID: jRCT1031240384

Registered date:09/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 09/10/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: The change in CDAI

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Yamaoka Kunihiro
• Source(s) of Monetary Support: Astellas Pharma Inc.