Uses of Baricetinib 4 mg or 2mg Versus MMF to Maintain Lupus Remission Randomized Controlled Trial: Outcomes Over 2 Years
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- proteins creatinine ratio
研究概览
简要总结
Baricitinib a selective Janus kinase (JAK) inhibitors 1&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date.
详细描述
Baricitinib a selective Janus kinase (JAK) inhibitors 1&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date. Objectives: To assess the efficacy and safety of Baricitinib in patients (pts) with LN by dose 4mg versus 2 mg versus MMF 1 gm daily dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
participant and investigator and outcome assessor
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Lupus nephritis Disease
- •Must be able to swallow tablets
- •lupus nephritis in remission
排除标准
- •antiphospholipid syndrome disease
- •thrombosis history
- •sever anemia, leukopenia or thrombocytopenia
- •impaired liver and renal function
研究组 & 干预措施
Baricetinib 4 mg
4 mg oral tablet daily
干预措施: Baricitinib 4 MG (Drug)
Baricetinib 2 mg
2 mg oral tablet daily
干预措施: Baricitinib 2 MG (Drug)
MMF
MMF 500 mg tablet twice daily
干预措施: MMF (Drug)
结局指标
主要结局
proteins creatinine ratio
时间窗: 1 year
nephritis
次要结局
- complement 3(1 year)
- anti ds DNA(1 year)
- ANA(1 year)
研究者
Manal Hassanien
Associate Professor
Assiut University