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Immune response to adjuvanted recombinant zoster vaccine in Japanese RA patients treated with upadacitinib

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051220105
Enrollment
69
Registered
2022-10-14
Start date
2022-12-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

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 pa

Sponsors

Watanabe Ryu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 ( 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

Design outcomes

Primary

MeasureTime frame
Immunogenicity 4 weeks after 2nd dose of shingrix injection

Secondary

MeasureTime frame
(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

Contacts

Public ContactRyu Watanabe

Osaka Metropolitan University Hospital

doctorwatanaberyu7@gmail.com+81-6-6645-3891

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Aug 16, 2026