Juvenile idiopathic arthritis complicated with macrophage activation syndrome
Conditions
Interventions
Traditional treatment group:Cyclosporin
Note: The initial study design included three groups (traditional treatment group, proactive tocilizumab treatment group, and delayed tocilizumab treatment grou
after January 21, 2024, the groups were revised to two (traditional treatment group and tocilizumab treatment group).
Tocilizumab active treatment group:Tocilizumab (Use on the fourth day)
Note: The initial study design included three groups (traditional treatment group, proactive tocilizumab treatment group, and del
Tocilizumab delayed treatment group:Tocilizumab (used two weeks after diagnosis)
Note: The initial study design included three groups (traditional treatment group, proactive tocilizumab treatment grou
Traditional treatment group:Cyclosporine
Note: This group represents the classification after the study protocol revision (enrollment period from January 21, 2024, until the end of the study)
the revised protocol divided participants into two groups (traditional treatment group and tocilizumab treatment group) with cases allocated in a 1:1 ratio.
Tociliz
Sponsors
Children's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Obtain an informed consent form signed by the patient's legal guardian and an informed consent form signed by the patient for children >= 8 years of age; 2. Age before randomization 2-16 years; 3. Diagnosis of sJIA, which meets the 2001 ILAR classification criteria or the 2018 PRINTO classification criteria for sJIA: Children with unexplained fever (excluding infections, tumors, autoimmune or monogenic autoimmune diseases), recurrent fever lasting for at least 2 weeks, accompanied by the following 2 main criteria or 1 main criterion+2 secondary criteria, including arthritis and reversible (unstable) erythematous rash; Secondary criteria included generalized lymphadenopathy and/or hepatomegaly and/or splenomegaly, serositis, duration of arthralgia > 2 weeks (without arthritis), and increased peripheral blood leukocytes (>= 15000/mm3). At the same time, the following conditions need to be excluded: patients with psoriasis and their first-degree relatives have a history of psoriasis, male arthritis patients older than 6 years old and HLA-B27 positive, ankylosing spondylitis or arthritis related to attachment point inflammation, or first-degree relatives have one of the above diseases and rheumatoid factor IgM positive with an interval of at least three months; 4. Meet the SJIA-MAS classification standard in 2005 or SJIA-MAS classification standard in 2016: children with persistent high fever, meet the ferritin > 684 ng/ml + any two items (platelet count 48 U/L, triglyceride > 156 mg/dl or fibrinogen <= 360 mg/ml), and exclude infection, tumor, etc.
Exclusion criteria
Exclusion criteria: 1. Patients with severe allergic reactions or transfusion reactions to biological agents; 2. There was an incurable active or recurrent infection before randomization; 3. Tuberculosis or latent tuberculosis infection; Clinical symptoms, radiological tests, and/or laboratory tests indicate tuberculosis infection; 4. Immunotherapy may cause immunosuppression of patients' underlying diseases (including metabolic, renal, liver, gastrointestinal, or infection), especially those with a history of multiple sclerosis or other demyelinating diseases; 5. Have a history of malignant tumors in any organ system that have been treated or have not been treated within the past 5 years; Or a malignant tumor that occurred 5 years before screening but is still active; 6. Significant QT interval prolongation; 7. Any person who is positive for HIV antibody, hepatitis B surface antigen, hepatitis C antibody or syphilis antibody during screening; 8. Patients who have used biological agents such as tocilizumab, infliximab, or IL-1 antagonists within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR Ped 30 response at 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| White blood cells/neutrophils;platelet;C-reactive protein;Serum ferritin;Aspartate transaminase/alanine transaminase;fibrinogen;triglyceride;cytokine; | — |
Countries
China
Contacts
Public ContactMeiping Lu
Children's Hospital, Zhejiang University School of Medicine
Outcome results
None listed