JPRN-jRCTs031210665进行中(未招募)未知
A Prospective Interventional Study to Evaluate the Effect of Sarilumab on Bone Destruction in Rheumatoid Arthritis Patients - APPRECIATE
Kawahito Yutaka0 个研究点目标入组 55 人开始时间: 2022年3月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 55
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
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •(1)Adult patients at the time of obtaining consent
- •(2)Patients who have been diagnosed with RA based on the American College of Rheumatology (ACR) criteria for RA diagnosis (revised in 1987) or the 2010 ACR/European College of Rheumatology (EULAR) criteria for RA classification.
- •(3)Patients who are scheduled to be newly started on sarilumab for RA.
- •(4)Patients with at least one bone erosion on radiographs of the phalanges and carpal bones.
- •(5) Patients for whom sarilumab is to be started at a dose of 200 mg every two weeks.
- •(6)Patients who can sign the consent document in person.
排除标准
- •(1) Patients for whom sarilumab is contraindicated according to the Japanese package insert.
- •(2) Patients who are currently participating in clinical trials other than this study.
- •(3) Patients who are scheduled to receive bDMARD or tsDMARD in combination with sarilumab.
- •(4) Patients whose corticosteroid dosage is more than 6 mg/day of prednisolone equivalent for the last 4 weeks.
- •(5) Patients with a history of treatment with sarilumab (including participation in clinical trials)
- •(6) Patients who have been treated with denosumab within 1 year
- •(7)Patients who have received romosozumab, teriparatide, teriparatide BS, or abaloparatide (if marketed)
- •(8)Patients who are pregnant, lactating, or who may become pregnant, or who are planning to become pregnant within one year.
- •(9)Patients who are judged to be uncooperative or who may not be able to comply with the procedures, etc. for conducting the study for some reason by the patient.
研究者
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