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

NCT07085117 | Completed FDA Drug

• 2 other identifiers: 20240345EUPAS1000000625
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Eye Disease

Keywords

Thyroid Eye Disease; Teprotumumab; TEPEZZA®

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Proptosis Response as of the Last IV Infusion Teprotumumab

  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.

  From baseline up to approximately 3 years

Secondary Outcomes (19)

• 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

Study Arms (1)

Teprotumumab

Participants with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone.

Drug: Teprotumumab

Interventions

Teprotumumab DRUG

Participants received teprotumumab as an intravenous (IV) infusion.

Also known as: TEPEZZA®

Teprotumumab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with TED that have received teprotumumab treatment in BOAO Pilot Zone.

You may qualify if:

• Receipt of at least 1 infusion of teprotumumab for treatment of the TED.
• Obtained study specific informed consent form (ICF), if required.

You may not qualify if:

• Documentation of non-Chinese ethnicity.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Boao Vanguard Hospital

Qionghai, Hainan, 571400, China

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

teprotumumab

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 25, 2025
• Study Start: July 2, 2025
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CN (1)