Adult-Onset Still’s disease (AOSD)
Conditions
Interventions
Control group:Glucocorticoids and immunosuppressive agents
Experimental group:Firsekibart, 200 mg, subcutaneous injection, once every 8 weeks.
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–75 years, diagnosed with AOSD according to the Yamaguchi criteria; 2.Patients are in "clinical remission," defined as: absence of fever (body temperature <= 37.5°C); absence of typical rash; swollen joint count (SJC) <= 1; normalization of C-reactive protein (CRP); 3.Received a stable dose of prednisone (or equivalent) of less than 10 mg/day for at least 8 weeks prior to screening to maintain remission.
Exclusion criteria
Exclusion criteria: 1.Disease activity or relapse within 4 weeks prior to randomization; 2.Current use (or use within 4 weeks) of other biologic agents or JAK inhibitors; 3.Severe infection, organ dysfunction, pregnancy, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of Firsekibart on maintaining remission, preventing relapse, safety, and improving quality of life.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving AOSD 50%/70%/90% improvement criteria;Changes in SF-36 score and fatigue VAS;Immunological mechanism outcomes: changes in peripheral blood immune cell subsets; inflammasome activity;Inflammatory storm-related biomarkers;Time to disease relapse;Adverse Events; | — |
Countries
China
Contacts
Public ContactRui Wu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed