STOP HZ Study

JRCT ID: jRCTs031230329

Registered date:06/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: rheumatoid arthritis
• Date of first enrollment: 27/09/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Group A: From Day 1, tofacitinib 5 mg twice daily
Group B: From Week 8, tofacitinib 5 mg twice daily
Both groups will receive Freeze-dried recombinant RZV on Day 1 and Week 8.
Observation is 12 weeks from day 1.

Outcome(s)

• Primary Outcome: Compare antibody titers of VZV-specific IgG antibodies at baseline and at weeks 12 between within group.

Secondary Outcome

a)Secondary immunogenicity outcome
- Compare antibody titers of VZV-specific IgG antibodies at baseline and at weeks 12 between for each group.
- Compare antibody titers of VZV-specific IgG antibodies at baseline and at weeks 4 and 8 between and for each group.
- Measure antibody titers of VZV-specific IgG antibodies at baseline and at weeks 4, 8, and 12 in both groups.
- Calculate of absolute geometric mean titers (GMT) of antibody titers of VZV-specific IgG antibodies in both groups.
- Calculate the percentage of patients with a fold change of at least 1.5 times from baseline in antibody titers of VZV-specific IgG antibodies in both groups at weeks 4, 8, and 12.
- Compare antibody titers of VZV-specific IgG antibodies between the two groups at weeks 4 and 8.
- Compare antibody titers of VZV-specific IgG antibodies between the two groups and each group between weeks 4 and 8 and 12 and between weeks 8 and 12.

b) Secondary clinical outcome
- Composite index of disease activity (including CDAI, SDAI, DAS28-CRP scores and HAQ-DI).
- HZ events until end of study (week 12) in patients treated with tofacitinib.
- The presence of a disease flare in RA until the end of the study.
- Adverse events and serious adverse events until the end of the study.

Key inclusion & exclusion criteria

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

Include criteria

Patients must meet all of the following criteria for study entry:
(1) Male and female patient aged 50 years or older at the time of obtaining consent.
(2) Patients diagnosed with RA based on 1987 ACR criteria or 2010 ACR/EULAR criteria.
(3) Patients who have had an inadequate response to conventional synthetic anti-rheumatic drugs (csDMARDs) and/or biologic disease-modifying anti-rheumatic drugs (bDMARDs), including methotrexate (MTX), and who meet one of the following criteria.
a. MTX and/or bDMARDs have been administered for more than 8 weeks without dose change.
b. Combined use of csDMARDs other than MTX for more than 4 weeks without dose change.
c. Baseline prednisolone-equivalent dose <= 10 mg/day for 28 days without dose change.
(4) Patients who have not achieved remission by CDAI index (CDAI>2.8).
(5) Scheduled to start tofacitinib 5 mg twice daily.
(6) Written informed consent from patient is obtained.

Exclude criteria

Patients who meet any of the following criteria will be excluded from study entry:
(1) Patients with at least one history of exposure to the dried recombinant RZV.
(2) Patients with a history of being vaccinated with the ZOSTAVAX vaccine (live vaccine).
(3) Patients with a history of vaccination of the dry, attenuated varicella vaccine "viken".
(4) Patients with a history of herpes zoster (HZ) episodes or smallpox within one year prior to enrollment in this clinical study.
(5) Patients who are currently pregnant, may become pregnant, wish to become pregnant, or are breastfeeding.
(6) Patients receiving chemotherapy or other systemic immunosuppressive therapy for malignancies or diseases other than RA.
(7) Patients with collagenosis except Sjogren's syndrome.
(8) Patients who were treated with rituximab within 9 months prior to enrollment in this clinical study.
(9) Patients who were treated with abatacept within 2 months prior to enrollment in this clinical study.
(10) Patients who have been treated with JAK inhibitors within 6 months prior to enrollment in this clinical study.
(11) Patients receiving or scheduled to receive other study drugs during the study period (week 12).
(12) Patients who receive immunoglobulin or blood products within 90 days prior to the first dose of dry recombinant RZV or by the end of the study (week 12).
(13) Patients scheduled to undergo surgery to affect this clinical study during the study period
(14) Patients with obvious fever.
(15) Patients who are obviously suffering from serious acute diseases.
(16) Patients with more than moderate renal (eGFR<30) or hepatic dysfunction (higher than 5 times upper limit of normal).
(17) Patients with serious infections (e.g. sepsis) and active tuberculosis.
(18) Patients with neutrophil count less than 500/mm3.
(19) Patients with lymphocyte count less than 500/mm3.
(20) Patients with hemoglobin levels less than 8 g/dL.
(21) Patients who are unsuitable for study participation in the opinion of the investigator .

Related Information

• Primary Sponsor: Kaneko Yuko
• Source(s) of Monetary Support: Pfizer Japan Inc.