Refractory Graves' disease.
Conditions
Interventions
Tocilizumab combined with ATD Group:Tocilizumab combined with ATD
ATD treatment group:ATD treatment
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Regular use of Antithyroid agent (ATD) for at least 2 years. 2.The TSHR antibody (TRAb) has not turned negative, with TRAb >=3 IU/L. 3.Age 18-65. 4.Voluntary participation in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Factors that may affect thyroid function and the immune state of the body, including various autoimmune diseases, liver and kidney dysfunction, infections, pregnancy, tumors, aids, and the use of sex hormones and lithium, recent use of immunosuppressants. 2.Chromosomal disorders, including Down syndrome and Turner syndrome, are known to be associated with an increased risk of autoimmune thyroid disease. 3.Pregnancy, planned pregnancy during the trial or current breastfeeding. 4.Patients with severe chronic cardiac, respiratory, or renal disease or non-autoimmune liver disease. 5.Patients with known allergy or contraindications to tocilizumab. 6.Active hepatitis, tuberculosis, with definite bacterial and fungal infections. 7.Patients with active hyperthyroid ophthalmopathy combined with CAS score >=3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TRAb seroconversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume of thyroid gland;ThyPRO-39;Blood routine;TPOAb?TgAb;FT3?FT4?TSH;Liver function and blood lipid;TSI seroconversion rate;IL-6; | — |
Countries
China
Contacts
Public ContactXuqin Zheng
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed