Japan post-marketing study of Peficitinib use in RA patients study-switch

Astellas Pharma Inc.0 个研究点目标入组 100 人开始时间: 2022年7月15日最近更新: 2024年11月21日

适应症

试验速览

暂无简介。

•Patients who provided written informed consent to study participation
•Patients aged 20 years old and older as of the index date
•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)
•Patients who are registered to Peficitinib PMS (SMR001)
•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)

•Patients who were administered Peficitinib for diseases other than RA
•Patients who were administered JAK inhibitors (including Peficitinib) for RA treatment before the index date
•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

The change in DAS28-ESR from the index date to 24 weeks

The evidence of remission/low disease activity (LDA) in DAS28-ESR at 4, 12 and 24 weeks(4, 12 and 24 weeks)
The evidence of remission/LDA in DAS28-CRP at 4, 12 and 24 weeks(4, 12 and 24 weeks)
The evidence of remission/LDA in SDAI at 4, 12 and 24 weeks(4, 12 and 24 weeks)
The evidence of remission/LDA in CDAI at 4, 12 and 24 weeks(4, 12 and 24 weeks)

发起方