STOP HZ Study
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-jRCTs031230329
- Lead Sponsor
- Kaneko Yuko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
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 .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare antibody titers of VZV-specific IgG antibodies at baseline and at weeks 12 between within group.
- Secondary Outcome Measures
Name Time Method