JPRN-jRCTs071190030进行中（未招募）4 期
Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 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 with 20 years older at the time of obtaining informed consent.
- •2.Patients with rheumatoid arthritis (RA) fulfilled the ACR/EULAR classification criteria for RA (2010).
- •3. Patients who have been treated with Remicade over 24 weeks and same dosage of Remicade over 12 weeks, and persisted with clinical remission (DAS28-ESR<2.6) on the last administration date of Remicade and the baseline visit.
- •4.Patients who give written informed consent after receiving sufficient information.
排除标准
- •1.Patients treated with more than 10mg/day of prednisolone, except for using on Remicade injection date only.
- •2.Patients treated with Infliximab BS previously.
- •3.Patients treated with biological agents and JAK inhibitors for RA, except for Remicade and Denosumab.
- •4.Patients with a history of infusion reaction to Remicade required medication.
- •5.Patients treated with corticosteroid or anti-rheumatic drugs changed the dose within 8 weeks prior to baseline visit.
- •6.Patients treated with prohibited substances or prohibited therapy within 8 weeks prior to baseline visit.
- •7.Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and 6 months after the study period and lactating women. Men who will not be compliant with a contraceptive regimen during and 6 months after the study period.
- •8.Patients who jugged unsuitable for this study by the investigator.
研究者
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