NCT07085117

Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients

Real World Use, Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Treated in China BOAO Pilot Zone: A Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab.

Detailed description

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.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	Teprotumumab	Participants received teprotumumab as an intravenous (IV) infusion.

Timeline

• Start date: 2025-07-02
• Primary completion: 2025-08-10
• Completion: 2025-08-10
• First posted: 2025-07-25
• Last updated: 2025-09-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study