Takayasu arteritis,TAK
Conditions
Interventions
Ivarmacitinib treatment group:ivarmacitinib
Glucocorticoids therapy group:Glucocorticoid
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Fulfillment of the 2022 ACR/EULAR classification criteria for large-vessel vasculitis (Takayasu arteritis, TAK); 2.TAK patients assessed as having active disease according to the 2018 European League Against Rheumatism (EULAR) recommendations; 3.Treatment-naïve TAK patients or those with relapsed disease after prior therapy; 4. Patient age 18-70 years;
Exclusion criteria
Exclusion criteria: 1.Severe disease or involvement of critical organs requiring urgent or immediate surgical intervention; 2.Involvement of major organs, such as myocardial or coronary artery involvement, for which intensified or corresponding treatment is anticipated during the study period; 3.Active infections, including tuberculosis, hepatitis B virus, hepatitis C virus, HIV infection, bacterial or fungal infections (patients with latent tuberculosis infection may receive prophylactic anti-tuberculosis therapy at the time of enrollment); 4.History of malignancy within 5 years prior to enrollment, or presence of an active, unresolved malignancy at the time of enrollment; 5.Poorly controlled diabetes mellitus; 6.History of venous thromboembolism; 7.Upper gastrointestinal bleeding within 3 months prior to enrollment; 8.Poorly controlled heart failure at the time of enrollment; 9.Refractory hypertension; 10.Severe hepatic impairment, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); 11.Severe renal insufficiency (eGFR < 30 mL/min); 12.Pregnant women or those planning pregnancy during the study period; 13.Prior use of Janus kinase (JAK) inhibitors or interleukin-17A inhibitors, or biosimilars/agents of the same class; 14.Any other medical, psychiatric, and/or social conditions that, in the investigator’s opinion, may prevent the subject from completing the study or pose a significant risk to the subject;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse after remission;Count of blood cell;Remission rate;Liver function;Kidney function; | — |
Countries
China
Contacts
Public ContactXinping Tian
Peking Union Medical College Hospital
Outcome results
None listed