A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Clinical Response
研究概览
简要总结
The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED).
The main question it aims to answer is:
* Is a shorter course equally effective and safe for patients who respond well early in treatment.
Participants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).
- •Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.
- •Participants must demonstrate a significant clinical response by the 4th infusion.
- •Ability to understand and provide signed written informed consent.
排除标准
- •Previous use of Teprotumumab or other biologic therapies for TED.
- •Participants who do not show early clinical response after the 4th infusion.
- •Participants who have any medical contraindications to Teprotumumab or any of its components.
- •Participants who have any known hearing problems.
研究组 & 干预措施
Standard of Care
Participants in this arm will receive the full standard-of-care course of Teprotumumab. This consists of a total of 8 intravenous (IV) infusions.
干预措施: Teprotumumab Injection [Tepezza] (Drug)
Shortened Treatment
Participants in this arm will receive a shortened course of Teprotumumab. After demonstrating an "Early Optimal Clinical Response" following the first 4 infusions, treatment will be discontinued. These participants will receive a total of 4 intravenous (IV) infusions instead of the standard 8.
干预措施: Teprotumumab Injection [Tepezza] (Drug)
结局指标
主要结局
Clinical Response
时间窗: 1 year
Defined as a reduction of 2 or more points in the Clinical Activity Score (CAS), improvement in diplopia and exophthalmos.
次要结局
未报告次要终点
研究者
Prof. Landau Prat Daphna
Oculoplastic and Orbital surgeon
Sheba Medical Center