JPRN-jRCTs071200007招募中4 期
Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
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.Patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I .
- •2.Patients who have been persisted with clinical remission or low disease activity during IFX-SIRIUS STUDY I period and the baseline visit.
- •3.Patients who give written informed consent after receiving sufficient information.
排除标准
- •1.Patients with a history of infusion reaction to infliximab BS required medication.
- •2.Patients changed the dosage of restricted drugs after IFX-SIRIUS STUDY I period.
- •3.Patients treated with prohibited substances or prohibited therapy after IFX-SIRIUS STUDY I period.
- •4.Women who detect a pregnancy after IFX-SIRIUS STUDY I period.
- •5.Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the study period and lactating women. Men who will not be compliant with a contraceptive regimen during the study period.
- •6.Patients who are judged unsuitable for this study by the investigator.
研究者
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不适用
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