jRCT2080224883已完成2 期
A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)
Novartis Pharma. K.K.1 个研究点目标入组 260 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Double-blind, Placebo-controlled, Multicenter, Randomized, Pararell Group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Classification of Sjogren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017)
排除标准
- •Sjogren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness
结局指标
主要结局
Change in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score
Cohort 1
Change in EULAR Sjogren Syndrome Patient Reported Index (ESSPRI) score
Cohort 2
次要结局
未报告次要终点
研究者
研究点 (1)
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