Thyroid Eye DiseaseNCT07085117
Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients
An observational study of Thyroid Eye Disease, run by Amgen at 1 site in China.
Trial summary
The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Teprotumumab
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2025to 10 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with TED that have received teprotumumab treatment in BOAO Pilot Zone.
Who may be able to join
- Receipt of at least 1 infusion of teprotumumab for treatment of the TED.
- Obtained study specific informed consent form (ICF), if required.
Who cannot join
- Documentation of non-Chinese ethnicity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Use, Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Treated in China BOAO Pilot Zone: A Retrospective Cohort Study
The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab.
Read the 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
- Being tested
- Teprotumumab
- Keywords
- Thyroid Eye Disease, Teprotumumab, TEPEZZA®
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeprotumumabDrug
Also called TEPEZZA®
Participants received teprotumumab as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Teprotumumab | Participants with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone. Receives: Drug: Teprotumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline up to approximately 3 years
Secondary outcomes (19)
Demographics of Participants at Teprotumumab Initiation
Demographics include age in years and sex (male, female, unknown).
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Body Mass Index at Index Date
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Smoking Status
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Disease Duration
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: TED Activity
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: TED Severity
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Eye symptoms
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Clinical Activity Score
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) Measurements
Measured: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Quality of Life
Measured: From baseline up to approximately 3 years
Number of Participants with Relevant Medical History at Teprotumumab Initiation
Medical history includes history of compressive optic neuropathy, hyperglycemia, inflammatory bowel disease (IBD), infusion reactions, and hearing impairment; therapeutic history for thyroid disease (Graves' disease or others) before teprotumumab administration; therapeutic history for TED before teprotumumab administration and complications if any; comorbidities; concomitant treatments; lab tests.
Measured: From baseline up to approximately 3 years
Teprotumumab Use
Teprotumumab use includes dose and dosing schedule, total number of infusions and duration, dose reduction and modification (including causes), treatment interruption and causes, time interval from interruption to re-initiation, and subsequent re-initiation treatment (if any), treatment discontinuation (including causes).
Measured: From baseline up to approximately 3 years
Proptosis Measurements of Participants
Proptosis measurements include all available proptosis measurements by eye for each participant and the change in proptosis measurement between baseline and the last infusion by eye.
Measured: From baseline up to approximately 3 years
Clinical Activity Scores (CAS) of Participants
CAS will include all available measures of CAS items by eye for each participant and the number of participants achieving CAS value of 0 or 1 as of the last infusion among patients with active TED at baseline.
Measured: From baseline up to approximately 3 years
Overall Response as of the Last Infusion Among Participants with Active TED
Overall response is defined as having ≥ 2-point reduction in CAS AND ≥ 2 mm reduction in proptosis from baseline in the most severely affected eye, provided there is no corresponding deterioration (≥ 2-point increase in CAS or ≥ 2 mm increase in proptosis) in the fellow eye following the last infusion.
Active TED is defined as CAS≥3 on a 7-point scale at baseline.
Measured: From baseline up to approximately 3 years
Diplopia Measurements for Participants
Diplopia measurements will include all available measures of diplopia for each participant, the binocular diplopia response as of the last infusion defined as having baseline binocular diplopia grade > 0 and a reduction of ≥ 1 grade between baseline and the last infusion, and complete diplopia response defined as having baseline binocular diplopia grade > 0 and achieving grade of 0 as of the last infusion.
Measured: From baseline up to approximately 3 years
Quality of Life (QoL) as Reported by Participants
All available participant-reported QoL for each participant, overall and at subscale level, and the change in QoL between baseline and the last infusion, overall and at subscale level.
Measured: From baseline up to approximately 3 years
Incidence of Adverse Events (AEs)
The incidence of AEs between the administration of the first dose and 30 days after the last dose of teprotumumab, including:
- Any AE
- Specific AEs, inclusive of infusion-related reactions, hyperglycemia, hearing impairment, and new onset or exacerbation of IBD
- Serious adverse event (SAE)
- AE leading to treatment discontinuation
- AE leading to death.
Measured: From baseline up to approximately 3 years
Status of Specific AEs up to 6 Months After Last Infusion of Teprotumumab
Specific AEs include infusion-related reactions, hyperglycemia, hearing impairment, and new onset or exacerbation of IBD.
Measured: From baseline up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start2 Jul 2025
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085117
- Sponsor's protocol ID
- 20240345
- Other IDs
- EUPAS1000000625
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Use, Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Treated in China BOAO Pilot Zone: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07085117
- Acronym / sponsor ID
- 20240345
- Conditions
- Thyroid Eye Disease
- Keywords
- Thyroid Eye Disease, Teprotumumab, TEPEZZA®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teprotumumab | – | Drug: TeprotumumabParticipants with Thyroid Eye Disease (TED) that have received teprotumumab treatment in BOAO Pilot Zone. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with TED that have received teprotumumab treatment in BOAO Pilot Zone.
Key inclusion criteria (2 listed)
- Receipt of at least 1 infusion of teprotumumab for treatment of the TED.
- Obtained study specific informed consent form (ICF), if required.
Key exclusion criteria (1 listed)
- Documentation of non-Chinese ethnicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeprotumumabAlso: TEPEZZA®Participants received teprotumumab as an intravenous (IV) infusion. | Drug | Teprotumumab |
Primary outcome
Number of Participants with Proptosis Response as of the Last IV Infusion Teprotumumab
Time frame: 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.
19 secondary outcomes
Demographics of Participants at Teprotumumab Initiation
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Body Mass Index at Index Date
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Smoking Status
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Disease Duration
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: TED Activity
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: TED Severity
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Eye symptoms
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Clinical Activity Score
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) Measurements
Time frame: From baseline up to approximately 3 years
Clinical Characteristics of Participants at Teprotumumab Initiation: Quality of Life
Time frame: From baseline up to approximately 3 years
Number of Participants with Relevant Medical History at Teprotumumab Initiation
Time frame: From baseline up to approximately 3 years
Teprotumumab Use
Time frame: From baseline up to approximately 3 years
Proptosis Measurements of Participants
Time frame: From baseline up to approximately 3 years
Clinical Activity Scores (CAS) of Participants
Time frame: From baseline up to approximately 3 years
Overall Response as of the Last Infusion Among Participants with Active TED
Time frame: From baseline up to approximately 3 years
Diplopia Measurements for Participants
Time frame: From baseline up to approximately 3 years
Quality of Life (QoL) as Reported by Participants
Time frame: From baseline up to approximately 3 years
Incidence of Adverse Events (AEs)
Time frame: From baseline up to approximately 3 years
Status of Specific AEs up to 6 Months After Last Infusion of Teprotumumab
Time frame: From baseline up to approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Eye Disease, run by Amgen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Proptosis Response as of the Last IV Infusion Teprotumumab (time frame: From baseline up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.