JPRN-jRCTs031230329招募中4 期
Effectiveness and SafeTy of Prophylactic Recombinant Herpes Zoster Virus Vaccination for Rheumatoid Arthritis Patients with Tofacitinib Treatment:A Multicenter Open-label Randomized Comparative Study
Kaneko Yuko0 个研究点目标入组 60 人开始时间: 2023年9月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 .
研究者
相似试验
招募中
2 期
Effect of erythropoietin on COVID-19IRCT20200509047364N1Bandare-abbas University of Medical Sciences20
进行中（未招募）
不适用
ow dose Prophylaxis study in children with haemaophilia ACTRI/2014/03/004494BAYER AWARD30
已完成
不适用
Prophylactic Effects of Levetiracetam on Migraine in 4-14 Years Old ChildreMigraine.MigraineIRCT2015101714333N44Vice chancellor for research, Kermanshah University of Medical Sciences30
招募中
3 期
Assessment of the prophylactic combined effect of diphenhydramine with paracetamol on agitation and pain after laparoscopic cholecystectomyCholecystectomy.IRCT20170411033365N4Oroumia University of Medical Sciences30
已完成
不适用
Investigation on efficacy and safety of combination treatment with imidafenacin and mirabegron in patients with overactive bladder.overactive bladderJPRN-UMIN000016236Clinical Research Support Center Kyushu30