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Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.
The aim of this clinical study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAO |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with overall response | 1 week after the end of treatment | |
| Percentage of participants with overall response | 24 weeks after the end of treatment | |
| Percentage of participants with overall response | 52 weeks after the end of treatment | |
| Percentage of participants with overall response | 104 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) | Safety and Tolerability | 1 week after the end of treatment |
| Change of Serum Lipids parameters from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| change of extraocular muscle volume and orbital fat volume by MRI | 104 weeks after the end of treatment | |
| Change of Serum T-cell subgroup | including CD3(%)、CD3 absolute value、CD4(%)、CD4 absolute value、CD8(%)、CD8 absolute value、CD4/CD8(%) |
Inclusion Criteria:
Exclusion Criteria:
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Moderate to severe active TAO patients who receive medical treatment and assessment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuo Dr. Li, Vice Professor | Contact | +86-13918507887 | dr.lituo@smmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34252869 | Background | Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3. | |
| 34007271 | Background |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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serum
including TG(mmol/L)、TC(mmol/L)、HDL(mmol/L)、LDL(mmol/L)
| 104 weeks after the end of treatment |
| Change of Serum T3、T4 level from baseline | including T3(nmol/L)、T4(nmol/L) | 104 weeks after the end of treatment |
| Change of Serum TSH level from baseline | including TSH(mIU/L) | 104 weeks after the end of treatment |
| Change of Serum FT3、FT4 level from baseline | including FT3(pmol/L)、FT4(pmol/L) | 104 weeks after the end of treatment |
| Change of Serum TRAb from baseline | including TRAb(IU/l) | 104 weeks after the end of treatment |
| 1 week after the end of treatment |
| Change of Serum T-cell subgroup | including CD3(%)、CD3 absolute value、CD4(%)、CD4 absolute value、CD8(%)、CD8 absolute value、CD4/CD8(%) | 104 weeks after the end of treatment |
| change of extraocular muscle volume and orbital fat volume by MRI | 4 weeks after the end of treatment |
| Cevik Y, Taylan Sekeroglu H, Ozgen B, Erkan Turan K, Sanac AS. Clinical and Radiological Findings in Patients with Newly Diagnosed Graves' Ophthalmopathy. Int J Endocrinol. 2021 Apr 30;2021:5513008. doi: 10.1155/2021/5513008. eCollection 2021. |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |