JASPER study-switch

JRCT ID: jRCT1031220112

Registered date:04/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 04/06/2022
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: The change in DAS28-ESR from the index date to 24 weeks

Secondary Outcome

1) Adverse drug reactions after being switched from bDMARDs to Peficitinib
2) The changes in DAS28-ESR from the index date to 4 and 12 weeks
3) The evidence of remission/low disease activity (LDA) in DAS28-ESR at 4, 12 and 24 weeks (DAS28-ESR < 3.2)
4) DAS28-ESR improvement based on assessment by EULAR improvement criteria at 4, 12 and 24 weeks
5) The change in DAS28-CRP from the index date to 4, 12 and 24 weeks
6) The evidence of remission/LDA in DAS28-CRP at 4, 12 and 24 weeks (DAS28-CRP < 3.2)
7) The change in SDAI from the index date to 4, 12 and 24 weeks
8) The evidence of remission/LDA in SDAI at 4, 12 and 24 weeks (SDAI =<11)
9) The change in CDAI from the index date to 4, 12 and 24 weeks
10) The evidence of remission/LDA in CDAI at 4, 12 and 24 weeks (CDAI =<10)

Key inclusion & exclusion criteria

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

Include criteria

1. Patients who provided written informed consent to study participation
2. Patients aged 20 years old and older as of the index date
3. RA patients switched from bDMARDs (anti-TNF antibody, TNFR-Ig, anti-IL-6R antibody, or CTLA4-Ig) to Peficitinib due to inadequate response* to bDMARDs. (switching from bDMARD to peficitinib must be within 60 days)
4. Patients who are registered to Peficitinib PMS (SMR001)
5. Patients who have been followed up for at least 24 weeks from the start of Peficitinib administration*** (including those who are discontinued before 24 weeks from the start of Peficitinib administration)
*: Use of one or more bDMARDs for at least 12 weeks as prior therapy and disease activity at Index date has not reached remission/LDA (DAS-ESR < 3.2)

Exclude criteria

1. Patients who were administered Peficitinib for diseases other than RA
2. Patients who were administered JAK inhibitors (including Peficitinib) for RA treatment before the index date
3. Patients who were administered Peficitinib 50 mg despite of not having moderate or more severe hepatic impairment from the index date to 24 weeks after the index date

Related Information

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