Thyoid eye disease
Conditions
Interventions
Methylprednisolone group:Intravenous infusion of 500mg methylprednisolone for QOD in the first week, three times in total, and discontinuation of medication in the second to fourth weeks
The treatment plan for weeks 1-4 was repeated for weeks 5-8 and 9-12, with a total dose of 4.5g methylprednisolone and a total course of 12 weeks.
Teprotumumab group:At weeks 1/3/6/9/12/15/18/21, teprotumumab N01 was administered once (10mg/kg for the first time and 20mg/kg for each subsequent dose), for a total of 8 doses, for a total treatment
Combination therapy group:Intravenous infusion of methylprednisolone 250mg QOD in weeks 1/5/9, a total of 3 times, with a total methylprednisolone dose of 2.25g
intravenous infusion of teprotumumab N01 on days 7/28/49/70 (initial 10mg/kg, subsequent 20mg/kg each time), a total of 4 times
The total course of treatment is 12 weeks.
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 18-75 years old; Diagnosed with thyroid related eye disease (diagnostic criteria refer to the 2022 edition of the "Chinese Guidelines for Diagnosis and Treatment of Thyroid Related Eye Diseases"); Activity score: CAS score >= 3/7 or >=4/10 (refer to EUGOGO guidelines for CAS score); The severity is moderate to severe (according to the EUGOGO guidelines for severity staging); The duration of the disease should not exceed 1 year from the onset of symptoms or signs related to the eyes; Individuals who have not received any treatment related to thyroid eye disease (including glucocorticoids, immunosuppressants, biologics, surgery, radiation therapy, etc.) and have received a cumulative dose of oral glucocorticoids <= 1g methylprednisolone (or equivalent doses of other glucocorticoids) after a 6-week washout period may be included.
Exclusion criteria
Exclusion criteria: Received radioactive iodine treatment within six months; Suffering from other causes of optic neuropathy, acute or chronic hepatitis, acute or chronic liver and kidney dysfunction, malignant tumors, active tuberculosis, digestive ulcers or bleeding, severe osteoporosis, femoral head necrosis, severe infections, contraindications to the use of other glucocorticoids or immunosuppressive agents; Hearing impairment; Pregnant and preconception women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAS score;Exophthalmos; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Diplopia Score; | — |
Countries
China
Contacts
Public ContactMing Liu
Tianjin Medical University General Hospital
Outcome results
None listed