A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Trough Serum Concentration (Ctrough) of TCZ at Steady State
研究概览
简要总结
This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GCA as classified according to protocol-specified criteria;
- •Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.
排除标准
- •Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
- •Evidence of serious uncontrolled disease;
- •Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
- •Active TB requiring treatment within the previous 3 years.
研究组 & 干预措施
TCZ IV Q4W
Participants will receive up to 6 doses of Dose 1 of TCZ IV Q4W followed by up to 6 doses of Dose 2 of TCZ IV Q4W.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Trough Serum Concentration (Ctrough) of TCZ at Steady State
时间窗: Baseline; Weeks 4, 8, 12, 16-24
Percentage of Participants With Adverse Events
时间窗: Baseline - Day 151
Maximum Serum Concentration (Cmax) of TCZ
时间窗: Baseline; Weeks 4, 8, 12, 16-24
Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State
时间窗: Baseline; Weeks 4, 8, 12, 16-24
次要结局
- Serum Concentration of Interleukin-6 (IL-6)(Baseline; Weeks 12, 16, 20, 24)
- Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)(Baseline; Weeks 12, 16, 20, 24)
- Serum Concentration of C-Reactive Protein (CRP)(Baseline; Weeks 4, 8, 12, 16-24)
- Erythrocyte Sedimentation Rate (ESR)(Baseline; Weeks 4, 8, 12, 16-24)