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

JRCT ID: jRCTs051220105

Registered date:14/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 26/12/2022
• Target sample size: 69
• Study type: Interventional

Intervention(s)

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)

Outcome(s)

• Primary Outcome: Immunogenicity 4 weeks after 2nd dose of shingrix injection

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Watanabe Ryu
• Secondary Sponsor: AbbVie GK