Takayasu arteritis
Conditions
Interventions
Experimental group:the combination of glucocorticoids and ivarmacitinib
Control group:glucocorticoids
Sponsors
Zhongshan hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. meet the 2022 ACR/EULAR classification criteria for aortitis; 2. age 18-65 years and gender; 3. active patients: NIH score >= 2; 4. women with negative serum or urine pregnancy test results and no plans to have children during the clinical trial; 5. Pre-enrolment prednisone or equivalent dose not exceeding 0.8mg/kg/day, and this dose stable for at least 4 weeks; 6. patients receiving other medications for aortitis prior to enrolment, for azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, methotrexate, and cyclophosphamide need to be discontinued for >=4 weeks, and for leflunomide need to be discontinued for 11 days if elimination methods are used (kolexylenolamine or activated charcoal), or for >=8 weeks if no elimination methods are used; 7. For infliximab withdrawal of 49 days, adalimumab withdrawal of 28 days, etanercept withdrawal of 21 days, rituximab withdrawal of 12 months without B-lymphocyte depletion.
Exclusion criteria
Exclusion criteria: 1. presence of organ failure, meeting any of the following: (1) Cardiac function New York classification grade 4; (2) Glomerular filtration rate = 10 mg/day or equivalent doses of prednisone equivalents) during the study period; 6. have a history of malignancy; 7. any serious acute or chronic infection, including hepatitis B surface antigen positive, active tuberculosis; 8. abnormal laboratory tests fulfilling any of the following: (1) Subjects with serum ALT or AST >= 1.5 times the upper limit of normal; (2) Blood leukocyte count <= 3 x 10^9/L; (3) Platelet count <= 100 x 10^9/L; (4) Haemoglobin < 90 g/L; (6) Other laboratory test results that may pose an unacceptable risk to participating subjects; 9. Previous failure of regular treatment with other JAK inhibitors for 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate;Severe adverse event rate;Imaging findings;The clinical remission rate;The improvement situation of the ITAS2010 score; | — |
Countries
China
Contacts
Public ContactLindi Jiang
Zhongshan hospital, Fudan University
Outcome results
None listed