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

Phase 4

Recruiting

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-jRCTs051220105
• Lead Sponsor: Watanabe Ryu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 69

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity 4 weeks after 2nd dose of shingrix injection

Secondary Outcome Measures

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