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

未提供0 个研究点目标入组 69 人开始时间: 2022年12月26日最近更新: 2025年5月20日

适应症

试验速览

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•Patients who have given informed consent to participate in this study
•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
•Patients who are 50 years old or older
•Patients who can come to our hospital according to the research schedule

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

Immunogenicity 4 weeks after 2nd dose of shingrix injection

Relapse of RA(12 weeks after the second administration)
Positive rate of anti-gE antibody(4 weeks after the first administration)
Antibodies of anti-gE antibody(4 weeks after the first and second administration)
Evaluation of gE-specific CD4 + T cells(4 weeks after the first and second administration)
Evaluation of VZV-specific antibody titer(4 weeks after the first and second administration)
Changes in RA disease activity

发起方

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