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
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