Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone: a Randomized, Multicenter, Adaptive, Blinded, Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Absence of a major relapse from randomization to 52 weeks
研究概览
简要总结
The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis
- with tocilizumab,
- while using less cortisone.
详细描述
The aim of this randomized clinical trial investigates whether 1) a shortened GC 8-week regimen is as effective as the current 26-week regimen and 2) associated with less GC exposure when introducing a GC-sparing agent in the treatment of GCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with giant cell arteritis
- •Start of tocilizumab treatment at baseline as part of routine clinical practice
- •Receive ≥ 20 mg/day prednisone (or equivalent) at baseline
- •Written informed consent
排除标准
- •Treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.
研究组 & 干预措施
8 weeks glucocorticoid
8 weeks glucocorticoid taper
干预措施: Prednisone (Drug)
26 weeks glucocorticoid
26 weeks glucocorticoid taper
干预措施: Prednisone (Drug)
结局指标
主要结局
Absence of a major relapse from randomization to 52 weeks
时间窗: 52 weeks
Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.
Cumulative glucocorticoid exposure from randomization to 52 weeks
时间窗: 52 weeks
Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.
次要结局
未报告次要终点