UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061392 |
|---|---|
| Receipt number | R000069630 |
| Scientific Title | A multicenter retrospective cohort study on the efficacy and safety with teprotumumab versus intravenous glucocorticoid for thyroid eye disease |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/27 16:57:43 |
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Basic information
Public title
A multicenter retrospective cohort study on the efficacy and safety with teprotumumab versus intravenous glucocorticoid for thyroid eye disease
Acronym
A multicenter retrospective study of thyroid eye disease treated with teprotumumab versus glucocorticoid
Scientific Title
A multicenter retrospective cohort study on the efficacy and safety with teprotumumab versus intravenous glucocorticoid for thyroid eye disease
Scientific Title:Acronym
A multicenter retrospective study of thyroid eye disease treated with teprotumumab versus glucocorticoid
Region
| Japan |
Condition
Condition
Thyroid eye disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are no randomized controlled trials (RCTs) on the therapeutic effects of the novel treatment with teprotumumab and conventional treatment (steroid-pulse therapy) for active thyroid eye disease (TED), and no guidelines have been established for choosing between the two treatments. Therefore, the purpose of this study is to collect real-world data in Japan based on the medical records of patients with TED, and to clarify the differences in the efficacy and safety between the treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in exophthalmometry values evaluating using orbital MRI from baseline to 24 weeks after the treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with moderate to severe active TED based on the "Diagnostic Criteria and Treatment Guidelines for Thyroid Eye Disease 2023" (hereinafter referred to as the TED Treatment Guidelines) formulated by the Japan Thyroid Association and the Japan Endocrine Society, who have received tepromumab treatment or steroid pulse therapy, and who have been receiving treatment for at least 24 weeks since the start of treatment.
2. Patients who started treatment for TED between January 1, 2023 and March 31, 2026.
3. Patients who have undergone orbital MRI within 8 weeks prior to the start of treatment for active TED, and 12 weeks (8 weeks to 156 days) after the start of treatment, or/and 24 weeks (16 weeks to 31 weeks 6 days) after the start of treatment, or/and 48 weeks (32 weeks to 64 weeks).
4. Age: Must be an adult (18 years or older) at the start of TED treatment.
5. Sex: Not specified.
6. Inpatient/Outpatient: Not specified.
7. Nationality: Both parents must be Japanese citizens born in Japan, and the patient must be a Japanese citizen.
Key exclusion criteria
1. Patients with a history of external beam radiation therapy for TED, eyelid surgery, orbital decompression surgery, or strabismus surgery at baseline (start of TED treatment)
2. Patients with a history of local steroid injection into the eyelids or orbit within the past 8 weeks from baseline
3. Patients with a history of local botulinum toxin injection into the eyelids or extraocular muscles within the past 12 weeks from baseline
4. Patients with a history of high-dose steroid use (cumulative prednisolone equivalent > 1.5g) within the past 12 weeks from baseline, or steroid use (cumulative prednisolone equivalent > 0.5g) within the past 8 weeks
5. Patients with a history of rituximab, tocilizumab, satralizumab, batoclimab, fgaltigimod, or K1-70 administration during the data extraction period and prior to baseline
6. Patients currently participating in or who have participated in a teprotumumab clinical trial
7. Pregnant or lactating women at baseline or during the data extraction period
8. Patients with diseases involving abnormal IGF-1 secretion or action, such as growth hormone deficiency or acromegaly.
9. Patients who have expressed their refusal to participate in this study.
10. Other patients deemed unsuitable as research subjects by the principal investigator or staff member.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
horie@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
Homepage URL
horie@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197262
horie@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069630
