Study Complete
Sponsor ID
20240345

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

Sponsor ID
20240345
Clinicaltrials.gov ID
NCT07085117
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
5
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: From baseline up to approximately 3 years

Secondary Outcome Measures

Demographics of Participants at Teprotumumab Initiation

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Body Mass Index at Index Date

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Smoking Status

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Disease Duration

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: TED Activity

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: TED Severity

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Eye symptoms

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Clinical Activity Score

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) Measurements

Timeframe: From baseline up to approximately 3 years

Clinical Characteristics of Participants at Teprotumumab Initiation: Quality of Life

Timeframe: From baseline up to approximately 3 years

Number of Participants with Relevant Medical History at Teprotumumab Initiation

Timeframe: From baseline up to approximately 3 years

Teprotumumab Use

Timeframe: From baseline up to approximately 3 years

Proptosis Measurements of Participants

Timeframe: From baseline up to approximately 3 years

Clinical Activity Scores (CAS) of Participants

Timeframe: From baseline up to approximately 3 years

Overall Response as of the Last Infusion Among Participants with Active TED

Timeframe: From baseline up to approximately 3 years

Diplopia Measurements for Participants

Timeframe: From baseline up to approximately 3 years

Quality of Life (QoL) as Reported by Participants

Timeframe: From baseline up to approximately 3 years

Incidence of Adverse Events (AEs)

Timeframe: From baseline up to approximately 3 years

Status of Specific AEs up to 6 Months After Last Infusion of Teprotumumab

Timeframe: From baseline up to approximately 3 years

Locations

Location
Status
Contact Us
Location
Boao Vanguard Hospital
Qionghai, Hainan, China, 571400
Status
N/A