Real World Use, Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Treated in China BOAO Pilot Zone: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants with Proptosis Response as of the Last IV Infusion Teprotumumab
研究概览
简要总结
The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab.
详细描述
A retrospective cohort will be followed retrospectively for endpoints at the only facility providing treatment of teprotumumab in mainland China. Eligible participants' data were collected retrospectively over a period of approximately 3 years. The target population is patients with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone. While the primary objective is to assess the proportion of patients with proptosis response as of the last intravenous infusion of teprotumumab, the secondary objectives are to describe baseline characteristics of patients at teprotumumab initiation, and the teprotumumab use at follow-up, to describe real-world effectiveness of clinical outcomes of interest, to describe patient-reported outcomes and to describe real-world safety of teprotumumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receipt of at least 1 infusion of teprotumumab for treatment of the TED.
- •Obtained study specific informed consent form (ICF), if required.
排除标准
- •Documentation of non-Chinese ethnicity.
研究组 & 干预措施
Teprotumumab
Participants with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone.
干预措施: Teprotumumab (Drug)
结局指标
主要结局
Number of Participants with Proptosis Response as of the Last IV Infusion Teprotumumab
时间窗: From baseline up to approximately 3 years
Proptosis response is defined as having a ≥ 2 mm reduction in proptosis measurement from baseline in the more severely affected eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye following the last infusion.
次要结局
- Demographics of Participants at Teprotumumab Initiation(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Body Mass Index at Index Date(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Smoking Status(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Disease Duration(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: TED Activity(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: TED Severity(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Eye symptoms(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Clinical Activity Score(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) Measurements(From baseline up to approximately 3 years)
- Clinical Characteristics of Participants at Teprotumumab Initiation: Quality of Life(From baseline up to approximately 3 years)
- Number of Participants with Relevant Medical History at Teprotumumab Initiation(From baseline up to approximately 3 years)
- Teprotumumab Use(From baseline up to approximately 3 years)
- Proptosis Measurements of Participants(From baseline up to approximately 3 years)
- Clinical Activity Scores (CAS) of Participants(From baseline up to approximately 3 years)
- Overall Response as of the Last Infusion Among Participants with Active TED(From baseline up to approximately 3 years)
- Diplopia Measurements for Participants(From baseline up to approximately 3 years)
- Quality of Life (QoL) as Reported by Participants(From baseline up to approximately 3 years)
- Incidence of Adverse Events (AEs)(From baseline up to approximately 3 years)
- Status of Specific AEs up to 6 Months After Last Infusion of Teprotumumab(From baseline up to approximately 3 years)