Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients
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About
The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
- Receipt of at least 1 infusion of teprotumumab for treatment of the TED.
- Obtained study specific informed consent form (ICF), if required.
Exclusion criteria
- Documentation of non-Chinese ethnicity.
Trial design
5 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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