Immune response to adjuvanted recombinant zoster vaccine in Japanese RA patients treated with upadacitinib - End Zoster-J study

Watanabe Ryu0 个研究点目标入组 69 人开始时间: 2022年10月14日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients who have given informed consent to participate in this study
•2) Patients who are treated with stable dose of 1) methotrexate (MTX) monotherapy, 2) upadacitinib monotherapy (15 mg/day), or 3) MTX + upadacitinib 15 mg/day (combo) for at least 1 months prior to the study entry
•3) Patients who are 50 years old or older
•4) Patients who can come to our hospital according to the research schedule

•1) Patients on dialysis
•2) Pregnant / lactating patients
•3) Patients with severe liver damage (Child-Pugh classification C)
•4) Patients with serious infections or active tuberculosis
•5) Patients with neutropenia (<1000 / mm3), lymphopenia (<500 / mm3), or anemia (hemoglobin <8 g / dL)
•6) Patients who have been treated with Singlix before obtaining consent
•7) Patients who have been vaccinated with live vaccine for herpes zoster within 8 weeks before obtaining consent
•8) Patients who developed shingles within 6 months before obtaining consent, or who had symptoms related to shingles
•9) Patients who have been administered any vaccine within 4 weeks before the administration of Singlix, or will be vaccinated with any vaccine other than Singlix within 4 weeks after the second administration of Singlix after obtaining consent. patient
•10) Patients with congenital or acquired immunodeficiency
•11) Patients receiving prednisolone (equivalent) > 10 mg
•12) Patients who had a history of using JAK inhibitors and discontinued due to insufficient efficacy
•13) Patients who are judged to be inappropriate for participation in this study

发起方

Watanabe Ryu