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Clinical Trials/jRCTs051220105
jRCTs051220105Active, not recruitingNot Applicable

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

Not provided0 sites69 target enrollmentStarted: December 26, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
69
Primary Endpoint
-

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Prevention Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
50age old over to No limit (—)
Sex
All

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

-

Immunogenicity 4 weeks after 2nd dose of shingrix injection

Secondary Outcomes

  • 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

Investigators

Sponsor
Not provided

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