NCT05805891招募中不适用
An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis
Chinese SLE Treatment And Research Group1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- DAS28 remission or LDA at week 24
研究概览
简要总结
This is a single-center, single-arm, prospective study on the efficacy and safety of Bortezomib in addition to standard therapy in patients with refractory rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18~70 years.
- •Fulfilling the 2010 ACR/EULAR classification criteria for RA.
- •Failed to at least two bDMARDs (including but not limited to TNF inhibitors, IL-6 receptor inhibitors, T cell costimulation inhibitor and anti-B cell biologics) or tsDMARDs (including but not limited to JAK inhibitors) in combination with a csDMARD for at least 12 weeks. The dosage of cs/b/tsDMARDs needs to be stable for at least 6 weeks.
- •For patients receiving glucocorticoids, the dosage of GC needs to be less than or equal to 10mg prednisone equivalent and stable for at least 6 weeks.
- •For patients receiving non-steroid anti-inflammatory drugs, the dosage of NSAID needs to be stable for at least 2 weeks.
- •Neutrophil≥1.0×10^9/L, platelet≥100×10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) within 3 ULN, total bilirubin within 1.5 ULN.
- •Informed consent obtained.
排除标准
- •Other concomitant autoimmune diseases (except for Sjogren's syndrome secondary to rheumatoid arthritis).
- •The presence of severe uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neuropsychiatric disorders, or abnormal laboratory tests. The investigators consider that participation in the study may make unacceptable risks to the subjects.
- •A history of malignancy with a clinical cure time of less than 5 years.
- •Pregnant or breast-feeding women, or planning to get pregnant or start breastfeeding during the study.
- •Vaccinated with live attenuated virus within 4 weeks before entering the study.
- •Allergic to bortezomib or mannitol.
- •Participated in any other investigational drug trial within 12 weeks before study initiation.
- •Active hepatitis or liver disease at the time of screening: Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb) positive; (Note: If Hepatitis B Core Antibody, (HBcAb) is positive and HBsAg is negative, HBV-DNA detection will be performed, patient is eligible if HBV-DNA was negative).
- •Active herpes zoster infection, or severe infection requiring intravenous antibiotics or hospitalization occurred 12 weeks before study initiation.
- •Other conditions that not suitable for inclusion in the study, assessed by the investigators.
研究组 & 干预措施
bortezomib
Experimental
bortezomib added on previous treatment
干预措施: bortezomib (Drug)
结局指标
主要结局
DAS28 remission or LDA at week 24
时间窗: 24 weeks
Proportion of patients who achieve remission or low disease activity (LDA) at week 24 according to DAS 28.
次要结局
- DAS28 improvement at week 12(12 weeks)
- SDAI improvement at week 12 and remission or LDA at week 24(24 weeks)
- CDAI improvement at week 12 and remission or LDA at week 24(24 weeks)
- ACR20, ACR50 and ACR70 at week 12 and week 24(24 weeks)
- Changes in glucocorticoid dose(24 weeks)
- Adverse events during the study(28 weeks)
研究者
研究点 (1)
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