臨床研究等提出・公開システム

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

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

Watanabe Ryu

Osaka Metropolitan University Hospital

1-5-7 Asahimachi, Abeno-ku, Osaka

doctorwatanaberyu7@gmail.com

Watanabe Ryu

Osaka Metropolitan University Hospital

1-5-7 Asahimachi, Abeno-ku, Osaka

+81-6-6645-3891

doctorwatanaberyu7@gmail.com

Not Recruiting

Oct. 14, 2022

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

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

Both

Rheumatoid arthritis

1) Shingrix administration to patients who are on methotrexate (MTX) monotherapy
2) Shingrix administration to patients who are on upadacitinib monotherapy (15 mg/day)
3) Shingrix administration to patients who are on MTX + upadacitinib 15 mg/day (combo)

Immunogenicity 4 weeks after 2nd dose of shingrix injection

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

+81-6-6645-3456

Sept. 29, 2022

Yes

When sending a sample to a research institution designated by AbbVie GK, only the case number, age, and sex registered in the EDC system (REDCap) of Osaka Metropolitan University Hospital will be given, and the treatment details will not be given. We will save the data associated with the case number and treatment details in REDCap.

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